-
New analyses show the effect of
OCREVUS on reducing the risk of disability progression is
associated with exposure and lower B-cell levels
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Long-term data in RMS and PPMS
show that earlier treatment with OCREVUS significantly reduced the
risk of permanent disability progression
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Over 100,000 people have been
treated with OCREVUS globally, in clinical trial and real-world
settings; data presented at the AAN Annual Meeting highlights a
consistent and favourable benefit-risk profile
Basel, 8 May 2019 - Roche (SIX: RO, ROG;
OTCQX: RHHBY) today announced new OCREVUS® (ocrelizumab) data in
relapsing and primary progressive multiple sclerosis (MS) were
presented at the 71st American
Academy of Neurology (AAN) Annual Meeting from 4-10 May in
Philadelphia, Pennsylvania. New analyses on OCREVUS show its effect
on reducing the risk of disability progression is associated with
higher exposure to the medicine and lower B-cell levels, and show
the positive impact of OCREVUS in significantly reducing disability
progression.
With rapidly growing real-world experience and more than 100,000
patients treated globally, OCREVUS is the first and only therapy
with six-month dosing approved for both relapsing MS (RMS),
(including RRMS and active, or relapsing, secondary progressive MS)
and primary progressive MS (PPMS). Additionally, new safety data
presented at AAN representing 4,501 patients with RMS and PPMS and
12,559 patient years of exposure to OCREVUS, across all OCREVUS
clinical trials, remain consistent with the medicine's favourable
benefit-risk profile.
"These are the first data to show that higher OCREVUS exposure is
associated with greater control of disability progression without
impacting safety," said Stephen Hauser, MD, chair of the Scientific
Steering Committee of the OPERA studies and director of the Weill
Institute for Neurosciences at the University of California, San
Francisco. "These analyses, along with long-term data that show
OCREVUS reduced the risk of permanent disability progression,
create a compelling case for initiating the therapy early in the
disease course and provide important information that clinicians
can use to inform treatment decisions."
New data from pharmacokinetic, pharmacodynamic and exposure
analyses - or how OCREVUS is processed in an individual's body over
time - show higher exposure to OCREVUS correlated with lower B-cell
levels and lower rates of disability progression in patients. In
patients with RMS, OCREVUS reduced the risk of 24-week confirmed
disability progression (CDP) at all exposure levels compared with
interferon beta-1a. There was lower risk of disability progression
with higher exposure to OCREVUS.
A similar pattern was observed for patients with PPMS, in which
OCREVUS reduced the risk of 24-week CDP at all exposure levels
compared with placebo. OCREVUS reduced T1 gadolinium-enhancing and
new/enlarging T2 MRI lesions to nearly undetectable levels in RMS
and PPMS patients and reduced annualized relapse rates to low
levels (0.13-0.18) in RMS patients across all exposure segments.
Notably, safety findings remained consistent across all OCREVUS
exposure levels, suggesting that higher exposure does not increase
the likelihood of adverse events.
Long-term data, of over five years, from the Phase III OPERA and
ORATORIO open-label extension (OLE) trials in RMS and PPMS, show
that earlier treatment with OCREVUS significantly reduced the risk
of permanent disability progression and this effect was sustained
over time. In the OPERA OLE, the proportion of RMS patients with
48-week CDP was lower for those treated with continuous OCREVUS
(total of five years on OCREVUS) compared with patients who
switched to OCREVUS after two years of interferon beta-1a treatment
in the double-blind period (total of three years on OCREVUS) (10.4%
vs. 15.7%; p=0.004). In the ORATORIO OLE, the proportion of PPMS
patients with 48-week CDP was lower in those treated with
continuous OCREVUS over five and a half years compared with
patients who switched to OCREVUS from placebo after the 120-week
double-blind period (43.7% vs 53.1%; p=0.03).
Additionally, interim results of the Phase III Ocrelizumab
Biomarker Outcome Evaluation (OBOE) study show that OCREVUS reduced
the presence of a nerve cell damage and inflammation biomarker in
serum and cerebrospinal fluid at 12, 24 and 52 weeks in patients
with RMS. These one-year data add to the growing body of evidence
to identify biomarkers of disease progression in MS and the benefit
of OCREVUS on these markers.
OCREVUS is now approved in 85 countries across North America, South
America, the Middle East, Eastern Europe, as well as in Australia,
Switzerland and the European Union.
Full session details and data presentation listings for the 2019
AAN Annual Meeting can be found at the meeting website:
https://www.aan.com/conferences-community/annual-meeting/.
