Trial Outcomes & Findings for Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis (NCT NCT03915496)

Last Updated: 2023-02-08

Results Overview

Mean fold-changes from baseline at Week 12 in the biomarkers for general inflammation (Matrix Metallopeptidase \[MMP\]12), hyperplasia (Keratin \[KRT\]16), Th2 immune response (C-C motif chemokine ligand \[CCL\]17, CCL18, CCL26), and Th22 immune response (S100 calcium binding protein A \[S100A\]8, S100A9, S100A12), in lesional (LS) and non-lesional (NL) skin tissues, respectively. Expression levels from RT-PCR are normalized to the housekeeping gene RPLP0 by negatively transforming the Ct values to -dCt.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2023-02-08

Participant Flow

A total of 46 adult participants with moderate-to-severe atopic dermatitis (AD) were randomized to the study and received study intervention, including 16 participants in the abrocitinib (PF-04965842) 100 mg once daily (QD) group, 14 participants in the abrocitinib 200 mg QD group, and 16 participants in the placebo group.

Participant milestones

Participant milestones
Measure	Abrocitinib 100 mg QD Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Overall Study STARTED	16	14	16
Overall Study COMPLETED	14	13	14
Overall Study NOT COMPLETED	2	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Abrocitinib 100 mg QD Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Overall Study Adverse Event	2	1	2

Baseline Characteristics

Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.	Total n=46 Participants Total of all reporting groups
Age, Continuous	46.6 Years STANDARD_DEVIATION 19.41 • n=5 Participants	41.4 Years STANDARD_DEVIATION 16.72 • n=7 Participants	38.9 Years STANDARD_DEVIATION 15.64 • n=5 Participants	42.4 Years STANDARD_DEVIATION 17.28 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	21 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants	25 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	36 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized White	10 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants	26 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Multiracial	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Not reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants measured and analyzed for each parameter at Week 12 visit.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12 CCL17 (LS)	-5.896 Fold change Standard Deviation 16.0867	-15.604 Fold change Standard Deviation 38.5469	-0.729 Fold change Standard Deviation 4.0821
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12 CCL17 (NL)	-0.506 Fold change Standard Deviation 7.5268	-3.150 Fold change Standard Deviation 2.6554	-3.354 Fold change Standard Deviation 7.6800
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12 CCL18 (LS)	-11.600 Fold change Standard Deviation 18.9748	-24.558 Fold change Standard Deviation 46.2466	-1.096 Fold change Standard Deviation 3.6800
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12 CCL18 (NL)	-18.307 Fold change Standard Deviation 24.0808	-12.328 Fold change Standard Deviation 13.3680	-0.761 Fold change Standard Deviation 2.8516
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12 CCL26 (LS)	-3.886 Fold change Standard Deviation 9.6426	-0.464 Fold change Standard Deviation 5.2150	-0.205 Fold change Standard Deviation 1.7928
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12 CCL26 (NL)	-3.619 Fold change Standard Deviation 2.1674	-4.369 Fold change Standard Deviation 8.0621	0.026 Fold change Standard Deviation 2.0613
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12 KRT16 (LS)	-24.604 Fold change Standard Deviation 47.3896	-53.285 Fold change Standard Deviation 70.6935	-1.898 Fold change Standard Deviation 19.4730
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12 KRT16 (NL)	-3.179 Fold change Standard Deviation 6.2518	-2.947 Fold change Standard Deviation 1.4188	-2.674 Fold change Standard Deviation 7.2836
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12 MMP-12 (LS)	-44.200 Fold change Standard Deviation 123.0708	-306.161 Fold change Standard Deviation 503.8312	-0.184 Fold change Standard Deviation 3.0962
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12 MMP-12 (NL)	-20.822 Fold change Standard Deviation 31.5640	-27.523 Fold change Standard Deviation 16.5608	-1.897 Fold change Standard Deviation 3.6968
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12 S100A12 (LS)	-13.931 Fold change Standard Deviation 23.9740	-1322.88 Fold change Standard Deviation 4594.187	5.994 Fold change Standard Deviation 57.0002
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12 S100A12 (NL)	4.052 Fold change Standard Deviation 0.4124	-4.300 Fold change Standard Deviation 4.2217	-14.200 Fold change Standard Deviation 21.2222
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12 S100A8 (LS)	-76.158 Fold change Standard Deviation 181.1015	-312.430 Fold change Standard Deviation 395.0796	1.213 Fold change Standard Deviation 31.0236
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12 S100A8 (NL)	-3.797 Fold change Standard Deviation 3.9226	-14.249 Fold change Standard Deviation 13.2540	-8.394 Fold change Standard Deviation 10.7181
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12 S100A9 (LS)	-52.132 Fold change Standard Deviation 113.0256	-304.023 Fold change Standard Deviation 376.0106	-2.136 Fold change Standard Deviation 17.2326
Fold-Change From Baseline in Atopic Dermatitis Biomarkers in Lesional and Non-lesional Skin at Week 12 S100A9 (NL)	-2.781 Fold change Standard Deviation 5.6012	-34.776 Fold change Standard Deviation 42.4019	-7.368 Fold change Standard Deviation 10.0856

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The analysis population included all participants randomly assigned to study interventionand who took at least 1 dose of study intervention. Number Analyzed refers to the numberof participants evaluable for each category.

Mean fold-changes from baseline in immunohistochemistry analysis in lesional skin endpoints at Week 12 are presented. Fold-changes are computed by obtaining the antilog of log2 fold-changes, retaining the sign for log2 fold-change.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12 CD11C	-1.622 Fold change Interval -2.404 to -1.094	-2.460 Fold change Interval -3.719 to -1.627	-1.326 Fold change Interval -1.968 to 1.118
Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12 CD3	-1.952 Fold change Interval -2.979 to -1.279	-2.371 Fold change Interval -3.696 to -1.521	-1.054 Fold change Interval -1.61 to 1.45
Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12 Fc Epsilon R1	-1.610 Fold change Interval -2.276 to -1.14	-2.088 Fold change Interval -3.003 to -1.453	1.092 Fold change Interval -1.295 to 1.545
Fold-Change From Baseline in Cellular (T-cell and Dendritic Cell) Inflammation Markers at Week 12 Macrophage mannose receptor 1	-1.249 Fold change Interval -1.538 to -1.015	-1.835 Fold change Interval -2.282 to -1.476	-1.155 Fold change Interval -1.422 to 1.066

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed refers to the number of participants evaluable for each category.

