40% of Adults with Alopecia Areata Realized About 80% Scalp Hair Coverage After Taking Oral JAK Inhibitor One Year

The New England Journal of Medicine published an Original Article on the finding from two randomized, placebo-controlled, phase 3 trials focused on adults with severe alopecia areata (AA) who took OLUMIANT® (baricitinib).

Participants 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.

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, 39% 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, 22.6% 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.

Eli Lilly and Company and Incyte stated in a press release issued on March 28, 2022, these 52-week pooled analyses demonstrate continued improvement in the scalp, eyebrows, and eyelash hair regrowth from 36-week results.

"OLUMIANT's long-term efficacy data reveal significant regrowth of scalp, eyelash, and eyebrow hair, and we're delighted by what these results can mean for patients. Our alopecia areata safety data add further evidence to one of the largest and longest sets of safety data in the JAK inhibitor class, including nine years and 19,000 patient-years across our program," commented Lotus Mallbris, M.D., Ph.D., vice president of global immunology development and medical affairs at Lilly, in the press statement.

"We're excited OLUMIANT may be a potential first-in-disease medicine approved this year for adults with severe alopecia areata."

In February 2022, the U.S. 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.

OLUMIANT, a once-daily oral JAK inhibitor, is approved in the U.S.

And in more than 75 countries, it is a treatment for adults with moderate to severe rheumatoid arthritis.

Furthermore, in more than 50 countries, including the European Union and Japan, it is a treatment for adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.

To date, more than 343,000 patients have been treated with OLUMIANT worldwide across approved indications.

Note: This press release and study results were edited for clarity and manually curated for mobile readers.