title: Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: a randomized, placebo-controlled study.
abstract: OBJECTIVE
  Despite treatment with corticosteroids, severe to moderately severe attacks of ulcerative colitis have a high colectomy rate. We intended to find a rescue therapy other than cyclosporin A, which imposes a high risk of side effects and cyclosporine-related mortality.
  
  
  METHODS
  This was a randomized double-blind trial of infliximab or placebo in severe to moderately severe ulcerative colitis not responding to conventional treatment. Patients were randomized to infliximab/placebo either on day 4 after the initiation of corticosteroid treatment if they fulfilled the index criteria for fulminant ulcerative colitis on day 3 or on day 6-8 if they fulfilled index criteria on day 5-7 for a severe or moderately severe acute attack of ulcerative colitis. Results were analyzed according to the intention-to-treat principle. The primary end point was colectomy or death 3 months after randomization. Secondary end points were clinical and endoscopic remission at that time in patients who did not undergo operation.
  
  
  RESULTS
  Forty-five patients were included (24 infliximab and 21 placebo). No patient died. Seven patients in the infliximab group and 14 in the placebo group had a colectomy (P = .017; odds ratio, 4.9; 95% confidence interval, 1.4-17) within 3 months after randomization. No serious side effects occurred. Three patients in the placebo group required operation for septic complications.
  
  
  CONCLUSIONS
  Infliximab 4-5 mg/kg is an effective and safe rescue therapy in patients experiencing an acute severe or moderately severe attack of ulcerative colitis not responding to conventional treatment.
authors.affiliation: Department of Medicine, Division of Gastroenterology, Orebro University Hospital, Sweden. gunnar.jarnerot@orebroll.se
authors.forename: Gunnar
authors.initials: G
authors.lastname: Järnerot
authors.forename: Erik
authors.initials: E
authors.lastname: Hertervig
authors.forename: Ingalill
authors.initials: I
authors.lastname: Friis-Liby
authors.forename: Lars
authors.initials: L
authors.lastname: Blomquist
authors.forename: Per
authors.initials: P
authors.lastname: Karlén
authors.forename: Christer
authors.initials: C
authors.lastname: Grännö
authors.forename: Mogens
authors.initials: M
authors.lastname: Vilien
authors.forename: Magnus
authors.initials: M
authors.lastname: Ström
authors.forename: Ake
authors.initials: A
authors.lastname: Danielsson
authors.forename: Hans
authors.initials: H
authors.lastname: Verbaan
authors.forename: Per M
authors.initials: PM
authors.lastname: Hellström
authors.forename: Anders
authors.initials: A
authors.lastname: Magnuson
authors.forename: Bengt
authors.initials: B
authors.lastname: Curman
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D004351:Drug Resistance; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab