Meta-analysis of the efficacy and safety of ustekinumab in the treatment of pediatric inflammatory bowel disease

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This study aimed to systematically evaluate the efficacy and safety of ustekinumab (UST) in the treatment of pediatric inflammatory bowel disease (PIBD) and to provide evidence-based support for its clinical application. The PubMed and Web of Science databases were searched to identify relevant studies investigating UST for the treatment of PIBD. Two researchers independently performed literature screening, data extraction, and quality assessment. Meta-analysis was conducted using STATA software. A total of 21 studies involving 839 pediatric patients with IBD were included. The pooled results showed that the 52-week clinical remission rate of UST in pediatric patients with IBD was 61% (95% CI: 50%–71%), the steroid-free clinical remission rate was 53% (95% CI: 44%–63%), and the 52-week clinical response rate was 55% (95% CI: 36%–74%). The 24-week clinical remission and clinical response rates were 45% (95% CI: 36%–54%) and 58% (95% CI: 47%–69%), respectively. The pooled endoscopic remission rate was 38% (95% CI: 20%–56%). The incidence of serious adverse events was 1% (95% CI: 0%–2%). Sensitivity analyses indicated that the results were robust, and Egger’s test did not detect significant publication bias ( P = 0.168). UST demonstrates favorable clinical efficacy and safety in pediatric patients with IBD, enabling more than half of patients to achieve long-term clinical remission and steroid-free clinical remission. For pediatric patients who have experienced treatment failure with or intolerance to previous biologic therapies, UST may represent an effective alternative therapeutic option.