Real-World Clinical Efficacy of Food and Drug Administration-Approved Budesonide Oral Suspension Across Histologic, Endoscopic, and Symptomatic Outcomes.

BACKGROUND AND AIMS: Though topical corticosteroids have long been used for the treatment of eosinophilic esophagitis (EoE), real-world data for the recently Food and Drug Administration-approved budesonide oral suspension (BOS) are lacking. We sought to determine the efficacy of BOS in a real-world cohort of EoE patients.

METHODS

We conducted a retrospective cohort study of patients with EoE who were treated with BOS. Baseline characteristics, history, and procedural data were extracted from the medical record. We assessed endoscopic, histologic, and symptomatic responses for the endoscopy immediately preceding and following 12 weeks of BOS.

RESULTS

We identified 145 EoE patients prescribed BOS at our center since 2024 (mean age 35.4 years; 60% male), of whom 111 (77%) ultimately obtained insurance approval and 94 (65%) were able to fill their prescription. Post-treatment data were available for 48 patients. Compared to before BOS treatment, post-BOS patients were more likely to achieve a histologic response at all thresholds (eg, 73% vs 19% for <15 eos/hpf; P < .001) and endoscopic response (64% vs 22% for EoE Endoscopic Reference Score ≤2; P < .001), with associated significant reductions in peak eosinophil count (15.0 ± 30.6 vs 66.7 ± 71.8; P < .001) and total EoE Endoscopic Reference Score (2.0 ± 1.9 vs 3.9 ± 2.2; P < .001). Global symptom improvement was reported in 78%.

CONCLUSION

In this initial real-world cohort treated with the Food and Drug Administration-approved BOS, histologic response rates reflected those seen in BOS clinical trials. Symptoms and endoscopic findings improved in parallel. Because the majority of prescriptions could be filled and significant improvement was achieved compared to prior treatments, BOS should be considered when topical steroids are selected for EoE.