title: Infliximab in the treatment of severe, steroid-refractory ulcerative colitis: a pilot study.
abstract: We report the experience of 11 patients (of 60 planned patients) enrolled in a double-blind, placebo-controlled clinical trial of infliximab in patients 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 corticosteroids were eligible to receive a single intravenous infusion of infliximab at 5, 10, or 20 mg/kg body weight. The primary endpoint used in this study was treatment failure at 2 weeks after infusion. Treatment failure was defined as 1) unachieved clinical response as defined by a modified Truelove and Witts severity score, 2) increase in corticosteroid dosage, 3) addition of immunosuppressants, 4) colectomy, or 5) death. Safety evaluations included physical examination, clinical chemistry and hematology laboratory tests, and occurrence of adverse experiences. Four of 8 patients (50%) who received infliximab were considered treatment successes at 2 weeks, compared with none of 3 patients who received placebo. Improvement in erythrocyte sedimentation rates and serum concentrations of C-reactive protein and interleukin-6 correlated with the clinical response observed in patients receiving infliximab. Infusion with infliximab produced no significant adverse events. Infliximab was well tolerated and may provide clinical benefit for some patients with steroid-refractory ulcerative colitis.
authors.affiliation: Center for the Study of Inflammatory Bowel Disease, Massachusetts General Hospital, Boston 02114, USA.
authors.forename: B E
authors.initials: BE
authors.lastname: Sands
authors.forename: W J
authors.initials: WJ
authors.lastname: Tremaine
authors.forename: W J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: P J
authors.initials: PJ
authors.lastname: Rutgeerts
authors.forename: S B
authors.initials: SB
authors.lastname: Hanauer
authors.forename: L
authors.initials: L
authors.lastname: Mayer
authors.forename: S R
authors.initials: SR
authors.lastname: Targan
authors.forename: D K
authors.initials: DK
authors.lastname: Podolsky
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000097:blood / Q000188:drug therapy* / Q000601:surgery; D004311:Double-Blind Method; D004351:Drug Resistance; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D013256:Steroids; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D013256:Steroids; D000069285:Infliximab