Publication date: Jan 23, 2025

ALLEGRO-LT is an ongoing, long-term, open-label, multicentre, phase 3 study of ritlecitinib in adults and adolescents with alopecia areata (AA). To evaluate ritlecitinib safety and efficacy through Month 24 in patients with AA and ≥25% scalp hair loss. ALLEGRO-LT enrolled rollover patients who previously received study intervention in either ALLEGRO phase 2a or 2b/3 studies and de novo patients who had not received treatment in either study. The de novo cohort results are reported here. Patients aged ≥12 years with AA and ≥25% scalp hair loss received a daily, 4-week 200-mg ritlecitinib loading dose, followed by daily 50-mg ritlecitinib. Analyses are based on data up to the cut-off (December 2022). Efficacy outcomes included proportions of patients achieving Severity of Alopecia Tool (SALT) scores ≤20 and ≤10, Patient Global Impression of Change (PGI-C) score of ‘moderately improved’ or ‘greatly improved’ and eyebrow assessment (EBA) and eyelash assessment (ELA) response (≥2-grade improvement from baseline or normal score in patients with abnormal baseline EBA/ELA). Mean (SD) ritlecitinib exposure among the 449 de novo patients enrolled was 728. 7 (273. 81) days. At Month 24 (as observed), 73. 5% and 66. 4% of patients achieved SALT score ≤20 and ≤10; 82. 4% had PGI-C response; 60. 8% and 65. 7% had EBA and ELA response. 86. 1% of patients reported treatment-emergent adverse events (AEs); most were mild or moderate in severity, with the most frequent being positive SARS-CoV-2 test (24. 2%), headache (20. 8%) and pyrexia (13. 0%). Rates of serious AEs, severe AEs and treatment discontinuations were 4. 9%, 6. 0% and 6. 5%, respectively. Herpes zoster infection occurred in six patients, serious infections in four, malignancies (excluding nonmelanoma skin cancer) in three and major adverse cardiovascular events in three. In patients with AA and ≥25% scalp hair loss, ritlecitinib demonstrated clinical efficacy and had an acceptable safety profile with long-term treatment. ClinicalTrials. gov NCT04006457.

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