P457 Long-term cumulative safety of ustekinumab in bionaive patients with Crohn’s Disease and Ulcerative Colitis

Abstract

i434 Poster presentations randomized controlled trials (RCTs) reporting malignant tumors in adults with autoimmune diseases. Peto odds ratios (PORs) were calculated as effect sizes to assess the risk of malignant tumors. Results: Fifteen RCTs involving 5835 patients were included in the study. The meta-analysis revealed that the risk of malignant tumors was not significantly different between patients treated with usteki-numab or placebo (POR=0.88, 95% confidence interval [CI] [0.37, 2.11], P=0.78). Similarly, no statistically significant difference existed in the incidence of non-melanoma skin cancers (POR=0.77, 95% CI [0.23, 2.61], P=0.68). No heterogeneity was observed in the comparisons. Conclusion: Compared with placebo, ustekinumab did not increase the risk of malignant tumors or non-melanoma skin cancers in patients with autoimmune diseases, indicating the safety of this biological agent.