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Low-Dose Budesonide for Maintenance of Clinical Inflammatory bowel disease ORIGINAL ARTICLE Gut: first published as 10.1136/gutjnl-2014-308363 on 25 November 2014. Downloaded from Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial Andreas Münch,1 Johan Bohr,2 Stephan Miehlke,3 Cecilia Benoni,4 Martin Olesen,5 Åke Öst,6 Lars Strandberg,7 Per M Hellström,8 Erik Hertervig,9 Peter Armerding,10 Jiri Stehlik,11 Greger Lindberg,12 Jan Björk,13 Annika Lapidus,14 Robert Löfberg,15 Ole Bonderup,16 Sören Avnström,17 Martin Rössle,18 Karin Dilger,19 Ralph Mueller,19 Roland Greinwald,19 Curt Tysk,2 Magnus Ström,1 on behalf of the BUC-63 investigators ▸ Additional material is ABSTRACT published online only. To view Objective This 1-year study aimed to assess low-dose Significance of this study please visit the journal online (http://dx.doi.org/10.1136/ budesonide therapy for maintenance of clinical remission in gutjnl-2014-308363). patients with collagenous colitis. Design A prospective, randomised, placebo-controlled For numbered affiliations see What is already known on this subject? end of article. study beginning with an 8-week open-label induction phase ▸ Collagenous colitis, a presentation of in which patients with histologically confirmed active microscopic colitis, is associated with severely Correspondence to collagenous colitis received budesonide (Budenofalk, 9 mg/ impaired health-related quality of life. Dr Andreas Münch, Division of day initially, tapered to 4.5 mg/day), after which 92 patients ▸ Oral budesonide at a dose of 9 mg/day for Gastroenterology and – – Hepatology, Department of in clinical remission were randomised to budesonide (mean 6 8 weeks induces remission in 77% 100% of Clinical and Experimental dose 4.5 mg/day; Budenofalk 3 mg capsules, two or one patients with collagenous colitis. Medicine, Faculty of Health capsule on alternate days) or placebo in a 12-month ▸ After withdrawal of budesonide, between 61% Sciences, Linköping University, double-blind phase with 6 months treatment-free follow-up. and 88% of patients experience clinical relapse Linköping 58185, Sweden; Primary endpoint was clinical remission throughout the [email protected] but long-term data on budesonide maintenance double-blind phase. therapy, and on the use of low-dose AM, JB, CB, MO, ÅÖ, PMH, Results Clinical remission during open-label treatment budesonide, are lacking. EH, JB, AL, RL, CT, MS are was achieved by 84.5% (93/110 patients). The median http://gut.bmj.com/ members of the Swedish timetoremissionwas10.5days(95%CI(9.0to What are the new findings? Organization for the Study of ▸ In a prospective, randomised, placebo-controlled Inflammatory Bowel Disease 14.0 days)). The maintenance of clinical remission at 1 year (SOIBD) was achieved by 61.4% (27/44 patients) in the budesonide trial of low-dose oral budesonide therapy (mean group versus 16.7% (8/48 patients) receiving placebo dose 4.5 mg/day) in patients with collagenous Received 1 September 2014 (treatment difference 44.5% in favour of budesonide; 95% colitis, clinical remission was maintained to 1 year Revised 19 October 2014 CI (26.9% to 62.7%), p<0.001). Health-related quality of in 61.4% (27/44 patients) in the budesonide Accepted 11 November 2014 group versus 16.7% (8/48 patients) receiving on September 23, 2021 by guest. Protected copyright. Published Online First life was maintained during the 12-month double-blind 25 November 2014 phase in budesonide-treated patients. During treatment-free placebo (p<0.001). follow-up, 82.1% (23/28 patients) formerly receiving ▸ Health-related quality of life was maintained to budesonide relapsed after study drug discontinuation. 1 year with low-dose oral budesonide. Low-dose budesonide over 1 year resulted in few suspected ▸ Low-dose budesonide over 1 year resulted in adverse drug reactions (7/44 patients), all non-serious. few suspected adverse drug reactions (7/44 Conclusions Budesonide at a mean dose of 4.5 mg/day patients), all of which were non-serious. maintained clinical remission for at least 1 year in the How might it impact on clinical practice in majority of patients with collagenous colitis and preserved the foreseeable future? health-related quality of life without safety concerns. ▸ Maintenance therapy with low-dose Treatment extension with low-dose budesonide beyond fi budesonide (mean 4.5 mg/day) appears 1 year may be bene cial given the high relapse rate after beneficial and safe in patients with collagenous Open Access budesonide discontinuation. Scan to access more colitis who have achieved clinical remission free content Trial registration numbers http://www.clinicaltrials. under standard budesonide therapy and gov (NCT01278082) and http://www.clinicaltrialsregister.eu reduces the high relapse rate observed after (EudraCT: 2007-001315-31). budesonide discontinuation. INTRODUCTION women1 and is associated with severely impaired To cite: Münch A, Bohr J, Collagenous colitis, a presentation of microscopic health-related quality