Budesonide as induction therapy for incomplete microscopic colitis: A randomised, placebo‐controlled multicentre trial

Abstract

Background and aims Incomplete microscopic colitis (MCi) is a subtype of microscopic colitis (MC). Budesonide is recommended as a first‐line treatment for MC. However, randomised trials on efficacy of treatment in MCi are missing. We therefore performed a randomised, placebo‐controlled trial to evaluate budesonide as induction therapy for MCi. Methods Patients with active MCi were randomly assigned to either budesonide 9 mg once daily or placebo for 8 weeks in a double‐blind, double‐dummy design. The primary endpoint was clinical remission, defined as a mean of <3 stools/day and a mean of <1 watery stool/day in the 7 days before week 8. Results Due to insufficient patient recruitment, the trial was discontinued prematurely. The intention‐to‐treat analysis included 44 patients (21 budesonide and 23 placebo). The primary endpoint of clinical remission at week 8 was obtained by 71.4% on budesonide and 43.5% on placebo (p = 0.0582). All clinical secondary endpoints were in favour of budesonide. Budesonide decreased the number of soft or watery stools (16.3 vs. 7.7, p = 0.0186) and improved health‐related quality of life for all four dimensions of the short health scale. Adverse events with a suspected relation to study drug were reported in one patient in the budesonide group and two patients in the placebo group. Neither serious nor severe adverse events occurred during the double‐blind phase. Conclusions Budesonide decreased the frequency of soft or watery stools and improved the patients' quality of life significantly in MCi, but the primary endpoint was not met due to the low sample size (type 2 error). Budesonide was safe and well tolerated during the 8‐weeks treatment course.

Differenzialdiagnosen von Kolitiden

“…Gleichzeitig wird aufgrund des hohen First-Pass-Effekts in der Leber die systemische Bioverfügbarkeit stark minimiert, sodass sich die glukokortikoide Wirkung von Budesonid – auch aufgrund seiner starken Rezeptorbindungsaffinität – lokal auf den Intestinaltrakt konzentriert. Klinisch relevante steroidassoziierte Nebenwirkungen bewegen sich in mehreren Studien auf Placebobiveau 33 , 34 , sodass von einem günstigen Sicherheitsprofil von Budesonid auszugehen ist.…”

Microscopic colitis: Etiopathology, diagnosis, and rational management

“…Accordingly, first-line treatment of active microscopic colitis is a dosage of 9 mg budesonide once daily for 8 weeks ( Miehlke et al, 2018b ). Budesonide has even shown efficacy in the management of incomplete microscopic colitis ( Münch et al, 2021 ).…”

Editorial: The Dark Side of Microscopic Colitis

“…Treatment is guided by response to symptoms, with budesonide identified as the most effective drug to control MC (19)(20)(21). Unfortunately, as reported by Mihaly et al not enough data have been received from extensive trials on alternative drugs including immunomodulators, aminosalicylates, and biological treatment such as TNF-alpha antagonists and integrin inhibitors.…”