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New phase 3 data from the BRAVE-AA trial program showed some patients who had little response to initial baricitinib achieved hair growth in year 2 of treatment.
Oral baricitinib (Olumiant) remained efficacious for the treatment of severe alopecia areata through 2 years among patients who initially reported response to the drug at 1 year, according to new data.1
In phase 3 findings presented during the late-breaking sessions at the American Academy of Dermatology (AAD) 2023 Annual Meeting in New Orleans this weekend, investigators from the BRAVE-AA clinical trial program reported that the landmark drug sustained its efficacy in previously benefitted patients with the chronic hair loss condition.
Coming less than a year after the US Food and Drug Administration (FDA) approved baricitinib as the first indicated systemic therapy for alopecia areata,2 the new 104-week data strengthen the validity of the JAK inhibitor for the previously unmet need of recovered scalp hair.
Led by Maryanne Senna, MD, a dermatologist with Lahey Hospital and Medical Center and Harvard Medical School, investigators sought to evaluate the efficacy of continued baricitinib in adult patients with alopecia areata through 104 weeks after the 52-week BRAVE-AA1 and BRAVE-AA2 trials.
Relevant data from the pivotal trial program included patients with Severity of Alopecia Tool (SALT) scores ≥50, indicating scalp hair loss of ≥50%. Senna and colleagues randomized these patients to either 2 mg or 4 mg baricitinib through 104 weeks, then patients with SALT SCORE >20 at week 52 but ≤20 at prior visits to 4 mg baricitinib through 104 weeks.
Seeking outcomes relevant to sustained hair regrowth, investigators set key outcomes including the following:
Among the cohort of patients who responded to baricitinib at 52 weeks, 117 (90.7%) receiving 4 mg baricitinib and 58 (89.2%) receiving 2 mg baricitinib had maintained a SALT score ≤20 at 104 weeks.
In 52-week responders with baseline ClinRO scores of ≥2, 67 (83.8%) and 25 (67.6%) had achieved ClinRO Eyebrow scores of 0 or 1, and 55 (80.9%) and 22 (73.3%) achieved ClinRO Eyelash 0 or 1 with 4 mg and 2 mg baricitinib, respectively, at 104 weeks.
In the cohort with SALT score >20 at 52 weeks, 4 mg baricitinib resulted in 43 (39.1%) patients reaching SALT score ≤20 by 104 weeks.
“Efficacy of baricitinib for severe alopecia areata was maintained at 104 weeks in week 52 responders,” investigators concluded. “Efficacy increased in patients with SALT score >20 at week 52, illustrating that long-term treatment may be needed to observe maximum benefit in some patients.”
In an interview with HCPLive at AAD 2023, Lotus Mallbris, MD, PhD, vice president of global immunology development and US and global medical affairs at Lilly, discussed the true value of confirming baricitinib’s “persistence” in combating alopecia areata hair loss, noting the historically frustrating interaction patients have had with prior treatments.
“Some of my own patients, when I was a doctor, would say ‘Don’t bring me up to paradise and then back to Hell’,” Mallbris said. “Not going up and down is very important for patients and their quality of life. And then there are some patients who at week 52 didn’t respond with full coverage of the hair, and here comes the most important part of the data: we see that their hair grows back—they respond later.”
Mallbris also highlighted the company’s ongoing pediatrics trial, where there remains a “huge unmet need” to address the psychosocial and development-related burdens of alopecia areata in children and adolescents.
“Patients say that when you lose your eyebrow and eyelashes, they don’t recognize themselves. It goes to the core of who you are as a person. And the burden in pediatric is that, it’s not only on the patients but on the family who cares for that patient. It has more impact on the quality of life.”