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Baricitinib meets primary endpoint in adults with atopic dermatitis

Baricitinib met the primary endpoint in adults with moderate to severe atopic dermatitis in BREEZE-AD7, the third pivotal phase 3 trial of the BREEZE-AD program, which is expected to be completed later this year.

The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of baricitinib (Olumiant, Eli Lilly), an oral Janus kinase inhibitor, in combination with topical corticosteroids in adults with moderate to severe atopic dermatitis, according to a press release from Eli Lilly and Incyte.

Using baricitinib with standard-of-care topical corticosteroids significantly improved disease severity, assessed by the validated Investigator’s Global Assessment for AD score of “clear or almost clear” skin, at 16 weeks.

BREEZE-AD7 is the third of five placebo-controlled trials in the phase 3 program and included patients from Asia, Europe, South America and Australia.

Safety data were consistent with the known profile for the treatment.

Baricitinib 4 mg and 2 mg both met the primary endpoints in the BREEZE-AD1 and BREEZE-AD2 clinical trials, reported earlier this year.

Eli Lilly plans to report on the detailed 16-week data at future scientific meetings and in peer-reviewed journals. Additional data from the remaining two phase 3 trials will be announced later this year or in early 2020.

Olumiant is approved for the treatment of moderate to severe rheumatoid arthritis in adults in more than 60 countries, according to the release.