New data on ocrelizumab (OCREVUS; Genentech, South San Francisco, CA) were presented at the American Academy of Neurology this week, including results from 4 years of continuous treatment of patients with relapsing multiple sclerosis (RMS), who sustained reduced underlying disease activity. The efficacy and safety data presented at the meeting are consistent with the risk-benefit profile of pivotal trials for both relapsing-remitting MS (RRMS) and primary progressive MS (PPMS). More than 40,000 people with MS have been treated with ocrelizumab worldwide.
Clinically, ocrelizumab treatment of patients with MS who stayed on treatment for a second year of the open-label extension sustained low annualized relapse rates and 24-week confirmed disability progression. Patients who were switched from treatment with interferon beta-1a to treatment with ocrelizumab had a significant decline in annualized relapse rates by year 1 of treatment that was maintained through year 2 of treatment.
New data on cognitive performance that examined 12-week and 24-week confirmed cognitive decline, defined as a loss of 4 our more points on the symbol digital modalities test (SMDT), was presented. Patients treated with ocrelizumab had a 38% and 39% (P < .001, P = .002) respective reduction in risk of cognitive decline compared to patients treated with interferon beta-1a during a 96-week treatment period. Pooled data from the OPERA I and OPERA II trials showed that people at increased risk of progressive disease who were treated with ocrelizumab had improvement in cognitive function compared to those taking interferon beta-1a for 96 weeks.
“Preserving cognitive function is an important treatment goal in MS as it relates to information processing, problem solving, and focusing in day-to-day life, “said Stanley Cohan, MD, PhD, Medical Director of Providence Multiple Sclerosis Center, Portland, OR. “These data, which show that OCREVUS not only delayed onset of documented cognitive decline but may also improve cognitive function in people with MS, support a potential role for this therapy in addressing one of the most important, common, and challenging realities of MS-induced disability.
In an interim report from a phase 3 study, ocrelizumab was shown to reduce nerve damage, MRI biomarkers of MS, and spinal fluid levels of neurofilament light (NFL), which is a biomarker of inflammation and neurodegeneration in the nervous system.
Ocrelizumab targets a specific class of B cells of the immune system, leaving the stem cells and memory cells intact and thereby preserving immune function while stopping the autoimmune response of MS, giving it a unique mechanism of action among disease-modifying treatments for MS.
“We’ve seen real evidence of success in the way physicians and patients have adopted this new therapy. It is a unique medicine in many ways. We’ve really seen how much of a difference it can make in patients’ lives,” said Paulo Fontoura, MD, PhD, Global Head Clinical Development, Neuroscience.Next Story