Lucendo, AJ;
Miehlke, S;
Schlag, C;
Vieth, M;
von Arnim, U;
Molina-Infante, J;
Hartmann, D;
Bredenoord, AJ;
Ciriza de Los Rios, C;
Schubert, S;
et al.
Lucendo, AJ; Miehlke, S; Schlag, C; Vieth, M; von Arnim, U; Molina-Infante, J; Hartmann, D; Bredenoord, AJ; Ciriza de Los Rios, C; Schubert, S; Brückner, S; Madisch, A; Hayat, J; Tack, J; Attwood, S; Mueller, R; Greinwald, R; Schoepfer, A; Straumann, A; International EOS-1 Study Group
(2019)
Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial.
Gastroenterology, 157 (1).
74-86.e15.
ISSN 1528-0012
https://doi.org/10.1053/j.gastro.2019.03.025
SGUL Authors: Hayat, Jamal
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Abstract
BACKGROUND & AIMS: Swallowed topical-acting corticosteroids are recommended as first-line therapy for eosinophilic esophagitis (EoE). Asthma medications not optimized for esophageal delivery are sometimes effective, although given off-label. We performed a randomized, placebo-controlled trial to assess the effectiveness and tolerability of a budesonide orodispersible tablet (BOT), which allows the drug to be delivered to the esophagus in adults with active EoE. METHODS: We performed a double-blind, parallel study of 88 adults with active EoE in Europe. Patients were randomly assigned to groups that received BOT (1 mg twice daily; n = 59) or placebo (n = 29) for 6 weeks. The primary end point was complete remission, based on clinical and histologic factors, including dysphagia and odynophagia severity ≤2 on a scale of 0-10 on each of the 7 days before the end of the double-blind phase and a peak eosinophil count <5 eosinophils/high power field. Patients who did not achieve complete remission at the end of the 6-week double-blind phase were offered 6 weeks of open-label treatment with BOT (1 mg twice daily). RESULTS: At 6 weeks, 58% of patients given BOT were in complete remission compared with no patients given placebo (P < .0001). The secondary end point of histologic remission was achieved by 93% of patients given BOT vs no patients given placebo (P < .0001). After 12 weeks, 85% of patients had achieved remission. Six-week and 12-week BOT administration were safe and well tolerated; 5% of patients who received BOT developed symptomatic, mild candida, which was easily treated with an oral antifungal agent. CONCLUSIONS: In a randomized trial of adults with active EoE, we found that budesonide oral tablets were significantly more effective than placebo in inducing clinical and histologic remission. Eudra-CT number 2014-001485-99; ClinicalTrials.gov ID NCT02434029.
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