title: Infliximab for induction and maintenance therapy for ulcerative colitis.
abstract: BACKGROUND
  Infliximab, a chimeric monoclonal antibody directed against tumor necrosis factor alpha, is an established treatment for Crohn's disease but not ulcerative colitis.
  
  
  METHODS
  Two randomized, double-blind, placebo-controlled studies--the Active Ulcerative Colitis Trials 1 and 2 (ACT 1 and ACT 2, respectively)--evaluated the efficacy of infliximab for induction and maintenance therapy in adults with ulcerative colitis. In each study, 364 patients with moderate-to-severe active ulcerative colitis despite treatment with concurrent medications received placebo or infliximab (5 mg or 10 mg per kilogram of body weight) intravenously at weeks 0, 2, and 6 and then every eight weeks through week 46 (in ACT 1) or week 22 (in ACT 2). Patients were followed for 54 weeks in ACT 1 and 30 weeks in ACT 2.
  
  
  RESULTS
  In ACT 1, 69 percent of patients who received 5 mg of infliximab and 61 percent of those who received 10 mg had a clinical response at week 8, as compared with 37 percent of those who received placebo (P<0.001 for both comparisons with placebo). A response was defined as a decrease in the Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute rectal-bleeding subscore of 0 or 1. In ACT 2, 64 percent of patients who received 5 mg of infliximab and 69 percent of those who received 10 mg had a clinical response at week 8, as compared with 29 percent of those who received placebo (P<0.001 for both comparisons with placebo). In both studies, patients who received infliximab were more likely to have a clinical response at week 30 (P< or =0.002 for all comparisons). In ACT 1, more patients who received 5 mg or 10 mg of infliximab had a clinical response at week 54 (45 percent and 44 percent, respectively) than did those who received placebo (20 percent, P<0.001 for both comparisons).
  
  
  CONCLUSIONS
  Patients with moderate-to-severe active ulcerative colitis treated with infliximab at weeks 0, 2, and 6 and every eight weeks thereafter were more likely to have a clinical response at weeks 8, 30, and 54 than were those receiving placebo. (ClinicalTrials.gov numbers, NCT00036439 and NCT00096655.)
authors.affiliation: University Hospital Gasthuisberg, Leuven, Belgium. paul.rutgeerts@uz.kuleuven.ac.be
authors.forename: Paul
authors.initials: P
authors.lastname: Rutgeerts
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Brian G
authors.initials: BG
authors.lastname: Feagan
authors.forename: Walter
authors.initials: W
authors.lastname: Reinisch
authors.forename: Allan
authors.initials: A
authors.lastname: Olson
authors.forename: Jewel
authors.initials: J
authors.lastname: Johanns
authors.forename: Suzanne
authors.initials: S
authors.lastname: Travers
authors.forename: Daniel
authors.initials: D
authors.lastname: Rachmilewitz
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Hanauer
authors.forename: Gary R
authors.initials: GR
authors.lastname: Lichtenstein
authors.forename: Willem J S
authors.initials: WJ
authors.lastname: de Villiers
authors.forename: Daniel
authors.initials: D
authors.lastname: Present
authors.forename: Bruce E
authors.initials: BE
authors.lastname: Sands
authors.forename: Jean Frédéric
authors.initials: JF
authors.lastname: Colombel
mesh_terms: D000328:Adult; D000906:Antibodies / Q000097:blood; D000974:Antibodies, Antinuclear / Q000097:blood; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003093:Colitis, Ulcerative / Q000145:classification / Q000188:drug therapy* / Q000276:immunology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007239:Infections / Q000209:etiology; D000069285:Infliximab; D008297:Male; D012074:Remission Induction; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000906:Antibodies; D000974:Antibodies, Antinuclear; D000911:Antibodies, Monoclonal; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab