In 2017, the FDA approved Genentech’s Ocrevus (ocrelizumab) for the treatment of relapsing forms of multiple sclerosis (MS) and primary progressive MS (PPMS) in adults. It was the first and remains the only disease-modifying treatment (DMT) FDA-approved for treating PPMS. The antibody is now approved in more than 100 countries, and over 300,000 people with MS worldwide have been treated with Ocrevus.
Genentech recently announced in a press release new data supporting Ocrevus’ long-term efficacy and safety in people with PPMS and relapsing forms of MS (RMS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. The results were presented last week at the 9th joint ECTRIMS-ACTRIMS (European and Americas Committee for Treatment and Research in Multiple Sclerosis) meeting in Milan, Italy.
Analysis of follow-up data from three phase 3 open-label extension trials demonstrated that 77% of patients with RMS had no disability progression, and 92% still walked unassisted after 10 years of continuous Ocrevus treatment. In the group of patients with PPMS, 36% had no progression of disability, and 80% still walked without assistance after 10 years of treatment.
According to the press release, participants with RMS and PPMS who started Ocrevus treatment earlier in the study (at the beginning of the double-blind trials) were less likely to have disability progression compared with those who began treatment later in the study (during the open-label extension trials). This underscores the significant role early treatment plays in preserving function in people with MS.
Pooled data from 6,155 patients across 12 clinical trials found that long-term exposure to Ocrevus did not increase the risk of serious infection or malignancies, such as breast cancer, compared with the rates seen in the controlled studies.
Additionally, analysis of real-world pregnancy and postpartum data from 3,253 people with MS showed that Ocrevus treatment did not increase the risk of congenital abnormalities or negative pregnancy outcomes compared with the general population.
Lastly, data from the MSBase registry, an international online registry for collaborative research in MS and other neuroimmunological disorders, showed that people who became pregnant during Ocrevus treatment or shortly after their last dose had lower relapse rates during pregnancy and postpartum relative to the rates of those treated with other DMTs during pregnancy. Specifically, the annualized relapse rate (ARR) during pregnancy in individuals treated with Ocrevus was 0.00 versus 0.05 to 0.32 for people treated with other DMTs. The postpartum ARR for people treated with Ocrevus was 0.09 versus 0.10 to 0.74 for those treated with other DMTs.
Two ongoing postmarketing trials are evaluating infant outcomes due to placental transfer of Ocrevus (SOPRANINO trial) and breast milk transfer of Ocrevus (MINORE trial).