Risankizumab 600mg/10ml solution for infusion vials

IntroductionSystemic treatments including standard and targeted drugs for psoriasis could increase the risk of serious infections. In this study we assessed the serious infection risk associated with systemic treatments in patients with psoriasis.MethodsA systematic review of randomised controlled trials (RCTs) and non-randomised studies of interventions (NRSIs) comparing systemic treatments with placebo or each other was performed. Studies included in Medline, Embase, Cochrane register, CINAHL and ClinicalTrials.gov until September 2024 were eligible if at least 50 adults or children with plaque psoriasis were studied. The primary outcome was serious infection defined as any infection resulting in hospitalization, administration of intravenous antibiotics, death or classified as serious by study authors. Two authors independently performed screening for study eligibility. A frequentist network meta-analysis (NMA) was performed using random effects model. RCT, NRSI and combined (RCT and NRSI) networks were created.ResultsFrom 119 eligible RCTs, 76 with at least one serious infection event (n = 39,044) and out of 33 eligible NRSIs, 6 without critical risk of bias (n = 306,762) were included in the NMA. Patients were predominantly male (up to 85%) with a mean age ranging from 13 to 52 years. The RCT network showed no increase in serious infection risk with any drug or drug class when compared with each other. The NRSI network showed higher risk with infliximab and adalimumab compared to several other drugs, especially infliximab vs methotrexate (IRR 2.85; 95% CI 1.48, 5.46), and adalimumab vs ustekinumab (IRR 1.51; 95% CI 1.25, 1.83). In the combined NMA, infliximab and adalimumab were additionally shown to have significantly higher risk than acitretin, bimekizumab, methotrexate, placebo, risankizumab, and secukinumab.ConclusionsThe tumour necrosis factor alpha (TNFα) inhibitors adalimumab and infliximab had higher risk of serious infections in the combined NMA. Our findings may inform clinicians and patients concerned about the risk of emergent serious infection on therapy.

Abstract licence: CC BY-NC

BackgroundRisankizumab, 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).MethodsA 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).ResultsEleven 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).ConclusionThis 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.

Abstract licence: CC BY-ND