Mean fold-changes from baseline in hyperplasia markers in skin biopsies at Week 12 are presented. Fold-changes are computed by obtaining the antilog of log2 fold-changes, retaining the sign for log2 fold-change.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Fold-Change From Baseline in Epidermal Hyperplasia Markers in Skin Biopsies and Skin Thickness at Week 12 Ki-67	-1.638 Fold change Interval -2.859 to 1.066	-1.911 Fold change Interval -3.432 to -1.064	-1.153 Fold change Interval -2.016 to 1.516
Fold-Change From Baseline in Epidermal Hyperplasia Markers in Skin Biopsies and Skin Thickness at Week 12 Thickness	-1.310 Fold change Interval -1.735 to 1.01	-1.508 Fold change Interval -2.024 to -1.123	-1.185 Fold change Interval -1.57 to 1.118

SECONDARY outcome

Timeframe: Baseline, Week 12

OLINK Proteomics Microassay was used to analyze biomarkers in serum to assess the effect of abrocitinib on the blood biomarkers. Mean fold-changes at Week 12 from baseline are listed. Baseline is defined as the last observation on or prior to day of first dose (Day 1).

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 C-C motif chemokine ligand 16 (CCL16)	-0.258 Fold change Standard Deviation 0.2716	-0.313 Fold change Standard Deviation 0.1866	-0.103 Fold change Standard Deviation 0.2040
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 C-C motif chemokine ligand 11 (CCL11)	0.030 Fold change Standard Deviation 0.2617	0.109 Fold change Standard Deviation 0.2891	0.060 Fold change Standard Deviation 0.2005
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 MMP-12	-0.554 Fold change Standard Deviation 0.9534	-0.756 Fold change Standard Deviation 0.6576	-0.631 Fold change Standard Deviation 0.9298
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 C-C motif chemokine ligand 23 (CCL23)	-0.247 Fold change Standard Deviation 0.3367	-0.519 Fold change Standard Deviation 0.3958	-0.245 Fold change Standard Deviation 0.4302
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 C-C motif chemokine ligand 17 (CCL17)	-0.619 Fold change Standard Deviation 0.8281	-0.880 Fold change Standard Deviation 1.0630	0.108 Fold change Standard Deviation 0.8299
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Selectin E (SELE)	-0.520 Fold change Standard Deviation 0.6198	-0.717 Fold change Standard Deviation 0.6172	-0.170 Fold change Standard Deviation 0.3571
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Integrin subunit beta 2 (ITGB2)	-0.280 Fold change Standard Deviation 0.3067	-0.574 Fold change Standard Deviation 0.2649	0.058 Fold change Standard Deviation 0.1877
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Platelet-derived growth factor (PDGF) subunit B	-0.057 Fold change Standard Deviation 0.2185	-0.182 Fold change Standard Deviation 0.3561	0.085 Fold change Standard Deviation 0.2916
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 PDGF subunit A	-0.360 Fold change Standard Deviation 0.3354	-0.590 Fold change Standard Deviation 0.3884	-0.039 Fold change Standard Deviation 0.1802
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Linker for activation of T cells (LAT)	-0.127 Fold change Standard Deviation 0.4281	-0.322 Fold change Standard Deviation 0.3329	-0.169 Fold change Standard Deviation 0.3493
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 C-C motif chemokine ligand 24 (CCL24)	-0.283 Fold change Standard Deviation 0.5321	-0.342 Fold change Standard Deviation 0.2439	-0.191 Fold change Standard Deviation 0.2425
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Lipoprotein lipase (LPL)	-0.037 Fold change Standard Deviation 0.5906	0.281 Fold change Standard Deviation 0.7465	-0.224 Fold change Standard Deviation 0.7340
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Interferon (IFN)-gamma	0.264 Fold change Standard Deviation 1.2382	0.903 Fold change Standard Deviation 1.9580	0.763 Fold change Standard Deviation 1.1019
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Interleukin 2 receptor subunit alpha (IL2-RA)	-0.852 Fold change Standard Deviation 0.6237	-0.921 Fold change Standard Deviation 0.4530	-0.219 Fold change Standard Deviation 0.3161
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Interleukin (IL)-1 alpha	0.118 Fold change Standard Deviation 0.4804	-0.114 Fold change Standard Deviation 0.2527	0.046 Fold change Standard Deviation 0.3275
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 C-C motif chemokine ligand 25 (CCL25)	0.229 Fold change Standard Deviation 0.3299	0.324 Fold change Standard Deviation 0.4351	0.149 Fold change Standard Deviation 0.2235
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 C-C motif chemokine ligand 28 (CCL28)	0.014 Fold change Standard Deviation 0.2452	0.108 Fold change Standard Deviation 0.2932	0.011 Fold change Standard Deviation 0.2962
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 C-C motif chemokine ligand 20 (CCL20)	-0.465 Fold change Standard Deviation 1.1905	0.111 Fold change Standard Deviation 0.8023	-0.333 Fold change Standard Deviation 0.6612
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 C-C motif chemokine ligand 19 (CCL19)	-0.653 Fold change Standard Deviation 0.6620	-1.217 Fold change Standard Deviation 0.9084	-0.012 Fold change Standard Deviation 0.5347
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Tumor necrosis factor receptor superfamily member 9 (TNFRSF9)	-0.437 Fold change Standard Deviation 0.3796	-0.608 Fold change Standard Deviation 0.2665	-0.136 Fold change Standard Deviation 0.2562
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Tumor necrosis factor receptor superfamily member 12A (TNFRSF12A)	-0.143 Fold change Standard Deviation 0.3348	-0.048 Fold change Standard Deviation 0.3744	-0.078 Fold change Standard Deviation 0.4294
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Matrix metalloproteinase-1 (MMP-1)	-0.118 Fold change Standard Deviation 0.1546	0.004 Fold change Standard Deviation 0.2445	-0.002 Fold change Standard Deviation 0.1309
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Interleukin 20 receptor subunit alpha (IL-20RA)	0.089 Fold change Standard Deviation 0.2394	-0.111 Fold change Standard Deviation 0.2573	-0.040 Fold change Standard Deviation 0.2018
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-18	-0.488 Fold change Standard Deviation 0.4737	-0.578 Fold change Standard Deviation 0.3460	-0.182 Fold change Standard Deviation 0.4037
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-16	-0.512 Fold change Standard Deviation 0.5606	-0.697 Fold change Standard Deviation 0.5642	-0.222 Fold change Standard Deviation 0.5656
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-12	-0.548 Fold change Standard Deviation 0.5020	-0.628 Fold change Standard Deviation 0.3935	-0.141 Fold change Standard Deviation 0.3341
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-12B	-0.560 Fold change Standard Deviation 0.4540	-0.637 Fold change Standard Deviation 0.3808	-0.059 Fold change Standard Deviation 0.3230
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-17C	-0.250 Fold change Standard Deviation 1.2265	0.136 Fold change Standard Deviation 0.5533	-0.784 Fold change Standard Deviation 1.0808
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-7	-0.082 Fold change Standard Deviation 0.4541	-0.425 Fold change Standard Deviation 0.5173	-0.020 Fold change Standard Deviation 0.5239
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-27	-0.099 Fold change Standard Deviation 0.1617	-0.177 Fold change Standard Deviation 0.2611	-0.073 Fold change Standard Deviation 0.2250
