Trial reportJournal of Crohn's & colitis2023
Mercaptopurine for the Treatment of Ulcerative Colitis: A Randomized Placebo-Controlled Trial.
Trial report in Journal of Crohn's & colitis, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 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
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.
- Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2025Pooled it
- AGA Living Clinical Practice Guideline on Pharmacological Management of Moderate-to-Severe Ulcerative Colitis.Gastroenterology · 2024Guideline
- Cost-effectiveness and cost-utility of optimized mercaptopurine treatment versus placebo in ulcerative colitis patients: The randomized controlled OPTIC trial.United European gastroenterology journal · 2024Trial
- Early proactive monitoring of DNA-thioguanine in patients with Crohn's disease predicts thiopurine-induced late leucopenia in NUDT15/TPMT normal metabolizers.World journal of gastroenterology · 2024Trial
- The roles and heterogeneity of CD8International journal of molecular medicine · 2026Review
- Understanding the therapeutic toolkit for inflammatory bowel disease.Nature reviews. Gastroenterology & hepatology · 2025Review
- Effectiveness of tacrolimus therapy in refractory ulcerative colitis compared to infliximab with propensity score matching.Scientific reports · 2025Article
- Clinical features and current treatment approach to ulcerative proctitis.Translational gastroenterology and hepatology · 2025Review
- Research progress on the regulatory effects and mechanisms of natural active products on intestinal barrier function.Frontiers in pharmacology · 2025Review
- Ulcerative Colitis: Advances in Pathogenesis, Biomarkers, and Therapeutic Strategies.Pharmacogenomics and personalized medicine · 2025Review
- Tofacitinib for ulcerative colitis: A promising treatment option.World journal of gastroenterology · 2024Article
- The Effectiveness and Safety of First-Line Thioguanine in Thiopurine-Naïve Inflammatory Bowel Disease Patients.Inflammatory bowel diseases · 2024Article
- Selecting first-line advanced therapy for ulcerative colitis: A clinical application of personalized medicine.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024Review
- Uphill battle: Innovation of thiopurine therapy in global inflammatory bowel disease care.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2024Review
- Pharmacological Therapy in Inflammatory Bowel Diseases: A Narrative Review of the Past 90 Years.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Review
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Authors and funding
16 authors at 9 institutions in 11 countries.
Funding
Abstract
BACKGROUND AND
aimsScepticism about the efficacy of thiopurines for ulcerative colitis [UC] is rising. This study aimed to evaluate mercaptopurine treatment for UC.
methodsIn this prospective, randomized, double-blind, placebo-controlled trial, patients with active UC, despite treatment with 5-aminosalicylates [5-ASA], were randomized for therapeutic drug monitoring [TDM]-guided mercaptopurine treatment or placebo for 52 weeks. Corticosteroids were given in the first 8 weeks and 5-ASA was continued. Proactive metabolite-based mercaptopurine and placebo dose adjustments were applied from week 6 onwards by unblinded clinicians. The primary endpoint was corticosteroid-free clinical remission and endoscopic improvement [total Mayo score ≤2 points and no item >1] at week 52 in an intention-to-treat analysis.
resultsBetween December 2016 and April 2021, 70 patients were screened and 59 were randomized at six centres. In the mercaptopurine group, 16/29 [55.2%] patients completed the 52-week study, compared to 13/30 [43.3%] on placebo. The primary endpoint was achieved by 14/29 [48.3%] patients on mercaptopurine and 3/30 [10%] receiving placebo (Δ = 38.3%, 95% confidence interval [CI] 17.1-59.4, p = 0.002). Adverse events occurred more frequently with mercaptopurine [808.8 per 100 patient-years] compared to placebo [501.4 per 100 patient-years]. Five serious adverse events occurred, four on mercaptopurine and one on placebo. TDM-based dose adjustments were executed in 22/29 [75.9%] patients, leading to lower mercaptopurine doses at week 52 compared to baseline.
conclusionsOptimized mercaptopurine treatment was superior to placebo in achieving clinical, endoscopic and histological outcomes at 1 year following corticosteroid induction treatment in UC patients. More adverse events occurred in the mercaptopurine group.
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