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Trial record 1 of 1 for:    B7451013
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Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis (JADE Mono-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03575871
Recruitment Status : Completed
First Posted : July 3, 2018
Results First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dermatitis, Atopic
Interventions Drug: PF-04965842 100 mg
Drug: PF-04965842 200 mg
Drug: Placebo
Enrollment 391
Recruitment Details Participants with age greater than or equal to (>=) 12 years with moderate to severe atopic dermatitis (AD) and a body weight of >=40 kilograms were enrolled in the study. Eligible participants had an option to enter into a long-term extension (LTE) study after completing 12 weeks of treatment in this study.
Pre-assignment Details This study was conducted from 29-June-2018 to 13-Aug-2019 at 106 sites in 13 countries.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug. Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug. Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Period Title: Overall Study
Started 158 155 78
Completed 137 141 52
Not Completed 21 14 26
Reason Not Completed
Adverse Event             5             5             8
Death             1             0             0
Lack of Efficacy             5             4             7
Lost to Follow-up             1             1             1
Protocol Deviation             1             1             1
Withdrawal by Subject             6             1             9
Other than specified             2             2             0
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo Total
Hide Arm/Group Description Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug. Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug. Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug. Total of all reporting groups
Overall Number of Baseline Participants 158 155 78 391
Hide Baseline Analysis Population Description
The full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 158 participants 155 participants 78 participants 391 participants
37.4  (15.8) 33.5  (14.7) 33.4  (13.8) 35.1  (15.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants 155 participants 78 participants 391 participants
Female
64
  40.5%
67
  43.2%
31
  39.7%
162
  41.4%
Male
94
  59.5%
88
  56.8%
47
  60.3%
229
  58.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants 155 participants 78 participants 391 participants
Hispanic or Latino
3
   1.9%
4
   2.6%
2
   2.6%
9
   2.3%
Not Hispanic or Latino
154
  97.5%
150
  96.8%
73
  93.6%
377
  96.4%
Unknown or Not Reported
1
   0.6%
1
   0.6%
3
   3.8%
5
   1.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 158 participants 155 participants 78 participants 391 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
46
  29.1%
54
  34.8%
29
  37.2%
129
  33.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
   5.7%
6
   3.9%
6
   7.7%
21
   5.4%
White
101
  63.9%
91
  58.7%
40
  51.3%
232
  59.3%
More than one race
1
   0.6%
2
   1.3%
1
   1.3%
4
   1.0%
Unknown or Not Reported
1
   0.6%
2
   1.3%
2
   2.6%
5
   1.3%
1.Primary Outcome
Title Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12
Hide Description IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 155 155 77
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
28.4
(21.3 to 35.5)
38.1
(30.4 to 45.7)
9.1
(2.7 to 15.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 19.3
Confidence Interval (2-Sided) 95%
9.6 to 29.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 28.7
Confidence Interval (2-Sided) 95%
18.6 to 38.8
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75 Percent (%) Improvement (EASI-75) From Baseline at Week 12
Hide Description EASI evaluates severity of participants AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks] on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 155 154 77
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
44.5
(36.7 to 52.3)
61.0
(53.3 to 68.7)
10.4
(3.6 to 17.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 33.9
Confidence Interval (2-Sided) 95%
23.3 to 44.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 50.5
Confidence Interval (2-Sided) 95%
40.0 to 60.9
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12
Hide Description Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.