of life.2 Miehlke S, et al. Gut colitis, is a well-recognised cause of chronic non- Oral budesonide, a locally active corticosteroid, – 2016;65:47 56. bloody watery diarrhoea, particularly in elderly has been shown in a number of randomised, Münch A, et al. Gut 2016;65:47–56. doi:10.1136/gutjnl-2014-308363 47 Inflammatory bowel disease placebo-controlled trials to induce remission in collagenous (ICH) Guideline for Good Clinical Practice and was approved by – Gut: first published as 10.1136/gutjnl-2014-308363 on 25 November 2014. Downloaded from colitis.3 8 Budesonide at a dose of 9 mg/day for 6–8 weeks the National Ethics Committee in each participating country. All – induces clinical response in 77–100% of patients,3 8 and a recent authors critically reviewed the manuscript and approved it for meta-analysis has confirmed that budesonide therapy is associated publication. with a threefold improvement in both short-term and long-term The primary objective of the study was to demonstrate the clinical responses compared with placebo.9 Budesonide therapy is superiority of pH-modified release oral budesonide (Budenofalk recommended by the European Microscopic Colitis Group 3 mg capsules, Dr Falk Pharma GmbH, Freiburg, Germany) com- (EMCG) as the treatment of choice for active disease.1 However, pared with placebo for maintaining patients with collagenous after withdrawal of budesonide 61–88% of patients experience colitis in clinical remission over a 1-year period. The study com- clinical relapse,571011necessitating long-term intervention in prised an initial open-label induction phase with budesonide patients with a chronic active course. Small studies (<50 patients) therapy for 8 weeks to achieve clinical remission of collagenous of up to 6 months’ duration investigating the efficacy of budeso- colitis. Those patients who achieved clinical remission (defined as nide at a dose of 6 mg/day in maintaining remission have previ- a mean of <3 stools/day, including a mean of <1 watery stool/ ously shown a significant benefit versus placebo.57However, the day over 1 week) during the last week of the open-label phase long-term disease course is not altered by maintenance therapy, as were eligible for randomisation into a double-blind, randomised, the risk of relapse after 24 weeks’ budesonide therapy is similar to placebo-controlled, parallel-group, multicentre, 12-month phase that observed after 6 weeks’ induction therapy,5 and more long- for maintenance of clinical remission (figure 1). Patients in clin- term data are therefore required. Moreover, the optimal budeso- ical remission at the end of the double-blind phase were followed nide dose for maintenance therapy remains undefined and no con- for a maximum of 6 months without study medication. trolled trial has assessed low-dose budesonide in this setting. Relapse was defined as a mean of ≥3 stools/day, including a A prospective, randomised, placebo-controlled trial was mean of ≥1 watery stool/day, during the week prior to the initiated by the Swedish Organization for the Study of study visit. Inflammatory Bowel Disease (SOIBD) to investigate the efficacy Stool consistency was described by patients according to the and safety of low-dose oral budesonide therapy for the long- Bristol Stool Chart. term maintenance of clinical remission in patients with collage- nous colitis. The study included a 12-month double-blind phase Study population to assess remission rates, with a 6-month treatment-free Adult patients (≥18 years) were eligible if they met the follow- follow-up period for patients still in remission after 52 weeks to ing criteria: (i) histologically established diagnosis of collagenous assess the maintenance of remission after cessation of the treat- colitis, defined as thickened subepithelial collagen layer ≥10 mm ment, and employed a newly established definition for clinical on well-orientated sections, and increased inflammatory cells 12 remission in collagenous colitis. indicating chronic inflammation in the lamina propria, (ii) pre- screening history of non-bloody, watery diarrhoea for ≥2 weeks METHODS in patients with newly diagnosed collagenous colitis, or a pre- Study design and setting screening history of clinical relapse for ≥1 week in patients with ≥ This was a multicentre phase III trial undertaken during April previously established collagenous colitis and (iii) a mean of 3 http://gut.bmj.com/ 2008 to March 2013 (with follow-up to September 2013) at 22 stools/day, including a mean of ≥1 watery stool/day, during the hospital clinics or private practices in Sweden, Belgium, Czech week prior to baseline. Patients were not eligible if they met any Republic, Denmark and Germany. The study was conducted in of the following main exclusion criteria: (i) diabetes mellitus, accordance with the International Conference on Harmonisation infection, glaucoma, tuberculosis, peptic ulcer disease or on September 23, 2021 by guest. Protected copyright. Figure 1 Study design. 48 Münch A, et al.
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