Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial.
- Lucendo AJ Department of Gastroenterology, Hospital General de Tomelloso, Tomelloso, Spain; Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Spain. Electronic address: ajlucendo@hotmail.com.
- Miehlke S Center for Digestive Diseases, Internal Medicine Center Eppendorf, Hamburg, Germany; Center for Esophageal Diseases, University Hospital Hamburg-Eppendorf, Germany.
- Schlag C II. Medizinische Klinik, Klinikum Rechts der Isar, Technische Universität München, München, Germany.
- Vieth M Institute for Pathology, Klinikum Bayreuth, Bayreuth, Germany.
- von Arnim U Department of Gastroenterology, Hepatology and Infectious Diseases, Otto von Guericke University, Magdeburg, Germany.
- Molina-Infante J Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Spain; Department of Gastroenterology, Hospital Universitario San Pedro de Alcantara, Caceres, Spain.
- Hartmann D Klinik für Innere Medizin I, Sana Klinikum Lichtenberg, Berlin, Germany.
- Bredenoord AJ Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.
- Ciriza de Los Rios C Department of Gastroenterology, Hospital Universitario 12 de Octubre, Madrid, Spain.
- Schubert S Gastroenterologist in private practice, Berlin, Germany.
- Brückner S Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus Technische Universität Dresden, Dresden, Germany.
- Madisch A Department of Gastroenterology, CRH Clinic Siloah, Hannover, Germany.
- Hayat J Department of Gastroenterology, Saint George's University Hospitals National Health Service Trust, London, United Kingdom.
- Tack J Department of Gastroenterology, University Hospital, Leuven, Belgium.
- Attwood S Department of Health Services Research, Durham University, Durham, United Kingdom.
- Mueller R Department of Clinical Research and Development, Dr Falk Pharma GmbH, Freiburg, Germany.
- Greinwald R Department of Clinical Research and Development, Dr Falk Pharma GmbH, Freiburg, Germany.
- Schoepfer A Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.
- Straumann A Swiss EoE Research Group, Olten, Switzerland.
- 2019-03-30
Published in:
- Gastroenterology. - 2019
Esophagus
Immune Response
Patient-Reported Outcomes
Phase 3 Trial
Administration, Oral
Adult
Antifungal Agents
Budesonide
Candidiasis, Oral
Double-Blind Method
Eosinophilic Esophagitis
Esophagoscopy
Female
Glucocorticoids
Humans
Male
Middle Aged
Tablets
Treatment Outcome
English
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.
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.
- Language
-
- English
- Open access status
- hybrid
- Identifiers
-
- DOI 10.1053/j.gastro.2019.03.025
- PMID 30922997
- Persistent URL
- https://sonar.ch/global/documents/283517
Statistics
Document views: 32
File downloads:
- fulltext.pdf: 0