Beclomethasone dipropionate in microscopic colitis: Results of an exploratory open‐label multicentre study (COLCO)

Abstract

Background: Budesonide has been proven to be an effective treatment for microscopic colitis (MC). However, the two current commercially available preparations are released in the ileum. Beclomethasone dipropionate (Clipper Õ ) is a synthetic corticosteroid with topical colonic release.Objective: This study aimed to explore whether an open-label treatment with beclomethasone dipropionate is an effective treatment for MC. Methods: Prospectively collected data of 30 patients from six centres were retrospectively analysed. All patients had a confirmed diagnosis of idiopathic MC (lymphocytic and collagenous colitis) and were symptomatic (i.e. 21 loose stools over a seven-day period). Treatment consisted of 10 mg beclomethasone daily for four weeks, followed by 5 mg daily for another four weeks. The primary end point was the proportion of patients in remission (i.e. a mean of < 3 stools/day and a mean of <1 watery stool per day) after an eight-week treatment period. Secondary end points were the proportion of patients responding to therapy at weeks 4 and 8, remission at weeks 4 and 12 and relapse at week 12. Reported adverse events were collected. Results: Overall, at week 8, remission was achieved in 70%, and 77% of patients were responding to treatment. After four weeks of treatment, 80% were responding, and 67% were in remission. Four weeks after stopping treatment, 60% were still in remission.Conclusion: This open-label study suggests that an eight-week course of beclomethasone could be a promising and relatively safe treatment for MC. A randomised controlled study is warranted.

Successful use of beclometasone dipropionate for the treatment of microscopic colitis

“…This series more than doubles the reported experience of beclometasone dipropionate in microscopic colitis and confirms the overall efficacy and safety. Results are comparable to the small series reported by Corte et al (remission 70%) 1 and Latella et al (remission 83%), 2 although in the latter study, the remission rate in the mesalazine‐treated group (13/15; 86%) was strikingly high, given that other studies have consistently shown that mesalazine is inferior to ileal‐release budesonide 4 , 5 . Colonic‐release formulations are a logical treatment for a disease that typically affects all segments of the colon.…”

“…Results are comparable to the small series reported by Corte et al. (remission 70%) 1 and Latella et al. (remission 83%), 2 although in the latter study, the remission rate in the mesalazine-treated group (13/15; 86%) was strikingly high, given that other studies have consistently shown that mesalazine is inferior to ileal-release budesonide.…”

“…The report by Corte et al. 1 showing efficacy of beclometasone dipropionate is of interest and adds to the limited reported data using this agent. Corte et al.…”

“…Colonic‐delivery preparations of corticosteroids are a logical treatment for microscopic colitis. The report by Corte et al 1 showing efficacy of beclometasone dipropionate is of interest and adds to the limited reported data using this agent. Corte et al included 30 patients.…”

European guidelines on microscopic colitis: United European Gastroenterology and European Microscopic Colitis Group statements and recommendations

“…170,173,288,311,312 An open-label retrospective study investigated beclomethasone dipropionate as a synthetic corticosteroid with topical colonic release in 30 patients with MC showing a response rate of 80% and remission rate of 67%. 313 Is there a role for immunomodulators and biologics in the treatment of patients with MC?…”