S1014 Budesonide Yields Superior Clinical and Histologic Remission in Adult Eosinophilic Esophagitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Introduction: Eosinophilic esophagitis (EoE) affects 1 in 1,000 adults and is a leading cause of refractory dysphagia with progressive fibro-stenotic remodeling. Topical budesonide delivered as oro-dispersible tablets (ODT) or viscous suspensions is recommended, yet dose, formulation, and depth-of-remission data remain fragmented. To our knowledge no prior meta-analysis has integrated every placebo-controlled randomized controlled trial (RCTs) with formulation- and dose-level subgrouping, leaving clinicians without quantitative guidance. We pooled 7 RCTs to quantify clinical, histologic, and deep remission and to explore dose-response. Methods: A systematic search of PubMed, Embase, Scopus, and Cochrane Library identified RCTs comparing budesonide with placebo or other formulations for EoE through May 2025. Data were analyzed using R (version 4.4.3). Pooled risk ratios (RRs) 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: Among 7 RCTs with over 500 patients, budesonide 0.5-2 mg twice per day decisively out-performed placebo. Pooled RRs (random-effects): histologic remission 6.15 (1.41-26.8); partial histologic remission 13.18 (6.53-26.6); deep histologic remission 17.63 (3.73-83.4); clinical remission (dysphagia/odynophagia numeric rating scale ≤2) 15.45 (1.98-120.8); and failure to achieve histologic remission 0.22 (0.12-0.42). Benefits were greatest with 2 mg twice per day. Heterogeneity was low to moderate for partial remission but higher for deep and clinical endpoints. Conclusion: This meta-analysis shows that budesonide increased deep histologic remission 18-fold and clinical remission 15-fold while halving non-responders. Benefits persisted across doses, though heterogeneity was high for deep endpoints and long-term effects remains unknown. By consolidating high-quality evidence for oral budesonide, these findings address a critical need and guide standardized topical therapy recommendations. Future pragmatic trials should evaluate maintenance strategies and sustained fibro-stenotic reversal.