Phase III BREEZE-AD3 trial of Olumiant shows long term efficacy in atopic dermatitis.- Eli Lilly and Incyte

Eli Lilly and Incyte announced new data for Olumiant (baricitinib) in moderate to severe atopic dermatitis (AD). In the data from BREEZE-AD3, a Phase III study evaluating the long-term efficacy and safety of baricitinib in adult patients with moderate to severe AD, responders were assessed by the validated Investigator Global Assessment score of "clear or almost clear" skin (vIGA 0,1) and partial responders (vIGA 2) from one of the 16-week originating studies entered and continued treatment with baricitinib 2-mg or 4-mg once daily for an additional 52 weeks. At the start of BREEZE-AD3 (after 16 weeks of treatment in the originating studies), 45.7% of responders and partial responders on 4-mg of baricitinib had a vIGA-AD score of 0 or 1, while 40% had a vIGA-AD score of 0 or 1 after 68 weeks of continuous therapy. Similarly, at the start of BREEZE-AD3 46.3% of responders and partial responders on 2-mg of baricitinib had a vIGA-AD score of 0 or 1, while 50% had a vIGA-AD score of 0 or 1 after 68 weeks of continuous therapy. These results indicate that baricitinib 4-mg and 2-mg dose groups were able to maintain clear or almost clear skin response rates through the 68-week treatment period. The safety profile in this study was consistent with the known safety findings of baricitinib in previous 16-week, placebo-controlled AD studies. Data will be presented at the 29th annual European Academy of Dermatology and Venereology (EADV) Congress taking place virtually October 29-31, 2020.