Risk Factors for Symptom Relapse in Collagenous Colitis After Withdrawal of Short-term Budesonide Therapy

Miehlke, Stephan; Hansen, Jane Møller; Madisch, Ahmed; Schwarz, F.; Kuhlisch, Eberhard; Morgner, Andrea; Teglbjærg, Peter Stubbe; Vieth, Michael; Aust, Daniela E.; Bonderup, Ole K.

doi:10.1097/01.mib.0000438135.88681.98

Cited by 29 publications

(19 citation statements)

References 19 publications

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“…This is in line with the observation that budesonide improves the consistency of the stool prior to a decrease in total stool numbers. These results are consistent with a recent multivariate analysis by Miehlke et al 11 based on pooled data from 123 patients in four randomised controlled trials that reported clinical remission after budesonide withdrawal. They found that a baseline stool frequency of more than five per day was associated with almost a fourfold increase in the risk of relapse after stopping budesonide therapy.…”

Section: Discussionsupporting

confidence: 91%

“… 9 Budesonide therapy is recommended by the European Microscopic Colitis Group (EMCG) as the treatment of choice for active disease. 1 However, after withdrawal of budesonide 61–88% of patients experience clinical relapse, 5 7 10 11 necessitating long-term intervention in patients with a chronic active course. Small studies (<50 patients) of up to 6 months’ duration investigating the efficacy of budesonide at a dose of 6 mg/day in maintaining remission have previously shown a significant benefit versus placebo.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial

Münch

Bohr

Miehlke³

et al. 2014

Gut

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ObjectiveThis 1-year study aimed to assess low-dose budesonide therapy for maintenance of clinical remission in patients with collagenous colitis.DesignA prospective, randomised, placebo-controlled study beginning with an 8-week open-label induction phase in which patients with histologically confirmed active collagenous colitis received budesonide (Budenofalk, 9 mg/day initially, tapered to 4.5 mg/day), after which 92 patients in clinical remission were randomised to budesonide (mean dose 4.5 mg/day; Budenofalk 3 mg capsules, two or one capsule on alternate days) or placebo in a 12-month double-blind phase with 6 months treatment-free follow-up. Primary endpoint was clinical remission throughout the double-blind phase.ResultsClinical remission during open-label treatment was achieved by 84.5% (93/110 patients). The median time to remission was 10.5 days (95% CI (9.0 to 14.0 days)). The maintenance of clinical remission at 1 year was achieved by 61.4% (27/44 patients) in the budesonide group versus 16.7% (8/48 patients) receiving placebo (treatment difference 44.5% in favour of budesonide; 95% CI (26.9% to 62.7%), p<0.001). Health-related quality of life was maintained during the 12-month double-blind phase in budesonide-treated patients. During treatment-free follow-up, 82.1% (23/28 patients) formerly receiving budesonide relapsed after study drug discontinuation. Low-dose budesonide over 1 year resulted in few suspected adverse drug reactions (7/44 patients), all non-serious.ConclusionsBudesonide at a mean dose of 4.5 mg/day maintained clinical remission for at least 1 year in the majority of patients with collagenous colitis and preserved health-related quality of life without safety concerns. Treatment extension with low-dose budesonide beyond 1 year may be beneficial given the high relapse rate after budesonide discontinuation.Trial registration numbershttp://www.clinicaltrials.gov (NCT01278082) and http://www.clinicaltrialsregister.eu (EudraCT: 2007-001315-31).

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial

Münch

Bohr

Miehlke³

et al. 2014

Gut

Self Cite

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“…However, 6-month maintenance therapy did not change the following disease course, as the relapse risk after withdrawal of 24 weeks’ maintenance treatment was similar to that observed after 6 weeks’ induction therapy, and the median time to clinical relapse was equal in the two groups (39 days versus 38 days) 115. A high stool frequency (more than five per day) at baseline and a long duration of diarrhea (>12 months) are risk factors for clinical relapse after withdrawal of short-term budesonide therapy in CC 117. In a recent randomized controlled trial, an even-lower dose of budesonide of 4.5 mg/day was found to be superior to placebo (clinical remission 61.4% versus 16.7%) during 12 months’ maintenance therapy 118.…”

Section: Therapymentioning

confidence: 52%

Diagnosis and management of microscopic colitis: current perspectives

Bohr¹,

Wickbom²,

Hegedus³

et al. 2014

CEG

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Collagenous colitis and lymphocytic colitis, together constituting microscopic colitis, are common causes of chronic diarrhea. They are characterized clinically by chronic nonbloody diarrhea and a macroscopically normal colonic mucosa where characteristic histopathological findings are seen. Previously considered rare, they now have emerged as common disorders that need to be considered in the investigation of the patient with chronic diarrhea. The annual incidence of each disorder is five to ten per 100,000 inhabitants, with a peak incidence in 60- to 70-year-old individuals and a predominance of female patients in collagenous colitis. The etiology and pathophysiology are not well understood, and the current view suggests an uncontrolled mucosal immune reaction to various luminal agents in predisposed individuals. Clinical symptoms comprise chronic diarrhea, abdominal pain, fatigue, weight loss, and fecal incontinence that may impair the patient’s health-related quality of life. An association is reported with other autoimmune disorders, such as celiac disease, thyroid disorders, diabetes mellitus, and arthritis. The best-documented treatment, both short-term and long-term, is budesonide, which induces clinical remission in up to 80% of patients after 8 weeks’ treatment. However, after successful budesonide therapy is ended, recurrence of clinical symptoms is common, and the best possible long-term management deserves further study. The long-term prognosis is good, and the risk of complications, including colonic cancer, is low. We present an update of the epidemiology, pathogenesis, diagnosis, and management of microscopic colitis.

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“…This may reduce relapse rates after budesonide discontinuation, which is quoted to be as high as 26%–82% 22. Relapse rates tend to be highest with the absence of budesonide maintenance treatment, baseline diarrhoea frequency >5/day and diarrhoea lasting longer than 12 months 24. This patient was not keen on maintenance budesonide treatment despite two induction courses and hence the need to escalate therapy.…”

Section: Discussionmentioning

confidence: 94%

Collagenous panenteritis: a rare cause of chronic diarrhoea

Singh

Loo

Watters

et al. 2017

Frontline Gastroenterol

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Collagenous panenteritis is a rare inflammatory condition that causes profound diarrhoea and weight loss. There has only been a handful of cases reported in the literature. We report this rare case and the diagnostic difficulties encountered in securing the diagnosis. A 59-year-old woman presented with an 8-month history of diarrhoea and weight loss on a background of a family history of coeliac disease. Her presentation was complicated with acute kidney injury secondary to prerenal losses. Repeated gastroscopies and colonoscopies along with biopsies were inconclusive. It was not until histology of biopsies taken at endoscopies were reviewed that a diagnosis of collagenous panenteritis was secured. Her management revolved around combination of budesonide, gluten-free diet and antidiarrhoeals, which has achieved clinical remission.

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Risk Factors for Symptom Relapse in Collagenous Colitis After Withdrawal of Short-term Budesonide Therapy

Abstract: Our data demonstrate that a high stool frequency at baseline and a long duration of diarrhea are risk factors for symptom relapse in collagenous colitis, whereas budesonide maintenance therapy is a protective factor against symptom relapse.

Cited by 29 publications

References 19 publications

Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial

Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial

Diagnosis and management of microscopic colitis: current perspectives

Collagenous panenteritis: a rare cause of chronic diarrhoea

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