Phase 3
Completed N=727
Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
Atopic Dermatitis
Source: ClinicalTrials.gov NCT04345367 ↗
Enrolled (actual)
727
Serious AEs
1.7%
Results posted
Jul 2022
Primary outcomePrimary: Percentage of Participants Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) From Baseline at Week 2 — 48.2; 25.5 Percentage of participants — p=<0.0001
◆ Published Evidence
Emerging
10citations · ~10 / year
Switching from Dupilumab to Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of Efficacy After Treatment With Dupilumab in JADE DARE.
Summary
This is a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally QD compared with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines) in adult participants on background topical therapy, with moderate to severe AD. The treatment duration is 26 weeks. A total of approximately 600 participants will be enrolled from approximately 220 sites globally. Approximately 600 participants will be randomly assigned to study intervention. There are primary efficacy assessments at Week 2 and Week 4, and a key secondary efficacy assessment at Week 16. Efficacy and safety endpoints will be assessed throughout the entire study. Exploratory endpoints related to hand eczema efficacy will be assessed throughout the study.
Linked Publications (5)
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Switching from Dupilumab to Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of Efficacy After Treatment With Dupilumab in JADE DARE.
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Comparing how well abrocitinib and dupilumab treat atopic dermatitis signs and symptoms: a plain language summary.
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Efficacy and Safety of Variable-Dose Versus Continuous-Dose Abrocitinib Treatment in Patients with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis.
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Itch Relief and Quality-of-Life Improvement with Abrocitinib and Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of JADE COMPARE and JADE DARE.
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Do Allergic Comorbidities Alter the Efficacy and Safety of Abrocitinib or Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) From Baseline at Week 2 |
48.2; 25.5 | <0.0001 sig |
| PRIMARY Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4 |
28.5; 14.6 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving EASI-90 Response at Week 16 |
54.3; 41.9 | 0.0008 sig |
| SECONDARY Percentage of Participants Achieving EASI-90 Response at Weeks 2, 8, 12, 20 and 26 |
11.6; 7.2; 45.4; 25.4; 47.6; 33.6 | — |
| SECONDARY Percentage of Participants Achieving >= 75% Improvement From Baseline in EASI (EASI-75) Response at Weeks 2, 4, 8, 12, 16, 20 and 26 |
29.4; 21.3; 57.6; 36.8; 71.0; 52.8 | — |
| SECONDARY Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline up to Week 26 |
14.4; 7.2; 38.0; 17.6; 50.1; 30.9 | — |
| SECONDARY Percentage of Participants Achieving PP-NRS4 From Baseline at Days 2 to 15 |
11.0; 3.8; 15.1; 8.6; 22.1; 10.7 | — |
| SECONDARY Percentage of Participants Achieving PP-NRS4 From Baseline at Week 4, 8, 12, 16, 20 and 26 |
58.1; 40.8; 65.8; 52.7; 66.0; 61.5 | — |
| SECONDARY Time to Achieve >=4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) |
11.0; 25.0 | — |
| SECONDARY Percent Change From Baseline in the Percentage (%) Body Surface Area (BSA) Affected at Week 2, 4, 8, 12, 16, 20 and 26 |
-42.7; -33.4; -62.0; -49.5; -74.0; -62.8 | — |
| SECONDARY Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8, 12, 16, 20 and 26 |
-44.5; -33.5; -59.6; -46.8; -65.8; -55.6 | — |
| SECONDARY Change From Baseline in Total Anxiety Score Measured Using the Hospital Anxiety and Depression Scale (HADS) at Week 12,16 and 26 |
-0.8; -0.8; -1.1; -1.2; -1.1; -1.2 | — |
| SECONDARY Change From Baseline in Total Depression Score Measured Using the HADS at Week 12,16 and 26 |
-0.7; -0.7; -0.8; -0.9; -0.8; -1.0 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 2, 12, 16, 20 and 26 |
-8.6; -6.7; -10.7; -9.7; -10.8; -10.0 | — |
| SECONDARY Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12, 16 and 26 |
12.370; 11.552; 12.567; 10.474; 13.484; 14.300 | — |
| SECONDARY Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Week 12, 16 and 26 |
-14.2; -12.6; -14.2; -12.8; -13.8; -13.4 | — |
| SECONDARY Change From Baseline in Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) at Week 12, 16 and 26 |
0.7; 0.5; 0.6; 0.5; 0.5; 0.4 | — |
| SECONDARY Change From Baseline in Skin Pain NRS at Week 2, 12, 16, 20 and 26 |
-3.7; -2.6; -4.5; -4.0; -4.4; -4.2 | — |
| SECONDARY Medicated Topical Background Therapy-free Days |
51.4; 33.3 | — |
| SECONDARY Percentage of Participants Achieving >=4 Points Improvement From Baseline in DLQI at Week 2, 12, 16, 20 and 26 |
81.3; 67.5; 85.4; 81.4; 82.7; 84.2 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Diagnosis of chronic atopic dermatitis (AD) for at least 6 months
- Moderate to severe AD (BSA at least 10%, IGA at least 3, EASI at least 16, and PP-NRS severity score at least 4)
- Recent history of inadequate response to treatment with medicated topical therapy for AD, or who have required systemic therapies for control of their disease
Exclusion Criteria
- Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
- Have increased risk of developing venous thromboembolism
- Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
- Prior treatment with systemic JAK inhibitors or IL-4 or IL-13 antagonists including dupilumab, lebrikizumab or tralokinumab
- Other active non-AD inflammatory skin diseases or conditions affecting skin
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
- Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
Data sourced from ClinicalTrials.gov (NCT04345367) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.