TY - JOUR
T1 - Budesonide orodispersible tablets for induction of remission in patients with active eosinophilic oesophagitis
T2 - A 6-week open-label trial of the EOS-2 Programme
AU - Miehlke, Stephan
AU - Schlag, Christoph
AU - Lucendo, Alfredo J.
AU - Biedermann, Luc
AU - Vaquero, Cecilio Santander
AU - Schmoecker, Christoph
AU - Hayat, Jamal
AU - Hruz, Petr
AU - Ciriza de Los Rios, Constanza
AU - Bredenoord, Albert Jan
AU - Vieth, Michael
AU - Schoepfer, Alain
AU - Attwood, Stephen
AU - Mueller, Ralph
AU - Burrack, Sarah
AU - Greinwald, Roland
AU - International EOS-2 Study Group
AU - Straumann, Alex
N1 - Funding Information: This study was funded by Dr. Falk Pharma GmbH, Freiburg, Germany. Funding Information: Stephan Miehlke reports receiving consulting fees from Celgene, Dr. Falk Pharma, EsoCap and Sanofi‐Regeneron; receiving lecture fees from Dr. Falk Pharma and Vifor; receiving payment for the development of educational presentations from Dr. Falk Pharma; and serving as a board member for the European Society of Eosinophilic Oesophagitis (EUREOS). Christoph Schlag reports receiving consulting fees from Adare, Celgene, EsoCap, Dr. Falk Pharma and Sanofi‐Regeneron; receiving lecture fees from Dr. Falk Pharma; and serving as a board member for EUREOS. Alfredo Lucendo reports receiving consulting fees from EsoCap, and Dr. Falk Pharma; receiving lecture fees from Dr. Falk Pharma; and serving as a board member for EUREOS. Luc Biedermann reports receiving consulting fees from Calypso Biotech; Esocap; Vifor, and Sanofi‐Regeneron; receiving lecture fees from Dr. Falk Pharma; Sanofi‐Aventis; and serving as a board member for EUREOS. Cecilio Santander Vaquero reports receiving lecture fees from Allergan and receiving payment for the development of educational presentations from Laborie. Christoph Schmoecker reports no conflict of interest. Jamal Hayat reports receiving lecture fees from Dr. Falk Pharma. Petr Hruz reports no conflict of interest. Jamal Hayat reports receiving consulting fees from Dr. Falk Pharma; and receiving lecture fees from Dr. Falk Pharma. Constanza Ciriza de los Rios reports receiving consulting and/or lecture fees from Allergan and Casen Recordati. Albert Jan Bredenoord reports receiving research funding from Nutricia, Norgine, SideSleepTechnologies and Bayer; receiving lecture and/or consulting fees from Laborie, Arena, EsoCap, Diversatek, Medtronic, Dr. Falk Pharma, Calypso Biotech, Thelial, Robarts, Reckett Benkiser, Regeneron, Celgene, Bayer, Norgine, AstraZeneca, Almirall, Arena and Allergan. Michael Vieth reports receiving lecture fees from Dr. Falk Pharma, Janssen‐Cilag, Malesci, Menarini, Olympus, Shire. Alain Schoepfer reports receiving consulting fees from Abbvie, Adare, Celgene, Dr. Falk Pharma, Janssen‐Cilag, MSD, Pfizer, Receptos, Regeneron, Vifor and Sanofi‐Regeneron; receiving lecture fees from Abbvie, Celgene, Dr. Falk Pharma, Pfizer, Receptos, Regeneron, and Vifor; and serving as a board member for The International Gastrointestinal Eosinophil Researchers (TIGERS). Stephen Attwood reports receiving consulting fees from Dr. Falk Pharma, EsoCap, AstraZeneca, and Reckitt Benkiser; receiving lecture fees from Dr. Falk Pharma, Medtronic; receiving payment for the development of educational presentations from Dr. Falk Pharma. Ralph Mueller reports being an employee of Dr. Falk Pharma GmbH. Sarah Burrack reports being an employee of Dr. Falk Pharma GmbH. Roland Greinwald reports being an employee of Dr. Falk Pharma GmbH. Alex Straumann reports receiving consulting fees from Allakos, AstraZeneca, EsoCap, Dr. Falk Pharma, Gossamer, GSK, Receptos‐Celgene and Regeneron‐Sanofi; receiving lecture fees from Dr. Falk Pharma and Vifor; receiving payment from Dr. Falk Pharma for the development of educational presentations; receiving payment from AstraZeneca for serving as member of IDMC (independent data monitor committee); and serving as a board member for EUREOS and TIGERS. Publisher Copyright: © 2022 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.
PY - 2022/4/1
Y1 - 2022/4/1
N2 - 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/mm2 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/mm2 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.
AB - 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/mm2 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/mm2 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.
KW - budesonide
KW - dysphagia
KW - eosinophilic oesophagitis
KW - topical corticosteroids
UR - http://www.scopus.com/inward/record.url?scp=85128086228&partnerID=8YFLogxK
U2 - https://doi.org/10.1002/ueg2.12220
DO - https://doi.org/10.1002/ueg2.12220
M3 - Article
C2 - 35412032
SN - 2050-6406
VL - 10
SP - 330
EP - 343
JO - United European gastroenterology journal
JF - United European gastroenterology journal
IS - 3
ER -