Budesonide Can Be Used for Maintaining Long-Term Remission in Eosinophilic Esophagitis

Eosinophilic esophagitis (EoE) is a chronic antigen-mediated immunological disorder that has a high relapse rate of >80% with cessation of therapy. Although corticosteroids (both topical and oral) are used in the acute setting and remission can be achieved, long-term data are lacking.

This randomized controlled study aimed to investigate the efficacy and safety of a budesonide orodispersible tablet (BOT) for sustained remission (fulfilling all of the following: no clinical or histological relapse, no food impaction requiring intervention, no need for dilation, and no premature withdrawal for any reason) of EoE in patients at 48 weeks. A total of 204 patients who achieved clinical-histopathological remission after 6 to 12 weeks of BOT treatment were randomized to receive 1 mg or 2 mg BOT, or placebo. Concurrent proton pump inhibitor treatment was maintained. Sustained remission after 48 weeks of treatment was achieved in 73.5%, 75%, and 4.4% of patients in the 1-mg BOT, 2-mg BOT, and placebo groups, respectively (P<.001). At the end of treatment, histological (peak ≥48 eosinophils/mm^2 high-power field) and clinical relapse (dysphagia or odynophagia with severity ≤4 points on a 0-10 point numerical rating scale) rates occurred significantly less in the study treatment groups compared to placebo. There were no serious drug-related adverse events. Oral candidiasis occurred in 10% to 15% of patients treated with BOT, whereas morning cortisol remained stable compared to baseline.