Time Frame Baseline, Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 156 153 76
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
23.1
(16.5 to 29.7)
35.3
(27.7 to 42.9)
3.9
(0.0 to 8.3)
Week 4
31.4
(24.1 to 38.7)
50.3
(42.4 to 58.2)
3.9
(0.0 to 8.3)
Week 8
39.1
(31.4 to 46.8)
51.6
(43.7 to 59.6)
11.8
(4.6 to 19.1)
Week 12
39.7
(32.1 to 47.4)
49.0
(41.1 to 56.9)
10.5
(3.6 to 17.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 19.2
Confidence Interval (2-Sided) 95%
11.0 to 27.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 31.2
Confidence Interval (2-Sided) 95%
22.3 to 40.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 27.5
Confidence Interval (2-Sided) 95%
18.9 to 36.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 46.4
Confidence Interval (2-Sided) 95%
37.2 to 55.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 27.4
Confidence Interval (2-Sided) 95%
16.8 to 38.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 39.8
Confidence Interval (2-Sided) 95%
28.9 to 50.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 29.3
Confidence Interval (2-Sided) 95%
18.9 to 39.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 38.6
Confidence Interval (2-Sided) 95%
28.1 to 49.1
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 12
Hide Description PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 156 155 77
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.4
(-2.8 to -2.1)
-3.0
(-3.3 to -2.7)
-0.8
(-1.3 to -0.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-2.3 to -1.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-2.8 to -1.6
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale (NRS) for Severity of Pruritus
Hide Description Participants were asked to assess their worst itching/pruritus due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst itch imaginable), where higher scores indicated greater severity.
Time Frame Baseline up to Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 90 110 20
Median (Inter-Quartile Range)
Unit of Measure: days
58.0 [1] 
(11.0 to NA)
29.0
(8.0 to 87.0)
112.0 [1] 
(58.0 to NA)
[1]
Upper limit was not evaluable as too few events were observed.
6.Secondary Outcome
Title Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement (EASI-75) From Baseline at Weeks 2, 4 and 8
Hide Description EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies the number of participants evaluable at specified time points.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 158 155 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 Number Analyzed 157 participants 152 participants 76 participants
10.2
(5.5 to 14.9)
24.3
(17.5 to 31.2)
1.3
(0.0 to 3.9)
Week 4 Number Analyzed 155 participants 153 participants 77 participants
26.5
(19.5 to 33.4)
51.0
(43.1 to 58.9)
6.5
(1.0 to 12.0)
Week 8 Number Analyzed 157 participants 154 participants 78 participants
43.3
(35.6 to 51.1)
60.4
(52.7 to 68.1)
12.8
(5.4 to 20.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0150
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 8.8
Confidence Interval (2-Sided) 95%
2.8 to 14.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 22.7
Confidence Interval (2-Sided) 95%
15.0 to 30.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 20.0
Confidence Interval (2-Sided) 95%
10.9 to 29.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 44.3
Confidence Interval (2-Sided) 95%
34.8 to 53.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 30.4
Confidence Interval (2-Sided) 95%
19.7 to 41.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 47.4
Confidence Interval (2-Sided) 95%
36.8 to 58.0
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Weeks 2, 4 and 8
Hide Description IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.
Time Frame Baseline, Weeks 2, 4, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies the number of participants evaluable at specified time points.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 158 155 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 Number Analyzed 157 participants 152 participants 76 participants
5.1
(1.7 to 8.5)
14.5
(8.9 to 20.1)
0
(0.0 to 4.7)
Week 4 Number Analyzed 155 participants 153 participants 77 participants
14.2
(8.7 to 19.7)
33.3
(25.9 to 40.8)
1.3
(0.0 to 3.8)
Week 8 Number Analyzed 157 participants 154 participants 78 participants
22.3
(15.8 to 28.8)
37.7
(30.0 to 45.3)
10.3
(3.5 to 17.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0459
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 5.1
Confidence Interval (2-Sided) 95%
0.2 to 10.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 14.2
Confidence Interval (2-Sided) 95%
7.8 to 20.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 12.9
Confidence Interval (2-Sided) 95%
6.3 to 19.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 31.8
Confidence Interval (2-Sided) 95%
23.6 to 39.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0246
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 11.9
Confidence Interval (2-Sided) 95%
2.4 to 21.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 26.9
Confidence Interval (2-Sided) 95%
17.0 to 36.9
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) at Week 2, 4, 8 and 12
Hide Description IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp.
