Updated Integrated Efficacy Analysis of Ritlecitinib Up to 3 Years in Adolescents With Alopecia Areata From the ALLEGRO Clinical Trials

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Introduction: We report updated efficacy results of ritlecitinib up to 3 years in adolescents with alopecia areata (AA) from the ALLEGRO phase 2b/3 and open-label ALLEGRO-LT phase 3 studies. Methods: Patients aged 12-17 years with AA and ≥50% scalp hair loss who received daily ritlecitinib 50-mg in ALLEGRO-2b/3 and rolled over to ALLEGRO-LT (in which they continued to receive 50 mg) were included. Continuation criteria for adolescents in ALLEGRO-LT required ≥50% improvement in Severity of Alopecia Tool (SALT) score by Month 3 for rollover patients from ALLEGRO-2b/3 and SALT score ≤20 by Month 6 in ALLEGRO-LT for all patients. Patients who received placebo and switched to ritlecitinib were re-baselined to align time points across groups. Data are reported as observed and imputed (last observation carried forward, LOCF) at the data cutoff date (June 25, 2024). Results: Of 27 adolescents included, 1 was ongoing at the data cutoff, 8 discontinued from ALLEGRO-LT due to availability of commercial drug, 1 completed ALLEGRO-2b/3 and did not rollover to ALLEGRO-LT, and 17 discontinued for other reasons (5 due to not meeting continuation criteria). At 3 years, 84.6% (11/13 observed) and 48.2% (13/27 LOCF) of adolescents had SALT score ≤20; SALT score ≤10 response rates were 76.9% (10/13 observed) and 40.7% (11/27 LOCF). Patients’ Global Impression of Change (PGI-C) response (“moderately” or “greatly” improved) rates were 100.0% (9/9 observed) and 73.1% (19/26 LOCF) at 3 years. Among adolescents with abnormal Eyebrow Assessment (EBA) or Eyelash Assessment (ELA) at baseline, EBA response rates were 100.0% (6/6 observed) and 57.9% (11/19 LOCF), and ELA response rates were 66.7% (4/6 observed) and 64.7% (11/17, LOCF). The decreasing number of adolescents who reached later study time points limits data interpretation. Conclusion: In adolescents with AA, ritlecitinib 50 mg had long-term clinician- and patient-reported efficacy up to 3 years. Funding: This study was funded by Pfizer Inc.

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