Pressemeddelelse: New OCREVUS (ocrelizumab) biomarker data
Roche presents new OCREVUS (ocrelizumab) biomarker data that increase understanding of disease progression in multiple sclerosis at ECTRIMS
- Blood neurofilament light chain (NfL) levels were significantly lowered following OCREVUS treatment in analyses of Phase III studies in RMS and PPMS
- New data show NfL may be a biomarker for predicting future disability outcomes
- Separate analyses presented from one of the first studies to demonstrate NfL levels are correlated with active MRI lesions in PPMS
Basel, 10 September 2019 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data from OCREVUS® (ocrelizumab) trials in relapsing and primary progressive multiple sclerosis (MS). The analyses provide new insights into the biology of MS that advance the understanding of disease progression, with the goal of identifying and slowing disease progression as early as possible to preserve patient function over the long term. Findings will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from 11-13 September in Stockholm, Sweden.
Following OCREVUS treatment, blood neurofilament light chain (NfL) levels were lowered to a healthy donor range1 in relapsing MS (RMS) and primary progressive MS (PPMS) patients. NfL is a protein that provides structural support to nerve fibres in the brain. An increase in the amount of NfL may be associated with nerve cell damage, and detection of increased NfL levels in blood or cerebrospinal fluid (CSF) may serve as a biomarker of nerve cell damage. In the Phase III OPERA I study in RMS and the ORATORIO study in PPMS, blood NfL levels were significantly lower after treatment with OCREVUS. In RMS, blood serum NfL levels were reduced by 43 percent from baseline to 96 weeks after OCREVUS treatment compared with a 31 percent reduction with interferon beta-1a (p<0.001). In PPMS, blood plasma NfL levels were reduced by 16 percent from baseline to 96 weeks after OCREVUS treatment compared with 0.2 percent reduction with placebo (p<0.001). Additionally, these analyses showed higher blood NfL levels at the start of the study were correlated with more disability progression in upper and lower limbs in PPMS and overall disability in the interferon beta-1a RMS treatment group at 96 weeks.
Few studies have described the relationship between NfL levels and MRI in a well-characterised PPMS patient group. New data from the Phase III OBOE study in PPMS and RMS show that PPMS patients with active MRI lesions (gadolinium-enhancing T1 lesions) had median cerebrospinal fluid (CSF) NfL levels twice as high as those without these lesions. As previously reported, RMS patients with active MRI lesions also had significantly higher NfL levels. Collectively, these data around NfL in MS advance the understanding of it as a potential biomarker of disease progression and may provide insight into the potential neuroprotective effects following OCREVUS treatment.
“These analyses from the OCREVUS trials strengthen the evidence for pursuing neurofilament light chain as a potential biomarker of disease activity and progression in MS, including its potential to predict future disability outcomes,” said Amit Bar-Or, MD, FRCP, FAAN, FANA, chair of the Scientific Steering Committee of the OBOE study and chief of the Multiple Sclerosis Division of the Department of Neurology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia. “Disease progression in MS can be challenging to identify without noticeable relapses or disability progression, and continued investigation into neurofilament light chain may help us better understand the underlying progression in all forms of this disease.”
OCREVUS is the first and only therapy approved for both RMS (including relapsing-remitting MS (RRMS) and active, or relapsing, secondary progressive MS, in addition to clinically isolated syndrome in the U.S.) and PPMS. OCREVUS is dosed every six months, with rapidly increasing real-world experience and more than 120,000 people with MS treated globally. OCREVUS is now approved in 89 countries across North America, South America, the Middle East, and Eastern Europe, as well as in Australia, Switzerland and the European Union.
Full session details and data presentation listings for ECTRIMS can be found at the congress website: https://www.ectrims-congress.eu/2019.html.
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 Samples were taken from 118 healthy donors to establish healthy donor NfL ranges of 5.5–9.8 pg/mL for blood serum and 4.3–7.9 pg/mL for blood plasma. Healthy donor range was defined as the 90th percentile of an age-matched healthy cohort.