Time Frame Weeks 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 158 155 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 Number Analyzed 157 participants 152 participants 76 participants
0
(0.0 to 2.3)
2.0
(0.0 to 4.2)
0
(0.0 to 4.7)
Week 4 Number Analyzed 155 participants 153 participants 77 participants
1.9
(0.0 to 4.1)
4.6
(1.3 to 7.9)
0
(0.0 to 4.7)
Week 8 Number Analyzed 157 participants 154 participants 78 participants
1.3
(0.0 to 3.0)
4.5
(1.3 to 7.8)
0
(0.0 to 4.6)
Week 12 Number Analyzed 155 participants 155 participants 77 participants
5.2
(1.7 to 8.6)
6.5
(2.6 to 10.3)
0
(0.0 to 4.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-3.7 to 3.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2262
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
-2.2 to 6.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2223
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
-2.2 to 6.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0597
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 4.5
Confidence Interval (2-Sided) 95%
-0.2 to 9.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3207
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-2.7 to 5.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0586
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 4.5
Confidence Interval (2-Sided) 95%
-0.2 to 9.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0419
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 5.2
Confidence Interval (2-Sided) 95%
0.3 to 10.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0244
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 6.3
Confidence Interval (2-Sided) 95%
1.2 to 11.4
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement (EASI-50) From Baseline at Weeks 2, 4, 8 and 12
Hide Description EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 158 155 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 Number Analyzed 157 participants 152 participants 76 participants
35.7
(28.2 to 43.2)
55.3
(47.4 to 63.2)
10.5
(3.6 to 17.4)
Week 4 Number Analyzed 155 participants 153 participants 77 participants
58.7
(51.0 to 66.5)
78.4
(71.9 to 84.9)
28.6
(18.5 to 38.7)
Week 8 Number Analyzed 157 participants 154 participants 78 participants
66.2
(58.8 to 73.6)
82.5
(76.5 to 88.5)
34.6
(24.1 to 45.2)
Week 12 Number Analyzed 155 participants 154 participants 77 participants
68.4
(61.1 to 75.7)
79.9
(73.5 to 86.2)
19.5
(10.6 to 28.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 25.0
Confidence Interval (2-Sided) 95%
14.8 to 35.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 44.2
Confidence Interval (2-Sided) 95%
33.9 to 54.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 30.2
Confidence Interval (2-Sided) 95%
17.5 to 42.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 49.8
Confidence Interval (2-Sided) 95%
37.8 to 61.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 31.5
Confidence Interval (2-Sided) 95%
18.8 to 44.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 47.6
Confidence Interval (2-Sided) 95%
35.7 to 59.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 48.7
Confidence Interval (2-Sided) 95%
37.2 to 60.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 60.1
Confidence Interval (2-Sided) 95%
49.1 to 71.0
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement (EASI-90) From Baseline at Weeks 2, 4, 8 and 12
Hide Description EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 158 155 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 Number Analyzed 157 participants 152 participants 76 participants
2.5
(0.1 to 5.0)
9.2
(4.6 to 13.8)
0
(0.0 to 4.7)
Week 4 Number Analyzed 155 participants 153 participants 77 participants
9.7
(5.0 to 14.3)
22.9
(16.2 to 29.5)
0
(0.0 to 4.7)
Week 8 Number Analyzed 157 participants 154 participants 78 participants
17.2
(11.3 to 23.1)
34.4
(26.9 to 41.9)
2.6
(0.0 to 6.1)
Week 12 Number Analyzed 155 participants 154 participants 77 participants
23.9
(17.2 to 30.6)
37.7
(30.0 to 45.3)
3.9
(0.0 to 8.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1623
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
-1.7 to 6.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0070
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 9.1
Confidence Interval (2-Sided) 95%
3.4 to 14.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0049
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 9.7
Confidence Interval (2-Sided) 95%
4.0 to 15.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 22.9
Confidence Interval (2-Sided) 95%
15.5 to 30.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 14.6
Confidence Interval (2-Sided) 95%
7.2 to 22.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 31.6
Confidence Interval (2-Sided) 95%
23.1 to 40.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 20.1
Confidence Interval (2-Sided) 95%
11.9 to 28.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 33.5
