Publication date: Sep 10, 2019
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(R) (ocrelizumab) trials in relapsing and primary progressive multiple sclerosis (MS).
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.
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 (p0. 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 (p0. 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.
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.
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.
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.
People with all forms of MS experience disease activity – inflammation in the nervous system and permanent loss of nerve cells in the brain – even when their clinical symptoms aren’t apparent or don’t appear to be getting worse.
This nerve cell damage can lead to disability in people with multiple sclerosis (MS).