IDEA is a Phase IV, prospective, randomised, open-label, multicentre clinical trial designed to evaluate the safety and efficacy of withdrawing thiopurines in elderly (≥60 years) patients with ulcerative colitis (UC) who are in sustained clinical and biological remission. The study compares discontinuation of thiopurines versus continuation while maintaining background mesalamine therapy over 24 months of treatment.
Male or female patients aged ≥60 years at screening.
Established diagnosis of ulcerative colitis according to ECCO criteria.
Clinical and endoscopic remission ≥12 months (Mayo score ≤2, subscore ≤1) according to clinical practice.
Treatment with a thiopurine (azathioprine 1-2.5 mg/kg/day or mercaptopurine 0.75-1.5 mg/kg/day) for ≥60 months. Treatment at stable doses (minimum effective dose without adverse events in the last 12 months.
Ulcerative proctitis (maximum observed extension <25 cm throughout the course of the disease)
History of colectomy or imminent need for surgery.
Presence of ileoanal reservoir
History of complex perianal disease
Parallel
Discontinuation of thiopurines.
DrugBecause thiopurine-related toxicity rises with age while late-onset UC tends to be less aggressive, replacing thiopurines with high-dose oral mesalazine (≥ 3 g/day) may preserve remission and simultaneously reduce long-term oncological and infectious risks.
Biologic Relapse at 24 Months in Elderly UC Patients After Thiopurine Discontinuation
To compare the biological-relapse rate at 24 months in elderly patients with quiescent ulcerative colitis (UC) in long-term remission who discontinue thiopurines versus those who continue thiopurine therapy.
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