The Food and Drug Administration (FDA) has approved Olumiant (baricitinib), a Janus kinase (JAK) inhibitor, for the treatment of adults with severe alopecia areata.
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 BRAVE-AA1 (ClinicalTrials.gov Identifier: NCT03570749) and BRAVE-AA2 (ClinicalTrials.gov Identifier: NCT03899259) trials, which evaluated the efficacy and safety of Olumiant in 1200 adults with severe alopecia areata. The trials included patients with a Severity of Alopecia Tool (SALT) score of at least 50 (≥50% scalp hair loss) and a current episode of severe alopecia areata lasting at least 6 months but less than 8 years.
Patients were randomly assigned to receive either Olumiant 2mg once daily, Olumiant 4mg once daily, or placebo. The primary endpoint was the proportion of patients achieving at least 80% scalp hair coverage (SALT score of ≤20) at week 36.
In the BRAVE-AA1 trial, 22% and 35% of patients treated with Olumiant 2mg and 4mg, respectively, achieved adequate scalp hair coverage compared with 5% of patients who received placebo.
In the BRAVE-AA2 trial, 17% and 32% of patients treated with Olumiant 2mg and 4mg, respectively, achieved adequate scalp hair coverage compared with 3% of the placebo group.
Treatment with Olumiant 2mg and 4mg was also associated with a greater proportion of patients achieving the following secondary outcomes at week 36 compared with placebo, respectively:
- SALT score of less than or equal to 10: 13% and 26% vs 4% (BRAVE AA-1); 11% and 24% vs 1% (BRAVE AA-2).
- Scalp Hair Assessment PRO™ score of 0 (no missing hair) or 1 (a limited area of scalp hair loss [1-20%]) with at least a 2-point reduction on the 5-point scale: 16% and 33% vs 5% (BRAVE AA-1); 16% and 34% vs 4% (BRAVE AA-2).
In the BRAVE-AA2 trial, patients who achieved adequate scalp hair coverage on Olumiant 4mg at 52 weeks of treatment were randomly assigned to receive Olumiant 2mg or remain on Olumiant 4mg for an additional 24 weeks. Findings showed that 75% (n=30/40) of patients who received Olumiant 2mg and 98% (n=41/42) of those who continued on Olumiant 4mg maintained response.
“People with alopecia areata, dermatologists and other health care providers have been looking forward to this day when there is an FDA-approved systemic medicine for this often-devastating disease,” said Brett King, MD, PhD, FAAD, associate professor of dermatology at Yale School of Medicine and lead investigator of the BRAVE-AA program. “The results of clinical trials are remarkable, as 1 in 5 adults taking Olumiant 2mg/day and 1 in 3 taking Olumiant 4mg/day achieved significant hair regrowth resulting in 80% or more scalp coverage, and eyebrow and eyelash improvements were also achieved for patients taking Olumiant 4mg/day with substantial eyebrow or eyelash hair loss.”
In the alopecia areata trials, the most common adverse reactions reported with Olumiant were upper respiratory tract infections, headache, acne, hyperlipidemia, increased creatinine phosphokinase, urinary tract infection, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and increased weight.
“There is a significant unmet medical need for people with alopecia areata given there has never been an FDA-approved systemic medicine,” said Patrik Jonsson, Lilly senior vice president, president of Lilly Immunology and Lilly USA, and chief customer officer. “Olumiant’s approval is a historic moment, and we’re delighted about what it can mean for adults with severe alopecia areata.”
- FDA approves first systemic treatment for alopecia areata. News release. US Food and Drug Administration. June 13, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-systemic-treatment-alopecia-areata
- FDA approves Lilly and Incyte’s Olumiant® (baricitinib) as first and only systemic medicine for adults with severe alopecia areata. June 13, 2022. https://www.prnewswire.com/news-releases/fda-approves-lilly-and-incytes-olumiant-baricitinib-as-first-and-only-systemic-medicine-for-adults-with-severe-alopecia-areata-301567120.html
- Olumiant. Package insert. Eli Lilly and Company; 2022. Accessed June 13, 2022. https://pi.lilly.com/us/olumiant-uspi.pdf