#AAN2022 – CONSONANCE Update Shows Ocrevus’ Effectiveness After 1 Year
Nearly three of every four participants in the CONSONANCE clinical trial, which is evaluating Ocrevus (ocrelizumab) in people with primary or secondary progressive multiple sclerosis (MS), showed no evidence of disease progression after a year of treatment.
That’s according to new data presented at the American Academy of Neurology (AAN) 2022 Annual Meeting, which is running in person April 2–7 in Seattle, Washington, and virtually April 24–26. The presentation was titled “A multicentre, open label, single-arm, phase 3b study (CONSONANCE) to assess the effectiveness and safety of ocrelizumab in patients with primary and secondary progressive multiple sclerosis: year-1 interim analysis.”
Ocrevus is a B-cell-depleting medication developed by Genentech, a member of the Roche Group. It is approved in the U.S. to treat relapsing forms of MS — including clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS) — and also for primary progressive multiple sclerosis (PPMS).
Roche is sponsoring an open-label Phase 3 clinical trial called CONSONANCE (NCT03523858) that is evaluating the safety and effectiveness of Ocrevus in an estimated 900 people with progressive forms of MS (PPMS or SPMS). The trial is actively recruiting participants at more than 130 locations around the world.
The presentation covered data for 629 participants — 325 with SPMS and 304 with PPMS — who were treated with a standard regimen of Ocrevus for one year. Researchers assessed the segment of participants with no evidence of disease progression (NEP), defined as no substantial worsening in disability lasting at least six months, and less than 20% worsening in walking abilities and manual dexterity.
“NEP is a novel composite endpoint and reflects no evidence of worsening of a person’s physical disability,” according to a press release from Roche.
Results showed that 74.9% of the patients achieved NEP after one year on Ocrevus — 78.2% of those with SPMS, and 71.3% of the PPMS patients.
The team also assessed the proportion of patients with no evidence of progression or disease activity (NEPAD), defined as NEP plus no disease relapses and no new or worsening brain lesions. A total of 58.7% achieved NEPAD after one year of treatment, including 58.9% of patients with SPMS and 58.4% of those with PPMS.
“Effectiveness and safety were similar for patients with SPMS and PPMS … suggesting treatment with ocrelizumab over one year is associated with low levels of disease progression and activity in both forms of progressive MS,” the researchers concluded.
Among patients who did experience disease progression, the main drivers of progression were worsening by 20% or more in walking ability (16% of participants) and/or new or enlarging brain lesions (19% of participants).
A separate presentation at AAN assessed cognitive outcomes in the CONSONANCE trial, specifically the Symbol Digit Modalities Test (SDMT), a general measure of cognitive ability, and the Brief Visuospatial Memory Test-Revised (BVMT-R), which assesses problems with memory and visual/spatial reasoning.
The presentation was titled “A multicenter, open label, single-arm, phase 3b study (CONSONANCE) to assess efficacy of ocrelizumab in patients with primary and secondary progressive multiple sclerosis: year 1 interim analysis of cognition outcomes.”
Results showed that after a year on Ocrevus, the average score on the SDMT increased by 10.7%, while the average score on the BVMT-R increased by 14.9%.
Based on SDMT scores, 34.4% of participants experienced a clinically meaningful improvement in cognition after a year on Ocrevus, while 30% experienced a clinically meaningful worsening in cognition. Cognitive outcomes were generally similar among patients with SPMS or PPMS.
“At year 1, treatment with ocrelizumab was associated with stable or improved cognitive function in most patients, and observations were similar in patients with SPMS and PPMS,” the researchers concluded.
“We are encouraged by the low levels of disability progression and cognitive decline in OCREVUS-treated patients seen across the complete spectrum of progressive MS for the first time, since SPMS and PPMS often bring a substantial quality of life burden,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche.
Note: The Multiple Sclerosis News Today team is providing coverage of the American Academy of Neurology (AAN) 2022 Annual Meeting. Go here to see the latest stories from the conference.