Nearly 40% of adults with alopecia areata taking Olumiant 4-mg saw at least 80% scalp hair coverage at 52 weeks in pivotal phase III studies.- Eli Lilly
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 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 greater than 50 ( greater than 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 greater than 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 less than 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 less than 10, or 90% hair coverage, at 52 weeks. Separately, more than two out of five patients with ClinRO baseline scores greater than 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.
In an evaluation of Olumiant 4-mg and 2-mg long-term safety, incidence rates of frequently reported adverse events up to 52 weeks (median 56 weeks exposure) were consistent with the 36-week, placebo-controlled period and included upper respiratory tract infection, headache, acne, urinary tract infection and increases in muscle-related blood markers. There were no new safety signals.
See-"Two Phase III Trials of Baricitinib for Alopecia Areata": B. King and Others10.1056/NEJMoa2110343. 26 March 2022
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