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-13	-0.230 Fold change Standard Deviation 0.4810	-0.490 Fold change Standard Deviation 0.6399	-0.213 Fold change Standard Deviation 0.6765
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-17D	0.057 Fold change Standard Deviation 0.3222	-0.222 Fold change Standard Deviation 0.2921	-0.105 Fold change Standard Deviation 0.2420
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-20	-0.155 Fold change Standard Deviation 0.2843	-0.171 Fold change Standard Deviation 0.2315	-0.137 Fold change Standard Deviation 0.3877
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-4	-0.130 Fold change Standard Deviation 0.6704	-0.308 Fold change Standard Deviation 0.5324	-0.128 Fold change Standard Deviation 0.3287
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-4RA	-0.075 Fold change Standard Deviation 0.2436	-0.619 Fold change Standard Deviation 0.7577	-0.340 Fold change Standard Deviation 0.5764
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-2	0.005 Fold change Standard Deviation 0.1927	-0.069 Fold change Standard Deviation 0.2345	0.050 Fold change Standard Deviation 0.3024
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-8	0.080 Fold change Standard Deviation 0.8463	0.090 Fold change Standard Deviation 0.8062	0.152 Fold change Standard Deviation 0.9180
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-5	0.049 Fold change Standard Deviation 0.2578	-0.164 Fold change Standard Deviation 0.3214	-0.020 Fold change Standard Deviation 0.3306
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-6	-0.086 Fold change Standard Deviation 0.9560	0.150 Fold change Standard Deviation 1.4005	-0.228 Fold change Standard Deviation 1.1986
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-10	-0.180 Fold change Standard Deviation 0.4616	-0.087 Fold change Standard Deviation 0.4255	-0.182 Fold change Standard Deviation 0.6735
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-33	0.022 Fold change Standard Deviation 0.2275	-0.116 Fold change Standard Deviation 0.2353	-0.138 Fold change Standard Deviation 0.2815
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Cluster of differentiation (CD) 5	-0.373 Fold change Standard Deviation 0.2546	-0.405 Fold change Standard Deviation 0.1488	-0.064 Fold change Standard Deviation 0.1640
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 CD4	-0.252 Fold change Standard Deviation 0.3139	-0.406 Fold change Standard Deviation 0.2184	-0.159 Fold change Standard Deviation 0.3220
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 CD40	-0.049 Fold change Standard Deviation 0.1755	-0.065 Fold change Standard Deviation 0.3002	0.039 Fold change Standard Deviation 0.2065
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Peptidase Inhibitor 3 (PI3)	-0.463 Fold change Standard Deviation 0.6634	-0.332 Fold change Standard Deviation 0.6725	-0.583 Fold change Standard Deviation 0.8686
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Tumor necrosis factor (TNF)	-0.328 Fold change Standard Deviation 0.3560	-0.227 Fold change Standard Deviation 0.6622	0.036 Fold change Standard Deviation 0.9515
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 C-X-C motif chemokine ligand 5 (CXCL5)	-0.208 Fold change Standard Deviation 0.2889	-0.364 Fold change Standard Deviation 0.4082	0.068 Fold change Standard Deviation 0.4028
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 X-C motif chemokine ligand 1 (XCL1)	-0.540 Fold change Standard Deviation 0.4209	-0.897 Fold change Standard Deviation 0.4253	-0.051 Fold change Standard Deviation 0.3028
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Thymic stromal lymphopoietin (TSLP)	-0.100 Fold change Standard Deviation 0.4871	-0.047 Fold change Standard Deviation 0.5610	0.019 Fold change Standard Deviation 0.4495
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 CXCL10	-0.268 Fold change Standard Deviation 0.9825	-0.549 Fold change Standard Deviation 0.9508	0.363 Fold change Standard Deviation 0.4782
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 CXCL11	-0.399 Fold change Standard Deviation 0.6089	-0.695 Fold change Standard Deviation 0.7402	0.210 Fold change Standard Deviation 0.4335
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 CXCL9	-0.161 Fold change Standard Deviation 0.6273	-0.406 Fold change Standard Deviation 0.9061	0.159 Fold change Standard Deviation 0.5395
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 CXCL1	-0.218 Fold change Standard Deviation 0.3795	-0.375 Fold change Standard Deviation 0.3356	-0.062 Fold change Standard Deviation 0.3892
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 CXCL16	0.031 Fold change Standard Deviation 0.2575	-0.033 Fold change Standard Deviation 0.2503	-0.011 Fold change Standard Deviation 0.1563
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Transforming growth factor (TGF)-beta-1	-0.199 Fold change Standard Deviation 0.2853	-0.465 Fold change Standard Deviation 0.2884	-0.077 Fold change Standard Deviation 0.2521
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 CCL3	-0.168 Fold change Standard Deviation 0.4852	-0.171 Fold change Standard Deviation 0.5503	0.247 Fold change Standard Deviation 0.7508
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 CX3CL1	0.346 Fold change Standard Deviation 0.4784	0.458 Fold change Standard Deviation 0.4269	0.012 Fold change Standard Deviation 0.2771
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 CCL4	-0.187 Fold change Standard Deviation 0.3558	-0.085 Fold change Standard Deviation 0.5211	0.204 Fold change Standard Deviation 0.4349
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Membrane cofactor protein (MCP)-4	-0.627 Fold change Standard Deviation 0.7270	-0.860 Fold change Standard Deviation 0.6659	-0.116 Fold change Standard Deviation 0.6018
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 MCP-3	-0.418 Fold change Standard Deviation 0.8078	-0.676 Fold change Standard Deviation 0.5462	-0.229 Fold change Standard Deviation 0.7573
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 MCP-1	0.053 Fold change Standard Deviation 0.4337	0.108 Fold change Standard Deviation 0.3722	-0.081 Fold change Standard Deviation 0.3836
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 MCP-2	-0.204 Fold change Standard Deviation 0.2714	-0.552 Fold change Standard Deviation 0.3286	-0.007 Fold change Standard Deviation 0.2398
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-1ra	-0.295 Fold change Standard Deviation 0.4298	-0.234 Fold change Standard Deviation 0.6936	-0.128 Fold change Standard Deviation 0.6599
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 IL-6RA	-0.162 Fold change Standard Deviation 0.2087	-0.274 Fold change Standard Deviation 0.1833	-0.022 Fold change Standard Deviation 0.1817
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 Tumor necrosis factor-related apoptosis-inducing ligand (TRAIL)	-0.062 Fold change Standard Deviation 0.2606	-0.283 Fold change Standard Deviation 0.2998	0.086 Fold change Standard Deviation 0.2172
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 TNF-related weak inducer of apoptosis (TWEAK)	-0.057 Fold change Standard Deviation 0.2239	-0.157 Fold change Standard Deviation 0.1705	0.099 Fold change Standard Deviation 0.1471
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 EN-RAGE	-0.175 Fold change Standard Deviation 0.6414	-0.383 Fold change Standard Deviation 0.9149	0.175 Fold change Standard Deviation 0.7755
Fold-Change From Baseline in Blood Biomarkers for Inflammation and Immune Response at Week 12 P-selectin glycoprotein ligand-1 (PSGL-1)	-0.025 Fold change Standard Deviation 0.2592	-0.087 Fold change Standard Deviation 0.1646	-0.012 Fold change Standard Deviation 0.1856

