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

Miehlke S, Schlag C, Lucendo AJ, Biedermann L, Vaquero CS, Schmoecker C, Hayat J, Hruz P, Ciriza De Los Rios C, Jan Bredenoord A, Vieth M, Schoepfer A, Attwood S, Mueller R, Burrack S, Greinwald R, Straumann A (2022)

Publication Type: Journal article

Publication year: 2022

Journal

United European Gastroenterology Journal SAGE Publications

Book Volume: 10

Pages Range: 330-343

Journal Issue: 3

DOI: 10.1002/ueg2.12220

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(2) 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(2) 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.

Authors with CRIS profile

Michael Vieth Medizinische Fakultät

Involved external institutions

Academic Medical Centre / Academisch Medisch Centrum (AMC) NL Netherlands (NL) Universitätsklinikum Hamburg-Eppendorf (UKE) DE Germany (DE) Universitätsspital Zürich (USZ) CH Switzerland (CH) Durham University GB United Kingdom (GB) St. Claraspital AG CH Switzerland (CH) Sana Klinikum Lichtenberg DE Germany (DE) Dr. Falk Pharma GmbH DE Germany (DE) Centro de Investigación Biomédica en Red - Enfermedades Hepáticas y Digestivas (CIBERHD) ES Spain (ES) Technische Universität München (TUM) DE Germany (DE) Public General Hospital Tomelloso / Hospital General de Tomelloso ES Spain (ES) Hospital Universitario 12 de Octubre ES Spain (ES) Lausanne University Hospital / Centre hospitalier universitaire vaudois (CHUV) CH Switzerland (CH) St George's, University of London (SGUL) / St George's Hospital Medical School GB United Kingdom (GB)

How to cite

APA:

Miehlke, S., Schlag, C., Lucendo, A.J., Biedermann, L., Vaquero, C.S., Schmoecker, C.,... Straumann, A. (2022). Budesonide orodispersible tablets for induction of remission in patients with active eosinophilic oesophagitis: A 6-week open-label trial of the EOS-2 Programme. United European Gastroenterology Journal, 10(3), 330-343. https://doi.org/10.1002/ueg2.12220

MLA:

Miehlke, Stephan, et al. "Budesonide orodispersible tablets for induction of remission in patients with active eosinophilic oesophagitis: A 6-week open-label trial of the EOS-2 Programme." United European Gastroenterology Journal 10.3 (2022): 330-343.

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