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. 2022 Apr;10(3):330-343.
doi: 10.1002/ueg2.12220.

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  1   2 , Christoph Schlag  3 , Alfredo J Lucendo  4   5   6 , Luc Biedermann  7 , Cecilio Santander Vaquero  5   6   8 , Christoph Schmoecker  9   10 , Jamal Hayat  11 , Petr Hruz  12 , Constanza Ciriza de Los Rios  13 , Albert Jan Bredenoord  14 , Michael Vieth  15 , Alain Schoepfer  16 , Stephen Attwood  17 , Ralph Mueller  18 , Sarah Burrack  18 , Roland Greinwald  18 , Alex Straumann  7   19 ; International EOS-2 Study Group
Affiliations

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 et al. United European Gastroenterol J. 2022 Apr.

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/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.

Keywords: budesonide; dysphagia; eosinophilic oesophagitis; topical corticosteroids.

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Conflict of interest statement

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.

Figures

FIGURE 1
FIGURE 1
Clinical and/or histological remission after 6 weeks of BOT 1 mg BID treatment. Clinical remission: Dysphagia Score ≤2 (NRS 0–10) and Odynophagia Score ≤2 (NRS 0–10) on each day in the last treatment week; Histological remission: <16 eos/mm2 high power field (hpf) [corresponds to <5 eos/hpf as reported by Straumann et al. 2010] 2010]. BID, twice daily; BOT, budesonide orodispersible tablet; eos, eosinophils; hpf, high power field (400x); NRS, Numerical Rating Scale; LOCF, last observation carried forward
FIGURE 2
FIGURE 2
Deep histological remission (i.e., ‘0’ eos/hpf) after 6 weeks of BOT 1 mg BID treatment stratified by the localization of the affected oesophagus segment BID, twice daily; BOT, budesonide orodispersible tablet; eos, eosinophils; hpf, high power field (400x)
FIGURE 3
FIGURE 3
Individual pre‐ and post‐treatment (with BOT 1 mg BID) peak eos/mm2 hpf counts and median group values with IQR. BID, twice daily; BOT, budesonide orodispersible tablet; eos, eosinophils; hpf, high power field (400x); IQR, interquartile range; LOCF, last observation carried forward
FIGURE 4
FIGURE 4
(a) Course of patient's global assessment of their EoE severity (PatGA) during treatment with BOT 1 mg BID Course of achieved clinical improvement defined as a Patient's Global Assessment of their EoE severity (PatGA) score of ≤2 on a 0–10 points numerical rating scale (‘0’ points: no EoE activity; ‘10’ points: most severe EoE activity). (b) Course of clinical remission defined by symptom resolution during treatment with BOT 1 mg BID Course of achieved clinical remission defined as symptom resolution ≤2 on both 0–10 points numerical rating scales for dysphagia and odynophagia, respectively (‘0’ points: no dysphagia or odynophagia, respectively; ‘10’ points: most severe dysphagia or odynophagia, respectively). (c) Course of clinical remission defined by Eosinophilic Esophagitis Activity Index Patient Reported Outcome (EEsAI‐PRO) ≤20 points during treatment with BOT 1 mg BID
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