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Safety of icotrokinra through 1 year in PsO: Pooled results from four phase III ICONIC trials
Results from a pooled analysis of the randomized, double-blind, phase III ICONIC-LEAD (NCT06095115; n = 684), ICONIC-TOTAL (NCT06095102; n = 311), ICONIC-ADVANCE 1 (NCT06143878; n = 772), and ICONIC-ADVANCE 2 (NCT06220604; n = 731) trials evaluating the safety of icotrokinra in adults and adolescents with moderate-to-severe plaque psoriasis (PsO) and PsO affecting high-impact sites were published in Dermatology and Therapy by Lebwohl et al. Pooled safety data were summarized for the placebo-controlled period (Weeks 0–16, all studies), active-controlled period (Weeks 0–24, ICONIC-ADVANCE 1 and 2), and through Week 52 (all studies).
Key data: Through Week 16, pooled exposure-adjusted incidence rates (EAIRs) per 100 patient-years (PY) of adverse events (AEs), serious AEs (SAEs), infections, and AEs leading to treatment discontinuation were 232.0, 5.2, 91.0, and 6.6, respectively, with icotrokinra (n = 1296) vs 269.0, 6.6, 104.0, and 10.0, respectively, with placebo (n = 568). Through Week 24, in the ICONIC-ADVANCE 1 and 2 trials, EAIRs/100 PY for AEs, SAEs, infections, and AEs leading to treatment discontinuation were 204.0, 6.4, 81.0, and 5.7 with icotrokinra (n = 632) vs 265.0, 7.2, 119.0, and 6.8 with deucravacitinib (n = 634). Through Week 52, EAIRs/100 PY for AEs, SAEs, infections, and AEs leading to treatment discontinuation in patients receiving icotrokinra were 167.0, 4.6, 76.0, and 3.0, respectively (n = 2400).
Key learning: In this pooled analysis of the ICONIC trials, icotrokinra demonstrated a favorable and consistent safety profile through 1 year of treatment in adults and adolescents with moderate-to-severe plaque PsO or PsO affecting high-impact sites, with EAIRs/100 PY similar to placebo through Week 16 and numerically lower than observed with deucravacitinib through Week 24, supporting its use in this patient population.
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This content is accurate as of the date of publication and is not updated retrospectively. Please refer to the latest available evidence, guidelines, and relevant regulatory information when making clinical decisions.
