Magnitude and Time Course of Response to Abrocitinib for Moderate-to-Severe Atopic Dermatitis

被引:8
|
作者
Reich, Kristian [1 ]
Lio, Peter A. [2 ]
Bissonnette, Robert [3 ]
Alexis, Andrew F. [4 ]
Lebwohl, Mark G. [5 ]
Pink, Andrew E. [6 ]
Kabashima, Kenji [7 ]
Boguniewicz, Mark [8 ,9 ]
Nowicki, Roman J. [10 ]
Valdez, Hernan [11 ]
Zhang, Fan [12 ]
DiBonaventura, Marco [11 ]
Cameron, Michael C. [11 ]
Clibborn, Claire [13 ]
机构
[1] Univ Med Ctr Hamburg Eppendorf, Hamburg, Germany
[2] Northwestern Univ, Feinberg Sch Med, Chicago, IL USA
[3] Innovaderm Res Inc, Montreal, PQ, Canada
[4] Weill Cornell Med, New York, NY USA
[5] Icahn Sch Med Mt Sinai, New York, NY USA
[6] Guys & St Thomas NHS Fdn Trust, St Johns Inst Dermatol, London, England
[7] Kyoto Univ, Grad Sch Med, Kyoto, Japan
[8] Nat Jewish Hlth, Denver, CO USA
[9] Univ Colorado, Sch Med, Denver, CO USA
[10] Med Univ Gdansk, Pomorskie, Poland
[11] Pfizer Inc, New York, NY USA
[12] Pfizer Inc, Groton, CT USA
[13] Pfizer Ltd, Dorking Rd, Tadworth KT20 7NS, Surrey, England
关键词
Atopic dermatitis; Abrocitinib; Dupilumab; Janus kinase inhibitor; PLACEBO; DUPILUMAB; ADULTS;
D O I
10.1016/j.jaip.2022.08.042
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
BACKGROUND: Emerging treatments for moderate-to-severe atopic dermatitis (AD) may provide greater and faster improvement in AD signs and symptoms than current therapies. OBJECTIVE: To examine JADE COMPARE (NCT03720470) data using stringent efficacy end points. METHODS: Adults with moderate-to-severe AD were randomly assigned 2:2:2:1 to receive oral abrocitinib 200 or 100 mg once daily, subcutaneous dupilumab 300 mg every 2 weeks (600-mg loading dose), or placebo, with medicated topical therapy for 16 weeks. Stringent response thresholds were applied for Eczema Area and Severity Index (EASI), Investigator's Global Assessment, Dermatology Life Quality Index, Peak Pruritus Numerical Rating Scale, and Night Time Itch Scale severity. RESULTS: At week 16, 48.9%, 38.0%, and 38.8% of the abrocitinib 200-mg, 100-mg, and dupilumab groups, respectively, achieved greater than or equal to 90% improvement from baseline in EASI versus 11.3% placebo; 14.9%, 12.6%, and 6.5% achieved Investigator's Global Assessment 0 (clear) versus 4.8% placebo; 29.7%, 21.6%, and 24.0% achieved Dermatology Life Quality Index 0/1 (no/minimal impact on quality of life) versus 10.6% placebo; and 57.1%, 44.5%, and 46.1% achieved Night Time Itch Scale severity 0/1 (no/minimal night-time itch) versus 31.9% placebo. Kaplan-Meier median time to greater than or equal to 90% improvement from baseline in EASI was 59, 113, and 114 days in the abrocitinib 200-mg, 100-mg, and dupilumab groups, respectively, and was not evaluable for placebo; median time to Peak Pruritus Numerical Rating Scale 0/1 (no/ very minimal itch) was 86 and 116 days for abrocitinib 200-mg and dupilumab groups, respectively, and was not evaluable for abrocitinib 100-mg and placebo groups. CONCLUSIONS: A greater proportion of patients treated with abrocitinib than placebo had almost complete control of AD signs and symptoms. (c) 2022 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
引用
收藏
页码:3228 / +
页数:12
相关论文
共 50 条
  • [41] Integrated safety analysis of abrocitinib in 3802 patients with moderate-to-severe atopic dermatitis with over 5000 patientyears of exposure
    Simpson, Eric L.
    Silverberg, Jonathan I.
