– 10-year efficacy data highlight Ocrevus’ impact on preventing disability progression and maintaining mobility in both relapsing and progressive forms of multiple sclerosis (MS) –
– 10-year safety data from over 6,000 patients continue to reinforce consistent long-term safety profile of Ocrevus –
– More than 3,200 women with MS treated with Ocrevus reported no increased risk in adverse pregnancy and infant outcomes with real-world analyses showing low risk of relapse during and after pregnancy –
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new clinical and real-world data for Ocrevus® (ocrelizumab) demonstrating its role in continuing to transform care for people living with relapsing or primary progressive multiple sclerosis (RMS or PPMS) presented at the 9th Joint ECTRIMS-ACTRIMS Meeting (European and Americas Committees for Treatment and Research in Multiple Sclerosis). Ocrevus is the first and only disease-modifying treatment (DMT) in MS to benefit both people with RMS and PPMS and now has 10 years of follow-up data from its three Phase III trials.
“Ocrevus is the first B-cell therapy approved for RMS and PPMS and it’s remarkable to see that after 10 years of treatment, a great majority of RMS patients remain free from disease progression,” said Stephen Hauser, M.D., chair of the Scientific Steering Committee of the OPERA studies and director of the Weill Institute for Neurosciences at the University of California, San Francisco. “These results signify that people with both RMS and PPMS have more years to spend their days living independently without the need for walking aids or wheelchairs.”
10-year disability outcomes from Phase III Ocrevus open-label extension (OLE) trials
After 10 years of continuous Ocrevus treatment, 77% of patients with RMS were free from disability progression based on 48-week confirmed disability progression (CDP) events and 92% of patients were still walking unassisted. In patients with PPMS, 36% were free from disability progression based on 48-week CDP events and 80% of those patients treated continuously with Ocrevus over 10 years were still able to walk. These long-term data reinforce the critical importance of early treatment in preserving function across the MS spectrum, showing a lower risk of reaching disability events in patients with RMS and PPMS who initiated Ocrevus treatment earlier (initiating at the start of the double-blind studies vs. the start of the OLEs).
10-year safety profile of Ocrevus
New safety data from 6,155 patients with 28,269 patient-years of exposure to Ocrevus across 12 clinical trials further support the medicine’s favorable benefit-risk profile, which has remained consistent over 10 years. The risk characteristics of Ocrevus in the all-exposure population (RMS and PPMS) remained consistent with the characteristics observed during the controlled treatment periods. Serious infections and malignancy rates remain within the range reported for patients with MS in real-world registries. Longer exposure to Ocrevus did not lead to an increased risk of serious infections regardless of the immunoglobulin G (IgG) status of the patients (normal levels or levels below the lower limit of normal). No new or unexpected safety signals were seen in patients treated with Ocrevus in ongoing clinical trials.
Real-world analyses on pregnancy & infant outcomes and postpartum relapses
Family planning is an essential aspect in the care of women living with MS, many of whom are of child-bearing age. Genentech safety data from 3,253 cumulative pregnancies in women with MS do not suggest an increased risk of adverse pregnancy or infant outcomes in women with MS treated with Ocrevus. Outcomes were known for 1,145 prospectively reported pregnancies and 512 of these had in utero exposure to Ocrevus. Respective outcomes from these two groups were: 83.6% and 84.2% live births (1.3% and 1.6% with major congenital anomalies); 1.2% and 0.8% ectopic pregnancy; 5.1% and 7.4% elective terminations; 10.0% and 7.4% spontaneous abortions;