S1015 Efficacy and Safety of Dupilumab in the Treatment of Eosinophilic Esophagitis: A Comprehensive Systematic Review and Meta-Analysis of Randomized Controlled Trials With Subgroup Analysis by Dosage and Prior Steroid Use

Introduction: Eosinophilic esophagitis (EoE) is a chronic immunologic disorder with limited therapeutic options available. Despite the symptomatic relief brought on by the steroids and dietary modifications, many patients continue to suffer. Biologics such as dupilumab that target the Interleukin (IL)-4/IL-13 pathway have shown great promise in the recent trials. This systematic review and meta-analysis evaluates the efficacy and the safety of dupilumab in the treatment of EoE with using subgroup analysis by dosage and prior steroid use. Methods: A systematic search of PubMed, Embase, Scopus, and Cochrane Library identified randomized controlled trials (RCTs) comparing dupilumab with placebo in EoE through March 2025. Data were analyzed using R (4.4.3). Pooled risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated using Mantel-Haenszel methods. Random- or fixed-effects models were applied based on heterogeneity (Higgins’ I²). Statistical significance was set at P < 0.05. Risk of bias was assessed using Risk of Bias 2.0. Results: Four RCTs (N = 844) showed that dupilumab significantly improved 5 key endpoints, with only a modest increase in mostly mild adverse events. Histologic remission (<15 eos/hpf) was significantly higher with dupilumab (RR 6.78; 95% CI 3.39-13.58; P < 0.001; I² = 83.5%). Weekly dosing showed a benefit over longer intervals in fixed-effect models (χ² = 6.73; P = 0.0095) but not under random-effects (P = 0.56), indicating comparable efficacy. Remission rates were unaffected by prior topical steroid use (χ² = 3.04; P = 0.22), supporting efficacy in steroid-refractory patients. Endoscopic severity (Endoscopic Reference Score) improved significantly (MD -2.01; 95% CI -3.44 to -0.59; P = 0.0057; I² = 42.7%), with borderline subgroup interaction by dose and steroid history. Dysphagia improved by MD -8.73 (95% CI -12.40 to -5.05; P < 0.001; I² = 96.5%) without significant subgroup interaction. Quality-of-life changes were modest and statistically nonsignificant (MD -0.12; P = 0.39; I² = 83%). Adverse events were slightly more frequent with dupilumab (RR 1.15; 95% CI 1.01-1.29; P = 0.028; I² = 51.4%), with no subgroup-specific differences. Conclusion: Regardless of dosage or steroid history, dupilumab exhibits robust and steady efficacy in EoE across histologic, endoscopic, and symptomatic outcomes. Subgroup interactions were negligible despite some heterogeneity. With only a slight increase in mild adverse events, dupilumab stands out as a safe and highly effective biologic.