Open AccessBudesonide orodispersible tablets for induction of remission in patients with active eosinophilic oesophagitis: A 6‐week open‐label trial of the EOS‐2 Programme
Author(s) -
Miehlke Stephan,
Schlag Christoph,
Lucendo Alfredo J.,
Biedermann Luc,
Vaquero Cecilio Santander,
Schmoecker Christoph,
Hayat Jamal,
Hruz Petr,
Ciriza de los Rios Constanza,
Bredenoord Albert Jan,
Vieth Michael,
Schoepfer Alain,
Attwood Stephen,
Mueller Ralph,
Burrack Sarah,
Greinwald Roland,
Straumann Alex
Publication year - 2022
Publication title -
united european gastroenterology journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.667
H-Index - 35
eISSN - 2050-6414
pISSN - 2050-6406
DOI - 10.1002/ueg2.12220
Subject(s) - medicine , tolerability , gastroenterology , dysphagia , eosinophilia , eosinophilic esophagitis , clinical endpoint , prospective cohort study , budesonide , eosinophil , placebo , clinical trial , surgery , adverse effect , asthma , pathology , disease , alternative medicine
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.