当前位置： SCI文献检索 > JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY期刊下所有文献 > Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study.

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

Abstract：

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.

journal_name

J Am Acad Dermatol

journal_title

Journal of the American Academy of Dermatology

authors

Deleuran M,Thaçi D,Beck LA,de Bruin-Weller M,Blauvelt A,Forman S,Bissonnette R,Reich K,Soong W,Hussain I,Foley P,Hide M,Bouaziz JD,Gelfand JM,Sher L,Schuttelaar MLA,Wang C,Chen Z,Akinlade B,Gadkari A,Eckert L,Da

doi

10.1016/j.jaad.2019.07.074

subject

Has Abstract

pub_date

2020-02-01 00:00:00

pages

377-388

issue

2

eissn

0190-9622

issn

1097-6787

pii

S0190-9622(19)32465-X

journal_volume

82

pub_type

杂志文章,多中心研究

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