Updated Integrated Safety Analysis of Ritlecitinib Over 72 Months In Patients With Alopecia Areata From the ALLEGRO Clinical Trial Program
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Keywords
alopecia areata, ritlecitinib, ALLEGRO-LT, safety
Abstract
Introduction: Ritlecitinib, an oral, selective JAK3/TEC family kinase inhibitor, demonstrated efficacy and safety up to 48 weeks in patients aged ≥12 years with alopecia areata (AA) in the ALLEGRO phase 2b/3 study (NCT03732807). This updated integrated safety analysis evaluated the safety of ritlecitinib over 72 months in patients with AA in two phase 2a studies (NCT04517864; NCT02974868), the phase 2b/3 study, and an ongoing long-term, phase 3, open-label study (NCT04006457) from the ALLEGRO program.
Methods: Safety data were pooled from the 4 studies. Proportions and incidence rates (IRs; IR/100 patient-years [PYs]) of adverse events (AEs) are reported for the any-ritlecitinib (any dose) and ritlecitinib 50-mg ± 200-mg (50 mg ± 4-week 200-mg loading dose) groups. These analysis groups are not additive and are overlapping populations, with the any-ritlecitinib group including all patients.
Results: In the any-ritlecitinib (n=1294) and 50-mg ± 200-mg (n=1228) groups, median duration of exposure was 1204 (3539.5 PYs) and 1197 (3261.5 PYs) days, respectively. AEs occurred in 1158 (89.5%; 167.9/100 PYs) and 1070 (87.1%; 148.1/100 PYs) patients in the any-ritlecitinib and 50-mg ± 200-mg groups, respectively. The most common AEs included headache, positive SARS-CoV-2 test, and nasopharyngitis. Serious AEs occurred in 88 (6.8%; 2.5/100 PYs) patients in the any-ritlecitinib group and 84 (6.8%; 2.6/100 PYs) patients in the 50-mg ± 200-mg group, and included 2 deaths (breast cancer and acute respiratory failure/cardiorespiratory arrest) in the 50-mg ± 200-mg group. Discontinuations due to AEs occurred in 7.0% and 6.6% in the any-ritlecitinib and 50-mg ± 200-mg groups, respectively. IRs for both groups were 0.1/100 PYs for opportunistic infections; 1.0/100 PYs for herpes zoster; 0.3/100 PYs for malignancies, excluding nonmelanoma skin cancer; and 0.2/100 PYs for major adverse cardiovascular events.
Conclusion: Ritlecitinib was generally well tolerated over 72 months in patients with AA. Safety was consistent with previous data.
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