NEW ORLEANS (FRONTLINE MEDICAL NEWS) – Risk tolerance to current disease modifying therapies by patients with multiple sclerosis varies widely, results from a large national survey demonstrated.

“We have therapies available with a wide range of risks,” study author Sneha Natarajan, PhD, said in an interview at the annual meeting of the Consortium of Multiple Sclerosis Centers. “Some of the risks are relatively minor like injection site reactions or flu-like symptoms and some are as bad as PML [progressive multifocal leukoencephalopathy], which can be fatal. We don’t know what kind of risks people tolerate.”

To find out, she and her associates conducted a survey of participants of North American Research Committee on Multiple Sclerosis and visitors to the National Multiple Sclerosis Society website who reported having MS. The benefit of a hypothetical oral disease modifying therapy (DMT) was set at 50% reduction in clinical relapses and 30% reduction in disability progression. The researchers chose six different risk scenarios to evaluate tolerance to six risks: risk of infection, skin rash, kidney injury, thyroid injury, liver injury, and risk of PML. Starting from a risk tolerance of 1:1,000, the risk was adjusted to identify the highest risk tolerated, ranging from “would take regardless of the risk of death” to “no acceptable risk.”

Dr. Natarajan, research coordinator at the Mellen Center for Multiple Sclerosis at the Cleveland Clinic, reported results from 3,371 survey respondents. Their mean age was 55 years, 93% were white, 61% had the relapsing-remitting form of MS, and 53% were currently taking a DMT. Overall, respondents reported the highest risk tolerance for infection or thyroid risks (1:1,000 for both) and lowest risk tolerance for PML and kidney injury risks (1:1,000,000 for both). Males reported a higher risk tolerance to all six risks (P less than .0001 for all). Females reported a risk tolerance to skin rash that was similar to kidney injury and PML.

“There is a pattern to the risks that our patients accept,” Dr. Natarajan said. “I don’t think a doctor would not recommend a therapy benefit because of a skin rash [risk], but he may need to address the concerns of the patient upfront and have a talk with the patient.”

The researchers also found that current DMT users expressed increased risk tolerance for all outcomes, compared with those not using any DMT (P less than .001). Higher risk tolerance was also expressed by respondents who were older, more disabled, and by those taking infusion therapies.

The National Multiple Sclerosis Society funded the study. Dr. Natarajan reported having no financial disclosures.


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