Novel multiple sclerosis agents-associated cardiotoxicity: A real-world pharmacovigilance study

Area of Science:

• Pharmacovigilance
• Cardiovascular Medicine
• Neurology

Background:

• Novel therapeutics for multiple sclerosis (MS) are emerging.
• Adverse events associated with these new MS therapies are not well understood.
• Cardiovascular complications of new MS drugs require thorough investigation.

Purpose of the Study:

• To investigate the cardiovascular complications of newly approved anti-MS therapies.
• To analyze adverse event data for FDA-approved MS medications since 2015.

Main Methods:

• Utilized the U.S. Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) database.
• Conducted disproportionality signal analysis using reporting odds ratio (ROR) with 95% confidence intervals.
• Evaluated cardiovascular adverse events for MS therapies approved between 2015 and 2021.

Main Results:

• CD20 inhibitors (ocrelizumab, ofatumumab) and CD25 inhibitors (daclizumab) were linked to significant cardiovascular adverse events.
• Coronary artery disease, cardiac failure, and atrial fibrillation were predominant among CD20/CD25 inhibitor users.
• Sphingosine-1-phosphate receptor (S1PR) agonists (fingolimod, siponimod) showed fewer cardiac events but were associated with AV block and bradycardia.

Conclusions:

• Newly approved MS agents are associated with various cardiovascular complications.
• Findings suggest a need for personalized prescribing of MS therapies based on patient cardiovascular profiles.
• Further research is warranted to understand and mitigate cardiovascular risks of novel MS treatments.