Budesonide Orodispersible Tablets Maintain Remission in a Randomized, Placebo-Controlled Trial of Patients With Eosinophilic Esophagitis.
- Straumann A Swiss Eosinophilic Esophagitis Research Group, Olten, Switzerland; Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland. Electronic address: alex.straumann@hin.ch.
- Lucendo AJ Department of Gastroenterology, Hospital General de Tomelloso, Tomelloso, Spain; Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Madrid, Spain; Instituto de Investigación Sanitaria Princesa, Madrid, Spain.
- Miehlke S Center for Digestive Diseases, Internal Medicine Center Eppendorf, Hamburg, Germany; Center for Esophageal Disorders, University Hospital Hamburg-Eppendorf, Germany.
- Vieth M Institute for Pathology, Klinikum Bayreuth, Bayreuth, Germany.
- Schlag C II. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
- Biedermann L Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.
- Vaquero CS Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Madrid, Spain; Instituto de Investigación Sanitaria Princesa, Madrid, Spain; Servicio de Aparato Digestivo, Hospital Universitario de La Princesa, Madrid, Spain.
- Ciriza de Los Rios C Department of Gastroenterology, Hospital Universitario 12 de Octubre, Madrid, Spain.
- Schmoecker C Department of Gastroenterology, Sana Klinikum Lichtenberg, Berlin, Germany.
- Madisch A Department of Gastroenterology, Clinical-Center Region Hannover Clinic Siloah, Hannover, Germany.
- Hruz P Department of Gastroenterology, University Hospital Basel, Basel, Switzerland.
- Hayat J Department of Gastroenterology, Saint George's University Hospitals National Health Service Trust, London, UK.
- von Arnim U Department of Gastroenterology, Hepatology and Infectious Diseases, University Hospital Magdeburg, Magdeburg, Germany.
- Bredenoord AJ Department of Gastroenterology and Hepatology, Academic Medical Center Amsterdam, Amsterdam, the Netherlands.
- Schubert S Private Practice, Berlin, Germany.
- 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 Department of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland.
- Attwood S Department of Health Services Research, Durham University, Durham, UK.
- 2020-07-30
Published in:
- Gastroenterology. - 2020
English
BACKGROUND & AIMS
Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder. Swallowed topical-acting corticosteroids are effective in bringing active EoE into remission. However, it is not clear whether these drugs are effective for long-term maintenance of remission.
METHODS
We performed a double-blind trial to compare the efficacy and safety of 2 dosages of a budesonide orodispersible tablet (BOT) vs placebo in maintaining remission of EoE. Maintenance of remission was defined as absence of clinical and histologic relapse and no premature withdrawal for any reason. Two hundred and four adults with EoE in clinical and histologic remission, from 29 European study sites, were randomly assigned to groups given BOT 0.5 mg twice daily (n = 68), BOT 1.0 mg twice daily (n = 68), or placebo twice daily (n = 68) for up to 48 weeks.
RESULTS
At end of treatment, 73.5% of patients receiving BOT 0.5 mg twice daily and 75% receiving BOT 1.0 mg twice daily were in persistent remission compared with 4.4% of patients in the placebo group (P < .001 for both comparisons of BOT with placebo). Median time to relapse in the placebo group was 87 days. The frequency of adverse events was similar in the BOT and placebo groups. Morning serum levels of cortisol were in the normal range at baseline and did not significantly change during treatment. Four patients receiving BOT developed asymptomatic, low serum levels of cortisol. Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment.
CONCLUSIONS
In a phase 3 trial, up to 48 weeks of treatment with BOT (0.5 mg or 1.0 mg twice daily) was superior to placebo in maintaining remission of EoE. Both dosages were equally effective and well tolerated. EudraCT number; 2014-001485-99; ClinicalTrials.gov number, NCT02434029.
Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder. Swallowed topical-acting corticosteroids are effective in bringing active EoE into remission. However, it is not clear whether these drugs are effective for long-term maintenance of remission.
METHODS
We performed a double-blind trial to compare the efficacy and safety of 2 dosages of a budesonide orodispersible tablet (BOT) vs placebo in maintaining remission of EoE. Maintenance of remission was defined as absence of clinical and histologic relapse and no premature withdrawal for any reason. Two hundred and four adults with EoE in clinical and histologic remission, from 29 European study sites, were randomly assigned to groups given BOT 0.5 mg twice daily (n = 68), BOT 1.0 mg twice daily (n = 68), or placebo twice daily (n = 68) for up to 48 weeks.
RESULTS
At end of treatment, 73.5% of patients receiving BOT 0.5 mg twice daily and 75% receiving BOT 1.0 mg twice daily were in persistent remission compared with 4.4% of patients in the placebo group (P < .001 for both comparisons of BOT with placebo). Median time to relapse in the placebo group was 87 days. The frequency of adverse events was similar in the BOT and placebo groups. Morning serum levels of cortisol were in the normal range at baseline and did not significantly change during treatment. Four patients receiving BOT developed asymptomatic, low serum levels of cortisol. Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment.
CONCLUSIONS
In a phase 3 trial, up to 48 weeks of treatment with BOT (0.5 mg or 1.0 mg twice daily) was superior to placebo in maintaining remission of EoE. Both dosages were equally effective and well tolerated. EudraCT number; 2014-001485-99; ClinicalTrials.gov number, NCT02434029.
- Language
-
- English
- Open access status
- hybrid
- Identifiers
-
- DOI 10.1053/j.gastro.2020.07.039
- PMID 32721437
- Persistent URL
- https://folia.unifr.ch/global/documents/200395
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