Long-term baricitinib continues efficacy in alopecia areata

Key takeaways:

• Patients with alopecia who responded to baricitinib at week 52 continued that response at week 104 90% of the time.
• Eyebrow and eyelash regrowth was also recorded in most patients in the treatment groups.

NEW ORLEANS — Patients who responded to baricitinib treatment for alopecia areata continued to maintain those results with long-term treatment, according to a speaker at the American Academy of Dermatology Annual Meeting.

“Alopecia areata is a relatively common immune-mediated, nonscarring form of alopecia that considerably impacts quality of life,” Maryanne M. Senna, MD, director of the Lahey Hair Loss Center of Excellence and Research Unit at Beth Israel Lahey Health and assistant professor of dermatology at Harvard Medical School, said during her presentation. “While long-term data on the use of baricitinib in other indications such as psoriatic arthritis have a decent among of long-term safety data, there’s really limited data on chronic use of Janus kinas inhibitors in alopecia areata.”

Senna presented 104-week data from the BRAVE-AA1 and BRAVE-AA2 phase 3 clinical trials, which included patients treated with baricitinib 4 mg or 2 mg.

Subjects who achieved a Severity of Alopecia Tool (SALT) score of 20 or less at week 52 were deemed responders. Mixed responders were patients taking 4 mg of baricitinib who reached a SALT score of 20 or less at some time during the trial but not at week 52, or patients who achieved an improvement of at least 2 points in Clinician Reported Outcome (ClinRo) eyebrow/eyelash (EB/EL) scores at week 52.

Of those who responded at week 52, 90.7% of those taking 4 mg baricitinib maintained that response at week 104, whereas 89.2% of those on the 2 mg dose did so.

Of the mixed responder group, 39.1% achieved a SALT score of 20 or less with 4 mg of baricitinib at week 104.

ClinRo EB of 0/1 wash achieved by 83.8% of week 52 responders at week 104 with the 4 mg dose and 67.6% of those in the 2 mg dose group. Also at week 104, ClinRo EL of 0/1 was achieved by 80.9% of the 4 mg group and 73.3% of the 2 mg group.

Lotus Mallbris, MD, PhD, senior vice president and global head of immunology product development at Eli Lilly, discussed these results with Healio in an exclusive video perspective.

“This shows important information for our clinicians that continuous treatment among the mixed responders is important,” Mallbris said.

No new safety signals were observed in the long-term trial and no serious adverse events were reported.

Adverse events of special interest included one major adverse cardiovascular event, one patient with deep vein thrombosis and one nonmelanoma skin cancer case in the 2 mg group, as well as two cases of malignancies other than nonmelanoma skin cancer in the 4 mg group.

“Among patients with severe [alopecia areata] who were week 52 responders, a high level of efficacy or regrowth of scalp hair was maintained at week 104 by 90% of patients,” Senna said during the presentation.