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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)

Published:February 15, 2021DOI:https://doi.org/10.1016/j.jaad.2021.02.028

      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.

      Key words

      Abbreviations used:

      AD (atopic dermatitis), AE (adverse event), EASI75 (≥75% improvement from baseline in the Eczema Area and Severity Index), HS (herpes simplex), JAK (Janus kinase), LSM (least squares mean), NRS (Numeric Rating Scale), RA (rheumatoid arthritis), SAE (serious adverse event), TEAE (treatment-emergent adverse event), vIGA-AD (validated Investigator Global Assessment for atopic dermatitis)
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