Confidence Interval (2-Sided) 95%
24.6 to 42.5
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement (EASI-100) From Baseline at Weeks 2, 4, 8 and 12
Hide Description EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 158 155 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 Number Analyzed 157 participants 152 participants 76 participants
0
(0.0 to 2.3)
1.3
(0.0 to 3.1)
0
(0.0 to 4.7)
Week 4 Number Analyzed 155 participants 153 participants 77 participants
1.3
(0.0 to 3.1)
3.9
(0.8 to 7.0)
0
(0.0 to 4.7)
Week 8 Number Analyzed 157 participants 154 participants 78 participants
1.3
(0.0 to 3.0)
3.9
(0.8 to 7.0)
0
(0.0 to 4.6)
Week 12 Number Analyzed 155 participants 154 participants 77 participants
5.2
(1.7 to 8.6)
7.1
(3.1 to 11.2)
0
(0.0 to 4.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-3.7 to 3.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3261
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-2.8 to 5.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3207
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-2.7 to 5.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0810
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 3.9
Confidence Interval (2-Sided) 95%
-0.8 to 8.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3207
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-2.7 to 5.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0810
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 3.8
Confidence Interval (2-Sided) 95%
-0.7 to 8.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0419
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 5.2
Confidence Interval (2-Sided) 95%
0.3 to 10.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0180
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 7.0
Confidence Interval (2-Sided) 95%
1.8 to 12.2
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 8 and 12
Hide Description EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 158 155 78
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
Change at Week 2
-39.2
(-43.8 to -34.7)
-51.3
(-55.9 to -46.7)
-9.0
(-15.4 to -2.5)
Change at Week 4
-54.3
(-59.1 to -49.5)
-69.0
(-73.7 to -64.2)
-24.4
(-31.1 to -17.7)
Change at Week 8
-59.5
(-65.0 to -54.0)
-73.2
(-78.7 to -67.7)
-33.0
(-41.1 to -25.0)
Change at Week 12
-60.0
(-66.5 to -53.6)
-73.3
(-79.7 to -66.9)
-28.6
(-38.4 to -18.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -30.2
Confidence Interval (2-Sided) 95%
-38.1 to -22.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -42.3
Confidence Interval (2-Sided) 95%
-50.3 to -34.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -29.9
Confidence Interval (2-Sided) 95%
-38.1 to -21.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -44.6
Confidence Interval (2-Sided) 95%
-52.8 to -36.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -26.4
Confidence Interval (2-Sided) 95%
-36.2 to -16.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -40.2
Confidence Interval (2-Sided) 95%
-50.0 to -30.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -31.4
Confidence Interval (2-Sided) 95%
-43.1 to -19.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -44.7
Confidence Interval (2-Sided) 95%
-56.4 to -33.0
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in the Percentage Body Surface Area (%BSA) Affected at Week 2, 4, 8, and 12
Hide Description 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
Time Frame Baseline, Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 158 155 78
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage of BSA
Change at Week 2
-27.8
(-33.0 to -22.6)
-35.4
(-40.6 to -30.2)
-1.3
(-8.7 to 6.0)
Change at Week 4
-45.0
(-50.4 to -39.6)
-55.7
(-61.1 to -50.3)
-15.3
(-22.9 to -7.7)
Change at Week 8
-53.4
(-60.0 to -46.8)
-61.1
(-67.7 to -54.5)
-20.5
(-30.1 to -10.9)
Change at Week 12
-56.4
(-63.1 to -49.6)
-65.0
(-71.7 to -58.3)
-16.8
(-26.9 to -6.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -26.5
Confidence Interval (2-Sided) 95%
-35.5 to -17.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -34.1
Confidence Interval (2-Sided) 95%
-43.1 to -25.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -29.7
Confidence Interval (2-Sided) 95%
-39.0 to -20.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -40.5
Confidence Interval (2-Sided) 95%
-49.8 to -31.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -32.9
Confidence Interval (2-Sided) 95%
-44.6 to -21.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -40.6
Confidence Interval (2-Sided) 95%
-52.2 to -28.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -39.6
Confidence Interval (2-Sided) 95%
-51.8 to -27.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -48.2
Confidence Interval (2-Sided) 95%
-60.4 to -36.0
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants With Percentage Body Surface Area (%BSA) (From EASI) < 5% at Weeks 2, 4, 8 and 12
