Patients treated with ocrelizumab had a 6.2% risk of progressing to wheelchair use compared to people taking placebo who had a 9.8% risk.
Genentech, a member of the Roche Group, shared new analyses of phase 3 data for ocrelizumab (Ocrevus) that show that the drug may delay the progression of disability, such as the need for a wheelchair, in patients with primary progressive multiple sclerosis (PPMS).
The company announced that new ocrelizumab data will be presented this weekend at the 4th Congress of the European Academy of Neurology (EAN) in Lisbon, Portugal.
“To a person living with primary progressive MS, for whom disability accumulates twice as fast as in relapsing MS, seven more years without the need for a wheelchair could extend the time they can live independently in their home, continue working or looking after their families,” said Helmut Butzkueven, Professor and Chair of MS and Neuroimmunology Research at Central Clinical School, Monash University, Head of MS and Neuroimmunology Service at Alfred Health and Director of MS Service at Eastern Health.
The additional analysis came from the extended control period of the phase 3 ORATORIO study in PPMS. Researchers measured the length of time it took for participants to reach Expanded Disability Status Scale 7 or greater (EDSS≥7) using 24-week confirmed disability progression (CDP).
Patients treated with ocrelizumab experienced a 46% reduction in the risk of progressing to wheelchair use compared to placebo (6.2% vs. 9.8% risk, respectively, p = 0.022). When extrapolated, these results showed that patients taking ocrelizumab would need a wheelchair at 19.2 years compared to patients in the placebo group at 12.1 years, creating a 7-year gap.
“The data at EAN show the significant impact that OCREVUS, the first disease-modifying medicine for PPMS approved in more than 60 countries around the world, can have on people with MS with the greatest unmet need,” said Butzkueven.
Ocrelizumab made headlines when it became the first treatment approved for by the US Food and Drug Administration (FDA) for primary progressive multiple sclerosis in 2017. This followed years of clinical studies and successful results from the ORATORIO trial that showed efficacy for PPMS patients.
The company additionally announced 2 new worldwide phase 3b studies to evaluate the efficacy of ocrelizumab in a broad range of patients with progressive multiple sclerosis.