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Background Thiopurine-treated inflammatory bowel disease (IBD) patients are monitored every 3 to 4 months with outpatient visits and laboratory assessments to evaluate disease activity and safety of therapy. However, the risk of thiopurine-related adverse events decreases after the initiation phase. The aim of this study was to assess the safety of reduced clinical monitoring in steroid-free quiescent IBD patients on stable maintenance thiopurine monotherapy. Methods This single-centre prospective cohort study evaluated a reduced monitoring strategy that involved 6-monthly laboratory assessment combined with alternating outpatient and phone appointments, during 104 weeks. We enrolled IBD patients who were in steroid-free remission &amp;gt; 6 months on thiopurine monotherapy including azathioprine, 6-mercaptopurine or tioguanine. The primary outcome was thiopurine-related adverse events (AE) requiring change or discontinuation of thiopurine therapy after 104 weeks of follow-up. Secondary outcomes were assessed at week 52 and included other thiopurine-related AEs and laboratory abnormalities. Results We included 85 patients (42 years median age, 61.2% Crohn’s disease, 62% female) with a median disease duration of 12.5 years. At baseline, 47 patients were treated with azathioprine (55.3%), 25 with 6-mercaptopurine (29.4%) and 13 with tioguanine (15.3%) for a median duration of 6.7 years. During 104 weeks of follow-up, thiopurine therapy was ceased in two patients because of multiple infections (n=1) and gastrointestinal complaints (n=1). Other reasons for thiopurine cessation (n=37) were stable remission (n=26), patient preferences (n=9) and high 6-TGN levels (n=2). In total, 20 patients underwent thiopurine dose adjustments due to high metabolite levels (n=9), remission (n=3), disease flare (n=3), patient preferences (n=3), and low metabolite levels (n=2). At 52 weeks, 27 laboratory abnormalities were observed, yet none required therapy adjustments. In 13 patients (15.3%) myelotoxicity was detected, including mild leukopenia (n=11), mild and moderate thrombopenia (n=2). In 16.5%, hepatoxicity was observed (n=14) including mild (n=9) and moderate (n=1) elevated aspartate aminotransferase and mild elevated alkaline phosphatase (n=4). Conclusion A reduced monitoring strategy appeared relatively safe in a strictly selected cohort of stable thiopurine-treated IBD patients. Overall, two patients had to cease thiopurine therapy due to thiopurine-related AEs independent of monitoring frequency. No laboratory abnormalities required therapy adjustments and 57.1% of patients continued therapy throughout 104 weeks of follow-up. This strategy may contribute to safe reduction of time and health care costs for both IBD patients and physicians in daily IBD practice.

P512 Safety of reduced clinical monitoring in patients with stable Inflammatory Bowel Disease on maintenance thiopurine therapy