Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis

Aust, Daniela E.; Mihály, Emese; Kupčinskas, Juozas; Nacak, Tanju; Greinwald, Roland; Stehlk, Jiri; Bonderup, Ole K.; Munck, Lars Kristian; Rannem, T.; Armerding, Peter; Bläker, Michael; Böhm, G.; Hoesl, M; Kirsch, Christian; Madisch, Ahmed; Meier, Eberhard; Miehlke, Stephan; Rehbehn, Kai-Uwe; Kiss, G; Nagy, Ferenc; Tulassay, Zsolt; Zsigmond, F; Kupčinskas, Limas; Bouma, Gerd; Pierik, Marieke; Fernández‐Bañares, Fernando; Lucendo, Alfredo J.; Bohr, Johan; Hellström, Per M.; Lebrun, Barbro; Lindberg, Greger; Münch, Andreas; Vigren, Lina; Wielondek, M; Krauß, Martin; Dignaß, Axel; Kruis, Wolfgang

doi:10.1053/j.gastro.2018.08.042

Cited by 60 publications

(56 citation statements)

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“…89 HRQoL was evaluated in five RCTs including CC patients [189][190][191][192][193][194] and in two RCTs including LC patients. 192,195 In all seven RCTs, HRQoL was markedly altered at baseline in both CC and LC patients, and improved after budesonide treatment. [196][197][198] Are there established metrics to measure disease activity and clinical remission in MC?…”

Section: Very Lowmentioning

confidence: 99%

“…Clinical response. A pooled analysis for clinical response in three studies 192,195,297 shows a statistically significant benefit for budesonide over placebo. Clinical remission was noted in 84% (43/51) of budesonide patients and 43% (19/44) of placebo patients (RR 1.89, 95% CI: 1.3-2.7), without heterogeneity (I 2 ¼ 0%) (see also Appendix D, supplementary material).…”

Section: Diagnosis Of MC What Is the Endoscopic Appearance Of Mc?mentioning

confidence: 99%

“…Various definitions for relapse or clinical remission have been used in clinical trials on MC, mainly based on stool frequency 191,[199][200][201][202][203][204] and stool weight. 200,202 A reduction of the mucosal inflammation or thinning of the collagen layer has also been used to assess histopathological response in trials, 195,[199][200][201]203 but the correlation between histology and clinical symptoms is weak. 205 In a Swedish population-based survey, CC patients with a mean of <3 stools per day and a mean of <1 watery stool/day during a one-week symptom registration had no or only mild impact on their HRQoL and were, hence, defined as being in remission.…”

Section: Very Lowmentioning

confidence: 99%

“…Neither the "Hjortswang criteria" nor the MCDAI have undergone formal prospective validation and they do not fulfil the new requirements from the Food and Drug Administration for a patient reported outcome in clinical trials. 207 However, the "Hjortswang criteria" has been used in seven published clinical studies, of which three were RCTs, 193,195,203 which represents a real-life external and prospective validation of the score in clinical practice.…”

Section: Very Lowmentioning

confidence: 99%

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

et al. 2021

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Introduction Microscopic colitis is a chronic inflammatory bowel disease characterised by normal or almost normal endoscopic appearance of the colon, chronic watery, non-bloody diarrhoea and distinct histological abnormalities, which identify three histological subtypes, the collagenous colitis, the lymphocytic colitis and the incomplete microscopic colitis. With ongoing uncertainties and new developments in the clinical management of microscopic colitis, there is a need for evidence-based guidelines to improve the medical care of patients suffering from this disorder. Methods Guidelines were developed by members from the European Microscopic Colitis Group and United European Gastroenterology in accordance with the Appraisal of Guidelines for Research and Evaluation II instrument. Following a systematic literature review, the Grading of Recommendations Assessment, Development and Evaluation methodology was used to assess the certainty of the evidence. Statements and recommendations were developed by working groups consisting of gastroenterologists, pathologists and basic scientists, and voted upon using the Delphi method. Results These guidelines provide information on epidemiology and risk factors of microscopic colitis, as well as evidence-based statements and recommendations on diagnostic criteria and treatment options, including oral budesonide, bile acid binders, immunomodulators and biologics. Recommendations on the clinical management of microscopic colitis are provided based on evidence, expert opinion and best clinical practice. Conclusion These guidelines may support clinicians worldwide to improve the clinical management of patients with microscopic colitis.

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Section: Very Lowmentioning

confidence: 99%

Section: Diagnosis Of MC What Is the Endoscopic Appearance Of Mc?mentioning

confidence: 99%

Section: Very Lowmentioning

confidence: 99%

Section: Very Lowmentioning

confidence: 99%

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

et al. 2021

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“…Similarly, biologic (anti-tumour necrosis factor α) immunosuppressant drugs have been used in patients with refractory symptoms, with potentially encouraging results, but again these have not been assessed in clinical trials 45. The most recent clinical trials of mesalamine in patients with CC and LC have shown this drug to be no more effective than placebo 55 56…”

Section: Is a Highly Treatable Conditionmentioning

confidence: 99%

Undiagnosed microscopic colitis: a hidden cause of chronic diarrhoea and a frequently missed treatment opportunity

Münch

Sanders

Molloy‐Bland³

et al. 2019

Frontline Gastroenterol

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Microscopic colitis (MC) is a treatable cause of chronic, non-bloody, watery diarrhoea, but physicians (particularly in primary care) are less familiar with MC than with other causes of chronic diarrhoea. The colon in patients with MC is usually macroscopically normal. MC can only be diagnosed by histological examination of colonic biopsies (subepithelial collagen band >10 µm (collagenous colitis) or >20 intraepithelial lymphocytes per 100 epithelial cells (lymphocytic colitis), both with lamina propria inflammation). The UK National Health Service exerts downward pressure to minimise colonoscopy referrals. Furthermore, biopsies are often not taken according to guidelines. These factors work against MC diagnosis. In this review, we note the high incidence of MC (comparable to ulcerative colitis and Crohn’s disease) and its symptomatic overlap with irritable bowel syndrome. We also highlight problems with the recommendation by National Health Service/National Institute for Health and Care Excellence guidelines for inflammatory bowel diseases that colonoscopy referrals should be based on a faecal calprotectin level of ≥100 µg/g. Faecal calprotectin is <100 µg/g in over half of individuals with active MC, building into the system a propensity to misdiagnose MC as irritable bowel syndrome. This raises important questions—how many patients with MC have already been misdiagnosed, and how do we address this silent burden? Clarity is needed around pathways for MC management; MC is poorly acknowledged by the UK healthcare system and it is unlikely that best practices are being followed adequately. There is an opportunity to identify and treat patients with MC more effectively.

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

et al. 2021

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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.

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Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis

Cited by 60 publications

References 34 publications

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

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

Undiagnosed microscopic colitis: a hidden cause of chronic diarrhoea and a frequently missed treatment opportunity

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

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