Effectiveness and Safety of Biologic Agents in the Treatment of Patients With Very Early‐Onset Inflammatory Bowel Diseases: A Systematic Review and Single‐Arm Meta‐Analysis

Background Very early‐onset inflammatory bowel disease (VEO‐IBD) represents a distinct subset of IBD. This study aims to systematically review the effectiveness and safety of biologics in this population. Methods A comprehensive literature search was conducted to identify original studies on the effectiveness and safety of biologics in VEO‐IBD. Two researchers independently conducted study screening, data extraction, and quality assessment. Analyses used Stata 18.0. Results The screening process identified 16 studies. During the induction phase, the biologic persistence rate for biologics reached 80.8% (95% CI: 68.8%–92.8%), with a clinical response rate of 57.9% (95% CI: 50.2%–65.6%) and a clinical remission rate of 24.5% (95% CI: 13.0%–37.9%). In the maintenance phase, the biologic persistence rate dropped to 52.2% (95% CI: 25.8%–78.7%), while the clinical response and remission rates were 53.7% (95% CI: 17.7%–87.8%) and 32.4% (95% CI: 16.6%–48.1%), respectively. Short‐term follow‐up showed rates of any adverse events and serious adverse events at 39.4% (95% CI: 18.7%–62.1%) and 10.5% (95% CI: 0.5%–27.2%), respectively. Long‐term follow‐up indicated these rates were 16.2% (95% CI: 10.3%–22.1%) and 0.0% (95% CI: 0.0%–0.3%), respectively. Conclusions This study indicated that biologics had a positive clinical response in most patients during the induction and maintenance phases, but the effect of clinical remission was limited, and the biologic persistence rate declined in the maintenance phase. Although adverse events occurred frequently, the risk of serious adverse events remained relatively low. The effectiveness and safety of biologics appeared comparable between VEO‐IBD and later‐onset pediatric IBD. Larger studies are needed to validate these findings.