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.
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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.
Authors: Aaron M Drucker; Deanna E Morra; David Prieto-Merino; Alexandra G Ellis; Zenas Z N Yiu; Bram Rochwerg; Sonya Di Giorgio; Bernd W M Arents; Tim Burton; Phyllis I Spuls; Jochen Schmitt; Carsten Flohr Journal: JAMA Dermatol Date: 2022-05-01 Impact factor: 11.816
Authors: Jonathan I Silverberg; H Chih-Ho Hong; Jacob P Thyssen; Brian M Calimlim; Avani Joshi; Henrique D Teixeira; Eric B Collins; Marjorie M Crowell; Scott J Johnson; April W Armstrong Journal: Dermatol Ther (Heidelb) Date: 2022-04-18
Authors: Jonathan I Silverberg; Eric L Simpson; April W Armstrong; Marjolein S de Bruin-Weller; Alan D Irvine; Kristian Reich Journal: Am J Clin Dermatol Date: 2021-10-26 Impact factor: 7.403