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P442. Long-term outcome of treatment with infliximab in patients with steroid-dependent ulcerative colitis

A. Armuzzi1, D. Pugliese1, S. Danese2, G. Rizzo1, M. Marzo1, C. Felice1, G. Andrisani1, G. Fiorino2, O.M. Nardone1, I. De Vitis1, A. Papa1, G.L. Rapaccini1, L. Guidi1, 1Internal Medicine and Gastroenterology Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy, 2IBD Unit, Istituto Clinico Humanitas, Rozzano, Italy

Background

Up to 40% of ulcerative colitis (UC) patients need steroids during their course and 20% of them become steroid-dependent. Thiopurines are recommended in steroid-dependent UC, but their efficacy is debated. We recently reported more than 30% of steroid-free clinical remission and mucosal healing for UC patients after 1 year of infliximab (IFX) treatment [1]. Aims of our study were to describe the long-term outcome of IFX treatment in active steroid-dependent UC and to investigate if predictors of sustained clinical response and colectomy could be identified.

Methods

Consecutive patients with active steroid-dependent UC treated with IFX were studied. Co-primary outcomes were 1) sustained clinical response in patients who achieved clinical remission (no diarrhoea, no blood) or response (clinical improvement, despite persistent blood loss) after induction and 2) colectomy free-survival. Sustained clinical response was defined as a persistent clinical improvement during the follow-up, without need of a course of steroids.

Results

126 steroid-dependent UC patients were included. 45% of them were naïve to thiopurines and 56% were started on concomitant thiopurines. The median duration of follow-up was 32 months (IQR 22–62), with a median number of infusion per patient of 14 (IQR 7–24). The colectomy rate was 23% (29/126), with a median time to colectomy of 16 months (IQR 9–30). After induction, 77% (97/126) of patients achieved clinical benefit. Among them, 47% (46/97) had a sustained clinical response. 88 patients were on steroids at enrolment and 46% (41/88) withdrew steroids during long-term IFX treatment. Cox regression identified the Mayo endoscopic score ≥2 at baseline (p = 0.03, HR 2.7, 95% CI 1.1–6.9) and high C-reactive protein (CRP) after induction (p = 0.001, HR 5.5, 95% CI 1.9–15) as independent predictors of colectomy. Thiopurine naïve status (p = 0.03, HR 0.35, 95% CI 0.1–0.9) was protective from colectomy. Combination therapy (p < 0.0001, HR 6.2, 95% CI 2.6–14) was identified as independent predictor of sustained clinical response.

Conclusion

IFX long-term treatment is effective in this large cohort of steroid-dependent UC patients. The severity of endoscopic lesions at baseline and a persistently high CRP after induction are associated with higher rates of colectomy. Thiopurine naïve status is protective from colectomy. Combination therapy is predictive of sustained clinical response.

1. Armuzzi A, et al. Gastroenterology 2012; 142(Suppl. 1): S205; Inflamm Bowel Dis 2012: in press.