EFFICACY OF GUSELKUMAB FOR MODERATE-TO-SEVERE INFLAMMATORY BOWEL DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS

Abstract Background and Aims To our knowledge, no previous meta-analysis has analyzed guselkumab versus placebo for inflammatory bowel disease. Following publication of recent randomized controlled trials (RCTs), we aim to analyze evidence of its treatment during induction and maintenance. METHODS A systematic search across PubMed, Embase, and Cochrane Library was conducted to identify RCTs comparing guselkumab versus placebo in adult patients with Crohn’s disease (CD) or ulcerative colitis (UC). Binary endpoints were analyzed using risk ratios (RRs), each with corresponding 95% confidence intervals (CIs). Subgroup analysis was performed comparing CD vs UC. All analyses were performed using R software (version 4.4.3). RESULTS A total of six RCTs were included, three of which reported separate induction and maintenance phases, comprising 1,655 patients. Of these, 1,219 received guselkumab and 436 received placebo. Four RCTs included patients with CD and two with UC. Patients were followed for 12 weeks during induction and for 40 weeks during maintenance period. Compared with placebo, patients on guselkumab showed higher rates of (1) clinical remission during induction (RR 2.65; 95% CI, 2.40 to 3.47) and maintenance (RR 2.81; 95% CI, 1.84 to 4.28); (2) clinical response during induction (RR 2.25; 95% CI, 2.03 to 2.50); (3) endoscopic remission during induction (RR 2.36; 95% CI, 1.34 to 4.17); and (4) endoscopic response during induction (RR 2.44; 95% CI, 1.92 to 3.10) and maintenance (RR 4.92; 95% CI, 2.01 to 12.05). No difference was found between groups for clinical response during maintenance (RR 1.95; 95% CI, 0.54 to 6.98; two RCTs) and for endoscopic remission during maintenance (RR 4.29; 95% CI, 0.85 to 21.78). Across all endpoints, no significant difference was found between subgroups comparing CD and UC. CONCLUSION Guselkumab improves clinical and endoscopic outcomes during induction and continues on maintenance phase in both CD and UC.