Hide Description 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limb, 3.33% for trunk and 2.5% for lower limb. % BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
Time Frame Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 158 155 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 Number Analyzed 157 participants 152 participants 76 participants
1.9
(0.0 to 4.1)
5.9
(2.2 to 9.7)
0
(0.0 to 4.7)
Week 4 Number Analyzed 155 participants 153 participants 77 participants
6.5
(2.6 to 10.3)
17.0
(11.0 to 22.9)
0
(0.0 to 4.7)
Week 8 Number Analyzed 157 participants 154 participants 78 participants
15.9
(10.2 to 21.6)
27.3
(20.2 to 34.3)
1.3
(0.0 to 3.8)
Week 12 Number Analyzed 155 participants 154 participants 77 participants
22.6
(16.0 to 29.2)
34.4
(26.9 to 41.9)
3.9
(0.0 to 8.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2353
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
-2.2 to 6.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0332
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 5.8
Confidence Interval (2-Sided) 95%
0.8 to 10.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0227
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 6.5
Confidence Interval (2-Sided) 95%
1.4 to 11.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 16.8
Confidence Interval (2-Sided) 95%
10.1 to 23.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 14.5
Confidence Interval (2-Sided) 95%
7.7 to 21.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 25.8
Confidence Interval (2-Sided) 95%
18.1 to 33.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 18.5
Confidence Interval (2-Sided) 95%
10.5 to 26.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 30.2
Confidence Interval (2-Sided) 95%
21.4 to 39.0
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8 and 12
Hide Description SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
Time Frame Baseline, Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 158 155 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 Number Analyzed 157 participants 152 participants 76 participants
12.7
(7.5 to 18.0)
32.9
(25.4 to 40.4)
0
(0.0 to 4.7)
Week 4 Number Analyzed 155 participants 153 participants 77 participants
36.1
(28.6 to 43.7)
60.8
(53.0 to 68.5)
7.8
(1.8 to 13.8)
Week 8 Number Analyzed 157 participants 154 participants 78 participants
43.3
(35.6 to 51.1)
61.7
(54.0 to 69.4)
15.4
(7.4 to 23.4)
Week 12 Number Analyzed 155 participants 155 participants 78 participants
49.0
(41.2 to 56.9)
62.6
(55.0 to 70.2)
12.8
(5.4 to 20.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 12.7
Confidence Interval (2-Sided) 95%
6.5 to 18.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 32.6
Confidence Interval (2-Sided) 95%
24.6 to 40.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 28.3
Confidence Interval (2-Sided) 95%
18.5 to 38.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 52.8
Confidence Interval (2-Sided) 95%
43.2 to 62.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 28.0
Confidence Interval (2-Sided) 95%
17.0 to 39.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 46.1
Confidence Interval (2-Sided) 95%
35.2 to 57.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 36.2
Confidence Interval (2-Sided) 95%
25.4 to 47.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 49.6
Confidence Interval (2-Sided) 95%
38.9 to 60.3
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >=75% Improvement From Baseline at Week 2, 4, 8 and 12
Hide Description SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
Time Frame Baseline, Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, "Number Analyzed" signifies number of participants evaluable at the specified time points.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 158 155 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 Number Analyzed 157 participants 152 participants 76 participants
1.9
(0.0 to 4.1)
5.3
(1.7 to 8.8)
0
(0.0 to 4.7)
Week 4 Number Analyzed 155 participants 153 participants 77 participants
7.1
(3.1 to 11.1)
17.6
(11.6 to 23.7)
0
(0.0 to 4.7)
Week 8 Number Analyzed 157 participants 154 participants 78 participants
11.5
(6.5 to 16.4)
26.0
(19.0 to 32.9)
0
(0.0 to 4.6)
Week 12 Number Analyzed 155 participants 155 participants 78 participants
18.7
(12.6 to 24.8)
30.3
(23.1 to 37.6)
2.6
(0.0 to 6.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2261
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
-2.2 to 6.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0451
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 5.2
Confidence Interval (2-Sided) 95%
0.3 to 10.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0171
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 7.0
Confidence Interval (2-Sided) 95%
1.8 to 12.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 17.7
Confidence Interval (2-Sided) 95%
10.9 to 24.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0018
Comments P-value was adjusted by randomization strata (baseline disease severity and age category)
