Abstract
Abstract Background Ustekinumab has shown efficacy in treating psoriasis, psoriatic arthritis, and inflammatory bowel disease and is generally safe in the short term; however, data on its long-term safety, especially in terms of malignant tumors, are lacking, which has aroused great public concern. Methods The PubMed, Web of Science, Embase, and Cochrane Library databases were searched from their establishment to July 2021 for 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 ustekinumab 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.
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