Abstract
BackgroundLong-term clinical registries are essential tools to evaluate new therapies in a patient population that differs from those in randomized clinical trials. The objectives are to describe the profile of rheumatoid arthritis (RA) patients treated with anti-TNF agents in Canadian routine care.MethodsRA patients eligible for treatment with Infliximab (IFX), golimumab (GLM) or intravenous golimumab (GLM-IV) as per their respective Canadian product monographs were enrolled into the BioTRAC registry between 2002 and 2017. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in disease activity. Safety was evaluated by the incidence of adverse events (AEs) and drug survival.ResultsOf the 890 IFX-, 530 GLM- and 157 GLM-IV-treated patients, the proportion of females ranged from 77.0–86.6%, the mean ages from 55.8–57.7 and the mean disease duration from 6.5–8.6 years. A significant decrease in baseline disease duration and disease activity parameters (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) was observed over time. Treatment with IFX, GLM- and GLM-IV significantly improved all disease parameters over time. The incidence of AEs was 105, 113 and 82.6 /100 PYs and the incidence of SAEs was 11.7, 11.2 and 4.68 /100 PYs for IFX, GLM- and GLM-IV-treated patients, respectively.ConclusionDifferences in baseline characteristics between patients treated with an anti-TNFs over time shows the evolution of treatment modalities over time. All treatments significantly reduced disease activity and improved functionality in a similar fashion. The incidence of adverse events was consistent with the safety profiles of IFX and GLM.Trial registrationClinicalTrials.gov Identifier: NCT00741793 (Retrospectively registered on August 26, 2008).
Highlights
Long-term clinical registries are essential tools to evaluate new therapies in a patient population that differs from those in randomized clinical trials
Biologic Treatment Registry Across Canada (BioTRAC) was originally designed and launched in February 2002 as an effectiveness and safety registry for rheumatoid arthritis (RA) patients treated with IFX
The registry was amended once more in 2014 to include RA patients treated with Golimumab intravenous (GLM-IV) and psoriatic arthritis patients treated with UST
Summary
Long-term clinical registries are essential tools to evaluate new therapies in a patient population that differs from those in randomized clinical trials. Since the approval of the first bDMARDs, the anti-TNF agents infliximab (IFX) and etanercept, several new agents and strategies have been introduced for the treatment of moderate to severe RA [3] These guidelines predominantly use data from randomized clinical trials (RCTs) which, designed to minimize potential biases, are carried out in selected populations which usually differ from patients treated in a real-world setting [4]. RCTs cannot answer important questions concerning long term safety or therapeutic strategy, and data from RCTs cannot be extrapolated to daily practice [5] Despite their methodological limitations, observational studies allow the investigation of the long-term effectiveness and safety of new therapies and/or treatment strategies in a larger, more representative populations
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