Early Treatment with Ocrelizumab Reduces Disability Risk by Nearly Half in Relapsing MS

April 28, 2020

Six-year data from the new analyses add evidence to the benefit-risk profile of ocrelizumab (Ocrevus, Genentech) for patients with multiple sclerosis. 

Early treatment initiation with ocrelizumab (Ocrevus, Genentech) reduces the risk of disease and disability progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS) by nearly half, according to new 6-year data from a clinical trial.

Ocrelizumab, the first and only therapy approved for both RMS and PPMS, is a humanized monoclonal antibody designed to target CD20-positive B cells.

According to Genentech, data from the new analyses, which was selected for the 72nd American Academy of Neurology Annual Meeting, add additional evidence to the benefit-risk profile of ocrelizumab.

Related: FDA Accepts sBLA for Shorter Infusion Time with Ocrelizumab

In the open-label extension of the phase 3 OPERA studies in RMS, earlier treatment initiation with ocrelizumab demonstrated reduced risk of needing a walking aid compared with those who switched from interferon beta-1a 2 years later, according to the post-hoc analysis. Patients who were treated with ocrelizumab had a 49% reduction in the risk of needing a walking aid compared with those who received interferon beta-1a over 6 years of study (4.3% versus 7.2%*; p=0.0042). Overall, safety profiles in the double-blind period and open-label extension were generally consistent.

Additionally, ocrelizumab progressively slowed thalamic atrophy in patients with RMS or PPS, according to results from the double-blind periods of the phase 3 OPERA I, OPERA II, and ORATORIO studies. Based on the findings, ocrelizumab treatment resulted in significantly less thalamic atrophy compared with interferon beta-1a and placebo, respectively (both p<0.001).

“For people with MS, maintaining mobility for as long as possible is very important,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, said in a press release. “We are encouraged by these new longer-term analyses showing that earlier initiation of Ocrevus treatment may reduce the risk of needing a walking aid by nearly 50% over 6 years. Slowing MS progression earlier in the disease course–not just treating relapses–may bring additional clinically meaningful outcomes to people living with this disease.”

Ocrelizumab is administered by intravenous infusion every 6 months. The initial dose is given as two 300 mg infusions given 2 weeks apart, and subsequent doses are given as single 600 mg infusions.

References:

1. New 6-Year Data for Genentech’s Ocrevus (ocrelizumab) Show Earlier Treatment Initiation Nearly Halves Risk of Needing Walking Aid in Relapsing Multiple Sclerosis. News Release. Genentech; April 27, 2020. Accessed April 28, 2020. https://www.gene.com/media/press-releases/14848/2020-04-27/new-6-year-data-for-genentechs-ocrevus-o.