Risankizumab versus Deucravacitinib in Adults With Moderate Plaque Psoriasis: 16-Week Results from the Phase 4 IMMpactful Trial

Introduction: Risankizumab (RZB) and deucravacitinib (DEU) are both approved for the treatment of moderate-to-severe psoriasis. Physicians value head-to-head comparisons between available therapies to make evidence-based treatment decisions. This study evaluates the safety and efficacy of RZB compared with DEU for the treatment of patients with moderate psoriasis who have not previously received biologic treatment. Methods: Patients with moderate psoriasis, eligible for systemic treatment and without prior biologic exposure, were enrolled in a 1:2 ratio to RZB or DEU, respectively. The 52-week treatment was divided into two periods: period A (baseline to week 16) and period B (weeks 16-52). Results from period A are presented here. In period A, patients either received a single subcutaneous injection of RZB 150 mg on day 1 and week 4 or oral DEU 6 mg daily. The coprimary endpoints in period A were achievement of ≥ 90% improvement in Psoriasis Area and Severity Index (PASI 90) and achievement of sPGA 0 or 1 (sPGA 0/1) with at least a two-grade improvement from baseline. Ranked secondary endpoints for period A included the achievement of PASI 100 and sPGA 0 with at least a two-grade improvement from baseline at week 16. Additional endpoints were also assessed. Safety was based on assessment of treatment-emergent adverse events (TEAEs). Results: A significantly higher proportion of patients treated with RZB achieved PASI 90 (57.3% versus 22.9%), sPGA 0/1 (80.2% versus 39.7%), PASI 100 (27.5% versus 6.5%), and sPGA 0 (27.5% versus 6.9%) compared with patients treated with DEU at week 16 (P < 0.0001). The proportion of patients with TEAEs was 33.6% (RZB) and 42.9% (DEU). Safety was consistent with the known profiles of RZB and DEU. Conclusions: In this 16-week analysis, treatment with RZB demonstrated superior efficacy compared with DEU in adults with moderate psoriasis. No new or unexpected safety signals were identified. Clinical trials: ClinicalTrials.gov identifier: NCT06333860.