Pooled analysis extending phase III BRAVE-AA1 and BRAVE-AA2 trials of Olumiant demonstrates benefits in alopecia areata and is presented at AAD 2022 and published in NEJM.- Eli Lilly
Extending phase III BRAVE-AA1 and BRAVE-AA2 trials, a new 52-week pooled analysis shows that adults with severe alopecia areata (AA) who took Olumiant (baricitinib), from Eli Lilly, achieved significant scalp, eyelash and eyebrow hair regrowth and nearly 75% of those who responded to Olumiant 4-mg achieved 90% scalp coverage at 52 weeks.
Patients at baseline had a mean Severity of Alopecia Tool (SALT) score of 85.5 (85.5% scalp hair loss, or 14.5% scalp hair coverage); severe AA is defined as having a SALT score at least 50 (at least 50% scalp hair loss). At baseline, 69.4% and 57.9% had significant eyebrow and eyelash hair loss, respectively, as defined by Clinician-Reported Outcome (ClinRO) scores at least 2. Patients' average age was 37.6 years, with hair loss starting around age 25 and a mean of 12.2 years since symptom onset.
Among patients who took Olumiant 4-mg, two out of five (39.0%, n=201/515) achieved significant scalp hair regrowth, defined as a SALT score of 20 or less, or 80% or more scalp hair coverage, and nearly three out of four of those patients (74.1%, n=149/201) also achieved a SALT score of 10 or less, or 90% hair coverage, at 52 weeks. Separately, more than two out of five patients with ClinRO baseline scores at least 2 (eyebrow: 44.1%, n=154/349; eyelash: 45.3%, n=139/307) saw full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair.
Among patients who took Olumiant 2-mg, more than one out of five (22.6%, n=77/340) achieved significant scalp hair regrowth and two out of three of those patients (67.5%, n=52/77) achieved 90% or more hair coverage at 52 weeks. Separately, more than one in five and one in four patients, respectively (eyebrow: 22.9%, n=55/240; eyelash: 25.5%, n=51/200), saw full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair. These 52-week pooled analyses demonstrate continued improvement in scalp, eyebrows and eyelash hair regrowth from 36-week results published in the New England Journal of Medicine and presented at the 2021 European Academy of Dermatology and Venereology (EADV) Congress. his new data was presented at the 2022 American Academy of Dermatology (AAD) Annual Meeting. In February 2022, the U.S. Food and Drug Administration (FDA) granted priority review for Olumiant in severe AA as a potential first-in-disease medicine. Lilly expects regulatory decisions in the U.S., European Union and Japan in 2022.
See: "Two Phase 3 Trials of Baricitinib for Alopecia Areata." Brett King et al. NEJM March 26, 2022 DOI: 10.1056/NEJMoa2110343
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