Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that baricitinib met the primary endpoint in BREEZE-AD5, an investigational Phase 3, randomized, placebo-controlled study evaluating the safety and efficacy of baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis (AD). The primary endpoint was defined by the proportion of patients achieving at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) at Week 16.
"Today's results, together with the previously reported positive top-line results from our Phase 3 trials, reinforce our commitment to pursue the first oral JAK inhibitor treatment in the U.S. for individuals living with the chronic and often relapsing skin condition that is AD," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly.
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.
Baricitinib 1-mg (n=147)
Baricitinib 2-mg (n=146)
EASI75 at Week 16, n (%)
19 (12.9) ǂ
vIGAa of 0 or 1 at Week 16, n (%)
4-point improvement in Itch NRS at
ǂ P n.s. * P ≤ 0.05, and *** P≤0.001 for baricitinib compared to placebo by analysis unadjusted for multiplicity. Non-responder imputation upon rescue with Topical corticosteroid (TCS).
avIGA = validated Investigator's Global Assessment.
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.
"The results show the potential that baricitinib could offer as an additional treatment option to patients where there are otherwise limited choices," said Eric Simpson, MD, MCR, Professor of Dermatology and Director of Clinical Research at Oregon Health & Science University in Portland, and global Principal Investigator for the BREEZE-AD5 clinical development program.
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.
Baricitinib is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in more than 60 countries, including the U.S., member states of the EU and Japan, and is marketed as OLUMIANT®.