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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).
- Source :
- Journal of the American Academy of Dermatology; Jul2021, Vol. 85 Issue 1, p62-70, 9p
- Publication Year :
- 2021
-
Abstract
- <bold>Background: </bold>Baricitinib, an oral selective Janus kinase 1/Janus kinase 2 inhibitor, is being studied for moderate-to-severe atopic dermatitis (AD) in adults.<bold>Objective: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Limitations: </bold>Short-term clinical trial results may not be generalizable to real-world settings.<bold>Conclusion: </bold>Baricitinib was efficacious for patients with moderate-to-severe AD with no new safety findings over 16 weeks. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 01909622
- Volume :
- 85
- Issue :
- 1
- Database :
- Supplemental Index
- Journal :
- Journal of the American Academy of Dermatology
- Publication Type :
- Academic Journal
- Accession number :
- 150752111
- Full Text :
- https://doi.org/10.1016/j.jaad.2021.02.028