Long-Term Effectiveness and Safety of Infliximab, Golimumab and Golimumab-IV in Rheumatoid Arthritis Patients from a Canadian Prospective Observational Registry

Abstract

Background Long-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. Methods RA 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. Results Of the 890 IFX-, 530 GLM-SC- 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-SC 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-SC and GLM-IV-treated patients, respectively. Conclusion Differences 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.

Effectiveness and Safety of Tofacitinib in Canadian Patients With Rheumatoid Arthritis: Primary Results From a Prospective Observational Study

“…CANTORAL is the first study reporting the real‐world effectiveness and safety of a JAK inhibitor for moderate to severe RA in Canada and complements previous Canadian observational studies of patients with RA receiving bDMARDs (26–29). The proportion of patients with CDAI‐defined LDA and remission at month 6 was 52.9% and 15.4%, respectively, demonstrating the effectiveness of tofacitinib for moderate to severe RA.…”

Laying the Foundation for Real-World Evidence Studies of Psoriatic Disease in Newfoundland and Labrador

“…The opposite scenario also occurs, as noted in a Canadian biologic registry, where patients with such milder disease PsA are over-represented in clinic patients receiving biologic agents compared to the clinical trials [26]. This has economic implications as patients with milder disease may be managed with palliative care, and the therapeutic effect size between DMARDs and biologics appears to be smaller [26]. So, including real-life data from registries will be important in determining the actual value of biologic agents and, overall, the prevalence and effect of psoriatic disease in the province.…”

Golimumab Ameliorates Pancreatic Inflammatory Response in the Cerulein-Induced Acute Pancreatitis in Rats

“…Golimumab has been shown to reduce the level of reactive oxygen species which are closely related to C-reactive protein, TNF-alpha, and IL-1 and IL-6 expressions. 10 - 12 There is no study in the literature that examines the effects of TNF-alpha receptor antagonist GLM on the experimental acute AP models.…”