Stopping Ocrevus in stable MS doesn’t seem to raise 2-year risk, study finds
But patients should restart treatment after 2.5 years or disease activity
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- For people whose MS is stable, stopping Ocrevus for as long as two years may not increase disease activity, a study found.
- Beyond 2.5 years, pausing treatment might increase multiple sclerosis progression.
- Patients should restart Ocrevus if disease activity occurs or after 25-34 months of discontinuation, according to the researchers.
For people with multiple sclerosis (MS) on Ocrevus (ocrelizumab) whose disease is well controlled after at least a year of treatment, discontinuing the infusion therapy does not appear to increase the risk of new disease activity or disability progression for about two years.
That’s according to a new retrospective study from Germany, in which researchers investigated the likelihood of such outcomes among individuals with MS with stable disease who stopped taking Ocrevus.
However, beyond about two to 2.5 years after discontinuation, patients may be at increased risk of MS activity if they don’t restart treatment, the team found.
The findings were detailed in “Discontinuation of ocrelizumab in multiple sclerosis: reoccurrence of disease activity,” a study published in the Journal of Neurology, Neurosurgery & Psychiatry.
Ocrevus is an approved disease-modifying therapy for relapsing forms of MS and primary progressive MS. Administered by infusion into the bloodstream every six months, the treatment works by depleting B-cells, immune cells that play a central role in MS-related inflammation.
Among people with MS both in clinical trials and the real world, treatment with Ocrevus has been shown to reduce the risk of disease relapses and slow disability progression.
That often sparks a question, however, for patients whose disease is well controlled on Ocrevus: Is it necessary to continue receiving lifelong infusions, or can treatment be stopped, or at least paused, without increasing the risk of MS getting worse?
Not enough information is available to answer this question.
Interest in an answer increased during the COVID-19 pandemic. In addition to challenges in assessing treatment during this period, there were worries that patients on B-cell-depleting therapies like Ocrevus could be especially susceptible to the virus. This led some patients whose MS was well controlled to receive Ocrevus less frequently or to stop treatment altogether.
Researchers investigate what happens when patients stop treatment
To examine what happens after treatment is discontinued, a research team analyzed data from 58 patients treated at two German MS centers who stopped Ocrevus, mainly due to COVID-related concerns, after receiving it for at least one year. For comparison, the team evaluated outcomes from 232 so-called continuers — people with MS who stayed on Ocrevus.
The researchers carefully selected both groups to ensure that patients were matched based on factors like demographics. All patients had well-controlled MS, without new disease lesions or relapses and no disability progression, for at least one year while on treatment with Ocrevus.
“A key factor of this analysis is the inclusion of [people with MS] with at least 12 months of [Ocrevus] treatment and disease stability, thus effectively applying a landmark approach, ensuring that both continuers and discontinuers entered the analysis from a comparable, clinically stable phase,” the researchers wrote.
Over a median follow-up time of 28.5 months, or slightly more than two years, 10% of those who discontinued Ocrevus experienced a relapse. A similar proportion of patients who continued on Ocrevus experienced a relapse (11%), with no significant difference between the groups.
Rates of disability progression in the absence of relapses, known as progression independent of relapse activity (PIRA), also were comparable, at 19% among discontinuers and 14% among continuers.
In more granular analyses, the researchers found that relapse and PIRA rates were essentially similar between the groups over the first two years of follow-up. However, after about 2.5 years or longer, there was a tendency toward increased disease activity among discontinuers, the data showed.
This difference wasn’t statistically significant, and the researchers noted that the long-term analyses included only a few patients, so caution is needed when interpreting the results.
Importantly, the researchers also reported that in patients whose MS had remained stable for at least one year, continuing Ocrevus beyond four to five treatment cycles — about 29 to 30 months, or about 2.5 years — appeared to provide little additional reduction in inflammatory disease activity and PIRA.
Stopping Ocrevus for a time may help limit side effects
Overall, the data indicate that, in patients whose disease is well controlled, pausing Ocrevus for about two years might help limit side effects without increasing the risk of worsening MS activity. Still, after that, it is likely necessary to restart the therapy, according to the team.
Reinitiation of [Ocrevus] should be considered if disease activity occurs or after 25-34 months of discontinuation (corresponding to four to six paused cycles).
“In conclusion, in [people with MS] with a stable disease course and no inflammatory disease activity in the preceding 12 months, treatment with [Ocrevus] beyond four to five cycles (29 to 30 months) added little further reduction in [disease activity],” the researchers concluded. The team, however, noted as a limitation of the study its small number of patients.
“Reinitiation of [Ocrevus] should be considered if disease activity occurs or after 25-34 months of discontinuation (corresponding to four to six paused cycles),” the scientists added.
Ocrevus is sold by Genentech, a member of the Roche Group, which was not involved in this study.
