Managing ambulatory ulcerative colitis patients with infliximab: a long term follow-up study in primary gastroenterology centers.

ABSTRACT

BACKGROUND: Infliximab (IFX) is the key treatment for ulcerative colitis (UC) unresponsive to standard treatments. The aim of the present study was to assess the efficacy and safety of IFX in treating ambulatory UC patients in primary gastroenterology centers. METHODS: One hundred and eighteen patients (65 M, 63 F, median age 34 years, range 19-71 years), affected by UC, were treated with IFX. Clinical efficacy, safety, mucosal healing (MH), and histological healing (HH) were assessed at a scheduled follow-up of 42 months. RESULTS: Percentage of patients with clinical remission persistence at 42-month follow-up was 70.4%. Colectomy occurred in only 3 patients (2.7%). At 42-month follow-up percentage of patients with MH was 44.6%, and percentage of patients with HH was 24.3%. HH at 6-month follow-up occurred in 13 out of 34 patients (38.2%) with C-reactive protein (CRP) <3 and in 8 out of 76 patients (10.5%) with CRP ≥ 3 (p=0.002). Side effects were reported in 16 patients (13.6%) infusion reactions occurred in 7 patients, other severe side-effects occurred in 3 patients, and opportunistic infections occurred in 3 patients (2.5%). Finally, 3 cancers (2.5%) occurred during the follow-up period (1 breast, 1 kidney and 1 rectal cancer). Both univariate and multivariate analyses showed Hb <11.5 g/dL and HH at 6-month follow-up to be significantly associated with treatment failure during follow-up. CONCLUSIONS: IFX seems to be effective and safe in long-term treatment of outpatients affected by UC.