Positive top-line results from the BREEZE-AD5 Phase III study of baricitinib for moderate to severe atopic dermatitis. Eli Lilly + Incyte Corpn.

Eli Lilly and Company and Incyte Corporation announced that baricitinib met the primary endpoint in BREEZE-AD7, the third pivotal Phase III trial in the BREEZE-AD program to be completed in 2019. BREEZE-AD7, an investigational study evaluating the efficacy and safety of baricitinib, an oral JAK inhibitor, to treat moderate to severe atopic dermatitis (AD) in adults met its primary endpoint. Adding baricitinib to standard-of-care topical corticosteroids significantly improved disease severity, measured by the validated Investigator's Global Assessment for AD (vIGA) score of "clear or almost clear" skin (vIGA 0, 1), the primary endpoint of the study at 16 weeks. BREEZE-AD5 is a multicenter, double-blind, randomized, placebo-controlled study designed for and conducted in North America, evaluating the efficacy and safety of the 1-mg and 2-mg doses of baricitinib monotherapy for the treatment of adult patients with moderate to severe AD. In this study, the 2-mg dose of baricitinib met the primary endpoint as defined by the proportion of participants achieving EASI75 at Week 16, and key secondary endpoints including another measure of skin inflammation defined by clear or almost clear skin and at least 2 points improvement on the validated Investigator's Global Assessment for AD (vIGA 0 or 1 at Week 16), and reduced itch severity. The safety profile in BREEZE-AD5 was consistent with the known safety findings of baricitinib in AD. The most common treatment-emergent adverse events (TEAEs) included upper respiratory tract infections, nasopharyngitis, and diarrhea. No venous thromboembolic events (VTEs) or deaths were reported in the trial. Lilly recently submitted baricitinib for regulatory review in Europe as a treatment for patients with moderate to severe AD and plans to submit for approval in the U.S. and Japan in 2020. The full results from the BREEZE-AD5 study will be disclosed at future scientific venues and in peer-reviewed journals.