Infliximab in treatment of Crohn's disease: the Milan experience

Background Efficacy of infliximab in treatment of patients with moderate-to-severe refractory and fistulizing Crohns disease has been shown in controlled clinical trials. Moreover audit data from North America and North Europe have confirmed efficacy in clinical practice comparable to that In clinical trials. Aim. To report clinical experience using infliximab in treatment of Crohns disease In Italy, comparing efficacy and safety with those reported In clinical trials and other published series. Patients and methods. The study population comprised 63 patients (31 males and 32 females, median age 33 years] treated with infliximab for refractory/inflammatory (31 patients] and/or fistulizing Crohns disease (32 patients). All patients received an infusion of infliximab at a dose of 5 mg/kg at weeks 0, 2 and 6. After the first infusion, clinical and laboratory assessments were repeated at weeks 2, 6 and 10. For refractory inflammatory Crohns disease, clinical remission was defined as a Crohns Disease Activity Index of:5 150 at each scheduled visit, clinical response as a reduction in the Crohns Disease Activity Index score of greater than or equal to 70 points in comparison to baseline. For fistulizing Crohns disease, a complete response was defined as closure of any draining fistulae at week 10. A fistula was defined as closed when it no longer drained despite gentle finger pressure. A partial response was defined as reduction in number size or drainage of fistulae, at the same visit. Results. According to an intention-to-treat evaluation on the 31 patients with refractory/inflammatory Crohns disease, at week 2, 42.5% (14 patients] had a clinical response and 31.3% of patients (I D patients) were in clinical remission. At week I D (4 weeks after the end of third infusion], 80.6% [25 patients) had a clinical response and 71% (22 patients) were in clinical remission and 14/19 (74%) had discontinued steroid treatment. Of the 32 patients with fistulizing Crohn's Disease, 15 (46.9%) had a complete response, 8 (25%) a partial response, and 9 [28.1%] no response at week 10 check-up. The incidence of side-effects was low (1656) and not influenced by concurrent immunomodulatory therapy. Conclusion. The present experience with infliximab in clinical practice confirms its efficacy, in particular in inflammatory/refractory Crohns disease and its safety at least, in short-term follow-up.