Less frequent Ocrevus infusions in MS may limit risk of side effects
Longer dosing interval didn't affect efficacy, may improve safety: Study
Less frequent Ocrevus (ocrelizumab) infusions are as effective as standard dosing — when treatment is given typically every six months — for controlling multiple sclerosis (MS) disease activity, but may help limit the risk of side effects, a new study reports.
“These findings suggest that [extended-interval dosing] could be a preferable option for long-term disease management, reducing treatment burden and side effects without compromising efficacy,” the researchers wrote.
The idea for the review study resulted from treatment delays that occurred during the global pandemic, when clinicians seeking to reduce the risk of a COVID-19 infection allowed certain patients to receive in-clinic Ocrevus infusions less frequently. Now, a team of researchers in Pakistan sought to assess any differences between standard dosing, dubbed SID, and extended dosing, or EID.
Given the similar efficacy found in their analysis, the researchers suggested that less frequent dosing may improve the safety of Ocrevus over the long term: “EID offers a potential benefit of reducing side effects compared to SID,” the team wrote.
The study, “Comparing the efficacy and safety of extended vs standard dosing of ocrelizumab in MS: A systemic review and meta-analysis,” was published in Multiple Sclerosis and Related Disorders.
In-clinic Ocrevus infusions used to treat relapsing types of MS
Ocrevus is approved in more than 95 countries as a treatment for MS, according to its developer Genentech, which was not involved in this study. In the U.S., it is indicated for relapsing types of MS as well as primary progressive MS. The therapy works by depleting B-cells, a type of immune cell that is involved in the inflammatory attack that drives MS. It has been shown to reduce relapse rates in people with relapsing disease, and to limit disability progression in MS.
Treatment is given via infusion into the bloodstream. Under the approved dosing schedule in the U.S., patients first receive two infusions two weeks apart, then subsequent infusions every six months. Because the therapy is given intravenously, or into the vein, administration is done in a clinic or hospital. The total appointment time for each infusion ranges from four to six hours.
Although Ocrevus has been proven effective in patients, the immune-suppressing therapy carries risks of side effects, most notably infections.
During the pandemic, many clinicians worried that patients on Ocrevus would be more vulnerable to COVID-19, given that fewer than 20% of individuals on this treatment were shown to develop an adequate antibody response to the virus.
This led some patients to postpone their infusions, either due to COVID-19 infection, safety concerns, or the worsening of the situation at the hospital or clinic where they would receive their infusion. As a result, international MS experts recommended that Ocrevus infusions be given less frequently when needed, as long as patients’ clinical status was closely monitored.
This less-frequent dosing schedule is called extended-interval dosing or EID. Although EID might lower infection risk, it’s possible it would make Ocrevus less effective for controlling MS, prompting several studies to be conducted to assess the efficacy of EID.
Now, scientists pooled data from 11 published studies, covering more than 2,500 MS patients, to compare the effects of EID against the standard dosing schedule for Ocrevus. In all the studies, EID infusions were delayed by at least a month compared with the standard schedule.
Patients significantly less likely to experience side effects
The results broadly showed that both EID and standard dosing were similarly effective at controlling disease activity. In fact, statistical tests showed that patients given either regimen were equally likely to have no evidence of disease activity, or NEDA-3 — meaning no relapses, no confirmed disability worsening, and no new activity on MRI scans.
“The pooled result suggests that clinicians could safely consider EID for patients without compromising their likelihood of achieving NEDA-3,” the researchers wrote.
This finding is particularly important for patients with MS, where minimizing adverse effects is critical for improving adherence and maintaining quality of life.
Further, no significant differences were found in each of the outcomes individually, with patients in both groups being equally as likely to experience a relapse, confirmed disability progression or a worsening in Expanded Disability Status Scale scores, or new lesions on MRI scans.
At the same time, patients given EID were significantly less likely to experience side effects or other safety-related issues, the data showed. As such, this study supports the idea that EID can help make Ocrevus safer without reducing its efficacy for controlling MS.
“This finding is particularly important for patients with MS, where minimizing adverse effects is critical for improving adherence and maintaining quality of life,” the researchers wrote.
The team called for further study on the long-term effects of less frequent Ocrevus infusions and research to “establish standardized dosing intervals that optimize both safety and efficacy.” Overall, however, the researchers concluded that less frequent dosing is effective for patients.
“The efficacy in achieving [no evidence of disease activity] coupled with the significantly reduced risk of adverse events, makes EID an attractive option for both patients and healthcare providers,” the team concluded.
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