Background: There are no data coming from Italian centres about long-term treatment with infliximab (IFX) in patients with inflammatory bowel disease (IBD) and follow-up after discontinuation for stable remission. Methods: This is a retrospective observational 'real-life' single-centre study (ClinicalTrials.gov Identifier: NCT02057016). Patients in clinical remission (CR) after 1 year of IFX scheduled treatment (baseline) were included. Primary endpoint: sustained CR in patients with IBD receiving long-term (> 2 years) IFX scheduled treatment. The primary endpoint was evaluated at week 54 from baseline and then every year during the follow-up. Secondary endpoints: identification of predictors of sustained CR during long-term IFX treatment and predictors for maintaining CR in patients who discontinued infliximab because of long-lasting steroid-free CR. Stata 13.0 was used for statistical analyses. Results: In total, 258 IBD patients (144 Crohn's disease [CD] and 114 ulcerative colitis [UC]) have completed at least 1 year of treatment with IFX. At that time, 192/258 (74.4%) patients were in CR, 108/144 CD (75%), and 84/114 UC (74%). The median follow-up was 64.5 months (IQR 48.75-89.25). The overall rate of loss of remission was 6.9 per 100 patient-years (95% CI 4.5, 10); for UC it was 6.3 per 100 patient-years (95% CI 3.5, 11), and for CD 7.6 per 100 patient-years (95% CI 4.2, 14). Steroid sparing (risk ratio 0.20, 95% CI 0.08, 0.49; p = 2 years) maintenance of CR during IFX therapy. High CRP and absence of mucosal healing at the time of IFX discontinuation are associated with higher risk of subsequent clinical relapse. This study was supported by an unrestricted research grant from Merck Sharp & Dohme Italy.
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