Are Different Types of Biologic Medications Associated with Different Risks of Adverse Events? What Real-World Data Tells Us

Scientific Study Title:

Comparing the Risk of Adverse Events Associated with Different Classes of Biologic or Targeted Synthetic Agents: A Population-based Study

Study Start Date:

May 2023

End Date:

May 2025

Why Do This Research?

The results of treatment for inflammatory arthritis (e.g. rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA)) with new medications, known as biologics and targeted synthetic medications, have been impressive. These medications are remarkably effective at reducing inflammation, relieving symptoms, and preventing joint damage and long-term complications. Many different types of these medications that work in different ways – known as different ‘classes’ – are now available. Choosing between them can be difficult for clinicians and patients because little information is available that directly compares the risks and benefits of different medications or their use in real-life clinical care.

What Will Be Done?

We will compare the risks and benefits of different classes of biologic and targeted synthetic drugs by looking at everyone in British Columbia who has been prescribed these medications for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis. To do this, we will use advanced statistical methods to analyze data regularly collected by the BC Ministry of Health, with information identifying persons removed, and we will compare how often people using different classes of medications have infections requiring hospitalization, heart attacks, strokes and clots in the veins.

The list of medications included in the study can be found in the table below. As drugs typically have both official technical names and easier-to-say brand names, we have included both names for each drug.

By providing real-world evidence comparing the different treatments available, this study will help clinicians and people with inflammatory arthritis better weigh risks and benefits and make more informed decisions about their treatment options.

Who Is Involved?

Everyone in BC who has used a biologic or targeted medication for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis. This will include approximately 24,000 people.

How Do People Get Involved?

The project will use data already collected, so we are not asking people to participate.

How are Equity, Diversity and Inclusion Addressed or Taken Into Consideration?

As our study includes everyone in British Columbia, our sample is representative of all groups, and the results will apply to everyone in BC. To ensure that our comparisons are fair and accurate, our analyses will consider social determinants of health that could affect the results, such as differences in age, sex, socioeconomic status, and living area.

Research Team

Principal Investigator:

Diane Lacaille, MDCM, MHSc, FRCPC, Scientific Director, Arthritis Research Canada (University of British Columbia)

Co-Investigator(s):

Hui Xie, BSc, MS, PhD, Research Scientist, Arthritis Research Canada (Simon Fraser University)
J. Antonio Avina-Zubieta, MD, MSc, PhD, FRCPC, Senior Scientist, Arthritis Research Canada (University of British Columbia)

Trainee:

Kasra Moolooghy, MD, MSc Candidate, Research Trainee, Arthritis Research Canada (University of British Columbia)

Research Staff:

Yufei Zheng, MSc, Statistician, Arthritis Research Canada

Patient Partners

Alison Hoens, BScPT, MSc, Arthritis Research Canada
Steve Sutherland, MA, Arthritis Patient Advisory Board, Arthritis Research Canada

Funding Agency:

University of Calgary Cumming School of Medicine Clinical Research Fund (CRF) Grant

TNF: Tumor Necrosis Factor; IL: Interleukin; JAK: Janus Kinase