SECONDARY outcome

Timeframe: Baseline, Week 12

Mean percent changes from baseline at Week 12 in T-cell lymphocyte subset populations (CD3+ T cells, CD4+ T cells, CD8+ T cells, NK cells, B cells) are presented. Baseline is defined as the last observation on or prior to day of first dose (Day 1).

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12 T-cells TBNK Screening (%)	-0.2 Percent change Standard Deviation 5.25	3.6 Percent change Standard Deviation 6.65	1.7 Percent change Standard Deviation 3.69
Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12 T-cells TBNK Screening (absolute)	-14.5 Percent change Standard Deviation 19.50	14.2 Percent change Standard Deviation 43.43	1.5 Percent change Standard Deviation 29.10
Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12 T lymphocytes CD3+CD4 (%)	1.4 Percent change Standard Deviation 7.18	6.7 Percent change Standard Deviation 11.73	5.6 Percent change Standard Deviation 7.96
Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12 T lymphocytes CD3+CD4 (absolute)	-13.2 Percent change Standard Deviation 20.06	17.1 Percent change Standard Deviation 41.66	5.2 Percent change Standard Deviation 29.79
Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12 T lymphocytes CD3+CD8 (%)	-0.7 Percent change Standard Deviation 12.22	3.2 Percent change Standard Deviation 10.59	-1.6 Percent change Standard Deviation 8.75
Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12 T lymphocytes CD3+CD8 (absolute)	-15.1 Percent change Standard Deviation 22.19	16.2 Percent change Standard Deviation 54.75	-1.1 Percent change Standard Deviation 33.17
Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12 B-cells TBNK Screening (%)	35.5 Percent change Standard Deviation 41.18	42.4 Percent change Standard Deviation 37.49	7.8 Percent change Standard Deviation 23.69
Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12 B-cells TBNK Screening (absolute)	18.3 Percent change Standard Deviation 52.71	55.0 Percent change Standard Deviation 59.81	7.7 Percent change Standard Deviation 39.19
Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12 NK Cells TBNK Screening (%)	-27.3 Percent change Standard Deviation 40.12	-55.9 Percent change Standard Deviation 24.04	-15.2 Percent change Standard Deviation 28.64
Percent-Change From Baseline in T-cell Lymphocyte Subset Populations at Week 12 NK Cells TBNK Screening (absolute)	-40.0 Percent change Standard Deviation 29.41	-53.2 Percent change Standard Deviation 26.96	-17.9 Percent change Standard Deviation 26.81

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and had response based on at least 4-points improvement from baseline in the severity of PP-NRS. Number Analyzed refers to the number of participants evaluable for each category.

PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder. Spearman correlation coefficient was calculated to assess the relationship between PP-NRS CFB and fold CFB of IHC and gene expression biomarkers.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Response Based on at Least 4 Points Improvement in the Severity of Peak Pruritus Numerical Rating Scale (NRS) From Baseline and Changes From Baseline in Immunohistochemistry (IHC) and Gene Expression Biomarkers in Lesional Skin CD11C	0.242 Spearman correlation coefficient	0.484 Spearman correlation coefficient	0.439 Spearman correlation coefficient
Response Based on at Least 4 Points Improvement in the Severity of Peak Pruritus Numerical Rating Scale (NRS) From Baseline and Changes From Baseline in Immunohistochemistry (IHC) and Gene Expression Biomarkers in Lesional Skin FC Epsilon R1	0.474 Spearman correlation coefficient	0.464 Spearman correlation coefficient	0.238 Spearman correlation coefficient
Response Based on at Least 4 Points Improvement in the Severity of Peak Pruritus Numerical Rating Scale (NRS) From Baseline and Changes From Baseline in Immunohistochemistry (IHC) and Gene Expression Biomarkers in Lesional Skin CD3	0.438 Spearman correlation coefficient	0.408 Spearman correlation coefficient	0.151 Spearman correlation coefficient
Response Based on at Least 4 Points Improvement in the Severity of Peak Pruritus Numerical Rating Scale (NRS) From Baseline and Changes From Baseline in Immunohistochemistry (IHC) and Gene Expression Biomarkers in Lesional Skin Macrophage mannose receptor 1	0.396 Spearman correlation coefficient	0.162 Spearman correlation coefficient	-0.134 Spearman correlation coefficient
Response Based on at Least 4 Points Improvement in the Severity of Peak Pruritus Numerical Rating Scale (NRS) From Baseline and Changes From Baseline in Immunohistochemistry (IHC) and Gene Expression Biomarkers in Lesional Skin S100A9	0.390 Spearman correlation coefficient	0.529 Spearman correlation coefficient	0.334 Spearman correlation coefficient
Response Based on at Least 4 Points Improvement in the Severity of Peak Pruritus Numerical Rating Scale (NRS) From Baseline and Changes From Baseline in Immunohistochemistry (IHC) and Gene Expression Biomarkers in Lesional Skin S100A8	0.365 Spearman correlation coefficient	0.510 Spearman correlation coefficient	0.413 Spearman correlation coefficient
Response Based on at Least 4 Points Improvement in the Severity of Peak Pruritus Numerical Rating Scale (NRS) From Baseline and Changes From Baseline in Immunohistochemistry (IHC) and Gene Expression Biomarkers in Lesional Skin KRT16	0.313 Spearman correlation coefficient	0.486 Spearman correlation coefficient	0.522 Spearman correlation coefficient
Response Based on at Least 4 Points Improvement in the Severity of Peak Pruritus Numerical Rating Scale (NRS) From Baseline and Changes From Baseline in Immunohistochemistry (IHC) and Gene Expression Biomarkers in Lesional Skin S100A12	0.238 Spearman correlation coefficient	0.454 Spearman correlation coefficient	0.460 Spearman correlation coefficient
Response Based on at Least 4 Points Improvement in the Severity of Peak Pruritus Numerical Rating Scale (NRS) From Baseline and Changes From Baseline in Immunohistochemistry (IHC) and Gene Expression Biomarkers in Lesional Skin CCL18	0.395 Spearman correlation coefficient	0.410 Spearman correlation coefficient	0.365 Spearman correlation coefficient

