Olumiant (baricitinib) delivered high rates of hair regrowth for adolescents with severe alopecia areata in phase III BRAVE-AA-PEDS study – Eli Lilly

Late-breaking results from Eli Lilly and Company and Incyte found adolescent patients (ages 12 to under 18) with severe alopecia areata (AA) treated with once-daily, oral baricitinib 4 mg and 2 mg saw clinically meaningful improvements in hair regrowth on the scalp, eyebrows and eyelashes at Week 36. Findings from the Phase III BRAVE-AA-PEDS study were presented in a late-breaker presentation at the American Academy of Dermatology (AAD) Annual Meeting in Orlando. AA is an immune system condition that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress over time. Approximately 40% of patients with AA experience first onset by 20 years of age.

“Early onset alopecia areata can be more severe, leading to extensive hair loss that frequently does not improve with topicals or corticosteroids often prescribed as first-line therapy,” said Brittany Craiglow, M.D., Adjunct Associate Professor of Dermatology, Yale School of Medicine. “These initial results are exciting because they demonstrate that baricitinib can provide significant hair regrowth for adolescents at 36 weeks, a promising early signal of baricitinib’s potential as an effective treatment for adolescents with severe disease.”

In the BRAVE-AA-PEDS study, 257 patients were randomized to receive once-daily baricitinib 4 mg, baricitinib 2 mg or placebo. The primary endpoint of this study was a Severity of Alopecia Tool (SALT) score ≤20 (i.e., 80% or more scalp hair coverage) at Week 36. At the start of the study, patients had an average of 89% scalp hair loss (near total hair loss), 65% had minimal or no eyebrow hair (clinician-reported outcome [ClinRO] score of 2 or 3) and 57% had minimal or no eyelash hair (ClinRO score of 2 or 3). At Week 36:

i) 60.0% of patients receiving baricitinib 4 mg and 36.9% of patients receiving baricitinib 2 mg saw at least a 50% improvement in their disease (as measured by SALT score) compared to 5.7% on placebo (p=0.001).

ii) 42.4% of patients receiving baricitinib 4 mg and 27.4% of patients receiving baricitinib 2 mg achieved 80% or more scalp hair coverage, compared to 4.5% on placebo (p=0.001).

iii) 36.5% of patients receiving baricitinib 4 mg and 21.4% of patients receiving baricitinib 2 mg had 90% or more scalp hair coverage (SALT ≤10), compared to 2.3% on placebo (p=0.001).

iv) 50.0% of patients receiving baricitinib 4 mg and 24.1% of patients receiving baricitinib 2 mg achieved significant eyebrow regrowth (ClinRO scores of 0 or 1 with a ≥2 point improvement from baseline) compared to 0% on placebo (p<0.01).

v) 42.9% of patients receiving baricitinib 4 mg achieved significant eyelash regrowth, and 25.5% receiving baricitinib 2 mg saw improved eyelash regrowth, compared to 14.0% on placebo (p=0.002 for 4 mg, p=0.097 for 2 mg).

Results achieved by adolescents at 36 weeks were comparable to results achieved by adults after 52 weeks of treatment, suggesting that hair regrowth may be faster in adolescents compared to adults. In the BRAVE-AA1 and BRAVE-AA2 studies, 40.9% of adult patients treated with baricitinib 4 mg and 21.2% of patients treated with baricitinib 2 mg achieved 80% or more scalp hair coverage at Week 52.

“With these data, baricitinib is the most well-studied JAK inhibitor in severe alopecia areata, a chronic immune system disorder that can have an especially devastating social and emotional impact on adolescent patients and their families,” said Anabela Cardoso, senior vice president, Lilly Immunology Medical Affairs. “We are excited about these initial results, which show baricitinib can provide significant scalp hair regrowth in adolescents, potentially at an even faster rate compared to adults. We look forward to sharing longer-term data results at upcoming congresses and discussing findings with global regulators in the months ahead.”

The most common treatment-emergent adverse events in BRAVE-AA-PEDS included acne, influenza and upper respiratory tract infection. A higher frequency of serious adverse events was seen in the placebo group compared to baricitinib groups. No deaths, opportunistic infections, major adverse cardiovascular events, venous thromboembolic events or malignancies were reported in the trial. The safety profile of baricitinib in adolescents with AA was consistent with the safety profile seen in clinical trials for adolescent patients with juvenile idiopathic arthritis and moderate-to-severe atopic dermatitis. Over 14,600 patients have received baricitinib in clinical trials; of these, 866 have been patients between the ages of >1 month to <18 years.

Lilly will present additional data from the BRAVE-AA-PEDS study at scientific meetings later this year and submit the results for peer-reviewed publication. Baricitinib is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly. In 2022, the U.S. Food and Drug Administration (FDA) approved baricitinib (commercially available as Olumiant) for adult patients with severe AA, making it the first systemic treatment approved in the U.S. for severe disease.

Baricitinib is also approved in the U.S. and more than 75 countries as a treatment for adults with moderately to severely active rheumatoid arthritis, in more than 40 countries for the treatment of patients down to the age of two with moderate-to-severe atopic dermatitis who are candidates for systemic therapy and in Europe and Japan for adult patients with severe AA. Marketing authorization for the treatment of hospitalized patients with COVID-19 has been granted for baricitinib in multiple countries.

About BRAVE-AA-PEDS Study: BRAVE-AA-PEDS (NCT05723198) is an ongoing, placebo-controlled, Phase III trial involving children ages 6 to under 18 years with severe AA, as measured by a Severity of Alopecia Tool (SALT) score of ≥50 (i.e., who had ≥ 50% scalp hair loss) and a current episode of severe AA lasting at least six months but no more than eight years. Adolescent participants were randomized in a 1:1:1 ratio to receive once-daily placebo, baricitinib 4 mg or baricitinib 2 mg. The first cohort of patients enrolled included adolescents (ages 12 to under 18 years, weighing ≥ 30 kg). The next cohort of children ages 6 to under 12 will begin enrollment in the next year. An additional cohort of adolescents were randomized 1:1 to baricitinib 4 mg or baricitinib 2 mg.