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Randomized Controlled Trial
. 2019 Jul;157(1):74-86.e15.
doi: 10.1053/j.gastro.2019.03.025. Epub 2019 Mar 26.

Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial

Alfredo J Lucendo  1 , Stephan Miehlke  2 , Christoph Schlag  3 , Michael Vieth  4 , Ulrike von Arnim  5 , Javier Molina-Infante  6 , Dirk Hartmann  7 , Albert Jan Bredenoord  8 , Constanza Ciriza de Los Rios  9 , Stefan Schubert  10 , Stefan Brückner  11 , Ahmed Madisch  12 , Jamal Hayat  13 , Jan Tack  14 , Stephen Attwood  15 , Ralph Mueller  16 , Roland Greinwald  16 , Alain Schoepfer  17 , Alex Straumann  18 ; International EOS-1 Study Group
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Free article
Randomized Controlled Trial

Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial

Alfredo J Lucendo et al. Gastroenterology. 2019 Jul.
Free article

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.

Keywords: Esophagus; Immune Response; Patient-Reported Outcomes; Phase 3 Trial.

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