PMID- 27048632 OWN - NLM STAT- MEDLINE DCOM- 20170106 LR - 20181113 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 6 IP - 4 DP - 2016 Apr 5 TI - Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis. PG - e009661 LID - 10.1136/bmjopen-2015-009661 [doi] LID - e009661 AB - OBJECTIVES: 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. SETTING: 46 primary care rheumatology practices across Canada. PARTICIPANTS: 303 biological-naive 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). INTERVENTION: Not applicable (non-interventional study). PRIMARY AND SECONDARY OUTCOMES: 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-alpha 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. TRIAL REGISTRATION NUMBER: NCT00741793. CI - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ FAU - Rahman, Proton AU - Rahman P AD - Department of Medicine & Rheumatology, Memorial University, St. John's, Newfoundland, Canada. FAU - Choquette, Denis AU - Choquette D AD - Institut de Rhumatologie de Montreal, Montreal, Quebec, Canada. FAU - Bensen, William G AU - Bensen WG AD - St. Joseph's Hospital, Hamilton, Ontario, Canada McMaster University, Hamilton, Ontario, Canada. FAU - Khraishi, Majed AU - Khraishi M AD - Memorial University of Newfoundland, St. John's, Newfoundland, Canada. FAU - Chow, Andrew AU - Chow A AD - Credit Valley Rheumatology, Mississauga, Ontario, Canada. FAU - Zummer, Michel AU - Zummer M AD - Universite de Montreal, Montreal, Quebec, Canada Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada. FAU - Shaikh, Saeed AU - Shaikh S AD - McMaster University, Hamilton, Ontario, Canada. FAU - Sheriff, Maqbool AU - Sheriff M AD - Nanaimo Regional General Hospital, Nanaimo, British Columbia, Canada. FAU - Dixit, Sanjay AU - Dixit S AD - McMaster University, Hamilton, Ontario, Canada. FAU - Sholter, Dalton AU - Sholter D AD - University of Alberta, Edmonton, Alberta, Canada. FAU - Psaradellis, Eliofotisti AU - Psaradellis E AD - JSS Medical Research Inc., St-Laurent, Quebec, Canada McGill University, Montreal, Quebec, Canada. FAU - Sampalis, John S AU - Sampalis JS AD - JSS Medical Research Inc., St-Laurent, Quebec, Canada McGill University, Montreal, Quebec, Canada. FAU - Letourneau, Vincent AU - Letourneau V AD - Janssen Inc. Medical Affairs, Toronto, Ontario, Canada. FAU - Lehman, Allen J AU - Lehman AJ AD - Janssen Inc. Medical Affairs, Toronto, Ontario, Canada. FAU - Nantel, Francois AU - Nantel F AD - Janssen Inc. Medical Affairs, Toronto, Ontario, Canada. FAU - Rampakakis, Emmanouil AU - Rampakakis E AD - JSS Medical Research Inc., St-Laurent, Quebec, Canada McGill University, Montreal, Quebec, Canada. FAU - Otawa, Susan AU - Otawa S AD - Janssen Inc. Medical Affairs, Toronto, Ontario, Canada. FAU - Shawi, May AU - Shawi M AD - Janssen Inc. Medical Affairs, Toronto, Ontario, Canada. LA - eng SI - ClinicalTrials.gov/NCT00741793 PT - Clinical Trial, Phase IV PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20160405 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 RN - 0 (Antirheumatic Agents) RN - 9007-41-4 (C-Reactive Protein) RN - B72HH48FLU (Infliximab) SB - IM MH - Adult MH - Antirheumatic Agents/adverse effects/*therapeutic use MH - Blood Sedimentation MH - C-Reactive Protein/analysis MH - Canada MH - Cost of Illness MH - Female MH - Humans MH - Infliximab/adverse effects/*therapeutic use MH - Kaplan-Meier Estimate MH - Male MH - Middle Aged MH - Prospective Studies MH - Registries MH - Regression Analysis MH - Severity of Illness Index MH - Spondylitis, Ankylosing/*drug therapy MH - Surveys and Questionnaires PMC - PMC4823435 OTO - NOTNLM OT - EPIDEMIOLOGY OT - RHEUMATOLOGY OT - THERAPEUTICS EDAT- 2016/04/07 06:00 MHDA- 2017/01/07 06:00 PMCR- 2016/04/05 CRDT- 2016/04/07 06:00 PHST- 2016/04/07 06:00 [entrez] PHST- 2016/04/07 06:00 [pubmed] PHST- 2017/01/07 06:00 [medline] PHST- 2016/04/05 00:00 [pmc-release] AID - bmjopen-2015-009661 [pii] AID - 10.1136/bmjopen-2015-009661 [doi] PST - epublish SO - BMJ Open. 2016 Apr 5;6(4):e009661. doi: 10.1136/bmjopen-2015-009661.