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, and 12

The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline at Week 2, 4, 8 and 12 Week 2	0 Percentage of participants Interval 0.0 to 0.0	7.7 Percentage of participants Interval 0.0 to 22.2	0 Percentage of participants Interval 0.0 to 0.0
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline at Week 2, 4, 8 and 12 Week 4	26.7 Percentage of participants Interval 4.3 to 49.0	35.7 Percentage of participants Interval 10.6 to 60.8	0 Percentage of participants Interval 0.0 to 0.0
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline at Week 2, 4, 8 and 12 Week 8	26.7 Percentage of participants Interval 4.3 to 49.0	64.3 Percentage of participants Interval 39.2 to 89.4	0 Percentage of participants Interval 0.0 to 0.0
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline at Week 2, 4, 8 and 12 Week 12	25.0 Percentage of participants Interval 3.8 to 46.2	57.1 Percentage of participants Interval 31.2 to 83.1	0 Percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, and 12

The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12 Week 2	6.3 Percentage of participants Interval 0.0 to 18.1	38.5 Percentage of participants Interval 12.0 to 64.9	0 Percentage of participants Interval 0.0 to 0.0
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12 Week 4	46.7 Percentage of participants Interval 21.4 to 71.9	50.0 Percentage of participants Interval 23.8 to 76.2	0 Percentage of participants Interval 0.0 to 0.0
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12 Week 8	46.7 Percentage of participants Interval 21.4 to 71.9	78.6 Percentage of participants Interval 57.1 to 100.0	0 Percentage of participants Interval 0.0 to 0.0
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline Week 2, 4, 8 and 12 Week 12	43.8 Percentage of participants Interval 19.4 to 68.1	78.6 Percentage of participants Interval 57.1 to 100.0	0 Percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12

PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Higher scores indicated worse itch. Participants who withdrew from the study were counted as non-responder.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Percentage of Participants With >=4 Points at Baseline and Achieving >=4 Points Improvement From Baseline in Numeric Rating Scale for Severity of Pruritus (PP-NRS) at Weeks 2, 4, 8 and 12 Week 2	25.0 Percentage of participants Interval 3.8 to 46.2	57.1 Percentage of participants Interval 31.2 to 83.1	6.3 Percentage of participants Interval 0.0 to 18.1
Percentage of Participants With >=4 Points at Baseline and Achieving >=4 Points Improvement From Baseline in Numeric Rating Scale for Severity of Pruritus (PP-NRS) at Weeks 2, 4, 8 and 12 Week 4	53.3 Percentage of participants Interval 28.1 to 78.6	64.3 Percentage of participants Interval 39.2 to 89.4	0 Percentage of participants Interval 0.0 to 0.0
Percentage of Participants With >=4 Points at Baseline and Achieving >=4 Points Improvement From Baseline in Numeric Rating Scale for Severity of Pruritus (PP-NRS) at Weeks 2, 4, 8 and 12 Week 8	46.7 Percentage of participants Interval 21.4 to 71.9	64.3 Percentage of participants Interval 39.2 to 89.4	13.3 Percentage of participants Interval 0.0 to 30.5
Percentage of Participants With >=4 Points at Baseline and Achieving >=4 Points Improvement From Baseline in Numeric Rating Scale for Severity of Pruritus (PP-NRS) at Weeks 2, 4, 8 and 12 Week 12	35.7 Percentage of participants Interval 10.6 to 60.8	64.3 Percentage of participants Interval 39.2 to 89.4	6.3 Percentage of participants Interval 0.0 to 18.1

SECONDARY outcome

Timeframe: Baseline to Week 2, 4, 8 and 12

The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12 Week 2	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0
Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12 Week 4	20.0 Percentage of participants Interval 0.0 to 40.2	28.6 Percentage of participants Interval 4.9 to 52.2	0 Percentage of participants Interval 0.0 to 0.0
Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12 Week 8	20.0 Percentage of participants Interval 0.0 to 40.2	57.1 Percentage of participants Interval 31.2 to 83.1	0 Percentage of participants Interval 0.0 to 0.0
Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline at Week 2, 4, 8 and 12 Week 12	37.5 Percentage of participants Interval 13.8 to 61.2	50.0 Percentage of participants Interval 23.8 to 76.2	0 Percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline to Week 2, 4, 8 and 12

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12 Week 2	37.5 Percentage of participants Interval 13.8 to 61.2	61.5 Percentage of participants Interval 35.1 to 88.0	12.5 Percentage of participants Interval 0.0 to 28.7
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12 Week 4	66.7 Percentage of participants Interval 42.8 to 90.5	100.0 Percentage of participants Interval 100.0 to 100.0	6.7 Percentage of participants Interval 0.0 to 19.3
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12 Week 8	53.3 Percentage of participants Interval 28.1 to 78.6	100.0 Percentage of participants Interval 100.0 to 100.0	6.7 Percentage of participants Interval 0.0 to 19.3
Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline at Week 2, 4, 8 and 12 Week 12	68.8 Percentage of participants Interval 46.0 to 91.5	92.9 Percentage of participants Interval 79.4 to 100.0	18.8 Percentage of participants Interval 0.0 to 37.9