    Nosbaum, Audrey
    Winthrop, Kevin
    Guttman-Yassky, Emma
    Egeberg, Alexander
    Fan, Haiyun
    Alderfer, Justine
    Johnson, Susan
    Farooqui, Saleem
    ALLERGY AND ASTHMA PROCEEDINGS, 2024, 45 (01)
  • [42] Time to improvement in daily signs and symptoms associated with atopic dermatitis (AD) in patients with moderate-to-severe AD in pooled monotherapy studies of abrocitinib
    Gooderham, Melinda J.
    Lebwohl, Mark G.
    Simpson, Eric L.
    JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2022, 87 (03) : AB120 - AB120
  • [43] Patient Preferences in the Treatment of Moderate-to-severe Atopic Dermatitis
    Ameen, Mahreen
    Alhusaye, Raed
    Brandi, Henrik
    Bogelund, Mette
    Jensen, Henrik H.
    Reitzel, Signe B.
    Thyssen, Jacob P.
    ACTA DERMATO-VENEREOLOGICA, 2024, 104
  • [44] Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis
    Beck, Lisa A.
    Thaci, Diamant
    Hamilton, Jennifer D.
    Graham, Neil M.
    Bieber, Thomas
    Rocklin, Ross
    Ming, Jeffrey E.
    Ren, Haobo
    Kao, Richard
    Simpson, Eric
    Ardeleanu, Marius
    Weinstein, Steven P.
    Pirozzi, Gianluca
    Guttman-Yassky, Emma
    Suarez-Farinas, Mayte
    Hager, Melissa D.
    Stahl, Neil
    Yancopoulos, George D.
    Radin, Allen R.
    NEW ENGLAND JOURNAL OF MEDICINE, 2014, 371 (02): : 130 - 139
  • [45] Symptom burden of patients with moderate-to-severe atopic dermatitis
    Alexander Egeberg
    Peter Anderson
    James Piercy
    Lucy Massey
    Joseph C. Cappelleri
    Gerardo A. Encinas
    Claire Feeney
    Marco Dibonaventura
    European Journal of Dermatology, 2021, 31 : 752 - 758
  • [46] Symptom burden of patients with moderate-to-severe atopic dermatitis
    Egeberg, Alexander
    Anderson, Peter
    Piercy, James
    Massey, Lucy
    Cappelleri, Joseph C.
    Encinas, Gerardo A.
    Feeney, Claire
    Dibonaventura, Marco
    EUROPEAN JOURNAL OF DERMATOLOGY, 2021, 31 (06) : 752 - 758
  • [47] Predictive Factors of Early Response to Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis
    Ferrucci, Silvia
    Casazza, Giovanni
    Zussino, Martina
    Tavecchio, Simona
    Marzano, Angelo V.
    Tedeschi, Micol
    JOURNAL OF CLINICAL MEDICINE, 2023, 12 (20)
  • [48] Long-term management of moderate-to-severe atopic dermatitis with abrocitinib: a phase III extension study (JADE EXTEND)
    Reich, K.
    Silverberg, J. I.
    Papp, K.
    Deleuran, M.
    Katoh, N.
    Strober, B.
    Beck, L. A.
    de Bruin-Weller, M.
    Werfel, T.
    Zhang, F.
    Biswas, P.
    DiBonaventura, M.
    Chan, G. L.
    Farooqui, S. A.
    Kerkmann, U.
    Clibborn, C.
    BRITISH JOURNAL OF DERMATOLOGY, 2021, 185 (03) : E141 - E142
  • [49] EFFICACY AND SAFETY OF ABROCITINIB MONOTHERAPY IN ADULTS AND ADOLESCENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS: A POST HOC ANALYSIS OF JADE REGIMEN
    Flohr, Carsten
    Cork, Michael J.
    Eichenfield, Lawrence F.
    Feeney, Claire
    Koppersteiner, Herwig
    Lazariciu, Irina
    Nesnas, John
    ACTA DERMATO-VENEREOLOGICA, 2022, 102 : 31 - 31
  • [50] Validation of the pruritus and symptoms assessment for atopic dermatitis in adults with moderate-to-severe atopic dermatitis
    Lebwohl, M. G.
    Simpson, E. L.
    Bushmakin, A. G.
    Cappelleri, J. C.
    Gooderham, M. J.
    Wollenberg, A.
    Hall, R.
    Gater, A.
    Wells, J. R.
    Papacharalambous, J.
    Hsu, M. A.
    Tallman, A. M.
    Peeva, E.
    Zhang, W.
    Chen, L.
    BRITISH JOURNAL OF DERMATOLOGY, 2018, 179 (01) : E44 - E44