Lilly, Incyte's JAK inhibitor baricitinib hits main goal in alopecia study

Eli Lilly and Incyte on Wednesday reported top-line results demonstrating that once-daily treatment with baricitinib met the primary endpoint of the Phase III BRAVE-AA2 study in adults with severe alopecia areata. The partners noted that there are currently no approved treatments for this condition in the US, where baricitinib has been granted breakthrough therapy designation, while the drug is the first JAK inhibitor to demonstrate hair regrowth in a late-stage trial.

The oral drug is currently sold as Olumiant in multiple countries, including the US, to treat certain patients with moderately-to-severely active rheumatoid arthritis. It is also cleared in the EU and Japan for adults with moderate-to-severe atopic dermatitis, making alopecia areata the second potential treatment indication for baricitinib in dermatology.

The BRAVE-AA2 study included 546 patients with ≥50% scalp hair loss, as measured by the Severity of Alopecia Tool (SALT), and a current episode of severe alopecia areata lasting at least six months, but no more than eight years. Participants were randomised to once-daily treatment with baricitinib at either the 2-mg or 4-mg doses, or placebo.

Readout from second trial due in H1

Eli Lilly and Incyte noted that both doses of baricitinib met the trial's primary endpoint, demonstrating significant improvement in scalp hair regrowth compared to placebo based on the percentage of participants achieving a SALT score of ≤ 20 after 36 weeks. Further, safety outcomes for baricitinib were consistent with its profile in rheumatoid arthritis and atopic dermatitis. The companies also said no deaths, major adverse cardiovascular events or venous thromboembolic events were reported in the BRAVE-AA2 trial.

"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," commented Lotus Mallbris, vice president of immunology development at Eli Lilly, adding "we are looking forward to sharing the totality of data from the overall clinical development programme for baricitinib as a potential first-in-disease treatment for alopecia areata." A readout from the Phase III BRAVE-AA1 trial in this indication is expected in the first half of this year.

Eli Lilly recently said Olumiant sales were up 50% in the fourth quarter of 2020 to $192.2 million. The drug is also being investigated as a potential treatment for systematic lupus erythematosus, juvenile idiopathic arthritis and COVID-19.

For related analysis, see Physician Views Results: JAKs could pose a threat to Dupixent.

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