SECONDARY outcome

Timeframe: Baseline and Week 2, 4, 8 and 12

BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12 Week 2	-9.6 Percent change Standard Deviation 12.06	-17.3 Percent change Standard Deviation 13.78	4.0 Percent change Standard Deviation 17.25
Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12 Week 4	-18.7 Percent change Standard Deviation 15.70	-23.8 Percent change Standard Deviation 14.19	2.1 Percent change Standard Deviation 18.35
Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12 Week 8	-18.7 Percent change Standard Deviation 20.96	-28.3 Percent change Standard Deviation 16.84	0.2 Percent change Standard Deviation 21.59
Percent Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8 and 12 Week 12	-22.0 Percent change Standard Deviation 19.03	-28.3 Percent change Standard Deviation 16.95	-0.2 Percent change Standard Deviation 23.20

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) All-causality TEAEs	10 Participants	7 Participants	8 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Treatment-related TEAEs	6 Participants	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Number of Participants With Serious Adverse Events (SAEs) All-causality SAEs	0 Participants	0 Participants	1 Participants
Number of Participants With Serious Adverse Events (SAEs) Treatment-related SAEs	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Number of Participants Who Discontinued From the Study Due to TEAEs All-causality TEAEs	2 Participants	1 Participants	2 Participants
Number of Participants Who Discontinued From the Study Due to TEAEs Treatment-related TEAEs	2 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants with at least one observation of the given laboratory test.

Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Hemoglobin (g/dL) <0.8*LLN	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Hematocrit (%) < 0.8*LLN	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Erythrocytes (10^6/mm3) < 0.8*LLN	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Reticulocytes (10^3/mm3) < 0.5*LLN	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Platelets (10^3/mm3) < 0.5*LLN	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Reticulocytes/Erythrocytes (%) > 1.5*ULN	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Leukocytes (10^3/mm3) < 0.6*LLN	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Lymphocytes (10^3/mm3) < 0.8*LLN	2 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Lymphocytes/Leukocytes (%) < 0.8*LLN	3 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Lymphocytes/Leukocytes (%) > 1.2*ULN	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Neutrophils (10^3/mm3) < 0.8*LLN	1 Participants	3 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Neutrophils/Leukocytes (%) < 0.8*LLN	0 Participants	2 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Basophils/Leukocytes (%) > 1.2*ULN	1 Participants	1 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Eosinophils (10^3/mm3) > 1.2*ULN	5 Participants	2 Participants	10 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Eosinophils/Leukocytes (%) > 1.2*ULN	6 Participants	2 Participants	10 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Monocytes (10^3/mm3) > 1.2x ULN	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Monocytes/Leukocytes (%) > 1.2*ULN	1 Participants	3 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Prothrombin Time (sec) > 1.1*ULN	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Bilirubin (mg/dL) > 1.5*ULN	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Indirect Bilirubin (mg/dL) > 1.5*ULN	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Aspartate Aminotransferase (U/L) > 3.0*ULN	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Alanine Aminotransferase (U/L) > 3.0*ULN	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Gamma Glutamyl Transferase (U/L) > 3.0*ULN	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Lactate Dehydrogenase (U/L) > 3.0*ULN	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Creatinine (mg/dL) > 1.3*ULN	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Urate (mg/dL) > 1.2*ULN	1 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Potassium (mEq/L) < 0.9*LLN	1 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Bicarbonate (mEq/L) > 1.1*ULN	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Creatine Kinase (U/L) > 2.0*ULN	1 Participants	3 Participants	2 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Cholesterol (mg/dL) > 1.3*ULN	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Ketones ≥ 1	0 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) URINE Protein ≥ 1	0 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) URINE Hemoglobin ≥ 1	2 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Leukocyte Esterase ≥ 1	5 Participants	3 Participants	1 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) URINE Leukocytes (Scalar) ≥ 20	2 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) Hyaline Casts (/LPF) > 1	2 Participants	1 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 2, 4, 8 and 12

Clinical laboratory tests including red blood cell (erythrocytes) were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12 Week 2	-0.12 10^6 cells/mm^3 Standard Deviation 0.212	-0.21 10^6 cells/mm^3 Standard Deviation 0.305	-0.10 10^6 cells/mm^3 Standard Deviation 0.242
Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12 Week 4	-0.16 10^6 cells/mm^3 Standard Deviation 0.279	-0.19 10^6 cells/mm^3 Standard Deviation 0.266	-0.11 10^6 cells/mm^3 Standard Deviation 0.274
Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12 Week 8	-0.21 10^6 cells/mm^3 Standard Deviation 0.301	-0.35 10^6 cells/mm^3 Standard Deviation 0.424	-0.02 10^6 cells/mm^3 Standard Deviation 0.246
Change From Baseline in Erythrocytes at Week 2, 4, 8 and 12 Week 12	-0.35 10^6 cells/mm^3 Standard Deviation 0.376	-0.47 10^6 cells/mm^3 Standard Deviation 0.434	0.07 10^6 cells/mm^3 Standard Deviation 0.183

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 2, 4, 8 and 12

Clinical laboratory tests including reticulocytes were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12 Week 2	-15.43 10^3 cells/mm^3 Standard Deviation 23.177	-25.14 10^3 cells/mm^3 Standard Deviation 28.057	5.33 10^3 cells/mm^3 Standard Deviation 12.199
Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12 Week 4	-11.64 10^3 cells/mm^3 Standard Deviation 27.845	-20.86 10^3 cells/mm^3 Standard Deviation 28.710	1.86 10^3 cells/mm^3 Standard Deviation 16.209
Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12 Week 8	-9.31 10^3 cells/mm^3 Standard Deviation 15.997	-13.23 10^3 cells/mm^3 Standard Deviation 18.682	0.07 10^3 cells/mm^3 Standard Deviation 15.345
Change From Baseline in Reticulocytes at Week 2, 4, 8 and 12 Week 12	-5.07 10^3 cells/mm^3 Standard Deviation 16.615	-7.64 10^3 cells/mm^3 Standard Deviation 28.169	4.33 10^3 cells/mm^3 Standard Deviation 20.318

