Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe atopic dermatitis after switching from dupilumab (JADE EXTEND).

Abstract

BACKGROUND:

Abrocitinib efficacy by prior dupilumab response status in patients with moderate-to-severe atopic dermatitis has not previously been assessed in phase 3 studies.

OBJECTIVE:

Examine efficacy and safety of abrocitinib among patients who received prior dupilumab.

METHODS:

Patients with moderate-to-severe atopic dermatitis received abrocitinib 200 mg or 100 mg once daily in JADE EXTEND (phase 3 extension) after dupilumab in double-blind, placebo-controlled phase 3 JADE COMPARE.

RESULTS:

Among prior dupilumab responders, ≥75% improvement in Eczema Area and Severity Index was achieved in 93.5% and 90.2% of patients who received 12 weeks of abrocitinib 200 mg and 100 mg, respectively; ≥4-point improvement in Peak Pruritus Numerical Rating Scale was achieved in 89.7% and 81.6%, respectively. Among prior dupilumab nonresponders, ≥75% improvement in Eczema Area and Severity Index was achieved with abrocitinib 200 mg and 100 mg in 80.0% and 67.7% and ≥4-point improvement in Peak Pruritus Numerical Rating Scale in 77.3% and 37.8%, respectively. Most common adverse events among abrocitinib-treated patients were nasopharyngitis, nausea, acne, and headache. Conjunctivitis occurred less frequently with abrocitinib in comparison to prior dupilumab.

LIMITATIONS:

Short-term, 12-week analysis; no placebo arm.

CONCLUSION:

Efficacy and safety profile of abrocitinib in JADE EXTEND supports the role of abrocitinib as a treatment for patients with moderate-to-severe atopic dermatitis, regardless of prior dupilumab response status.

• Authors: Vivian Y Shi, Tina Bhutani, Luz Fonacier, Mette Deleuran, Stephen Shumack, Hernan Valdez, Fan Zhang, Gary L Chan, Michael C Cameron, Natalie C Yin
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 87 Issue 2 Pg. 351-358 (08 2022) ISSN: 1097-6787 [Electronic] United States
• PMID: 35439608 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2022 American Academy of Dermatology, Inc. All rights reserved.

Chemical References

• Antibodies, Monoclonal, Humanized
• Pyrimidines
• Sulfonamides
• dupilumab
• abrocitinib

Topics

• Adult
• Antibodies, Monoclonal, Humanized
• Dermatitis, Atopic (drug therapy)
• Double-Blind Method
• Eczema (drug therapy)
• Humans
• Injections, Subcutaneous
• Pruritus (chemically induced, drug therapy)
• Pyrimidines
• Severity of Illness Index
• Sulfonamides
• Treatment Outcome