S1861 Safety and Efficacy of Guselkumab in the Treatment of Inflammatory Bowel Diseases: A Meta-Analysis of Randomized Controlled Trials

Introduction: Guselkumab, a human monoclonal antibody targeting the interleukin-23 p19 subunit, has emerged as a promising therapeutic option for inflammatory bowel disease (IBD). By inhibiting IL-23, Guselkumab modulates key inflammatory pathways implicated in IBD pathogenesis. While recent randomized controlled trials (RCTs) have reported its efficacy and favorable safety profile, the collective evidence remains to be comprehensively evaluated. This meta-analysis aimed to assess the safety and efficacy of Guselkumab as induction and maintenance therapy in patients with IBD. Methods: We systematically searched databases including Embase, Scopus, Web of Science, Medline, and Cochrane on 6th April 2025 without any automated filters or language restrictions. RCTs that compared guselkumab with placebo in IBD patients were eligible for inclusion. Pooling of the studies was performed by using the Risk Ratio (RR) with the corresponding 95% Confidence Interval (CI) using a random effects model. All analyses were done by STATA Corp M17. Results: A total of 1916 patients with a mean age ranged from 35.1 to 43.3 years were pooled through 5 RCTs. Use of the guselkumab as an induction therapy achieved higher clinical remission [RR: 2.32, 95% CI [1.89; 2.85], P < 0.001, I2 = 0%], and clinical response [RR: 1.81, 95% CI [1.59; 2.07], P < 0.001, I2 = 0%] at 12 weeks. Also, as maintenance therapy, it achieved higher clinical remission [RR: 2.19, 95% CI [1.76; 2.74], P < 0.001, I2 = 0%], and clinical response [RR: 1.62, 95% CI [1.34; 1.95], P < 0.001, I2 = 0%] in 12 weeks. The safety outcomes, including rates of serious adverse events and infections, were comparable between guselkumab and placebo 43.3. Conclusion: This meta-analysis underscores the higher efficacy of guselkumab in treating IBD patients within a good safety profile. Future research is needed to clarify the long-term effects of guselkumab regarding its safety.