Efficacy and safety of risankizumab in moderate to severe psoriasis: an updated systematic review and meta-analysis

Abstract

Background: Risankizumab, a selective IL-23 inhibitor, has emerged as a promising therapeutic agent for moderate-to-severe plaque psoriasis. This study aims to systematically assess its efficacy and safety through an updated meta-analysis of randomized controlled trials (RCTs). Methods: A comprehensive literature search of PubMed/MEDLINE, Embase, Scopus, Cochrane Library, and ClinicalTrials.gov was conducted from their inception to 15 April 2025 for RCTs comparing risankizumab with placebo or active comparators in adults with moderate-to-severe psoriasis. Data were pooled using random-effects models (RevMan 5.4), and heterogeneity was assessed using I 2 statistics. The Cochrane Risk of Bias Tool 2 (RoB 2) was utilized for risk of bias assessment of each included RCT. The forest plots were generated using risk ratios (RRs) with 95% confidence intervals (CIs). Results: Eleven RCTs ( n = 2664 patients) were included in the study. Risankizumab showed significantly greater efficacy than placebo for PASI 75 (OR: 23.93, 95% CI: 7.80–73.41), PASI 90 (OR: 18.11, 95% CI: 5.03–65.24), and PASI 100 (OR: 30.31, 95% CI: 12.36–74.34). Compared to active comparators (ustekinumab and adalimumab), risankizumab demonstrated a superior PASI 90 response (OR 3.40, 95% CI: 2.32–4.96). Quality of life (DLQI) improved significantly (OR: 31.53, 95% CI: 19.46–51.09). No increased risk of SAEs was observed (OR: 0.71, 95% CI: 0.33–1.54), although the infection risk was slightly elevated (OR: 1.38, 95% CI: 0.87–2.18). Conclusion: This meta-analysis confirms the superiority of risankizumab over placebo and other biologics in achieving complete or near-complete skin clearance, with a favorable safety profile. These findings suggest that risankizumab is a first-line biologic agent for moderate-to-severe plaque psoriasis, although infection monitoring remains warranted.