Improved treatment options for patients with relapsing-remitting multiple sclerosis and primary progressive multiple sclerosis.
In 3 separate studies, ocrelizumab (Ocrevus) significantly reduced new attacks in patients with relapsing-remitting multiple sclerosis (MS); and slowed new symptom progression in primary progressive MS (PPMS).
One study included 732 patients with PPMS who were randomized on a 2:1 ratio to receive either ocrelizumab or a placebo. Ocrelizumab is a humanized monoclonal antibody that depletes CD20+ B cells.
The results of the study showed that patients with 12-week confirmed disability progression was 39.3% with the placebo compared with 32.9% with ocrelizumab. After 24 weeks, patients with confirmed disability progression who were given the placebo was 35.7% compared with 29.6% with ocrelizumab.
At week 120, timed 25-foot walk worsened by 55.1% with placebo compared with 38.9% for ocrelizumab. The authors noted that patients given ocrelizumab had fewer new brain lesions and less brain volume loss than those given the placebo.
Ocrelizumab was also tested in 2 separate studies of patients with relapsing-remitting MS. One study included 821 patients and the other included 835 patients. The findings from all 3 studies were published in the New England Journal of Medicine.
In both studies, patients were randomized on a 1:1 ratio to receive either ocrelizumab or subcutaneous interferon-beta injected 3 times per week. The results of 1 study showed patients administered ocrelizumab had 46% lower relapse rates compared with placebo, while patients in the second study had 47% lower relapse rates.
Additionally, ocrelizumab was found to reduce the risk of disability progression after 12 and 24 weeks, and also reduced the number of new brain lesions, according to the studies.
Infusion-related reactions occurred in 34.3% of patients administered ocrelizumab. Serious adverse events were no more frequent with ocrelizumab compared with interferon (1.3% versus 2.9%, respectively). Malignancies occurred in 4 ocrelizumab-treated patients and in 2 interferon-treated patients, according to the study.
The authors noted that more research needs to be done to determine the long-term safety of ocrelizumab.
“The results in patients with relapsing-remitting MS not only demonstrate very high efficacy against relapses, but also underscore the important emerging role of B cells of the immune system in the development of relapses,” said investigator Amit Bar-Or. “While the results in patients with primary progressive MS are more modest, they nonetheless represent the very first successful trial in such patients, a break-through as primary progressive MS now transitions from a previously untreated condition to one that can be impacted by therapy. It is an important step forward in the field.”