Esophagus to Small Intestine
United European Gastroenterol J. 2022;10(3):330–43
Budesonide orodispersible tablets for induction of remission in patients with active eosinophilic esophagitis: A 6-week open-label trial of the EOS-2 Program
Background: A novel budesonide orodispersible tablet (BOT) has been proven effective in adult patients with active eosinophilic esophagitis (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 twice daily (BID) for 6 weeks. The primary end point 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 end points included clinical and histological remission rates, change in the Eosinophilic Esophagitis Activity Index Patient-Reported Outcome (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 budesonide orodispersible tablets 1 mg twice daily (BID) was highly effective and safe in achieving clinico-histological remission of active eosinophilic esophagitis and confirmed the results of the placebo-controlled EOS-1 trial.