Budesonide Can Be Used for Maintaining Long-Term Remission in Eosinophilic Esophagitis
Prateek Sharma, MD, FASGE, reviewing Straumann A, et al. Gastroenterology 2020 Jul 25.
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.
Note to readers: At the time we reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.
Straumann A, Lucendo AJ, Miehlke S, et al. Budesonide orodispersible tablets maintain remission in a randomized, placebo-controlled trial of patients with eosinophilic esophagitis. Gastroenterology 2020 Jul 25. (Epub ahead of print) (https://doi.org/10.1053/j.gastro.2020.07.039)