Adults with severe alopecia areata (AA) who took OLUMIANT® (baricitinib) 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, Eli Lilly and Company) and Incyte announced at the 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.
In the pooled 52-week analysis, 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 ≥50 (≥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 ≥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 ≤20, 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 ≤10, or 90% hair coverage, at 52 weeks. Separately, more than two out of five patients with ClinRO baseline scores ≥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.