Baricitinib achieves primary endpoint in BREEZE-AD4, BREEZE-AD5 studies

Eli Lilly and Company and Incyte announced that baricitinib met its primary endpoint in the BREEZE-AD4 and BREEZE-AD5 studies in patients with moderate to severe atopic dermatitis, according to two press releases.

“There is a high need for additional treatment options for patients living with moderate to severe AD, particularly those who failed conventional systemic treatments like cyclosporine,” Lotus Mallbris, MD, PhD, vice president of immunology development at Lilly, said in the BREEZE-AD4 release.

The primary endpoint for both studies was the proportion of patients who achieved a 75% or greater change in Eczema Area and Severity Index from baseline to week 16.

BREEZE-AD4 is a multicenter, double-blind, randomized, placebo-controlled study conducted outside the U.S. that assessed the safety and efficacy of three doses of baricitinib (1 mg [n = 93], 2 mg [n = 185] and 4 mg [n = 92]) compared with placebo (n = 93) in patients with moderate to severe AD who did not respond to, were intolerant to or had contraindications to cyclosporine.

BREEZE-AD5 is a multicenter, double-blind, randomized, placebo-controlled study evaluating the safety and efficacy of two doses of baricitinib (1 mg [n=147] and 2 mg [n=146]) compared with placebo (n=147).

Results from BREEZE-AD4 showed that the 4 mg dose of baricitinib plus topical corticosteroids met the primary endpoint (31.5% vs. 17.2% for placebo; P ≤ .05). In BREEZE-AD5, the 2 mg dose of baricitinib met the primary endpoint (29.5% vs 8.2% for placebo, P ≤ .001).

The safety profile for both studies was consistent with other findings of baricitinib in AD, and no venous thromboembolic events or deaths were reported.

Compared with placebo in BREEZE-AD4, all three doses of baricitinib were associated with a significant four-point improvement in Itch Numeric Rating Scale (NRS) at week 16: 23.1% for the 1 mg group (P ≤ .05), 22.9% for the 2 mg group (P ≤ .01) and 38.2% for the 4 mg group (P ≤ .001) vs. 8.2% for placebo. In BREEZE-AD5, both doses of baricitinib had significant four-point improvement in Itch NRS at week 16: 15.9% for the 1 mg group (P ≤ .05) and 25.2% for the 2 mg group (P ≤ .001) vs 5.7% for placebo.

“The results show the potential that baricitinib could offer as an additional treatment option for patients where there are otherwise limited choices,” 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, said in a release.

Baricitinib is approved to treat adults with moderately to severely active rheumatoid arthritis in more than 60 countries, including the U.S., member states of the EU and Japan.