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 2, 4, 8 and 12

Clinical laboratory tests including platelet counts were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12 Week 2	-72.86 10^3 cells/mm^3 Standard Deviation 93.413	-53.23 10^3 cells/mm^3 Standard Deviation 28.176	12.87 10^3 cells/mm^3 Standard Deviation 51.582
Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12 Week 4	-89.79 10^3 cells/mm^3 Standard Deviation 123.180	-93.29 10^3 cells/mm^3 Standard Deviation 36.123	11.79 10^3 cells/mm^3 Standard Deviation 33.025
Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12 Week 8	-68.15 10^3 cells/mm^3 Standard Deviation 102.846	-71.38 10^3 cells/mm^3 Standard Deviation 44.925	5.79 10^3 cells/mm^3 Standard Deviation 28.917
Change From Baseline in Platelet Counts at Week 2, 4, 8 and 12 Week 12	-59.00 10^3 cells/mm^3 Standard Deviation 104.408	-65.79 10^3 cells/mm^3 Standard Deviation 42.600	5.47 10^3 cells/mm^3 Standard Deviation 34.620

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 2, 4, 8 and 12

Clinical laboratory tests including hs-CRP were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12 Week 2	-0.26 milligrams per deciliter Standard Deviation 0.431	-0.07 milligrams per deciliter Standard Deviation 0.147	-0.13 milligrams per deciliter Standard Deviation 1.538
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12 Week 4	-0.24 milligrams per deciliter Standard Deviation 0.376	-0.09 milligrams per deciliter Standard Deviation 0.217	-0.43 milligrams per deciliter Standard Deviation 1.283
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12 Week 8	-0.19 milligrams per deciliter Standard Deviation 0.287	0.03 milligrams per deciliter Standard Deviation 0.253	-0.42 milligrams per deciliter Standard Deviation 1.182
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Week 2, 4, 8 and 12 Week 12	-0.15 milligrams per deciliter Standard Deviation 0.368	0.01 milligrams per deciliter Standard Deviation 0.254	-0.40 milligrams per deciliter Standard Deviation 1.114

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 2, 4, 8 and 12

Clinical laboratory tests including interleukin were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12 Week 2	-0.02 picograms per milliliter Standard Deviation 2.732	-0.11 picograms per milliliter Standard Deviation 7.021	-0.44 picograms per milliliter Standard Deviation 2.797
Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12 Week 4	0.16 picograms per milliliter Standard Deviation 2.533	-0.85 picograms per milliliter Standard Deviation 5.045	-1.83 picograms per milliliter Standard Deviation 6.034
Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12 Week 8	0.19 picograms per milliliter Standard Deviation 1.391	0.15 picograms per milliliter Standard Deviation 5.728	-3.52 picograms per milliliter Standard Deviation 8.228
Change From Baseline in Interleukin 6 at Week 2, 4, 8 and 12 Week 12	-0.23 picograms per milliliter Standard Deviation 2.712	-0.19 picograms per milliliter Standard Deviation 5.305	-2.59 picograms per milliliter Standard Deviation 6.339

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 2, 4, 8 and 12

Clinical laboratory tests including erythropoietin were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12 Week 2	5.38 milliunits per milliliter Standard Deviation 7.042	15.78 milliunits per milliliter Standard Deviation 29.596	0.59 milliunits per milliliter Standard Deviation 7.412
Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12 Week 4	5.30 milliunits per milliliter Standard Deviation 6.286	14.60 milliunits per milliliter Standard Deviation 30.438	0.35 milliunits per milliliter Standard Deviation 8.294
Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12 Week 8	7.84 milliunits per milliliter Standard Deviation 8.305	34.12 milliunits per milliliter Standard Deviation 58.113	-1.99 milliunits per milliliter Standard Deviation 8.101
Change From Baseline in Erythropoietin at Week 2, 4, 8 and 12 Week 12	7.86 milliunits per milliliter Standard Deviation 15.831	54.08 milliunits per milliliter Standard Deviation 136.613	-3.11 milliunits per milliliter Standard Deviation 6.391

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 2, 4, 8 and 12

Clinical laboratory tests including thrombopoietin were performed at Week 2, 4, 8, and 12 by collecting blood samples and performing the corresponding analysis per the laboratory manual. Fasting was only required prior to labs that included the lipid profile panel.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12 Week 8	26.93 Picograms per milliliter (pg/mL) Standard Deviation 49.260	76.54 Picograms per milliliter (pg/mL) Standard Deviation 116.433	4.57 Picograms per milliliter (pg/mL) Standard Deviation 33.073
Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12 Week 2	38.33 Picograms per milliliter (pg/mL) Standard Deviation 61.921	47.64 Picograms per milliliter (pg/mL) Standard Deviation 38.472	13.29 Picograms per milliliter (pg/mL) Standard Deviation 31.665
Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12 Week 4	107.93 Picograms per milliliter (pg/mL) Standard Deviation 274.324	103.07 Picograms per milliliter (pg/mL) Standard Deviation 136.964	-9.36 Picograms per milliliter (pg/mL) Standard Deviation 31.030
Change From Baseline in Thrombopoietin at Week 2, 4, 8 and 12 Week 12	30.93 Picograms per milliliter (pg/mL) Standard Deviation 53.723	89.57 Picograms per milliliter (pg/mL) Standard Deviation 201.700	-7.00 Picograms per milliliter (pg/mL) Standard Deviation 30.166

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 2, 4, 8 and 12

The severity and frequency of itch (pruritus) during the night due to AD was assessed using the Night Time Itch Scale Score. Participants assessed their worst itching due to AD during their most recent night's sleep on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Higher scores indicated worse itch. The frequency of itch was assessed using a 5-point qualitative scale, with responses including "Never", "Rarely", "Sometimes", "Often" and "Almost Always".