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 11.5
Confidence Interval (2-Sided) 95%
5.5 to 17.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category)
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 25.7
Confidence Interval (2-Sided) 95%
18.3 to 33.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 16.2
Confidence Interval (2-Sided) 95%
8.8 to 23.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value was adjusted by randomization strata (baseline disease severity and age category).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 27.6
Confidence Interval (2-Sided) 95%
19.3 to 35.8
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch at Weeks 2, 4, 8 and 12
Hide Description SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
Time Frame Baseline, Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 158 155 78
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Week 2
-2.3
(-2.7 to -2.0)
-3.5
(-3.8 to -3.1)
-0.6
(-1.1 to -0.1)
Change at Week 4
-3.1
(-3.5 to -2.7)
-4.3
(-4.6 to -3.9)
-1.2
(-1.7 to -0.6)
Change at Week 8
-3.4
(-3.8 to -3.0)
-4.3
(-4.7 to -4.0)
-1.8
(-2.4 to -1.2)
Change at Week 12
-3.5
(-3.9 to -3.1)
-4.2
(-4.7 to -3.8)
-2.1
(-2.7 to -1.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-2.3 to -1.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -2.9
Confidence Interval (2-Sided) 95%
-3.5 to -2.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-2.6 to -1.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -3.1
Confidence Interval (2-Sided) 95%
-3.8 to -2.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-2.3 to -0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -2.6
Confidence Interval (2-Sided) 95%
-3.3 to -1.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-2.2 to -0.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-3.0 to -1.4
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) Sleep Loss at Weeks 2, 4, 8 and 12
Hide Description SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
Time Frame Baseline, Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 158 155 78
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Week 2
-1.9
(-2.2 to -1.5)
-2.9
(-3.3 to -2.5)
-0.5
(-1.0 to 0.0)
Change at Week 4
-2.8
(-3.1 to -2.4)
-3.9
(-4.3 to -3.6)
-1.0
(-1.5 to -0.5)
Change at Week 8
-3.1
(-3.5 to -2.7)
-3.9
(-4.3 to -3.5)
-1.5
(-2.1 to -0.9)
Change at Week 12
-3.0
(-3.4 to -2.6)
-3.8
(-4.2 to -3.4)
-2.1
(-2.7 to -1.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-2.0 to -0.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-3.0 to -1.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-2.4 to -1.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-3.6 to -2.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-2.3 to -0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-3.1 to -1.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0164
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.7 to -0.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-2.5 to -1.0
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8 and 12
Hide Description SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where "0" = no itch or no sleeplessness and "10" = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome.
Time Frame Baseline, Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
Overall Number of Participants Analyzed 158 155 78
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
Change at Week 2
-27.2
(-30.5 to -23.9)
-38.5
(-41.8 to -35.1)
-6.3
(-11.0 to -1.6)
Change at Week 4
-38.9
(-42.6 to -35.1)
-53.1
(-56.9 to -49.4)
-17.2
(-22.5 to -12.0)
Change at Week 8
-42.6
(-46.7 to -38.4)
-56.7
(-60.9 to -52.6)
-23.1
(-29.2 to -17.1)
Change at Week 12
-45.8
(-50.9 to -40.7)
-56.2
(-61.2 to -51.1)
-22.7
(-30.4 to -15.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -20.9
Confidence Interval (2-Sided) 95%
-26.6 to -15.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -32.1
Confidence Interval (2-Sided) 95%
-37.9 to -26.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -21.6
Confidence Interval (2-Sided) 95%
-28.1 to -15.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -35.9
Confidence Interval (2-Sided) 95%
-42.3 to -29.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -19.4
Confidence Interval (2-Sided) 95%
-26.8 to -12.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -33.6
Confidence Interval (2-Sided) 95%
-41.0 to -26.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg, Placebo
Comments Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -23.1
Confidence Interval (2-Sided) 95%
-32.3 to -13.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg, Placebo
Comments Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -33.4
Confidence Interval (2-Sided) 95%
-42.6 to -24.3
Estimation Comments [Not Specified]
Time Frame Baseline up to Week 16
Adverse Event Reporting Description Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study.
