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, Cecílio Santander, Christoph Schmoecker, Jamal Hayat, Petr Hrúz, Constanza Ciriza de los Ríos, Albert J. Bredenoord, Michael Vieth, Alain Schoepfer, Stephen Attwood, Ralph Müeller, Sarah Burrack, Roland Greinwald, Alex Straumann, International EOS‐2 Study Group
Abstract
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.