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

被引:67
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
相关论文
共 30 条
[1]   Placebo response in phase 2 and 3 trials of systemic and biological therapies for atopic dermatitis-a systematic review and meta-analysis [J].
Andreasen, T. H. ;
Christensen, M. O. ;
Halling, A. -S. ;
Egeberg, A. ;
Thyssen, J. P. .
JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 2020, 34 (06) :1143-1150
[2]   Abrocitinib versus Placebo or Dupilumab for Atopic Dermatitis [J].
Bieber, Thomas ;
Simpson, Eric L. ;
Silverberg, Jonathan I. ;
Thaci, Diamant ;
Paul, Carle ;
Pink, Andrew E. ;
Kataoka, Yoko ;
Chu, Chia-Yu ;
DiBonaventura, Marco ;
Rojo, Ricardo ;
Antinew, Jeremias ;
Ionita, Ileana ;
Sinclair, Rodney ;
Forman, Seth ;
Zdybski, Jacek ;
Biswas, Pinaki ;
Malhotra, Bimal ;
Zhang, Fan ;
Valdez, Hernan .
NEW ENGLAND JOURNAL OF MEDICINE, 2021, 384 (12) :1101-1112
[3]   Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial [J].
Blauvelt, Andrew ;
de Bruin-Weller, Marjolein ;
Gooderham, Melinda ;
Cather, Jennifer C. ;
Weisman, Jamie ;
Pariser, David ;
Simpson, Eric L. ;
Papp, Kim A. ;
Hong, H. Chih-Ho ;
Rubel, Diana ;
Foley, Peter ;
Prens, Errol ;
Griffiths, Christopher E. M. ;
Etoh, Takafumi ;
Pinto, Pedro Herranz ;
Pujol, Ramon M. ;
Szepietowski, Jacek C. ;
Ettler, Karel ;
Kemeny, Lajos ;
Zhu, Xiaoping ;
Akinlade, Bolanle ;
Hultsch, Thomas ;
Mastey, Vera ;
Gadkari, Abhijit ;
Eckert, Laurent ;
Amin, Nikhil ;
Graham, Neil M. H. ;
Pirozzi, Gianluca ;
Stahl, Neil ;
Yancopoulos, George D. ;
Shumel, Brad .
LANCET, 2017, 389 (10086) :2287-2303
[4]   Quantifying patient preferences for systemic atopic dermatitis treatments using a discrete-choice experiment [J].
Boeri, Marco ;
Sutphin, Jessie ;
Hauber, Brett ;
Cappelleri, Joseph C. ;
Romero, William ;
Di Bonaventura, Marco .
JOURNAL OF DERMATOLOGICAL TREATMENT, 2022, 33 (03) :1449-1458
[5]   Atopic dermatitis yardstick: Practical recommendations for an evolving therapeutic landscape [J].
Boguniewicz, Mark ;
Fonacier, Luz ;
Guttman-Yassky, Emma ;
Ong, Peck Y. ;
Silverberg, Jonathan ;
Farrar, Judith Rosen .
ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY, 2018, 120 (01) :10-+
[6]   Acute arthritis and arthralgia as an adverse drug reaction to dupilumab [J].
de Wijs, L. E. M. ;
van der Waa, J. D. ;
de Jong, P. H. P. ;
Hijnen, D. J. .
CLINICAL AND EXPERIMENTAL DERMATOLOGY, 2020, 45 (02) :262-263
[7]  
Dupilumab, 2020, PRESCRIBING INFORM
[8]  
Dupixent, 2017, 300 MG SOL INJ PREF
[9]   Progression of cutaneous T-cell lymphoma after dupilumab: Case review of 7 patients [J].
Espinosa, Maria L. ;
Nguyen, Morgan T. ;
Aguirre, Amaia Saenz ;
Martinez-Escala, Maria Estela ;
Kim, Jane ;
Walker, Christina J. ;
Pontes, David S. ;
Silverberg, Jonathan I. ;
Choi, Jaehyuk ;
Pro, Barbara ;
Pincus, Laura B. ;
Guitart, Joan ;
Zhou, Xiaolong A. .
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2020, 83 (01) :197-199
[10]   Long-standing Dermatitis Treated With Dupilumab With Subsequent Progression to Cutaneous T-cell Lymphoma [J].
Hollins, L. Claire ;
Wirth, Paul ;
Fulchiero, Gregory J., Jr. ;
Foulke, Galen T. .
CUTIS, 2020, 106 (02) :E8-E11