 
Arm/Group Title PF-04965842 100 mg PF-04965842 200 mg Placebo
Hide Arm/Group Description Participants were randomized to receive a tablet of PF-04965842 (abrocitinib) 100 milligrams (mg) and a tablet of matching placebo orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug. Participants were randomized to receive PF-04965842 200 mg (2 tablets of 100 mg each) orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug. Participants were randomized to receive 2 tablets of placebo matched to PF-04965842 100 mg orally once daily for 12 weeks. Participants who discontinued early from treatment or who were not eligible for LTE study, were followed up to 4 weeks after last dose of study drug.
All-Cause Mortality
PF-04965842 100 mg PF-04965842 200 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/158 (0.63%)   0/155 (0.00%)   0/78 (0.00%) 
Hide Serious Adverse Events
PF-04965842 100 mg PF-04965842 200 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/158 (3.16%)   2/155 (1.29%)   1/78 (1.28%) 
General disorders       
Sudden death * 1  1/158 (0.63%)  0/155 (0.00%)  0/78 (0.00%) 
Immune system disorders       
Anaphylactic shock * 1  0/158 (0.00%)  1/155 (0.65%)  0/78 (0.00%) 
Infections and infestations       
Eczema herpeticum * 1  0/158 (0.00%)  0/155 (0.00%)  1/78 (1.28%) 
Herpangina * 1  1/158 (0.63%)  0/155 (0.00%)  0/78 (0.00%) 
Osteomyelitis bacterial * 1  1/158 (0.63%)  0/155 (0.00%)  0/78 (0.00%) 
Pneumonia * 1  1/158 (0.63%)  0/155 (0.00%)  0/78 (0.00%) 
Staphylococcal infection * 1  1/158 (0.63%)  0/155 (0.00%)  0/78 (0.00%) 
Staphylococcal skin infection * 1  0/158 (0.00%)  0/155 (0.00%)  1/78 (1.28%) 
Injury, poisoning and procedural complications       
Femoral neck fracture * 1  0/158 (0.00%)  1/155 (0.65%)  0/78 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis atopic * 1  1/158 (0.63%)  0/155 (0.00%)  0/78 (0.00%) 
1
Term from vocabulary, MedDRA v22.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PF-04965842 100 mg PF-04965842 200 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   56/158 (35.44%)   52/155 (33.55%)   22/78 (28.21%) 
Gastrointestinal disorders       
Nausea * 1  12/158 (7.59%)  22/155 (14.19%)  2/78 (2.56%) 
Vomiting * 1  2/158 (1.27%)  8/155 (5.16%)  1/78 (1.28%) 
Infections and infestations       
Nasopharyngitis * 1  20/158 (12.66%)  12/155 (7.74%)  5/78 (6.41%) 
Upper respiratory tract infection * 1  14/158 (8.86%)  5/155 (3.23%)  3/78 (3.85%) 
Nervous system disorders       
Headache * 1  9/158 (5.70%)  12/155 (7.74%)  2/78 (2.56%) 
Skin and subcutaneous tissue disorders       
Acne * 1  2/158 (1.27%)  9/155 (5.81%)  0/78 (0.00%) 
Dermatitis atopic * 1  9/158 (5.70%)  6/155 (3.87%)  12/78 (15.38%) 
1
Term from vocabulary, MedDRA v22.0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03575871    
Other Study ID Numbers: B7451013
MONO-2 ( Other Identifier: Alias Study Number )
2018-001136-21 ( EudraCT Number )
First Submitted: June 15, 2018
First Posted: July 3, 2018
Results First Submitted: March 4, 2020
Results First Posted: April 21, 2020
Last Update Posted: April 21, 2020