title: Long-term infliximab maintenance therapy for ulcerative colitis: the ACT-1 and -2 extension studies.
abstract: BACKGROUND
  The aim was to evaluate long-term efficacy, quality of life, and safety in ulcerative colitis patients who received infliximab during the ACT-1 and -2 extension studies.
  
  
  METHODS
  Adults with moderate-to-severely active ulcerative colitis in the 54-week ACT-1 and 30-week ACT-2 studies who achieved benefit from infliximab were eligible to participate in extension studies and receive up to 3 additional years of therapy. Patients received randomized study medication until all sites were unblinded; placebo-treated patients were discontinued. Patients receiving 5 or 10 mg/kg infliximab continued to receive open-label infliximab every 8 weeks. Patients receiving infliximab 10 mg/kg could decrease to 5 mg/kg; patients receiving infliximab 5 mg/kg could increase to 10 mg/kg if response was lost.
  
  
  RESULTS
  A total of 229 of 484 infliximab-treated patients from the ACT-1 and ACT-2 main studies entered the long-term extensions. Overall, 70 (30.6%) patients discontinued infliximab infusions for adverse events (24 [10.5%]), lack of efficacy (11 [4.8%]), required a colectomy (1 [0.4%]), or for other reasons (34 [14.8%]). Proportions of patients whose Physician's Global Assessment scores were indicative of no or mild disease (score = 0 or 1) were maintained during the extension studies; 76.5% at Extension week 0 and ranged between 90.0% and 94.3% through Extension week 152. Improvement in Inflammatory Bowel Disease Questionnaire scores observed in the main studies was maintained. During the long-term extension, the infliximab safety profile was consistent with that of the main studies; no new or unexpected safety signals were observed.
  
  
  CONCLUSIONS
  Long-term treatment with infliximab for up to 3 additional years was effective and well tolerated.
authors.affiliation: Department of Gastroenterology and Hepatology, Univ Klinik Innere Medizin III, AKH Wien, Vienna, Austria. walter.reinisch@meduniwien.ac.at
authors.forename: Walter
authors.initials: W
authors.lastname: Reinisch
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Paul
authors.initials: P
authors.lastname: Rutgeerts
authors.forename: Brian G
authors.initials: BG
authors.lastname: Feagan
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: Marion
authors.initials: M
authors.lastname: Blank
authors.forename: Yinghua
authors.initials: Y
authors.lastname: Lang
authors.forename: Jewel
authors.initials: J
authors.lastname: Johanns
authors.forename: Jean Frédéric
authors.initials: JF
authors.lastname: Colombel
authors.forename: Daniel
authors.initials: D
authors.lastname: Present
authors.forename: Bruce E
authors.initials: BE
authors.lastname: Sands
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D003082:Colectomy; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000601:surgery; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D016312:Treatment Refusal
chemical_list: D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab