ArticleAlimentary pharmacology & therapeutics2015
Induction of clinical and colonoscopic remission of mild-to-moderate ulcerative colitis with budesonide MMX 9 mg: pooled analysis of two phase 3 studies.
Article in Alimentary pharmacology & therapeutics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
40 citing papers in PubMed, 4 syntheses or guidelines pooled it, 76 citations in OpenAlex.
- Sphingosine 1-Phosphate (S1P) Receptor Modulators as an Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis: A Systematic Review and Meta-analysis of Randomized Controlled Trials.Digestive diseases and sciences · 2026Pooled it
- Definition of mild to moderate ulcerative colitis in clinical trials: A systematic literature review.United European gastroenterology journal · 2022Pooled it
- Ulcerative Colitis-Diagnostic and Therapeutic Algorithms.Deutsches Arzteblatt international · 2020Pooled it
- Oral budesonide for induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2015Pooled it
- Etrasimod as a Monotherapy or With Concomitant Use of Corticosteroids and/or Aminosalicylates: Results From the ELEVATE UC Clinical Program.Inflammatory bowel diseases · 2025Trial
- Effects of cuproptosis and its application in inflammatory bowel disease (Review).International journal of molecular medicine · 2026Review
- Efficacy and Safety of Oral Prednisolone and Budesonide MMX for Outpatient Induction Therapy in Active Ulcerative Colitis: A Multicenter Retrospective Cohort Study.Journal of clinical medicine · 2026Article
- Mechanism of cell death and its application in the repair of inflammatory bowel disease by mesenchymal stem cells.Frontiers in immunology · 2025Review
- The continuing value of mesalazine as first-line therapy for patients with moderately active ulcerative colitis.Frontiers in gastroenterology (Lausanne, Switzerland) · 2024Article
- Assessment of the effectiveness of Budesonide MMXPrzeglad gastroenterologiczny · 2023Article
- Analysis of the initial dose and reduction rate of corticosteroid for ulcerative colitis in clinical practice.JGH open : an open access journal of gastroenterology and hepatology · 2022Article
- A review of the therapeutic management of ulcerative colitis.Therapeutic advances in gastroenterology · 2022Review
- Comparative Outcomes of Budesonide MMX versus Prednisolone for Ulcerative Colitis: Results from a British Retrospective Multi-Centre Real-World Study.Journal of clinical medicine · 2021Article
- Budesonide-Loaded Pectin/Polyacrylamide Hydrogel for Sustained Delivery: Fabrication, Characterization and In Vitro Release Kinetics.Molecules (Basel, Switzerland) · 2021Article
- Treatment of Inflammatory Bowel Disease: A Comprehensive Review.Frontiers in medicine · 2021Review
- Budesonide MMX in the Treatment of Ulcerative Colitis: Current Perspectives on Efficacy and Safety.Therapeutics and clinical risk management · 2021Review
- A new kid on the budesonide block.United European gastroenterology journal · 2020Article
- First United Arab Emirates consensus on diagnosis and management of inflammatory bowel diseases: A 2020 Delphi consensus.World journal of gastroenterology · 2020Article
- Key Strategies to Optimize Outcomes in Mild-to-Moderate Ulcerative Colitis.Journal of clinical medicine · 2020Review
- Head-to-head trials in inflammatory bowel disease: past, present and future.Nature reviews. Gastroenterology & hepatology · 2020Review
Corrections and comments
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Authors and funding
10 authors at 6 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundConventional oral corticosteroids are effective at reducing inflammation associated with ulcerative colitis (UC); however, systemic adverse effects limit their use. Budesonide MMX is an extended-release, second-generation corticosteroid that targets delivery of budesonide to the entire colon.
aimTo analyse efficacy and safety outcomes from two phase 3 studies of budesonide MMX in patients with mild-to-moderate active UC.
methodsPatients were assigned to budesonide MMX 9 mg, budesonide MMX 6 mg, or placebo once daily in two randomised, double-blind, placebo-controlled, 8-week studies (CORE I and II). Pooled data were analysed for pre-defined primary (combined clinical and colonoscopic remission), secondary and exploratory endpoints. Primary endpoint data were analysed to evaluate the potential influence of demographical and baseline disease characteristics on remission.
resultsModified intent-to-treat population (histological evidence of baseline inflammation) had 232, 230 and 210 patients in budesonide MMX 9 mg, budesonide MMX 6 mg and placebo groups respectively. Combined clinical and colonoscopic remission rates were significantly greater than placebo (6.2%) for the budesonide MMX 9 mg group (17.7%; P = 0.0002), but not the budesonide MMX 6 mg group (10.9%). The primary endpoint of remission with budesonide MMX 9 mg was significantly greater than placebo in most subgroups analysed. Symptom resolution and colonoscopic improvement rates were significantly greater with budesonide MMX 9 mg vs. placebo. Budesonide MMX was safe and well tolerated.
conclusionThis pooled analysis showed that budesonide MMX 9 mg is efficacious, safe and well tolerated for inducing remission of mild-to-moderate UC.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.