Abstract
BackgroundThe objectives of this study were to describe the profile of ankylosing spondylitis (AS) patients treated with either infliximab (IFX) or subcutaneous golimumab (GLM) treatment in Canadian routine care setting along with assessing long-term effectiveness and safety.MethodsAS patients who were eligible for treatment with IFX or subcutaneous GLM as per their respective Canadian product monographs were enrolled into the BioTRAC registry from 2005 to 2017. The study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in clinical outcomes and acute phase reactants. Safety was evaluated by assessing the incidence of adverse events (AEs) and drug survival rates.ResultsA total of 389 IFX- and 421 GLM-treated patients were enrolled. A significant decrease in disease duration at baseline was observed in the IFX cohort, from a median of 8.0 in 2005–2008 to 1.0 years in 2009–2015 (p < 0.001). A reduction in baseline BASFI score (p = 0.011) and proportion of patients in ASDAS very high disease activity (p = 0.004) was also observed over time. Meanwhile, in the GLM cohort, most disease parameters remained similar from 2010 to 2017.Treatment with both agents significantly improved all disease parameters over time with similar efficacy between the two agents. The incidence of AEs and SAEs were 136 and 131 events/100 PYs and 10.5 and 8.45 events/100 PYs for IFX- and GLM-treated patients, respectively.ConclusionBoth IFX and GLM treatment in AS significantly reduced disease activity in most outcome measures in a similar fashion and were well tolerated in Canadian routine care.Trial registrationNCT00741793.
Highlights
The objectives of this study were to describe the profile of ankylosing spondylitis (AS) patients treated with either infliximab (IFX) or subcutaneous golimumab (GLM) treatment in Canadian routine care setting along with assessing long-term effectiveness and safety
Ankylosing spondylitis (AS) is a common form of spondyloarthritis (SpA) [1]. It is further classified under the subgroup axial spondyloarthritis (AxSpA), due to the predominant involvement of the spine and/or sacroiliac joints whether it be radiographic or non-radiographic AxSpA
Study design The Biologic Treatment Registry Across Canada (BioTRAC; NCT00741793) was a prospective, multi-centre (140 sites), registry that collected real-world clinical, laboratory, safety, and patient-reported data between 2002 and 2018 among AS, psoriatic arthritis, and rheumatoid arthritis patients treated with IFX, GLM or ustekinumab during routine institutional and private care in Canada
Summary
The objectives of this study were to describe the profile of ankylosing spondylitis (AS) patients treated with either infliximab (IFX) or subcutaneous golimumab (GLM) treatment in Canadian routine care setting along with assessing long-term effectiveness and safety. Ankylosing spondylitis (AS) is a common form of spondyloarthritis (SpA) [1]. It is further classified under the subgroup axial spondyloarthritis (AxSpA), due to the predominant involvement of the spine and/or sacroiliac joints whether it be radiographic or non-radiographic AxSpA. Extra-articular manifestations such as ophthalmologic, dermatological and gastrointestinal involvement are common in AS patients; the prevalence of uveitis, psoriasis and inflammatory bowel disease being 26, 9 and 7%, respectively [4]. Uveitis is the most common extraarticular manifestation, and generally involves the anterior chamber and is unilateral [5]. The overall disease prevalence is estimated to be between 0.1 and 1.4% [7] and varies with the prevalence of the HLA-B27 gene in a given population [8]. In Canada’s largest province (Ontario), the prevalence of AS in 2010 was estimated to be 213/100,000 [9]
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