Integrated Safety Analysis of Ritlecitinib for the Treatment of Alopecia Areata (AA) From the Phase 2 and Phase 3 ALLEGRO Clinical Trial Program

AA is an autoimmune disease with an underlying immunoinflammatory pathogenesis characterized by nonscarring hair loss ranging from small bald patches to complete loss of scalp, face, and body hair 1 • In the ALLEGRO phase 2b/3 study, ritlecitinib, an oral JAK3/TEC family kinase inhibitor, demonstrated efficacy and safety up to 48 weeks in patients aged ≥12 years with AA 2• Here we present an integrated safety analysis of ritlecitinib in patients with AA from 4 studies from the ALLEGRO clinical trial program ANALYSIS POPULATIONSTwo pools were analyzed: • A placebo-controlled pool (up to 24 weeks) • An all-exposure pool: patients who received ≥1 ritlecitinib dose (up to 36 months) -Data were analyzed for those exposed to any ritlecitinib dose (10 mg, 30 mg, 50 mg, 200/30 mg, or 200/50 mg) and for patients who only received ritlecitinib 50 mg (±200-mg loading dose) Key eligibility criteria included: • Male or female aged ≥12 years • Diagnosis of AA with ≥25% or ≥50% scalp hair loss • Current AA episode duration of 6 months to 10 years • No concomitant treatments for AA allowedFigure 1.Studies included in the placebo-controlled and all-exposure pools All-exposure pool (up to 36 months; N=1294) ALLEGRO-LT (NCT04006457) Rollover patients: Ritlecitinib 50 mg QD De novo patients: 4-week 200-mg QD loading dose and then ritlecitinib 50 mg QD Placebo-controlled pool (up to 24 weeks; N=881) ALLEGRO phase 2a safety (NCT04517864) Ritlecitinib 50 mg QD with an initial 4-week 200-mg QD loading dose, or placebo, for 24 weeks ALLEGRO phase 2b/3 (NCT03732807) Ritlecitinib 50 or 30 mg QD (±4-week 200-mg QD loading dose), 10 mg, or placebo for 24 weeks ALLEGRO phase 2a (NCT02974868) Ritlecitinib 50 mg QD with an initial 4-week 200-mg QD loading dose, or placebo, for 24 weeks Ritlecitinib for 24 weeks ‡ Ritlecitinib for 24 weeks † Ritlecitinib to Month 24* Extension period *In the ALLEGRO phase 2a safety study, the placebo-controlled period continued to Month 9.At Month 9, patients entered an active therapy extension; placebo groups switched to 200/50 mg and the 50-mg group continued 50 mg until Month 24.† In the ALLEGRO phase 2a study, following a 4-week washout period after Week 24, patients could continue treatment in a 24-week single-blind extension in which placebo and active nonresponders received 200/50 mg.After another 4-week washout period, nonresponders could enter into a 24-week, cross-over, open label extension period.‡ In ALLEGRO-2b/3, after Week 24, ritlecitinib groups continued their 50-, 30-, or 10-mg maintenance doses for another 24 weeks, and patients initially assigned to placebo switched to ritlecitinib 200/50 mg or 50 mg daily for 24 weeks.Eligible patients who completed ALLEGRO-2a or -2b/3 could roll over into ALLEGRO-LT.Data cutoff for ALLEGRO-LT and the phase 2a safety study: May 30, 2022. STATISTICAL METHODS• Safety data were integrated from the 4 phase 2/3 studies and were summarized descriptively using counts and percentages for adverse events (AEs) and lab abnormalities in each pool -In the all-exposure pool, safety events were evaluated:• Any-ritlecitinib group: from the start of the patients' first dose of ritlecitinib (any ritlecitinib dose: 10 mg, 30 mg, 50 mg, 200/30 mg, or 200/50 mg)• Ritlecitinib 50-mg group: from the time a patient started the 50-mg dose (or the 200-mg loading dose), as some patients received placebo or other ritlecitinib doses before switching to ritlecitinib 50 mg• Incidence rates (IRs) are reported -Study-size-adjusted IRs were reported per 100 patient-years (PY) and are presented with mid-p gamma CIs

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