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P162. Infliximab in steroid-dependent ulcerative colitis

A. Armuzzi, D. Pugliese, M. Marzo, C. Felice, G. Andrisani, G. Mocci, A. Papa, I. De Vitis, G. Rapaccini, L. Guidi

Internal Medicine and Gastroenterology Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy

Aim: Up to 40% of ulcerative colitis (UC) patients need steroids during their course and 20% of them become steroid-dependent. Immune suppression with thiopurines is the most widely used therapy in steroid-dependent UC, but the efficacy of AZA and 6-MP in UC is still under debate. Data exploring the use of infliximab (IFX) in patients affected by steroid-dependent UC are scarce. The aim of our study was to evaluate the efficacy of IFX in steroid-dependent UC.

Materials and methods: Consecutive patients with active steroid-dependent UC (according to definition of ECCO guidelines) attending our IBD unit were enrolled and intentionally treated with IFX (standard induction and maintenance treatment). The prospectively designed analyses evaluated: (1) proportion of patients on IFX therapy in steroid-free clinical remission and no colectomy at 6 and 12 months; (2) proportion of patients on IFX therapy with mucosal healing at 12 months; (3) proportion of patients on IFX therapy in steroid-free clinical remission, mucosal healing and no colectomy at 12 months Clinical remission was defined as Powell-Tuck index of 0 and mucosal healing as a Baron index of 0–1.

Results: We studied 106 UC patients (44 male) with a median age of 37.5 years (IQR: 28–51). The median duration of disease at the first infusion was 4 years (2–7). The extension of disease was extensive colitis in 71 patients (67%) and left-sided colitis in 35 patients (33%). 73 (68%) patients were taking steroids at the time of the first infusion, with a median dose of prednisone equivalents of 20 mg (15–30). 49 (46.3%) patients were naive to thiopurines and 59 patients (55.7%) were started on concomitant thiopurines. At 6 months, 56 patients (52.8%) were in steroid-free clinical remission. In the subgroup of thiopurine-naive, there was a significantly higher proportion of steroid-free clinical remission (naive: 63.2% vs non-naive: 42.1%; p = 0.019). At 12 months, the proportion of patients in steroid-free clinical remission was 45.2% (48 of 106 patients). A significant difference between the thiopurine-naive and non-naive group was confirmed (59.1% vs 33.3%; p = 0.013). 40 (37.7%) patients required IFX dose escalation. 12 patients (11.3%) underwent colectomy within the first year, with a median time to colectomy of 4.7 months (2.2–8). Adverse events were recorded in 14 patients (13.2%), but only 8 patients withdrew from treatment (7.5%). 31 of 89 patients (34.8%) achieved mucosal healing at 12 months. Finally, the proportion of patients on IFX therapy in steroid-free clinical remission, mucosal healing and no colectomy at 12 months was 32.6%, with a significantly higher proportion of thiopurine-naive group (naive: 46.5% vs non-naive: 23.9%; p = 0.04).

Conclusion: Infliximab therapy appears effective and safe in the treatment of steroid-dependent UC. Patients with steroid-dependent UC naive to thiopurines achieved significantly higher rates of clinical and endoscopic remission.