Esophagus to Small Intestine

United European Gastroenterol J. 2022;10(3):330–43

Miehlke S, Schlag C, Lucendo AJ, Biedermann L, Santander Vaquero C, Schmoecker C, Hayat J, Hruz P, Ciriza de los Rios C, Bredenoord AJ, Vieth M, Schoepfer A, Attwood S, Mueller R, Burrack S, Greinwald R, Straumann A; International EOS-2 Study Group

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.

Prof. Dr. S. Miehlke, Magen-Darm-Zentrum, Facharztzentrum Eppendorf, Hamburg, Germany,
E-Mail: miehlke@faz-eppendorf.de

DOI: DOI: 10.1002/ueg2.12220

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