Eli Lilly and Incyte announce results from its phase 3 study evaluating baricitinib 2 mg and 4 mg for the treatment of alopecia areata, making it the first phase 3 study with top-line results in patients with the hair disorder.
Eli Lilly and Company and Incyte Corporation announced positive results from its phase 3 study evaluating the safety and efficacy of baricitinib (Olumiant) 2 mg and 4 mg in adult patients with severe alopecia areata (AA).
"For patients who suffer from alopecia areata, it is not a cosmetic condition, it is a devastating autoimmune disease that can have significant psychological effects. They lose much more than just hair," said Lotus Mallbris, MD, PhD, vice president of immunology development at Eli Lilly. "We are looking forward to sharing the totality of data from the overall clinical development program for baricitinib as a potential first-in-disease treatment for alopecia areata."
Baricitinib is a once-daily, oral JAK inhibitor approved in the United States and over 70 countries as treatment for adults with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. The medication was also recently approved in the European Union and Japan for the treatment of moderate to severe atopic dermatitis (AD) in adult patients who are candidates for systemic therapy, according to a press release.1
Most recently, the FDA granted baricitinib Breakthrough Therapy designation for the treatment of AA.1 Currently, there are no FDA-approved treatments for AA.
The study (BRAVE-AA2), is a multicenter, randomized, double-blind, placebo-controlled study enrolled 546 adults with a Severity of Alopecia Tool (SALT) score ≥ 50 and a current episode of severe AA lasting at least 6 months but no more than 8 years. The patient population included participants from Argentina, Australia, Brazil, China, Israel, Japan, South Korea, Taiwan, and the U.S.
Investigators evaluated the safety and efficacy of baricitinib 2 mg and 4 mg in study patients. Both doses met the primary efficacy endpoint of demonstrating a statistically significant improvement in scalp hair regrowth compared to placebo at Week 36.1
The safety profile of baricitinib in BRAVE-AA2 was consistent with previous safety profiles in patients with RA and AD. The study reported no deaths, major adverse cardiovascular events (MACE), or venous thromboembolic events (VTEs).1
According to the release, BRAVE-AA2 is the first phase 3 study with top-line results in patients with AA.1
"These positive results are very promising and suggest that baricitinib has the potential to address the urgent needs of people living with alopecia areata," said Brett King, MD, PhD, associate professor of dermatology at Yale School of Medicine. "This level of high-quality research is needed to advance our understanding and the treatment of this frequently devastating disease."
Additional data from BRAVE-AA2 will be available in the first half of 2021, with detailed results from the BRAVE program expected to be presented at a future medical conference, as well as published in a peer-reviewed journal.
"Significant unmet need exists in the treatment of alopecia areata," said Abby Ellison, research director at the National Alopecia Areata Foundation (NAAF). "We appreciate Lilly's important work in this area and are excited that these data could bring us closer to a potential new treatment option for patients."