Efficacy and safety of budesonide for eosinophilic esophagitis: an updated systematic review and meta-analysis

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Background: Eosinophilic esophagitis (EoE), a chronic immune-mediated inflammatory disorder, is increasingly recognized globally. Budesonide, a topical corticosteroid, is widely used for EoE; but its efficacy and safety profile require comprehensive evaluation. Objective: To assess the efficacy and safety of budesonide in EoE through an updated systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: Following PRISMA guidelines and AMSTAR guidelines, we searched PubMed, EMBASE, and Google Scholar for RCTs comparing budesonide with placebo in EoE patients (conception to January 2025). A GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach was applied to rate the certainty of evidence across key outcomes. Primary outcomes included histologic response (≤15 eosinophils/high-power field), clinical symptom improvement, and safety. Data were pooled using random/fixed-effects models, with sensitivity analyses to address heterogeneity. Results: Eleven RCTs (1089 participants) were included. Budesonide significantly improved histologic remission (RR: 26.85; 95% CI: 13.72–52.56; P < 0.00001) and reduced peak eosinophil counts (SMD: −1.08; 95% CI: −1.40 to 0.77; P < 0.00001). Clinical response (RR: 1.58; 95% CI: 1.03–2.42; P = 0.04) and dysphagia symptom scores (SMD: −0.29; 95% CI: −0.49 to 0.09; P = 0.004) also favored budesonide. However, fibrosis scores showed no significant improvement ( P = 0.48). Adverse events were comparable to placebo overall (RR: 1.01; 95% CI: 0.82–1.24), though infections were more frequent with budesonide (RR: 2.14; 95% CI: 1.20–3.80; P = 0.009). Transient cortisol suppression occurred in sensitivity analyses (SMD: −0.41; 95% CI: −0.66 to 0.16; P = 0.001). Most infections were localized (e.g., oropharyngeal candidiasis) and rarely required treatment discontinuation. Conclusion: Budesonide effectively induces histologic and clinical remission in EoE but does not reverse fibrosis. While generally safe, long-term adrenal monitoring is warranted due to cortisol suppression. GRADE evaluation suggested moderate-to-high certainty for efficacy outcomes and moderate certainty for safety outcomes. Persistent symptoms in fibrostenotic disease highlight the need for adjunct therapies. Future research should optimize dosing regimens and evaluate combination strategies.

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