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

被引:52
|
作者
Shi, Vivian Y. [1 ]
Bhutani, Tina [2 ]
Fonacier, Luz [3 ]
Deleuran, Mette [4 ]
Shumack, Stephen [5 ]
Valdez, Hernan [6 ]
Zhang, Fan [7 ]
Chan, Gary L. [7 ]
Cameron, Michael C. [6 ]
Yin, Natalie C. [6 ]
机构
[1] Univ Arkansas Med Sci, Dept Med, Little Rock, AR 72205 USA
[2] Univ Calif San Francisco, Dept Dermatol, San Francisco, CA 94143 USA
[3] New York Univ Langone Hosp Long Isl, New York, NY USA
[4] Aarhus Univ Hosp, Dept Dermatol, Aarhus, Denmark
[5] Univ Sydney, Royal North Shore Hosp, Dept Dermatol, Sydney, NSW, Australia
[6] Pfizer Inc, New York, NY USA
[7] Pfizer Inc, 500 Arcola Rd, Groton, CT USA
关键词
abrocitinib; atopic dermatitis; dupilumab; efficacy; response; safety; PLACEBO; PROGRESSION; TRIALS;
D O I
10.1016/j.jaad.2022.04.009
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
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.
引用
收藏
页码:351 / 358
页数:8
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