Hair Regrowth Sustained Over 48 Weeks in Ritlecitinib-Treated Patients With Alopecia Areata

In a post-hoc analysis, researchers found that patients with alopecia areata (AA) who had a clinical response based on scalp, eyebrow, or eyelash regrowth at week 24 of the ALLEGRO phase 2b/3 trial, maintained that response at week 48 with continued ritlecitinib treatment. Their research was presented at the American Academy of Dermatology’s 2023 annual meeting in New Orleans, LA.

The ALLEGRO phase 2b/3 trial is a placebo-controlled study that examined the safety and efficacy of ritlecitinib, an oral JAK3/TEC kinase family inhibitor, in patients with AA who were 12 years of age or older and had 50% or greater scalp hair loss.

In the ALLEGRO trial, the study participants received daily ritlecitinib 10 mg, 30 mg, or 50 mg (± a 4-week 200 mg daily loading dose), or placebo for 24 weeks. Those in the ritlecitinib-treated groups continued receiving assigned doses in a 24-week extension, while the placebo group switched to ritlecitinib 200/50 or 50 mg.

The post-hoc analysis included patients who received ritlecitinib 200/50 mg (n = 132), 200/30 mg (n = 130), 50 mg (n = 130), or 30 mg (n = 132) and had a clinical response at week 24, based on:

·      Severity of Alopecia Tool (SALT) score of 20 or less (≤ 20% scalp without hair)

·      SALT score of 10 or less

·      Eyebrow (EBA) or eyelash (ELA) assessment (normal or ≥ 2-grade improvement from baseline)

In the 200/50, 200/30, 50, 30 mg ritlecitinib treatment groups, 36/132, 27/130, 28/130, and 16/132 patients, respectively, had a SALT score response of 20 or less at week 24 and had SALT data at week 48.

For those with SALT score at 48 weeks, 85% or greater maintained a response through week 48. Of those with a SALT score of 10 or less response at week 24, 68% or greater had a sustained response through week 48.

More than half of EBA and ELA responders at week 24 maintained a response through week 48 (≥ 52% and ≥ 70%, respectively). In terms of safety, ritlecitinib was well-tolerated through week 48 among patients 12 years of age or older.

“The majority of patients with AA treated with ritlecitinib who had SALT score ≤ 20, SALT score ≤ 10, EBA, or ELA responses at week 24 had sustained responses through Week 48,” the authors concluded.