title: Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis.
abstract: OBJECTIVE
  To describe the profile of patients with ankylosing spondylitis (AS) treated with infliximab in Canadian routine care and to assess the effectiveness and safety of infliximab in real world.
  
  
  METHODS
  46 primary care rheumatology practices across Canada.
  
  
  METHODS
  303 biological-naïve patients with AS or patients previously treated with a biological for <6 months and who were eligible for infliximab treatment as per routine care within the Biologic Treatment Registry Across Canada (BioTRAC).
  
  
  METHODS
  Not applicable (non-interventional study).
  
  
  METHODS
  Effectiveness was assessed with changes in disease parameters (AS Disease Activity Score (ASDAS), Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), Health Assessment Questionnaire Disease Index (HAQ-DI), physician global assessment of disease activity (MDGA), patient global disease activity (PtGA), back pain, C-reactive protein, erythrocyte sedimentation rate (ESR), morning stiffness). Safety was assessed with the incidence of adverse events (AEs).
  
  
  RESULTS
  Of the 303 patients included, 44.6% were enrolled in 2005-2007 and 55.4% in 2008-2013. Patients enrolled in 2005-2007 had significantly higher MDGA and ESR at baseline while all other disease parameters examined were numerically higher with the exception of PtGA. Treatment with infliximab significantly (p<0.001) improved all disease parameters over time in both groups. At 6 months, 56% and 31% of patients achieved clinically important (change≥1.1) and major (change≥2.0) improvement in ASDAS, respectively; at 48 months, these proportions increased to 75% and 50%, respectively. Among patients unemployed due to disability at baseline, 12.1% returned to work (mean Kaplan-Meier (KM)-based time=38.8 months). The estimated retention rate at 12 and 24 months was 78.3% and 60.1%, respectively. The profile and incidence of AEs were comparable to data previously reported for tumour necrosis factor-α inhibitors.
  
  
  CONCLUSIONS
  Characteristics of patients with AS at infliximab initiation changed over time towards lower disease activity and shorter disease duration. Infliximab treatment significantly reduced disease activity independent of treatment initiation year, although patients enrolled in recent years achieved lower disease activity over 48 months.
  
  
  BACKGROUND
  NCT00741793.
authors.affiliation: Department of Medicine & Rheumatology, Memorial University, St. John's, Newfoundland, Canada.
authors.forename: Proton
authors.initials: P
authors.lastname: Rahman
authors.affiliation: Institut de Rhumatologie de Montréal, Montreal, Quebec, Canada.
authors.forename: Denis
authors.initials: D
authors.lastname: Choquette
authors.affiliation: St. Joseph's Hospital, Hamilton, Ontario, Canada McMaster University, Hamilton, Ontario, Canada.
authors.forename: William G
authors.initials: WG
authors.lastname: Bensen
authors.affiliation: Memorial University of Newfoundland, St. John's, Newfoundland, Canada.
authors.forename: Majed
authors.initials: M
authors.lastname: Khraishi
authors.affiliation: Credit Valley Rheumatology, Mississauga, Ontario, Canada.
authors.forename: Andrew
authors.initials: A
authors.lastname: Chow
authors.affiliation: Université de Montréal, Montreal, Quebec, Canada Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada.
authors.forename: Michel
authors.initials: M
authors.lastname: Zummer
authors.affiliation: McMaster University, Hamilton, Ontario, Canada.
authors.forename: Saeed
authors.initials: S
authors.lastname: Shaikh
authors.affiliation: Nanaimo Regional General Hospital, Nanaimo, British Columbia, Canada.
authors.forename: Maqbool
authors.initials: M
authors.lastname: Sheriff
authors.affiliation: McMaster University, Hamilton, Ontario, Canada.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Dixit
authors.affiliation: University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Dalton
authors.initials: D
authors.lastname: Sholter
authors.affiliation: JSS Medical Research Inc., St-Laurent, Quebec, Canada McGill University, Montreal, Quebec, Canada.
authors.forename: Eliofotisti
authors.initials: E
authors.lastname: Psaradellis
authors.affiliation: JSS Medical Research Inc., St-Laurent, Quebec, Canada McGill University, Montreal, Quebec, Canada.
authors.forename: John S
authors.initials: JS
authors.lastname: Sampalis
authors.affiliation: Janssen Inc. Medical Affairs, Toronto, Ontario, Canada.
authors.forename: Vincent
authors.initials: V
authors.lastname: Letourneau
authors.affiliation: Janssen Inc. Medical Affairs, Toronto, Ontario, Canada.
authors.forename: Allen J
authors.initials: AJ
authors.lastname: Lehman
authors.affiliation: Janssen Inc. Medical Affairs, Toronto, Ontario, Canada.
authors.forename: François
authors.initials: F
authors.lastname: Nantel
authors.affiliation: JSS Medical Research Inc., St-Laurent, Quebec, Canada McGill University, Montreal, Quebec, Canada.
authors.forename: Emmanouil
authors.initials: E
authors.lastname: Rampakakis
authors.affiliation: Janssen Inc. Medical Affairs, Toronto, Ontario, Canada.
authors.forename: Susan
authors.initials: S
authors.lastname: Otawa
authors.affiliation: Janssen Inc. Medical Affairs, Toronto, Ontario, Canada.
authors.forename: May
authors.initials: M
authors.lastname: Shawi
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001799:Blood Sedimentation; D002097:C-Reactive Protein / Q000032:analysis; D002170:Canada; D017281:Cost of Illness; D000069285:Infliximab / Q000009:adverse effects / Q000627:therapeutic use; D053208:Kaplan-Meier Estimate; D011446:Prospective Studies; D012042:Registries; D012044:Regression Analysis; D012720:Severity of Illness Index; D013167:Spondylitis, Ankylosing / Q000188:drug therapy; D011795:Surveys and Questionnaires
chemical_list: D018501:Antirheumatic Agents; D002097:C-Reactive Protein; D000069285:Infliximab
keywords: EPIDEMIOLOGY; RHEUMATOLOGY; THERAPEUTICS