Roche announced new OCREVUS (ocrelizumab) data that show its benefit on disease progression and cognitive outcomes in primary progressive multiple sclerosis (PPMS) and secondary progressive MS (SPMS). Separate analyses on treatment disparities among newly diagnosed patients with MS by race and ethnicity will be a platform presentation at the 74th American Academy of Neurology (AAN) Annual Meeting 02–07 April 2022 in Seattle. CONSONANCE data will be presented virtually at AAN 24-26 April 2022.
“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. For people with progressive forms of MS and in some Black and Hispanic subpopulations, the disease may progress faster,” said Levi Garraway, M.D., Ph.D. Roche’s Chief Medical Officer and Head of Global Product Development. “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.”
CONSONANCE interim analysis: low levels of disease progression in SPMS and PPMS patients
Treatment with OCREVUS resulted in a majority of patients experiencing no disease progression in a one-year analysis of CONSONANCE, a first-of-its-kind open-label Phase IIIb trial to evaluate the effect of OCREVUS in SPMS and PPMS patients. After one year, 75% of OCREVUS-treated patients with SPMS and PPMS achieved No Evidence of Progression (NEP; no evidence of confirmed disability progression as measured by an increase in Expanded Disability Status Score sustained for at least 24 weeks, and less than 20% worsening of performance on the timed 25-foot walk [T25-FW] and Nine-Hole Peg Test [9-HPT]). NEP is a novel composite endpoint and reflects no evidence of worsening of a person’s physical disability.
Additionally, 59% of OCREVUS-treated patients in the trial achieved No Evidence of Progression or Active Disease (NEPAD; NEP plus no protocol-defined relapses, new and/or enlarging T2 lesions or T1 gadolinium-enhancing lesions) over one year. NEPAD is another novel composite endpoint and reflects no evidence of clinical or MRI disease activity or worsening of a person’s physical disability. Progression was primarily driven by T25-FW (16% of patients) and activity of new and/or enlarging T2 lesions (19% of patients), detected almost exclusively within the first 6 months of the trial.
The analysis also demonstrated the positive effects of OCREVUS on cognition, with 70% of patients having stable or improved cognition over one year, as measured with the Symbol Digit Modalities Test (SDMT). Clinically meaningful improvement (increase of ≥4 points on the SDMT) was observed in 34% of patients treated with OCREVUS and worsening (decrease of ≥4 points) in 30% of patients treated with OCREVUS. At enrolment, patients had moderate-to-severe dysfunction in information processing speed and visuospatial memory, which was stable or improved in a majority of patients after OCREVUS treatment.
After one year of participating in the trial, 75% of patients had one or more adverse events (AEs) and 7% experienced at least one serious AE. The interim analysis included 629 patients, and longer-term evaluation of OCREVUS will continue for four years with a target of 900 patients with PPMS or SPMS (in a 1:1 ratio) across 26 countries.
Continued research on the treatment patterns of minority populations living with MS
Current treatment guidelines recommend the initiation of high-efficacy disease modifying therapies (DMTs) for patients with highly active disease, as frequently seen with Black and Hispanic populations. However, a recent analysis of a U.S. commercial claims database found that only 30% of non-Hispanic Black, and 20% of Hispanic patients initiated any high-efficacy DMTs, in comparison to 39% of non-Hispanic white patients in the first two years after diagnosis.
These insights further support Roche’s Phase IV ‘Characterization of ocrelizumab in Minorities with Multiple Sclerosis’ (CHIMES) trial in Black/African-American and Hispanic/Latino patients with relapsing MS (RMS). The results are expected to improve the current understanding of MS disease biology and treatment response to OCREVUS among these populations with MS, to improve standard of care in traditionally underserved communities and improve inclusivity in clinical research.
With rapidly growing real-world experience and more than 225,000 people treated globally, OCREVUS is the first and only therapy approved for relapsing MS (RMS; including relapsing-remitting MS [RRMS] and active SPMS, in addition to clinically isolated syndrome [CIS] in the U.S.) and PPMS. At Roche, we are constantly striving to optimise the care for people with MS and a shorter two-hour OCREVUS infusion time, dosed twice yearly (six-monthly), is approved for eligible people with RMS or PPMS in the U.S. and European Union (EU).
OCREVUS is approved in 100 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland, the United Kingdom and the EU.