Alfredo J Lucendo1, Stephan Miehlke2, Christoph Schlag3, Michael Vieth4, Ulrike von Arnim5, Javier Molina-Infante6, Dirk Hartmann7, Albert Jan Bredenoord8, Constanza Ciriza de Los Rios9, Stefan Schubert10, Stefan Brückner11, Ahmed Madisch12, Jamal Hayat13, Jan Tack14, Stephen Attwood15, Ralph Mueller16, Roland Greinwald16, Alain Schoepfer17, Alex Straumann18. 1. 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. 2. Center for Digestive Diseases, Internal Medicine Center Eppendorf, Hamburg, Germany; Center for Esophageal Diseases, University Hospital Hamburg-Eppendorf, Germany. 3. II. Medizinische Klinik, Klinikum Rechts der Isar, Technische Universität München, München, Germany. 4. Institute for Pathology, Klinikum Bayreuth, Bayreuth, Germany. 5. Department of Gastroenterology, Hepatology and Infectious Diseases, Otto von Guericke University, Magdeburg, Germany. 6. Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Spain; Department of Gastroenterology, Hospital Universitario San Pedro de Alcantara, Caceres, Spain. 7. Klinik für Innere Medizin I, Sana Klinikum Lichtenberg, Berlin, Germany. 8. Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands. 9. Department of Gastroenterology, Hospital Universitario 12 de Octubre, Madrid, Spain. 10. Gastroenterologist in private practice, Berlin, Germany. 11. Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus Technische Universität Dresden, Dresden, Germany. 12. Department of Gastroenterology, CRH Clinic Siloah, Hannover, Germany. 13. Department of Gastroenterology, Saint George's University Hospitals National Health Service Trust, London, United Kingdom. 14. Department of Gastroenterology, University Hospital, Leuven, Belgium. 15. Department of Health Services Research, Durham University, Durham, United Kingdom. 16. Department of Clinical Research and Development, Dr Falk Pharma GmbH, Freiburg, Germany. 17. Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland. 18. Swiss EoE Research Group, Olten, Switzerland.
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.
RCT Entities:
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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