Baricitinib in patients with moderate-tosevere atopic dermatitis: Results from a randomized monotherapy phase 3 trial in the United States and Canada (BREEZE-AD5)

JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

卷:85

Article

Simpson, Eric L.¹  Forman, Seth²  Silverberg, Jonathan, I³  Zirwas, Matthew⁴  Maverakis, Emanual⁵  Han, George⁶  Guttman-Yassky, Emma⁶  Marnell, Daniel⁷  Bissonnette, Robert⁸  Waibel, Jill⁹  Nunes, Fabio P.¹⁰  DeLozier, Amy M.¹⁰  Angle, Robinette¹⁰  Gamalo, Margaret¹⁰  Holzwarth, Katrin¹⁰  Goldblum, Orin¹⁰  Zhong, Jinglin¹¹  Janes, Jonathan¹⁰  Papp, Kim¹² 

[1] Oregon Hlth & Sci Univ, 3181 Sw Sam Jackson Pk Rd, Portland, OR 97239 USA

[2] ForCare Clin Res, Tampa, FL USA

[3] George Washington Univ, Washington, DC USA

[4] Bexley Dermatol Res Clin, Bexley, OH USA

[5] Univ Calif Davis, Sacramento, CA 95817 USA

[6] Icahn Sch Med Mt Sinai, New York, NY 10029 USA

[7] Med Ctr Clin Res Wake Res, San Diego, CA USA

[8] Innovaderm Res, Montreal, PQ, Canada

[9] Miami Dermatol & Laser Inst, Miami, FL USA

[10] Eli Lilly & Co, Indianapolis, IN 46285 USA

[11] IQVIA, Morrisville, NY USA

[12] K Papp Clin Res & Prob Med Res, Waterloo, ON, Canada

关键词: adults;    atopic dermatitis;    baricitinib;    EASI;    eczema;    efficacy;    itch;    safety;    skin pain;    sleep;    vIGA;   

DOI  :  10.1016/j.jaad.2021.02.028

来源: Elsevier

【 摘 要 】

Background: Baricitinib, an oral selective Janus kinase 1/Janus kinase 2 inhibitor, is being studied for moderate-to-severe atopic dermatitis (AD) in adults. Objective: To evaluate the efficacy and safety of baricitinib monotherapy in a North American phase 3 trial (BREEZE-AD5/NCT03435081) of adults with moderate-to-severe AD who responded inadequately or were intolerant to topical therapy. Methods: Patients (N = 440) were randomized 1:1:1 to once-daily placebo or baricitinib (1 mg or 2 mg). The primary endpoint was the proportion of patients achieving >= 75% reduction in the Eczema Area and Severity Index at week 16. A key secondary endpoint was the proportion of patients achieving a validated Investigator Global Assessment for AD score of 0 (clear)/1(almost clear) with >= 2-point improvement. Results: At week 16, the proportion of patients achieving Eczema Area and Severity Index was 8%, 13%, and 30% (P < .001, 2 mg vs placebo) and those with a validated Investigator Global Assessment for AD score of 0/1 were 5%, 13%, and 24% (P < .001, 2 mg vs placebo) for placebo, baricitinib 1 mg, and baricitinib 2 mg, respectively. Safety findings were similar to those of other baricitinib AD studies. Limitations: Short-term clinical trial results may not be generalizable to real-world settings. Conclusion: Baricitinib was efficacious for patients with moderate-to-severe AD with no new safety findings over 16 weeks.

【 授权许可】

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