Spring 2019 (Volume 29, Number 1)

The Drug Safety and Effectiveness Network (DSEN)

By Sasha Bernatsky, MD, PhD

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The Canadian Network for Advanced Interdisciplinary Methods for comparative effectiveness research (CANAIM) is a pan-Canadian, highly interdisciplinary network of researchers working together to provide real-world information about drug safety and effectiveness for policymakers. Funding is provided by the Canadian Institute of Health Research (CIHR) through the Drug Safety and Effectiveness Network, which works with Health Canada and other decision-makers to respond to key knowledge gaps regarding comparative drug safety and effectiveness. The CAN-AIM team (PIs S. Bernatsky, M. Abrahamowicz, L. Pilote) responds to queries which arise from Health Canada and other regulatory parties. These focus on drug safety and effectiveness, drug use patterns, as well as patient preferences, prescription patterns and social media.

CAN-AIM was recently funded to build a biologic registry with the intent of providing real-world information comparing the safety and effectiveness of biosimilar drugs versus their originator biologic drugs. Our five-year study includes adults (aged 18 years and older) with inflammatory rheumatic disease or inflammatory bowel disease (primarily rheumatoid arthritis [RA] and ankylosing spondylitis [AS]) who are initiating therapy with a biosimilar or the originator biologic drug. The primary outcome measure is simply maintenance of treatment, but we will also collect information on start/stop/ changes in systemic steroids and immunosuppressive drugs, disease control, and adverse effects, particularly infection. Multiple investigators are involved, including D. Choquette, W. Maksymowych, G. Boire, V. Bykerk, R. Inman, C. Bombardier, C. Hitchon and C. Thorne. For more information on our team or the biosimilars registry, please contact Autumn Neville at autumn.neville@rimuhc.ca or visit canaim.ca.

Sasha Bernatsky, MD, PhD
Professor,
Department of Medicine,
Division of Rheumatology, Faculty of Medicine,
McGill University
Research Institute of the McGill University Health Centre
Centre for Outcome Research & Evaluation (CORE)
Montreal, Quebec