Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study

JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

卷:82

Article

Deleuran, Mette¹  Thaci, Diamant²  Beck, Lisa A.³  de Bruin-Weller, Marjolein⁴  Blauvelt, Andrew⁵  Forman, Seth⁶  Bissonnette, Robert⁷  Reich, Kristian^8,9  Soong, Weily¹⁰  Hussain, Iftikhar¹¹  Foley, Peter¹²  Hide, Michihiro¹³  Bouaziz, Jean-David¹⁴  Gelfand, Joel M.¹⁵  Sher, Lawrence¹⁶  Schuttelaar, Marie L. A.¹⁷  Wang, Chen¹⁸  Chen, Zhen¹⁹  Akinlade, Bolanle¹⁹  Gadkari, Abhijit¹⁹  Eckert, Laurent²⁰  Davis, John D.¹⁹  Rajadhyaksha, Manoj¹⁹  Staudinger, Heribert²¹  Graham, Neil M. H.¹⁹  Pirozzi, Gianluca²¹  Ardeleanu, Marius¹⁹ 

[1] Aarhus Univ Hosp, Aarhus, Denmark

[2] Univ Lubeck, Lubeck, Germany

[3] Univ Rochester, Med Ctr, Rochester, NY 14642 USA

[4] Univ Med Ctr Utrecht, Utrecht, Netherlands

[5] Oregon Med Res, Portland, OR USA

[6] Forman Dermatol & Skin Canc Inst, Tampa, FL USA

[7] Innovaderm Res, Montreal, PQ, Canada

[8] Univ Med Ctr Hamburg Eppendorf, Skinflammat Ctr, Inst Hlth Serv Res Dermatol & Nursing, Ctr Translat Res Inflammatory Skin Dis, Hamburg, Germany

[9] Dermatologikum Berlin, Berlin, Germany

[10] Alabama Allergy & Asthma Ctr, Birmingham, AL USA

[11] Vital Prospects Clin Res Inst, PC, Tulsa, OK USA

[12] Univ Melbourne, Skin & Canc Fdn Inc, Carlton, Vic, Australia

[13] Hiroshima Univ, Hiroshima, Japan

[14] St Louis Hosp, Paris, France

[15] Univ Penn, Philadelphia, PA 19104 USA

[16] Peninsula Res Associates, Rolling Hills Estates, CA USA

[17] Univ Groningen, Univ Med Ctr Groningen, Groningen, Netherlands

[18] Regeneron Pharmaceut Inc, Basking Ridge, NJ USA

[19] Regeneron Pharmaceut Inc, 777 Old Saw Mill River Rd, Tarrytown, NY 10591 USA

[20] Sanofi, Chilly Mazarin, France

[21] Sanofi, Bridgewater, NJ USA

关键词: atopic dermatitis;    biologic therapy;    dupilumab;    IL-4;    IL-13;    long-term;    open label;    monoclonal antibody;    efficacy;    quality of life;    safety;   

DOI  :  10.1016/j.jaad.2019.07.074

来源: Elsevier

【 摘 要 】

Background: Significant unmet need exists for long-term treatment of moderate to severe atopic dermatitis (AD). Objective: To assess the long-term safety and efficacy of dupilumab in patients with AD. Methods: This ongoing, multicenter, open-label extension study (NCT01949311) evaluated long-term dupilumab treatment in adults who had previously participated in phase 1 through 3 clinical trials of dupilumab for AD. This analysis examined patients given 300 mg dupilumab weekly for up to 76 weeks at data cutoff (April 2016). Safety was the primary outcome; efficacy was also evaluated. Results: Of 1491 enrolled patients (1042.9 patient-years), 92.9% were receiving treatment at cutoff. The safety profile was consistent with previously reported trials (420.4 adverse events/100 patient-years and 8.5 serious adverse events/100 patient-years), with no new safety signals; common adverse events included nasopharyngitis, conjunctivitis, and injection-site reactions. Sustained improvement was seen up to 76 weeks in all efficacy outcomes, including measures of skin inflammation, pruritus, and quality of life. Limitations: Lack of control arm, limited number of patients with 76 weeks or longer of treatment (median follow-up, 24 weeks), and patients not receiving the approved dose regimen of 300 mg every 2 weeks. Conclusion: The safety and efficacy profile from this study supports the role of dupilumab as continuous long-term treatment for patients with moderate to severe AD.

【 授权许可】

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