Infliximab in the treatment of severe, steroid-refractory ulcerative colitis: A pilot study

We report the experience of 11 patients (of 60 planned patients) enrolled i n a double-blind, placebo-controlled clinical trial of infliximab in patien ts with severe, active steroid-refractory ulcerative colitis. The study was terminated prematurely because of slow enrollment. Patients having active disease for at least 2 weeks and receiving at least 5 days of intravenous c orticosteroids were eligible to receive a single intravenous infusion of in fliximab at 5, 10, or 20 mg/kg body weight. The primary endpoint used in th is study was treatment failure at 2 weeks after infusion. Treatment failure was defined as 1) unachieved clinical response as defined by a modified Tr uelove and Witts severity score, 2) increase in corticosteroid dosage, 3) a ddition of immunosuppressants, 4) colectomy, or 5) death. Safety evaluation s included physical examination, clinical chemistry and hematology laborato ry tests, and occurrence of adverse experiences. Four of 8 patients (50%) w ho received infliximab were considered treatment successes at 2 weeks. comp ared with none of 3 patients who received placebo. Improvement in erythrocy te sedimentation rates and serum concentrations of C-reactive protein and i nterleukin-6 correlated with the clinical response observed in patients rec eiving infliximab. Infusion with infliximab produced no significant adverse events. Infliximab was well tolerated and may provide clinical benefit fur some patients with steroid-refractory ulcerative colitis.