Long-term Efficacy and Safety of Ritlecitinib in Adults and Adolescents with Alopecia Areata: 3-year Results from the ALLEGRO-LT Phase 3, Open-label Study

Abstract

Introduction: We report efficacy results of ritlecitinib up to 3 years in patients with AA from the ALLEGRO phase 2b/3 (NCT03732807) and ongoing, phase 3, open-label ALLEGRO-LT (NCT04006457) studies.

Methods: Patients aged ≥12 years with AA and ≥50% scalp hair loss who received daily ritlecitinib 50-mg in ALLEGRO-2b/3 and rolled over to ALLEGRO-LT (continued to receive 50-mg) were included. Patients who received placebo and switched to 50-mg were re-baselined to align time points and across groups. Visits were calculated as time since the first ritlecitinib dose, thus resulting in different months for some visits. Observed and last observation carried forward [LOCF]) data are reported at the time of data cutoff (June 25^th, 2024).

Results: 191 patients were included. At 3 years, 65.1% (71/109 observed) and 47.1% (90/191 LOCF) of patients had Severity of Alopecia Tool (SALT) score ≤20. SALT score ≤10 response rates were 52.3% (57/109 observed) and 36.7% (70/191) (LOCF). Patients’ Global Impression of Change response (“moderately” or “greatly” improved) rates at 3 years were 68.4% (52/76) (observed) and 55.6% (105/189) (LOCF).

Conclusions: Ritlecitinib 50-mg demonstrated clinically meaningful clinician- and patient-reported efficacy up to 3 years. These data are the longest duration of ritlecitinib treatment to be reported to date and support the long-term use of ritlecitinib in patients aged ≥12 years with AA.