Eli Lilly and Incyte reported Monday that two Phase III studies of Olumiant (baricitinib) for the treatment of adults with moderate-to-severe atopic dermatitis met their primary endpoints. Lotus Mallbris, vice president of immunology development at Eli Lilly, said "we are encouraged" by the top-line data for the once-daily, oral JAK inhibitor, "and look forward to seeing the collective results of all five studies."
The BREEZE-AD1 and BREEZE-AD2 trials randomised patients with moderate-to-severe atopic dermatitis to treatment with Olumiant or placebo. Eli Lilly and Incyte noted that Olumiant achieved the main goal at week 16 in both studies, defined by the Investigator's Global Assessment for AD score of clear or almost clear.
According to the companies, the incidence of treatment-emergent adverse events (AEs) and serious AEs with Olumiant were similar to placebo, with the most common treatment-emergent AEs being nasopharyngitis and headache. The drugmakers added that no venous thromboembolic events, major adverse cardiovascular events or deaths were identified.
Eli Lilly and Incyte indicated that data from both studies will be submitted for presentation at research conferences and publication in peer-reviewed journals later this year. Three further trials are ongoing, with top-line data expected later this year, with all five studies forming part of the placebo-controlled data programme designed to support global registrations for Olumiant in atopic dermatitis.
Olumiant has been authorised in more than 50 markets, including the US and EU, for the treatment of moderately-to-severely active rheumatoid arthritis. In December, Eli Lilly named Olumiant as one of its newer medicines predicted to drive overall sales this year to be between $25.3 billion and $25.8 billion, above analyst estimates of $24.7 billion.
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