PATIENTS with severe alopecia areata (AA) may experience prolonged hair regrowth even after discontinuing treatment with bempikibart, according to findings from the SIGNAL-AA phase 2a study presented at the American Academy of Dermatology (AAD) Annual Meeting.
Bempikibart is a bifunctional interleukin-7 receptor alpha antagonist antibody that also inhibits thymic stromal lymphopoietin (TSLP) signaling, both of which play a role in autoimmune and inflammatory responses.
The SIGNAL-AA study enrolled 27 patients with severe to very severe AA, defined as having a Severity of Alopecia Tool (SALT) score of 50 to 100. Participants received either bempikibart 200 mg subcutaneously every two weeks (n = 23) or placebo (n = 4) for 24 weeks.
By week 24, the study met its primary endpoint, demonstrating a significant reduction in SALT scores:
The bempikibart group saw a 16% mean reduction in SALT scores, compared to 2% in the placebo group.
9% of bempikibart-treated patients achieved a SALT score of 20 or less, indicating substantial hair regrowth.
Among patients with severe AA (SALT 50-95), 26.7% reached a SALT score of 30 by week 24.
The post-treatment follow-up period showed continued improvement. By week 36—12 weeks after stopping treatment—53.8% of severe AA patients had reached a SALT score of 30, nearly doubling the initial response rate at week 24.
Bempikibart demonstrated a favorable safety profile. Among 33 treated patients, no grade 3 or higher adverse events related to the drug were reported. Treatment-emergent adverse events were mild to moderate, occurring in 70% of the bempikibart group versus 38% of the placebo group.
These findings suggest that bempikibart not only induces hair regrowth but may also have lasting effects beyond the treatment period. Further studies are needed to confirm its long-term benefits and durability in alopecia areata management.
Reference: Healio. Diversity remains paramount in research from basic to clinical stages. March 11, 2025. Available at: https://www.healio.com/news/dermatology/20250310/bempikibart-may-incite-hair-regrowth-after-treatment-cessation-in-severe-alopecia-areata. Last accessed: March 11, 2025.
Anaya Malik | AMJ
