Grant: Travel Awards - Institute Community Support

Multiple sclerosis (MS) is a lifelong autoimmune disease that damages the brain and spinal cord. It most often affects young adults between the ages of 20 and 40 and has no cure. Over time, it can cause progressive disability that impacts movement, vision, balance, and cognition. To manage symptoms and slow disease progression, people with MS rely on long-term medications called disease-modifying therapies (DMTs). One of these, fingolimod, is effective in managing MS but has been linked in post-marketing clinical reports to serious cases of skin cancer, raising concern about its long-term safety. Since clinical trials are often limited in duration and include select participants, it remains uncertain whether fingolimod increases this risk in real-world settings. This study evaluates the long-term safety of fingolimod with respect to skin cancer using real-world, population-based administrative health data from British Columbia linked with MS registry information. The study is designed to closely mirror a randomized controlled trial, which is considered the gold standard for assessing post-marketing drug safety. We identify people with MS who are new users of fingolimod and compare them with those starting other similar MS medications to ensure fair comparisons among patients with similar risk factors. The 3-, 5-, and 10-year risks of skin cancer are assessed using advanced statistical modelling. Understanding long-term safety is vital, as MS affects younger individuals who may take these treatments for decades. By linking and analyzing large population health databases, this research provides real-world evidence on the potential skin cancer risks of fingolimod. The findings will help regulators, clinicians, and patients make informed treatment decisions and may also help inform future updates to drug labelling to improve patient safety.