Roche Holding AG said Ocrevus, when given early to patients with multiple sclerosis, delivered greater clinical benefit in late-stage studies.
Data from extension trials of previously conducted phase 3 studies Opera I, Opera II and Oratorio compared outcomes in multiple sclerosis, or MS, patients who received Ocrevus continuously for five years, to MS patients who switched over after two years of alternative therapy or placebo.
In the Opera I and Opera II trials, patients with relapsing MS received Ocrevus early or switched over from interferon beta-1a treatments such as Biogen Inc.'s Avonex and EMD Serono Inc.'s Rebif.
After five years, early Ocrevus-treated patients had lower brain atrophy, annualized relapse rates and central nervous system lesions. Confirmed disability progression, or CDP, after 24 weeks was also significantly lower in this patient group at 16.1%, compared to 21.3% in patients who initially received interferon beta-1a.
In the Oratorio trial, patients with primary progressive MS received Ocrevus early or switched over from placebo.
After five years, CDP was significantly reduced by 9.6% in early Ocrevus-treated patients, compared to patients who initially received placebo. Early Ocrevus-treated patients also saw a significant 13.4% reduction in upper limb disability progression.
Additionally, Roche said the safety data for Ocrevus was consistent with previous findings, and the drug maintains its favorable benefit-risk profile.
The Swiss pharmaceutical giant said the five-year results will be presented at the 34th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis in Berlin.
Roche said data from a phase 3b trial, called Chords, will also be presented. The trial enrolled patients with relapsing-remitting MS who had a suboptimal response to at least six months of alternative therapy. Interim analysis showed that 59% of patients who switched over to Ocrevus had no relapse, central nervous system lesions and CDP after 48 weeks of treatment.
Ocrevus, also known as ocrelizumab, is approved to treat MS in 68 countries. The drug, which is administered intravenously every six months, targets the CD20-positive B immune cells linked to MS.
Multiple sclerosis is a chronic disease where immune cells attack myelin, which covers nerve fibers. Myelin damage hinders communication between the brain and the body, leading to mental and physical disability.