Olumiant® (baricitinib) from Eli Lilly and company produced significant scalp, eyelash, and eyebrow hair regrowth at 52 weeks, with nearly 75% of those who responded to Olumiant 4mg achieving 90% scalp coverage. The 52-week pooled findings were presented at the American Academy of Dermatology (AAD) Annual Meeting. FDA last month granted priority review for Olumiant as a potential first-in-disease medicine for severe alopecia areata. 

These 52-week pooled analyses demonstrate continued improvement in scalp, eyebrows and eyelash hair regrowth from 36-week results published recently in the New England Journal of Medicine and presented at the 2021 European Academy of Dermatologyand Venereology (EADV) Congress.

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). 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 4mg, 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 2mg, 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.

"Whether people with alopecia areata suffer loss of all the hair on their body or bald spots and missing eyebrows or eyelashes, this autoimmune disease can be devastating. The disease affects people of all ages," says Brett King, MD, PhD, FAAD, associate professor of dermatology at Yale School of Medicine and lead author of these analyses. "In 2022, Olumiant could become the first medicine ever approved to treat adults with alopecia areata. It's remarkable that nearly 40% of patients on Olumiant 4mg, all of whom started out with at least 50% scalp hair loss, experienced full or nearly full scalp hair coverage, and similar improvements were achieved among those patients with significant eyebrows or eyelashes involvement." 

In an evaluation of Olumiant 4mg and 2mg 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.

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