Dataset Information

Mercaptopurine for the Treatment of Ulcerative Colitis: A Randomized Placebo-Controlled Trial.

ABSTRACT:

Background and aims

Scepticism about the efficacy of thiopurines for ulcerative colitis [UC] is rising. This study aimed to evaluate mercaptopurine treatment for UC.

Methods

In 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.

Results

Between 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.

Conclusions

Optimized 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.

SUBMITTER: Lowenberg M

PROVIDER: S-EPMC10394500 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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Publications

Mercaptopurine for the Treatment of Ulcerative Colitis: A Randomized Placebo-Controlled Trial.

Löwenberg Mark M Volkers Adriaan A van Gennep Sara S Mookhoek Aart A Montazeri Nahid N Clasquin Esmé E Duijvestein Marjolijn M van Bodegraven Adriaan A Rietdijk Svend S Jansen Jeroen J van Asseldonk Dirk D van der Zanden Esmerij E Dijkgraaf Marcel M West Rachel R de Boer Nanne N D'Haens Geert G

Journal of Crohn's & colitis 20230701 7

<h4>Background and aims</h4>Scepticism about the efficacy of thiopurines for ulcerative colitis [UC] is rising. This study aimed to evaluate mercaptopurine treatment for UC.<h4>Methods</h4>In 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 ...[more]

PMID: 36847130

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Dataset Information

Mercaptopurine for the Treatment of Ulcerative Colitis: A Randomized Placebo-Controlled Trial.

Background and aims

Methods

Results

Conclusions

Publications

Mercaptopurine for the Treatment of Ulcerative Colitis: A Randomized Placebo-Controlled Trial.

Similar Datasets

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