#ACTRIMS2021 – COVID-19 Vaccines Safe for MS Patients, Minimally Affected by DMTs
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Amit Bar-Or, MD, presented the analysis in a talk, titled “Vaccination Responses in Setting of Different Types of MS DMTs,” at the virtual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2021, held online Feb. 25-27. Bar-Or is a professor of neurology at the Perelman School of Medicine at the University of Pennsylvania, and chief of the multiple sclerosis division.
The COVID-19 vaccines are designed to limit the spread of the SARS-CoV-2 virus by making individuals more resistant to infection, particularly to severe infection.
These vaccines have raised no serious safety concerns among the general public, and were recently reported to pose little risk to the rare disease community broadly. Nonetheless, there was concern that they may trigger relapses or alter DMT effectiveness, or conversely, that DMT use might affect the vaccines’ efficacy.
Other questions revolve around how the timing of getting vaccinated affects a given DMT and whether official guidance exists to help clinicians and patients navigate that situation.
In his presentation, Bar-Or explained first that COVID-19 vaccines, in general, are considered safe in MS, with minimal risks, if any.
“The merits of being protected by the COVID vaccines are far outweighing any risk that one would consider associated with vaccines in individuals with MS,” Bar-Or said, adding that “there’s reason to think that the RNA vaccines may even be safer than prior more traditional vaccines.”
Regarding possible interactions with DMTs, Bar-Or stated that the COVID RNA vaccines are safe for use in patients with MS on DMTs. DMTs are treatments that can reduce the activity and progression of MS.
“They are non-live, non-inactivated vaccines, and there is no risk in terms of interacting with MS DMTs,” he said.
On the flip side, DMTs might lower a person’s vaccine response, although this effect appears unlikely to overcome the vaccine’s viral protection.
According to Bar-Or, a DMT’s impact on vaccine response would depend on which specific immune system elements a given DMT interacts with, and at which point during a patient’s immune response to the vaccine the DMT takes effect.
Aubagio (teriflunomide), an approved MS DMT “that has a relatively mild effect on the immune system and is not thought to particularly immunosuppress or delete immune cells,” and Ocrevus (ocrelizumab), “an immune cell-depleting DMT” (it depletes B-cells), provide two examples of how DMTs might interact with the COVID vaccines, Bar-Or noted.
In one study, some patients taking Aubagio and others receiving a placebo were given a rabies vaccine and their immune responses compared. While individuals taking Aubagio did show slightly delayed and somewhat reduced immune responses compared with those on the placebo, these responses remained above the threshold needed to develop immunity.
A similar result was seen in top-line data from the Phase 3 VELOCE study (NCT02545868), which tested the immune responses of patients taking Ocrevus to several vaccines. Once again, DMT treatment slightly attenuated or reduced patients’ immune responses to the vaccine but not below the threshold needed for protection.
Finally, Bar-Or addressed scheduling the administration of COVID-19 vaccines while taking DMTs.
According to the neurologist, there are no recommended adjustments for those beginning treatment with, or already taking, specific DMTs, such as Aubagio, Tysabri (natalizumab), Tecfidera (dimethyl fumarate) or other fumarates, interferon beta-1a therapies, and others.
For S1P receptor modulators, such as Gilenya (fingolimod), Mayzent (siponimod), and Zeposia (ozanimod), Bar-Or said that, “when possible, complete the vaccine injections four weeks or more prior to starting the DMT,” as these may limit the secondary vaccine response.
If one is already taking an S1P receptor modulator, no adjustments to the schedule are recommended, he said.
In the case of B cell-depleting therapies, such as Ocrevus, rituximab, and Kesimpta (ofatumumab), Bar-Or recommended completing the vaccine injections four weeks (one month) or more prior to starting the DMT, when possible, or starting the injections 12 weeks (about three months) or more after the last DMT dose, if already taking Ocrevus or Rituxan. For patients already on Kesimpta, they should consider waiting until prior to the next injection.
For Lemtrada (alemtuzumab) and Mavenclad (cladribine), which are more broadly cell-deleting therapies, “when possible, complete vaccine injections four weeks or more prior to starting the DMT; and if already taking DMT, consider starting the vaccine injections at least 12 weeks, or ideally even closer to 24 weeks (about six months),” Bar-Or said.
When possible, avoid resuming these cell-depleting therapies “until four weeks following the second vaccine injection,” he added.
Ultimately, however, Bar-Or suggested that the need for protection from COVID-19 might trump concerns over timing. “Patients in general are recommended to take [the vaccine] when it becomes available as it may be more important for them to get the vaccine than to try to time the vaccine relative to the DMT.”
“And of course,” he concluded, “patients are advised to work with their healthcare providers to determine the best timing.”
Of note, these guidelines were developed through a task force with the National MS Society working group. More information about them can be found here.