Budesonide is more effective than mesalamine or placebo in short-term treatment of collagenous colitis

Abstract

Background & Aims Studies reporting that budesonide is effective for the treatment of collagenous colitis have been small and differed in efficacy measures. Mesalamine has been proposed as a treatment option for collagenous colitis, although its efficacy has never been investigated in placebo-controlled trials. We performed a phase 3, placebo-controlled multicenter study to evaluate budesonide and mesalamine as short-term treatments for collagenous colitis. Methods Patients with active collagenous colitis were randomly assigned to groups given pH-modified release oral budesonide capsules (9 mg budesonide once daily, Budenofalk®, n=30), mesalamine granules (3 g mesalamine once daily, Salofalk®, n=25), or placebo for 8 weeks (n=37) in a double-blind double-dummy fashion. The study was conducted in 31 centers (hospital clinics and private practices) in Germany, Denmark, Lithuania, Spain, and the United Kingdom. The primary endpoint was clinical remission at 8 weeks defined as ≤3 stools/day. Secondary endpoints included clinical remission at 8 weeks, according to the Hjortswang-Criteria of disease activity, taking stool consistency into account. Results A greater percentage of patients in the budesonide group were in clinical remission at week 8 than the placebo group (intention-to-treat analysis, 80.0% vs 59.5%, P=.072; per protocol analysis, 84.8% vs 60.6%, P=.046). Based on the Hjortswang-Criteria, 80.0% of patients given budesonide achieved clinical remission compared with 37.8% of patients given placebo (P=.0006); 44.0% of patients given mesalamine achieved clinical remission, but budesonide was superior to mesalamine (P=.0035). Budesonide significantly improved stool consistency and mucosal histology, and alleviated abdominal pain. The rate of adverse events did not differ among groups. [...].