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

Abstract

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. 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). 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. 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. ClinicalTrials.gov identifier: NCT06333860. This study evaluated two approved therapies, risankizumab and deucravacitinib, in adults with moderate psoriasis who had never received biologic therapy. Over 16 weeks, people in the study received either two risankizumab subcutaneous injections (one on day 1 and one in week 4) or deucravacitinib as a daily pill. The primary objectives of this study were to assess the degree of improvement in the patients’ skin and to evaluate the safety of the treatments. The results showed that more patients had clear skin with risankizumab compared with deucravacitinib. Specifically, a higher percentage of patients taking risankizumab achieved at least 90% improvement or clear to almost clear skin, compared with patients taking deucravacitinib, at week 16. Patients treated with risankizumab reported improvement in quality of life and psoriasis symptoms. The safety side effects for both risankizumab and deucravacitinib were consistent with what is already known for both therapies at the time of this 16-week analysis. In summary, during the first 16 weeks of this study, risankizumab helped more patients achieve clearer skin compared with deucravacitinib, and none of the medications caused any new or unexpected side effects or safety problems.