Updated Integrated Safety Analysis of Ritlecitinib up to ~5 Years in Adolescents With Alopecia Areata From the ALLEGRO Clinical Trials

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Introduction This updated integrated safety analysis evaluated ritlecitinib in adolescents (aged 12-17 years) with alopecia areata (AA) in the ALLEGRO phase 2b/3 study and/or ongoing ALLEGRO-LT phase 3 study. Methods In ALLEGRO-2b/3, patients with ≥50% scalp hair loss received daily ritlecitinib 30-mg or 50-mg (±4-week 200-mg loading dose), 10-mg, or placebo. In ALLEGRO-LT, de novo patients (≥25% scalp hair loss) received daily ritlecitinib 50-mg with a 4-week 200-mg loading dose and ALLEGRO-2b/3 rollover patients received daily ritlecitinib 50-mg (data cutoff June 25, 2024). Continuation criteria in ALLEGRO-LT required ≥50% improvement in Severity of Alopecia Tool (SALT) score by Month 3 for rollover adolescents and SALT score ≤20 by Month 6 for all adolescents. Safety data were pooled; proportions and incidence rates of adverse events (AEs) are reported for adolescents receiving ritlecitinib 50-mg (50-mg ±4-week 200-mg loading dose) and any-ritlecitinib (any dose, including 50-mg). Results In the 50-mg group (n=172), median ritlecitinib exposure was 1111.5 days (427.2 total PY); 56.4% of adolescents were exposed for ≥36 months and 24.4% for ≥48. AEs occurred in 144 adolescents (83.7%; 146.3/100 PY) in the 50-mg group. The most common AEs included SARS-CoV-2 positive test (19.8%), acne (19.2%), headache (18.6%), and nasopharyngitis (14.5%). Serious AEs occurred in 10 adolescents (5.8%; 2.3/100 PY). Thirteen adolescents (7.6%; 3.0/100 PY) permanently discontinued due to AEs. Similar results were observed for adolescents in the any-ritlecitinib group (n=181). There were no deaths or incidence of opportunistic infections, herpes zoster, malignancies, cardiovascular, or thromboembolic events. Conclusion Longer-term use of ritlecitinib for up to ~5 years in adolescents with AA was well-tolerated and demonstrated no new safety signals. Funding This study was funded by Pfizer Inc.

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