NEW ORLEANS—Tolerance of risk related to cur- rent 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 coordina-
tor 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 leuko-
encephalopathy [PML], which can be fatal. We do not
know what kind of risks people tolerate.”
To address these questions, Dr. Natarajan and col-
leagues conducted a survey of participants in the North
American Research Committee on MS Registry and visi-
tors 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% reduc-
tion 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 ex-
pressed increased risk tolerance for all outcomes, com-
pared with those not using any DMT. Respondents who
were older, those who were more disabled, and those tak-
ing infusion therapies also reported higher risk tolerance.
The National MS Society funded this study. Dr.
Natarajan reported having no financial disclosures. NR
What Therapy-Related Risks
Can Patients With MS Tolerate?
Older and more disabled patients may have a higher tolerance of DMT-related risk.
Current DMT users expressed
increased risk tolerance for all
outcomes, compared with those
not using any DMT.