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03.15.19

Patient's Risk Tolerance for Disease Modifying Treatments for Multiple Sclerosis


In a study published in Neurology, researchers at the Cleveland Clinic evaluated patients’ tolerance for potential risks of multiple sclerosis (MS) medications. Studies show that 40% or more of patients diagnosed with MS do not receive disease-modifying treatment (DMT) in the first 2 years after diagnosis. This is concerning because evidence-based practice guidelines recommend treating MS with DMTs as early as possible. Understanding what barriers to treatment exist, and why, are important steps to improving care and quality-of-life for patients with MS. Patients willingness to risk the side effects of any medication are among such barriers. 

Researchers used an online survey to ask 3,176 people with MS if they would take a new medicine (50% effective at preventing relapse) with a risk that occurs at a rate of 1 in 1,000 people. If they answered yes, they were then asked if they would take it with a higher risk (eg, 1 in 100); if not, they were asked if they would at a lower risk (eg, 1 in 500). In this way individuals’ maximum tolerance for each of 6 side effects, known to occur with existing DMTs, were measured. The risks evaluated were:

  • bladder or respiratory infections that occasionally require hospitalization, 
  • thyroid injury that may require life-long daily medication, 
  • rash serious enough to require hospitalization,
  • liver problems that would require frequent blood testing, 
  • kidney disease that could result in need for life-long dialysis, and 
  • progressive multifocal leukoencephalopathy (PML) that could cause death. 

Overall, survey respondents were more willing to risk infection or thyroid complications and least willing to risk kidney disease or PML. Overall risk tolerance increased with disability progression and prior use of DMTs (infusion > injection) but decreased with age. Male patients had high tolerance risk for infection, thyroid injury, rash, and liver problems (1 in 1,000) but not for kidney injury (1 in 50,000) or PML (1 in 100,000). Women were less likely to tolerate risk for all complications (1 in 2,000 for infection or thyroid injury; 1 in 1 million for kidney in or PML).

 First author of the study, Robert J. Fox, MD of the Mellen Center for Multiple Sclerosis at the Cleveland Clinic said, “we hope the study will help clinicians better understand where to initiate a conversation with a given patient—not that they should stereotype patients with this—rather that they begin at a place more likely to resonate with a particular patient and refine the conversation from there.” 

Fox also noted that this information could help inform the assessments of risk-benefit analysis at a regulatory level because it “gives us quantified measurements of risk tolerance that can be used along with individual patient testimonies, which is all we’ve had available until now.” 

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