Three-Year Data Confirms Sustained Hair Regrowth with Ritlecitinib for Alopecia Areata
View StudyPlain-Language Summary
The ALLEGRO-LT Phase 3 extension study confirms that ritlecitinib (Litfulo) maintains meaningful hair regrowth at three years in adults and adolescents with alopecia areata. Among patients who responded by month 12, approximately 90% retained that benefit through month 36, with no new safety signals emerging over the extended follow-up period.
Abstract
Background: Ritlecitinib is a JAK3/TEC family kinase inhibitor approved for treatment of alopecia areata (AA) with at least 25% scalp hair loss. Long-term safety and efficacy data are needed to characterize outcomes over extended treatment periods.
Objective: To evaluate long-term safety and efficacy of ritlecitinib in adults and adolescents (12 years and older) with AA and at least 25% scalp hair loss in the ALLEGRO-LT Phase 3, open-label, long-term extension study.
Methods: Participants completing eligible Phase 2/3 ritlecitinib studies could enroll in ALLEGRO-LT and receive ritlecitinib 50 mg once daily. The primary endpoint was safety; secondary endpoints included Severity of Alopecia Tool (SALT) score and patient-reported outcomes at up to 36 months.
Results: Approximately 30% of participants achieved a SALT score of 20 or less at month 36. Among participants achieving SALT 20 or less at month 12, approximately 90% maintained this response through month 36. No new safety signals were identified. Most treatment-emergent adverse events were mild to moderate in severity.
Conclusions: Ritlecitinib demonstrated sustained hair regrowth over 36 months with a consistent long-term safety profile. Retention of clinical benefit achieved at month 12 was maintained in approximately 90% of responders at month 36.