title: Efficacy and safety of adalimumab in Canadian patients with moderate to severe Crohn's disease: results of the Adalimumab in Canadian SubjeCts with ModErate to Severe Crohn's DiseaSe (ACCESS) trial.
abstract: OBJECTIVE
  To evaluate open-label adalimumab therapy for clinical effectiveness, fistula healing, patient-reported outcomes and safety in Canadian patients with moderate to severe Crohn's disease (CD) who were either naive to or previously exposed to antitumour necrosis factor (anti-TNF) therapy.
  
  
  METHODS
  Patients with moderate to severe CD (CD activity index [CDAI] score of greater than 220, or Harvey-Bradshaw index [HBI] of 7 or greater) were eligible. Patients received open-label adalimumab as induction (160 mg and 80 mg subcutaneously [sc]) at weeks 0 and 2, respectively and maintenance (40 mg sc every other week) therapy. At or after eight weeks, patients with flare or nonresponse could have their dosage increased to 40 mg sc weekly. Patients were followed for a minimum of six months or until adalimumab was commercially available in Canada.
  
  
  RESULTS
  Of the 304 patients enrolled, 160 were infliximab experienced, while 144 were anti-TNF naive. HBI remission (HBI score of 4 or lower) at week 24 was achieved by 53% of anti-TNF-naive and 36% of infliximab-experienced patients (P<0.01; P<0.001 for both groups for all visits versus baseline). Fistula healing rates at week 12 were 48% for anti-TNF-naive patients, and 26% for infliximab-experienced patients. At week 24, fistula healing rates were significantly greater for the anti-TNF-naive group (60% versus 28%; P<0.01). Improvements in quality of life and work productivity were sustained from week 4 to week 24 for all patients. Serious infections occurred in 2% of patients.
  
  
  CONCLUSIONS
  Adalimumab therapy induced and sustained steroidfree remission in both infliximab-experienced and anti-TNF-naive patients with moderate to severe CD. Clinically meaningful rates of fistula healing were also observed. Improvements in patient-reported outcomes were sustained throughout the 24-week study period.
authors.affiliation: University of Calgary, Calgary, Alberta, USA. rpanacci@ucalgary.ca
authors.forename: Remo
authors.initials: R
authors.lastname: Panaccione
authors.forename: Edward V
authors.initials: EV
authors.lastname: Loftus
authors.forename: David
authors.initials: D
authors.lastname: Binion
authors.forename: Kevin
authors.initials: K
authors.lastname: McHugh
authors.forename: Shamsul
authors.initials: S
authors.lastname: Alam
authors.forename: Naijun
authors.initials: N
authors.lastname: Chen
authors.forename: Benoît
authors.initials: B
authors.lastname: Guerette
authors.forename: Parvez
authors.initials: P
authors.lastname: Mulani
authors.forename: Jingdong
authors.initials: J
authors.lastname: Chao
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D002170:Canada; D003424:Crohn Disease / Q000188:drug therapy* / Q000503:physiopathology; D004526:Efficiency; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000069285:Infliximab; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012074:Remission Induction / Q000379:methods; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab