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Title: Clinical trial: Combination allopurinol-thiopurine versus standard thiopurine in patients with IBD escalating to immunomodulators (the DECIDER study).
Austin Authors: Vasudevan, Abhinav ;Con, Danny;De Cruz, Peter P ;Sparrow, Miles P;Friedman, Antony B;Garg, Mayur;Kashkooli, Soleiman;Gibson, Peter R;van Langenberg, Daniel R
Affiliation: Department of Gastroenterology and Hepatology, Eastern Health, Box Hill, Victoria, Australia.;Monash University, Eastern Health Clinical School, Box Hill, Victoria, Australia.
Gastroenterology and Hepatology
Department of Gastroenterology, Central Clinical School, Monash University and Alfred Health, Melbourne, Victoria, Australia.
Department of Gastroenterology, Northern Health, Epping, Victoria, Australia.;Department of Medicine, Melbourne University, Melbourne, Australia.
Department of Gastroenterology, Central Clinical School, Monash University and Alfred Health, Melbourne, Victoria, Australia.
Issue Date: Feb-2024
Date: 2023
Publication information: Alimentary Pharmacology & Therapeutics 2024-02; 59(4)
Abstract: Thiopurines are established treatments for inflammatory bowel disease (IBD), yet concerns remain regarding their safety. To evaluate the use of thiopurine-allopurinol combination therapy compared to standard thiopurine therapy in IBD. We performed a multicentre, randomised, placebo-controlled trial to compare the efficacy and safety of thiopurine-allopurinol versus thiopurine with placebo for adults commencing a thiopurine for IBD. Patients had active disease at baseline; dosing of therapy was based on a pre-specified regimen and subsequent metabolites. The primary outcome was the proportion of patients achieving a composite of symptomatic disease activity remission (Harvey Bradshaw Index <5 for Crohn's disease, Simple Clinical Colitis Activity Index <4 for ulcerative colitis) and a faecal calprotectin <150 μg/g after 26 weeks of treatment. The trial was terminated early due to slow recruitment. We randomised 102 participants (54 thiopurine-allopurinol, 48 thiopurine with placebo) with similar age (median 42 vs 48 years) and sex distribution (46% women per group). A higher proportion achieved the primary outcome in the thiopurine-allopurinol group (50% vs 35%, p = 0.14) and fewer participants stopped their allocated therapy due to adverse events (11% vs 29%, p = 0.02). Also, within the thiopurine-allopurinol group, thiopurine dose adjustments were less frequent (69% vs 92%, p = 0.03), a higher proportion achieved an early therapeutic 6-TGN level at week 6 (71% vs 53%, p = 0.19), and adverse events attributed to therapy were less frequent (15% vs 44%, p = 0.002). Thiopurine-allopurinol therapy is safe and mitigates thiopurine adverse effects, thus enhancing tolerability without compromising efficacy (ACTRN12613001347752).
DOI: 10.1111/apt.17831
ORCID: 0000-0001-5026-9014
Journal: Alimentary Pharmacology & Therapeutics
PubMed URL: 38095246
ISSN: 1365-2036
Type: Journal Article
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