Budesonide orodispersible tablets for induction of remission in patients with active eosinophilic oesophagitis: A 6-week open-label trial of the EOS-2 Programme.

Stephan Miehlke, Christoph Schlag, Alfredo J Lucendo, Luc Biedermann, Cecilio Santander Vaquero, Christoph Schmoecker, Jamal Hayat, Petr Hruz, Constanza Ciriza de Los Rios, Albert Jan Bredenoord, Michael Vieth, Alain Schoepfer, Stephen Attwood, Ralph Mueller, Sarah Burrack, Roland Greinwald, Alex Straumann

Journal: United European gastroenterology journal 2022;10(3):330-343

PMID: 35412032

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Abstract

BACKGROUND

A novel budesonide orodispersible tablet (BOT) has been proven effective in adult patients with active eosinophilic oesophagitis (EoE) in a 6-week placebo-controlled trial (EOS-1).

AIMS

To report the efficacy of an open-label induction treatment with BOT in a large prospective cohort of EoE patients within the EOS-2 study.

METHODS

Patients with clinico-histological active EoE were treated with BOT 1 mg BID for 6 weeks. The primary endpoint was clinico-histological remission (≤2 points on numerical rating scales [0-10] each for dysphagia and odynophagia, and peak eosinophil count <16 eos/mm hpf (corresponds to <5 eos/hpf)). Further study endpoints included clinical and histological remission rates, change in the EEsAI-PRO score, change in peak eosinophil counts, and deep endoscopic remission using a modified Endoscopic Reference Score.

RESULTS

Among 181 patients enrolled, 126 (69.6%) achieved clinico-histological remission (histological remission 90.1%, clinical remission 75.1%). The mean peak eosinophil counts decreased by 283 eos/mm hpf (i.e., by 89.0%). Mean EEsAI-PRO score decreased from baseline by 29 points and deep endoscopic remission was achieved in 97 (53.6%) patients. The majority of patients judged tolerability as good or very good (85.6%) and compliance was high (96.5%). Local candidiasis was suspected in 8.3% of patients; all were of mild severity, resolved with treatment and none led to premature withdrawal from the study.

CONCLUSIONS

In this large prospective trial, a 6-week open-label treatment with BOT 1 mg BID was highly effective and safe in achieving clinico-histological remission of active EoE and confirmed the results of the placebo-controlled EOS-1 trial.

Address: Centre for Digestive Diseases, Internal Medicine Centre Eppendorf, Hamburg, Germany.; Centre for Oesophageal Disorders, University Hospital Eppendorf, Hamburg, Germany.; II. Medizinische Klinik, Klinikum rechts der Isar, TU München, München, Germany.; Department of Gastroenterology, Hospital General de Tomelloso, Tomelloso, Spain.; Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain.; Instituto de Investigación Sanitaria Princesa, Madrid, Spain.; Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.; Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain.; Instituto de Investigación Sanitaria Princesa, Madrid, Spain.; Department of Gastroenterology and Hepatology, Hospital Universitario de La Princesa, Madrid, Spain.; Klinik für Innere Medizin 1, Sana Klinikum Lichtenberg, Berlin, Germany.; Medizinische Hochschule Brandenburg, Campus Ruppiner Kliniken, Medizinische Klinik B, Neuruppin, Germany.; Department of Gastroenterology, Saint George's University Hospitals NHS Trust, London, UK.; Clarunis, University Centre for Liver and Gastrointestinal Diseases, St. Clara Hospital and University Hospital Basel, Basel, Switzerland.; Department of Gastroenterology, Hospital Universitario 12 de Octubre, Madrid, Spain.; Department of Gastroenterology and Hepatology, Academic Medical Centre, Amsterdam, the Netherlands.; Institute for Pathology, Friedrich-Alexander-University Erlangen-Nuremberg, Klinikum Bayreuth, Bayreuth, Germany.; Department of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland.; Department of Health Services Research, Durham University, Durham, UK.; Department of Clinical Research & Development, Dr. Falk Pharma GmbH, Freiburg, Germany.; Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland.; Swiss EoE Research Group, Olten, Switzerland.

DOI: 10.1002/ueg2.12220

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MeSH Terms: Adult, Budesonide, Deglutition Disorders, Eosinophilic Esophagitis, Humans, Prospective Studies, Remission Induction, Tablets