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* = Presenting author

P558 Long-term scheduled therapy with infliximab in inflammatory bowel disease: a single-centre observational study

C. Felice*1, 2, P. M. Ferraro3, M. Marzo1, D. Pugliese1, A. Papa1, G. L. Rapaccini1, L. Guidi1, A. Armuzzi1

1Catholic University of the Sacred Heart, Internal Medicine and Gastroenterology Unit, Complesso Integrato Columbus, Rome, Italy, 2Queen Mary University of London, Centre for Genomics and Child Health, Blizard Institute, London, United Kingdom, 3Catholic University of the Sacred Heart, Nephrology, Complesso Integrato Columbus, Rome, Italy

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 <0.01), and elevated CRP after induction (risk ratio 3.67, 95% CI 1.46, 9.24; p < 0.01) were significantly associated with loss of remission. Further, 76 patients (46 CD and 30 UC) discontinued IFX because of sustained steroid-free CR. During a median follow-up of 40 months (IQR 21.25–7 754.5) after discontinuation, 42 patients (55%) had clinical relapse. Clinical relapse was significantly associated with high C-reactive protein (CRP) (RR 1.72, 95% CI 1.16, 2.56; p = 0.03) and absence of mucosal healing (RR 0.54, 95% CI 0.36, 0.80; p = 0.01) at the time of discontinuation.

Conclusion

This Italian experience confirms that IFX is effective in long-term maintenance of CR in IBD patients. Steroid sparing and CRP drop off after induction best guarantee long-term (≥ 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.