Evidence map›Paper›PMID 27048632›Full record

Observational studyBMJ open2016

Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis.

Proton Rahman, Denis Choquette, William G Bensen, Majed Khraishi, Andrew Chow, Michel Zummer, Saeed Shaikh, Maqbool Sheriff, Sanjay Dixit, Dalton Sholter and 8 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00741793 (BioTRAC), which is not on this map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00741793 completednot on this map

BioTRAC (BIOLOGIC TREATMENT REGISTRY ACROSS CANADA)

TypeobservationalSponsorJanssen Inc.Ran2002 to 2018Enrolled2,821ConditionsArthritis, Rheumatoid, Spondyloarthritis, Axial, Arthritis, Psoriatic
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Regional risk ofFrontiers in pharmacology · 2023
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Article
  6. Article
  7. Observational
  8. RemicadeBiologics : targets & therapy · 2019
    Review
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Proton RahmanDepartment of Medicine & Rheumatology, Memorial University, St. John's, Newfoundland, Canada.
Denis ChoquetteInstitut de Rhumatologie de Montréal, Montreal, Quebec, Canada.
William G BensenSt. Joseph's Hospital, Hamilton, Ontario, Canada McMaster University, Hamilton, Ontario, Canada.
Majed KhraishiMemorial University of Newfoundland, St. John's, Newfoundland, Canada.
Andrew ChowCredit Valley Rheumatology, Mississauga, Ontario, Canada.
Michel ZummerUniversité de Montréal, Montreal, Quebec, Canada Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada.
Saeed ShaikhMcMaster University, Hamilton, Ontario, Canada.
Maqbool SheriffNanaimo Regional General Hospital, Nanaimo, British Columbia, Canada.
Sanjay DixitMcMaster University, Hamilton, Ontario, Canada.
Dalton SholterUniversity of Alberta, Edmonton, Alberta, Canada.
Eliofotisti PsaradellisJSS Medical Research Inc., St-Laurent, Quebec, Canada McGill University, Montreal, Quebec, Canada.
John S SampalisJSS Medical Research Inc., St-Laurent, Quebec, Canada McGill University, Montreal, Quebec, Canada.
Vincent LetourneauJanssen Inc. Medical Affairs, Toronto, Ontario, Canada.
Allen J LehmanJanssen Inc. Medical Affairs, Toronto, Ontario, Canada.
François NantelJanssen Inc. Medical Affairs, Toronto, Ontario, Canada.
Emmanouil RampakakisJSS Medical Research Inc., St-Laurent, Quebec, Canada McGill University, Montreal, Quebec, Canada.
Susan OtawaJanssen Inc. Medical Affairs, Toronto, Ontario, Canada.
May ShawiJanssen Inc. Medical Affairs, Toronto, Ontario, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo 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.

setting46 primary care rheumatology practices across Canada.

participants303 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).

interventionNot 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).

resultsOf 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.

conclusionsCharacteristics 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.

Indexed as

Antirheumatic AgentsInfliximabSpondylitis, AnkylosingAdultBlood SedimentationCanadaCost of IllnessC-Reactive ProteinFemaleHumansKaplan-Meier EstimateMaleMiddle AgedProspective StudiesRegistriesRegression AnalysisAntirheumatic AgentsC-Reactive ProteinInfliximabEPIDEMIOLOGYRHEUMATOLOGYTHERAPEUTICS

Identifiers

PMID27048632
PMCPMC4823435

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.