Risankizumab 360mg/2.4ml solution for injection cartridges

Background and aims: Crohn’s disease is a chronic inflammatory disorder with rising global prevalence, marked by abdominal pain, diarrhea, and fatigue. Interleukin (IL)-23 plays a pivotal role in Crohn’s disease pathogenesis, making it a therapeutic target. Risankizumab, a monoclonal antibody targeting the IL-23 p19 subunit, has shown potential in clinical trials. Objectives: This meta-analysis evaluates the efficacy and safety of Risankizumab in achieving clinical remission, clinical response, and endoscopic remission in patients with moderate-to-severe Crohn’s disease. Design: A systematic review and meta-analysis were conducted following PRISMA 2020 guidelines. Data sources and methods: A comprehensive search of PubMed, Embase, Cochrane CENTRAL, Web of Science, and ClinicalTrials.gov was performed to identify randomized controlled trials (RCTs) assessing Risankizumab in Crohn’s disease. Primary outcomes were clinical remission, clinical response, and endoscopic remission, with secondary outcomes focusing on treatment-related adverse events. A random-effects model estimated odds ratios (ORs) with 95% confidence intervals. Meta-regression analyzed dose- and duration-dependent effects. Results: Four RCTs involving 1774 participants showed that Risankizumab significantly improved clinical remission (OR = 2.223), clinical response (OR = 2.483), and endoscopic remission (OR = 4.112). Dose-dependent improvements were observed, with treatment duration affecting clinical remission (p = 0.0158) but not clinical response or endoscopic remission. Adverse event rates were comparable between Risankizumab and placebo groups (OR = 0.872, p = 0.592). Conclusion: Risankizumab is effective in achieving clinical and endoscopic outcomes in moderate-to-severe Crohn’s disease, demonstrating dose-dependent benefits and a favorable safety profile, supporting its use as a therapeutic option. However, the limited number of studies may affect the robustness of these findings. Further large-scale RCTs are needed to validate its long-term efficacy, safety in elderly populations, and effectiveness in biologic-naïve patients. Trial registration: This systematic review and meta-analysis were registered with the INPLASY database under registration number INPLASY202530014. The full protocol is accessible at DOI: 10.37766/inplasy2025.3.0014. Plain language summary How Risankizumab helps treat Crohn’s disease: a review of clinical trial results Crohn’s disease is a long-term condition that causes inflammation in the digestive system. People with Crohn’s disease often experience symptoms like stomach pain, diarrhea, and tiredness, which can significantly affect their daily lives. Researchers have found that a protein called interleukin-23 (IL-23) plays a key role in this disease. Targeting IL-23 may help control the inflammation. Risankizumab is a medicine designed to block a part of IL-23, and it has been tested in clinical trials to see if it can help people with moderate-to-severe Crohn’s disease. To understand how well it works and whether it is safe, we combined the results of multiple high-quality studies in a process called a metaanalysis. Our analysis included four studies with a total of 1,774 patients. We found that Risankizumab significantly improved three key outcomes: Clinical remission: Fewer or no symptoms of Crohn’s disease. Clinical response: Noticeable improvement in symptoms. Endoscopic remission: Healing of the digestive tract, confirmed by a camera test. Patients who received Risankizumab were more likely to achieve these outcomes compared to those who received a placebo. The benefits were stronger with higher doses of the medication and with longer treatment durations for clinical remission. Importantly, the medicine was found to be safe. The rates of side effects were similar between patients taking Risankizumab and those taking a placebo. In conclusion, Risankizumab is an effective and safe treatment for people with moderate-to-severe Crohn’s disease. It helps reduce symptoms, promotes healing in the digestive tract, and works better at higher doses. This makes it a promising option for managing this challenging condition.

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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.

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BackgroundCrohn's disease (CD) is a chronic inflammatory disorder with limited therapeutic options for treatment-refractory patients. This meta-analysis evaluates the efficacy and safety of risankizumab (IL-23 p19 inhibitor) in moderate-to-severe CD.ObjectivesTo evaluate the clinical, endoscopic, and safety outcomes of risankizumab in patients with moderate-to-severe CD.DesignSystematic review and meta-analysis of randomized controlled trials (RCTs).Data sources and methodsA systematic search identified seven RCTs evaluating risankizumab at different doses, including a total of 4411 patients. We searched multiple databases, including PubMed, Cochrane CENTRAL, ClinicalTrials.gov, and Web of Science. Outcomes included clinical and endoscopic remission, endoscopic response, mucosal healing, stool frequency and abdominal pain scores. Data were pooled using a random-effects model, with risk ratios (RRs) and 95% confidence intervals (CIs) reported. Separate meta-analyses were conducted for the induction and maintenance phases.ResultsRisankizumab was significantly more effective than placebo or active comparator in achieving clinical remission (CDAI) during induction (RR, 1.85; 95% CI, 1.69-2.01; p I 2 = 0%) and maintenance (RR, 1.40; 95% CI, 1.21-1.62; p I 2 = 58%). Endoscopic outcomes were robust, with significant rates of endoscopic remission (RR, 2.81; 95% CI, 2.04-3.87; p I 2 = 50%) and endoscopic response (RR, 4.17; 95% CI, 3.31-5.77; p I 2 = 0%) post-induction. Risankizumab significantly increased mucosal healing (RR, 3.40; p I 2 = 61%) and reduced the risk of CD-related hospitalizations by 78% (RR, 0.22; 95% CI, 0.14-0.34; p I 2 = 0%). While fecal calprotectin levels significantly improved (RR, 1.79; p I 2 = 0%), no significant benefit was observed for high-sensitivity C-reactive protein maintenance (p = 0.39; I 2 = 59%). Subgroup analyses indicated consistent treatment effects across doses, with the Peyrin-Biroulet (2024) and FORTIFY trials identified as primary sources of observed heterogeneity in maintenance outcomes.ConclusionThese findings suggest that risankizumab is an effective and safe option for inducing and maintaining remission in moderate-to-severe CD. Further long-term studies should refine dosing, assess long-term outcomes, and support its integration into clinical guidelines.Trial registrationPROSPERO ID: CRD42024611707.

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