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- Document type:
- Journal Article
- Author(s):
- Lucendo, Alfredo J; Miehlke, Stephan; Schlag, Christoph; Vieth, Michael; von Arnim, Ulrike; Molina-Infante, Javier; Hartmann, Dirk; Bredenoord, Albert Jan; Ciriza de Los Rios, Constanza; Schubert, Stefan; Brückner, Stefan; Madisch, Ahmed; Hayat, Jamal; Tack, Jan; Attwood, Stephen; Mueller, Ralph; Greinwald, Roland; Schoepfer, Alain; Straumann, Alex
- Title:
- Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial.
- 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.
- Journal title abbreviation:
- Gastroenterology
- Year:
- 2019
- Journal volume:
- 157
- Journal issue:
- 1
- Pages contribution:
- 74-86.e15
- Fulltext / DOI:
- doi:10.1053/j.gastro.2019.03.025
- Pubmed ID:
- http://view.ncbi.nlm.nih.gov/pubmed/30922997
- Print-ISSN:
- 0016-5085
- TUM Institution:
- II. Medizinische Klinik und Poliklinik (Gastroenterologie)
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