What Therapy-Related Risks Can Patients With MS Tolerate?

NEW ORLEANS—Tolerance of risk related to current disease-modifying therapies (DMTs) on the part of patients with multiple sclerosis (MS) varies widely, according to results from a large national survey presented at the 31st Annual Meeting of the Consortium of MS Centers.

“We have therapies available with a wide range of risks,” said Sneha Natarajan, PhD, a research coordinator at the Mellen Center for MS Treatment and Research at the Cleveland Clinic. “Some of the risks are relatively minor, like injection-site reactions or flu-like symptoms, and some are as bad as progressive multifocal leukoencephalopathy [PML], which can be fatal. We do not know what kind of risks people tolerate.”

To address these questions, Dr. Natarajan and colleagues conducted a survey of participants in the North American Research Committee on MS Registry and visitors to the National MS Society website who reported having MS. The benefit of a hypothetical oral DMT was set at 50% reduction in clinical relapses and 30% reduction in disability progression. The researchers chose six risk scenarios to evaluate tolerance to the following six risks: infection, skin rash, kidney injury, thyroid injury, liver injury, and 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 and colleagues reported results from 3,371 survey respondents. The mean age was 55, 93% of participants were white, 61% of participants had relapsing-remitting MS, and 53% of participants 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 (1:1,000,000 for both). Males reported a higher risk tolerance to all six risks. Females reported a risk tolerance to skin rash that was similar to that of kidney injury and PML.

“There is a pattern to the risks that our patients accept,” Dr. Natarajan said. “I do not 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 up front and have a talk with the patient.”

Researchers also found that current DMT users expressed increased risk tolerance for all outcomes, compared with those not using any DMT. Respondents who were older, those who were more disabled, and those taking infusion therapies also reported higher risk tolerance.

The National MS Society funded this study. Dr. Natarajan reported having no financial disclosures.

—Doug Brunk

NEW ORLEANS—Tolerance of risk related to current disease-modifying therapies (DMTs) on the part of patients with multiple sclerosis (MS) varies widely, according to results from a large national survey presented at the 31st Annual Meeting of the Consortium of MS Centers.

“We have therapies available with a wide range of risks,” said Sneha Natarajan, PhD, a research coordinator at the Mellen Center for MS Treatment and Research at the Cleveland Clinic. “Some of the risks are relatively minor, like injection-site reactions or flu-like symptoms, and some are as bad as progressive multifocal leukoencephalopathy [PML], which can be fatal. We do not know what kind of risks people tolerate.”

To address these questions, Dr. Natarajan and colleagues conducted a survey of participants in the North American Research Committee on MS Registry and visitors to the National MS Society website who reported having MS. The benefit of a hypothetical oral DMT was set at 50% reduction in clinical relapses and 30% reduction in disability progression. The researchers chose six risk scenarios to evaluate tolerance to the following six risks: infection, skin rash, kidney injury, thyroid injury, liver injury, and 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 and colleagues reported results from 3,371 survey respondents. The mean age was 55, 93% of participants were white, 61% of participants had relapsing-remitting MS, and 53% of participants 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 (1:1,000,000 for both). Males reported a higher risk tolerance to all six risks. Females reported a risk tolerance to skin rash that was similar to that of kidney injury and PML.

“There is a pattern to the risks that our patients accept,” Dr. Natarajan said. “I do not 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 up front and have a talk with the patient.”

Researchers also found that current DMT users expressed increased risk tolerance for all outcomes, compared with those not using any DMT. Respondents who were older, those who were more disabled, and those taking infusion therapies also reported higher risk tolerance.

The National MS Society funded this study. Dr. Natarajan reported having no financial disclosures.

—Doug Brunk

NEW ORLEANS—Tolerance of risk related to current disease-modifying therapies (DMTs) on the part of patients with multiple sclerosis (MS) varies widely, according to results from a large national survey presented at the 31st Annual Meeting of the Consortium of MS Centers.

“We have therapies available with a wide range of risks,” said Sneha Natarajan, PhD, a research coordinator at the Mellen Center for MS Treatment and Research at the Cleveland Clinic. “Some of the risks are relatively minor, like injection-site reactions or flu-like symptoms, and some are as bad as progressive multifocal leukoencephalopathy [PML], which can be fatal. We do not know what kind of risks people tolerate.”

To address these questions, Dr. Natarajan and colleagues conducted a survey of participants in the North American Research Committee on MS Registry and visitors to the National MS Society website who reported having MS. The benefit of a hypothetical oral DMT was set at 50% reduction in clinical relapses and 30% reduction in disability progression. The researchers chose six risk scenarios to evaluate tolerance to the following six risks: infection, skin rash, kidney injury, thyroid injury, liver injury, and 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 and colleagues reported results from 3,371 survey respondents. The mean age was 55, 93% of participants were white, 61% of participants had relapsing-remitting MS, and 53% of participants 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 (1:1,000,000 for both). Males reported a higher risk tolerance to all six risks. Females reported a risk tolerance to skin rash that was similar to that of kidney injury and PML.

“There is a pattern to the risks that our patients accept,” Dr. Natarajan said. “I do not 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 up front and have a talk with the patient.”

Researchers also found that current DMT users expressed increased risk tolerance for all outcomes, compared with those not using any DMT. Respondents who were older, those who were more disabled, and those taking infusion therapies also reported higher risk tolerance.

The National MS Society funded this study. Dr. Natarajan reported having no financial disclosures.

—Doug Brunk