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 Participants Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12 NRS01-Severity of Night Time Itch Week 2	-2.4 Units on a scale Standard Deviation 2.16	-4.6 Units on a scale Standard Deviation 2.79	-0.3 Units on a scale Standard Deviation 1.83
Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12 NRS01-Severity of Night Time Itch Week 4	-4.4 Units on a scale Standard Deviation 3.38	-4.9 Units on a scale Standard Deviation 3.52	-1.1 Units on a scale Standard Deviation 2.53
Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12 NRS01-Severity of Night Time Itch Week 8	-3.5 Units on a scale Standard Deviation 4.14	-5.5 Units on a scale Standard Deviation 3.52	-0.8 Units on a scale Standard Deviation 2.85
Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12 NRS01-Severity of Night Time Itch Week 12	-3.4 Units on a scale Standard Deviation 3.80	-4.8 Units on a scale Standard Deviation 3.77	-1.1 Units on a scale Standard Deviation 2.46
Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12 NRS01-Frequency of Night Time Itch Week 2	-0.8 Units on a scale Standard Deviation 0.91	-2.1 Units on a scale Standard Deviation 1.14	-0.2 Units on a scale Standard Deviation 1.08
Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12 NRS01-Frequency of Night Time Itch Week 4	-1.8 Units on a scale Standard Deviation 1.08	-2.5 Units on a scale Standard Deviation 1.09	-0.6 Units on a scale Standard Deviation 1.12
Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12 NRS01-Frequency of Night Time Itch Week 8	-1.4 Units on a scale Standard Deviation 1.35	-2.7 Units on a scale Standard Deviation 1.14	-0.6 Units on a scale Standard Deviation 1.39
Change From Baseline in Night Time Itch Scale Score at Week 2, 4, 8 and 12 NRS01-Frequency of Night Time Itch Week 12	-1.2 Units on a scale Standard Deviation 1.21	-2.5 Units on a scale Standard Deviation 1.45	-0.4 Units on a scale Standard Deviation 1.22

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose

Population: The PK analysis included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number Analyzed in each row refers to the number of participants with the corresponding PK parameter measured and analyzed at specified visit.

Pharmacokinetic (PK) samples were collected at Week 4 and 12 for measurement of plasma concentration of PF-04965842.

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Plasma PF-04965842 Concentration Day 29 Hour 0	14.77 nanogram per milliliter (ng/mL) Standard Deviation 29.293	135.7 nanogram per milliliter (ng/mL) Standard Deviation 272.53	—
Plasma PF-04965842 Concentration Day 29 30 minute	266.6 nanogram per milliliter (ng/mL) Standard Deviation 381.11	802.7 nanogram per milliliter (ng/mL) Standard Deviation 1128.2	—
Plasma PF-04965842 Concentration Day 85 30 minute	617.6 nanogram per milliliter (ng/mL) Standard Deviation 588.85	792.2 nanogram per milliliter (ng/mL) Standard Deviation 1013.9	—
Plasma PF-04965842 Concentration Day 85 Hour 4	433.0 nanogram per milliliter (ng/mL) Standard Deviation 255.44	1147 nanogram per milliliter (ng/mL) Standard Deviation 580.56	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose

PK samples were collected at Week 4 and 12 for measurement of plasma concentration of abrocitinib's metabolite PF-06471658 (M1).

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Plasma PF-06471658 (M1) Concentration Day 29 Hour 0	2.588 ng/mL Standard Deviation 3.4071	23.13 ng/mL Standard Deviation 47.649	—
Plasma PF-06471658 (M1) Concentration Day 29 30 minute	65.82 ng/mL Standard Deviation 137.66	95.54 ng/mL Standard Deviation 108.21	—
Plasma PF-06471658 (M1) Concentration Day 85 30 minute	92.51 ng/mL Standard Deviation 80.717	65.03 ng/mL Standard Deviation 51.765	—
Plasma PF-06471658 (M1) Concentration Day 85 Hour 4	82.84 ng/mL Standard Deviation 70.532	104.9 ng/mL Standard Deviation 80.782	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose

PK samples were collected at Week 4 and 12 for measurement of plasma concentration of abrocitinib's metabolite PF-07055087 (M2).

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Plasma PF-07055087 (M2) Concentration Day 29 Hour 0	9.933 ng/mL Standard Deviation 22.629	23.86 ng/mL Standard Deviation 40.798	—
Plasma PF-07055087 (M2) Concentration Day 29 30 minute	42.89 ng/mL Standard Deviation 66.789	73.84 ng/mL Standard Deviation 75.245	—
Plasma PF-07055087 (M2) Concentration Day 85 30 minute	77.56 ng/mL Standard Deviation 63.483	70.58 ng/mL Standard Deviation 67.136	—
Plasma PF-07055087 (M2) Concentration Day 85 Hour 4	100.0 ng/mL Standard Deviation 46.321	132.9 ng/mL Standard Deviation 69.048	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 29 Hour 0 (prior to dosing) and 30 miniute post-dose, Day 85 30 minute and Hour 4 post-dose

PK samples were collected at Week 4 and 12 for measurement of plasma concentration of abrocitinib's metabolites PF-07054874 (M4).

Outcome measures

Outcome measures
Measure	Abrocitinib 100 mg QD n=16 Participants Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 Participants Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Plasma PF-07054874 (M4) Concentration Day 29 Hour 0	16.10 ng/mL Standard Deviation 33.537	48.43 ng/mL Standard Deviation 83.563	—
Plasma PF-07054874 (M4) Concentration Day 29 30 minute	63.76 ng/mL Standard Deviation 80.663	153.4 ng/mL Standard Deviation 163.23	—
Plasma PF-07054874 (M4) Concentration Day 85 30 minute	149.9 ng/mL Standard Deviation 126.33	158.2 ng/mL Standard Deviation 174.55	—
Plasma PF-07054874 (M4) Concentration Day 85 Hour 4	170.4 ng/mL Standard Deviation 68.419	268.2 ng/mL Standard Deviation 173.11	—

Adverse Events

Abrocitinib 100 mg QD

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Abrocitinib 200 mg QD

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Abrocitinib 100 mg QD n=16 participants at risk Adult participants with moderate-to-severe AD received abrocitinib 100 mg QD for 12 weeks.	Abrocitinib 200 mg QD n=14 participants at risk Adult participants with moderate-to-severe AD received abrocitinib 200 mg QD for 12 weeks.	Placebo n=16 participants at risk Adult participants with moderate-to-severe AD received placebo QD for 12 weeks.
Infections and infestations Eczema herpeticum	0.00% 0/16 • Baseline up to 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/14 • Baseline up to 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.2% 1/16 • Number of events 1 • Baseline up to 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Periorbital cellulitis	0.00% 0/16 • Baseline up to 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/14 • Baseline up to 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.2% 1/16 • Number of events 1 • Baseline up to 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Sepsis	0.00% 0/16 • Baseline up to 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/14 • Baseline up to 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	6.2% 1/16 • Number of events 1 • Baseline up to 16 weeks The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

Other adverse events

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER