Durable efficacy of ritlecitinib maintained through 3-year follow-up in alopecia areata

By 12 months, 89.6% of participants treated with ritlecitinib 50 mg once daily achieved a Severity of Alopecia Tool (SALT) score ≤20, and this benefit was maintained through month 36. Complete scalp hair regrowth was found in up to 31.2% of participants at 36 months.

“Ritlecitinib is an oral, selective Janus kinase 3 (JAK3) and TEC family kinase inhibitor approved for the treatment of adolescents and adults with severe alopecia areata (AA),” explained Dr Brett King (Fairfield, CT, USA) [1]. He presented a late-breaking analysis of 191 participants who received ritlecitinib 50 mg once daily for 3 years as a part of the ALLEGRO study programme (NCT03732807 and NCT04006457). “The first approved medicines for severe AA have only become available in the past 3 years. This represents the first time we are seeing truly long-term efficacy data,” he emphasised.

Baseline characteristics comprised 14.1% of adolescents, 56% women, a mean baseline SALT score of 90.8, and a median duration of the current AA episode of 2.2 years.

At month 36, SALT≤20 and ≤10 scores were achieved by 47.1% and 36.7% in the last observation carried forward (LOCF) analysis, and by 65.1% and 52.3% in the as-observed analysis. Within the group of participants who achieved SALT≤20 at month 12, 89.6% (LOCF) maintained this response at month 36. Similarly, 84.8% (LOCF) maintained SALT≤10.

Complete regrowth of scalp hair was achieved in 31.2% of participants (observed) and in 22.5% (LOCF) at month 36. Furthermore, 29.8% achieved a SALT score of 0 at ≥1 visit, and 61.5% of these participants maintained this response without subsequent worsening. Among participants who relapsed, 5.2% had SALT scores ≥20 at a later time point; however, Dr King emphasised that most of them remained at SALT≤5.

Treatment responses in the Eyebrows (EBA) and Eyelashes (ELA) Assessment Tools were defined as ≥2-grade improvement or a normal score of 3 in patients with a prior abnormal score. EBA responses at 36 months were 63.2% (observed) and 48.7% (LOCF), while ELA responses were 60.4% (observed) and 49.6% (LOCF).

“In conclusion, ritlecitinib 50 mg once daily demonstrated clinically meaningful efficacy up to 3 years,” Dr King stated, further highlighting that almost 1 quarter of participants achieved complete scalp hair regrowth, as well as normal eyebrows and normal eyelashes at more than 1 time point in the clinical trial.

1. King B, et al. Long-term efficacy and complete scalp hair regrowth in patients with alopecia areata receiving ritlecitinib 50 mg QD up to 3 years in the ALLEGRO clinical trial program. D2T01.4A, EADV Congress 2025, 17–20 September, Paris, France.

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Posted on 18 November 202518 November 2025