Follow Roche on Twitter via @Roche and keep up to date with AAN
2019 Annual Meeting news and updates by using the hashtag
#AANAM.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic disease that affects up to a
million people in the U.S., for which there is currently no cure.
MS occurs when the immune system abnormally attacks the insulation
and support around nerve cells (myelin sheath) in the brain, spinal
cord and optic nerves, causing inflammation and consequent damage.
This damage can cause a wide range of symptoms, including muscle
weakness, fatigue and difficulty seeing, and may eventually lead to
disability. Most people with MS experience their first symptom
between 20 and 40 years of age, making the disease the leading
cause of non-traumatic disability in younger adults.
Relapsing-remitting MS (RRMS) is the most common form of the
disease and is characterized by episodes of new or worsening signs
or symptoms (relapses) followed by periods of recovery.
Approximately 85 percent of people with MS are initially diagnosed
with RRMS. The majority of people who are diagnosed with RRMS will
eventually transition to secondary progressive MS (SPMS), in which
they experience steadily worsening disability over time. Relapsing
forms of MS (RMS) include people with RRMS and people with active
SPMS who continue to experience relapses. Primary progressive MS
(PPMS) is a debilitating form of the disease marked by steadily
worsening symptoms but typically without distinct relapses or
periods of remission. Approximately 15 percent of people with MS
are diagnosed with the primary progressive form of the disease.
Until the FDA approval of OCREVUS, there have been no FDA approved
treatments for 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. An important goal of
treating MS is to reduce disease activity as soon as possible to
slow how quickly a person's disability progresses.
About OCREVUS (ocrelizumab)
OCREVUS is the first and only therapy approved for both RMS
(including RRMS and active, or relapsing, SPMS) and PPMS, with
six-month dosing. OCREVUS is a humanized monoclonal antibody
designed to target CD20-positive B cells, a specific type of immune
cell thought to be a key contributor to myelin (nerve cell
insulation and support) and axonal (nerve cell) damage. This nerve
cell damage can lead to disability in people with multiple
sclerosis (MS). Based on preclinical studies, OCREVUS binds to CD20
cell surface proteins expressed on certain B cells, but not on stem
cells or plasma cells, and therefore important functions of the
immune system may be preserved.
OCREVUS is administered by intravenous infusion every six months.
The initial dose is given as two 300 mg infusions given two weeks
apart. Subsequent doses are given as single 600 mg
infusions.
About
Roche in neuroscience
Neuroscience is a major
focus of research and development at Roche. The company's goal is
to develop treatment options based on the biology of the nervous
system to help improve the lives of people with chronic and
potentially devastating diseases. Roche has more than a dozen
investigational medicines in clinical development for diseases that
include multiple sclerosis, spinal muscular atrophy, neuromyelitis
optica spectrum disorder, Alzheimer's disease, Huntington's
disease, Parkinson's disease, Duchenne muscular dystrophy and
autism.
About Roche
Roche is a
global pioneer in pharmaceuticals and diagnostics focused on
advancing science to improve people's lives. The combined strengths
of pharmaceuticals and diagnostics under one roof have made Roche
the leader in personalised healthcare - a strategy that aims to fit
the right treatment to each patient in the best way
possible.
Roche is the world's largest biotech company, with truly
differentiated medicines in oncology, immunology, infectious
diseases, ophthalmology and diseases of the central nervous system.
Roche is also the world leader in in vitro diagnostics and
tissue-based cancer diagnostics, and a frontrunner in diabetes
management.
Founded in 1896, Roche continues to search for better ways to
prevent, diagnose and treat diseases and make a sustainable
contribution to society. The company also aims to
improve patient access to medical innovations by working with
all relevant stakeholders. Thirty medicines developed by Roche are
included in the World Health Organization Model Lists of Essential
Medicines, among them life-saving antibiotics, antimalarials and
cancer medicines. Moreover, for the tenth consecutive year, Roche
has been recognised as the most sustainable company in the
Pharmaceuticals Industry by the Dow Jones Sustainability Indices
(DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in
over 100 countries and in 2018 employed about 94,000 people
worldwide. In 2018, Roche invested CHF 11 billion in R&D and
posted sales of CHF 56.8 billion. Genentech, in the United
States, is a wholly owned member of the Roche Group. Roche is the
majority shareholder in Chugai Pharmaceutical, Japan. For more
information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by
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Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail:
media.relations@roche.com
- Nicolas Dunant (Head)
- Patrick Barth
- Ulrike Engels-Lange
- Simone Oeschger
- Anja von Treskow
20190508_AAN_Ocrevus_ EN