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

医学 特应性皮炎 随机对照试验 皮肤病科 外科
作者
Eric L. Simpson,Seth Forman,Jonathan I. Silverberg,Matthew Zirwas,Emanual Maverakis,George Han,Emma Guttman‐Yassky,Daniel Marnell,Robert Bissonnette,Jill Waibel,Fabio P. Nunes,Amy M. DeLozier,Robinette Angle,Margaret Gamalo,Katrin Holzwarth,Orin M. Goldblum,Jinglin Zhong,Jonathan Janes,Kim Papp
出处
期刊:Journal of The American Academy of Dermatology [Elsevier BV]
卷期号:85 (1): 62-70 被引量:108
标识
DOI:10.1016/j.jaad.2021.02.028
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. Baricitinib, an oral selective Janus kinase 1/Janus kinase 2 inhibitor, is being studied for moderate-to-severe atopic dermatitis (AD) in adults. 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. 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. 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. Short-term clinical trial results may not be generalizable to real-world settings. Baricitinib was efficacious for patients with moderate-to-severe AD with no new safety findings over 16 weeks.
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