New data show that ocrelizumab (Ocrevus®) has benefits on disease progression and cognitive outcomes in primary and secondary progressive multiple sclerosis (MS), as published in a press release by Genentech.
The data come from a prospective, multicenter, open-label, single-arm phase 3b clinical trial called CONSONANCE, which is assessing the safety and efficacy of ocrelizumab in an estimated 900 participants, aged 18 to 65 years with progressive MS.
Participants receive ocrelizumab by intravenous infusion at an initial dose of 300 mg followed by a second infusion of the same dose 14 days later. This is followed by an infusion of 600 mg every 24 weeks for 192 weeks.
The primary outcome measures are the proportion of patients with no evidence of progression and no active disease. Secondary outcome measures include changes from baseline in cognitive function, Expanded Disability Status Scale score, patient-reported outcomes, the number of falls and near-falls, and brain magnetic resonance imaging findings. Other secondary outcome measures include the percentage of participants with adverse events and rates of study discontinuation because of these.
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A 1-year analysis showed that ocrelizumab led to the majority of patients experiencing no disease progression. Moreover, 75% of patients achieved no evidence of progression and 70% of them demonstrated stable or improved cognition. Clinically meaningful improvements occurred in 34% of ocrelizumab-treated patients. However, the majority of patients (75%) had 1 or more adverse events and 7% had at least 1 serious adverse event.
“We continue to work on closing treatment gaps for all people impacted by MS, as everyone living with this neurodegenerative condition experiences disease progression from the start,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development of Genentech, in a press release.
The trial is still recruiting participants at 135 study locations across the world and is expected to be completed on December 4, 2026. Ocrelizumab is a disease-modifying treatment for MS approved by the US Food and Drug Administration.
New data for Genentech’s Ocrevus (ocrelizumab) show benefit in disability progression and cognitive decline in both secondary progressive and primary progressive multiple sclerosis. News release. Genentech; April 3, 2022.
A study to evaluate ocrelizumab treatment in participants with progressive multiple sclerosis (CONSONANCE). US National Library of Medicine. Updated March 16, 2022. Accessed April 8, 2022.