Roche presents new OCREVUS (ocrelizumab) biomarker data that increase understanding of disease progression in multiple sclerosis at ECTRIMS

Roche presents new OCREVUS (ocrelizumab) biomarker data that increase understanding of disease progression in multiple sclerosis at ECTRIMS

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).

Concepts Keywords
35th Congress MRI
Alzheimer Clinically isolated syndrome
Antibiotics Hoffmann-La Roche
Antimalarials Genentech
Australia Ocrelizumab
Autism Biomarkers
Basel Neurological disorders
Biomarker Autoimmune diseases
Biotech Clinical medicine
Blood Organ systems
Blood Plasma Multiple sclerosis
Blood Serum Intravenous infusion
Brain Antibiotics
CD20 Diagnostics frontrunner diabetes
Central Nervous System Mail media relations
Cerebrospinal Fluid Muscle weakness fatigue
CHF Pharmaceuticals
Diabetes Search ways
Disability
Duchenne Muscular Dystrophy
Eastern Europe
Engels
European Union
FAAN
FANA
Fatigue
FDA
FRCP
Gadolinium
Genentech
Hashtag
Healthcare
Humanised Monoclonal Antibody
Huntington
Immune System
Immunology
Infectious Diseases
Inflammation
Insulation
Interferon Beta 1a
Intravenous Infusion
Japan
Lange
Mail
Middle East
MRI
Multiple Sclerosis
Muscle Weakness
Myelin
Myelin Sheath
Nerve
Nerve Cell
Nervous System
Neurofilament
Neurology
Neuromyelitis Optica
Neuroprotective
NfL
North America
OBOE
Oncology
OPERA
Ophthalmology
Optic Nerves
OTCQX
Parkinson
Pennsylvania
Percentile
Pharmaceuticals
Philadelphia
Placebo
Plasma Cells
Progressive
Remission
Society
South America
Spectrum
Spinal Cord
Spinal Muscular Atrophy
Stockholm
Sweden
Switzerland
Symptom
Twitter
United States

Semantics

Type Source Name
disease DOID SPMS
disease DOID syndrome
disease MESH syndrome
drug DRUGBANK Interferon beta-1a
drug DRUGBANK Gadolinium
gene UNIPROT BFAR
gene UNIPROT NR1H4
disease MESH relapses
drug DRUGBANK Tropicamide
disease DOID relapsing-remitting MS
gene UNIPROT CSF2
gene UNIPROT MAGEE1
drug DRUGBANK Ocrelizumab
disease MESH disease progression
disease MESH multiple sclerosis
disease DOID multiple sclerosis
gene UNIPROT TNFSF14
gene UNIPROT NEFL
disease DOID PPMS
gene UNIPROT CYREN
drug DRUGBANK Nonoxynol-9
disease MESH primary progressive multiple sclerosis
gene UNIPROT DYNAP
gene UNIPROT NFKBIZ
pathway BSID Release
drug DRUGBANK Coenzyme M
disease DOID CHF
disease DOID cancer
disease MESH cancer
disease MESH infectious diseases
disease DOID autism
disease MESH autism
disease DOID Duchenne muscular dystrophy
disease MESH Duchenne muscular dystrophy
disease MESH neuromyelitis optica spectrum disorder
disease DOID spinal muscular atrophy
disease MESH spinal muscular atrophy
disease MESH development
gene UNIPROT MS4A1
disease MESH inflammation
pathway BSID Immune System
disease MESH sclerosis
disease MESH chronic disease

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