This is proof of concept project demonstrates the feasibility of creating a platform of clinical cohorts and other resources to provide real-world evidence (RWE) on biosimilar agents in Canada. We use new and established prospective cohorts of inflammatory arthritis (rheumatoid arthritis, RA and ankylosing spondylitis, AS) and inflammatory bowel diseases (IBD, ulcerative colitis, UC and Crohn’s disease, CD). We use the National Prescription Drug Utilization Information System (NPDUIS), a database of prescription claims from publicly financed drug programs in different provinces linked to the hospital Discharge Abstract Database (DAD) data and the National Ambulatory Care Reporting System (NACRS). Similarly, MarketScan includes data on filled drug prescriptions, physician services, emergency room visits, and hospitalizations.

Inflammatory rheumatic disease cohorts

CAN-AIM’s biosimilars registry was built on existing RA and AS clinical research cohorts across Canada that collect information on disease activity, lab data, and patient outcomes. The cohorts include the Canadian Early Arthritis Cohort (CATCH), a consortium of 19 clinical sites across Canada; RHUMADATA Clinical Database and Registry in Montreal and Quebec City; Alberta’s Rheumatoid Arthritis Pharmacovigilance Program and Outcomes Research in Therapeutics (RAPPORT) and the Early Undifferentiated PolyArthritis (EUPA) and Biologic Database, in Sherbrooke, Quebec; and the Spondyloarthritis Research Consortium of Canada (SPARCC) Toronto Western Hospital site. 

Canadian IBD Research Consortium (CIRC)

CIRC is a research consortium organized to promote collaborative Canadian IBD research. Prospective enrollments in CAN-AIM’s Biosimilar Registry. Participating CIRC centres include Montreal, Vancouver, Winnipeg, Hamilton, Toronto, Calgary, Edmonton, Thunder Bay:

Results: Preliminary analyses, which suggest that therapy persistence and discontinuation rates are similar among biosimilar users versus equivalent bio-originator agents. Overall, we were unable to demonstrate any significant difference in the risk of discontinuation between biosimilars versus bio-originators.  Similarly, in the initial assessment, we were unable to identify significant differences in infections among users of infliximab biosimilar versus bio-originator (US data only).