Early treatment with Roche's OCREVUS leads to reduced disease
progression and healthcare costs; nine-year safety data reinforce
favourable benefit-risk profile
- 77% of early-stage
relapsing-remitting multiple sclerosis (RRMS) patients who had not
received prior treatment achieved no evidence of disease activity
(NEDA) at two years
- Initiation of OCREVUS as
first-line treatment reduces relapses,
hospitalisations and costs compared with
using OCREVUS in second-line setting
- Nine-year long-term safety
data for OCREVUS further reinforce
favourable benefit-risk profile; more than
250,000 people have been treated globally
- Pregnancy outcomes reported
for more than 2,000 women with multiple sclerosis (MS) treated with
OCREVUS do not suggest an increased risk of adverse pregnancy and
infant outcomes
Basel, 26 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
today announced new OCREVUS® (ocrelizumab) data on disease
progression and healthcare costs in patients with early-stage RRMS
and long-term safety from all clinical trials in patients with
relapsing MS (RMS) and primary progressive MS (PPMS). Data from the
largest database of pregnancy outcomes for an anti-CD20 therapy in
MS suggest consistent outcomes with epidemiological data in
pregnant women and was an oral presentation today at the 38th
Congress of the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS).
“MS often impacts young people at a time in their lives when
they are starting a career or planning a family,” said Levi
Garraway, M.D., Ph.D. Roche's Chief Medical Officer and Head of
Global Product Development. “These new data show that using OCREVUS
as a first-line treatment brings substantial clinical and cost
benefits to patients, thereby further emphasizing the efficacy that
OCREVUS may bring with continued long-term use.”
Two-year interim analysis of open-label Phase IIIb ENSEMBLE: No
evidence of disease progression in early-stage RRMS
OCREVUS treatment provided consistent benefit over two years in
patients who were recently diagnosed with RRMS and had not received
prior disease modifying treatment (DMT) in an interim analysis of
open-label Phase IIIb study ENSEMBLE. After 96 weeks of OCREVUS
treatment, 77% of patients achieved no evidence of disease activity
(NEDA; no relapses, no worsening of disability or no evidence of
MRI lesion activity with pre-specified MRI re-baselining at 8
weeks). The majority of patients had no relapses (93%), no MRI
lesion activity (89%) and no 24-week confirmed disability
progression (91%).
Over two years, the average annualised relapse rate (ARR) across
all patients in the ENSEMBLE study was low (0.033), which equates
to 1 relapse every 30 years. The mean Expanded Disability Status
Scale (EDSS) score from baseline significantly improved from 1.8 to
1.67 (p<0.0001). The safety profile of OCREVUS in this trial was
consistent with its overall favourable safety profile.
U.S. claims analysis: Early initiation of OCREVUS may benefit
both patients and the healthcare system
Patients who were newly diagnosed and initiated OCREVUS
treatment had a lower rate of annualised events often associated
with a relapse (EOAR; 0.36) compared with patients who initiated
OCREVUS as a second-line or later treatment (0.51). Additionally,
patients treated with first-line OCREVUS had lower hospitalisation
rates within one year compared with patients treated with
second-line or later OCREVUS (0.02 vs. 0.042, respectively).
Costs were also lower after first-line OCREVUS treatment,
including the total annual non-DMT costs ($18,389 vs. $26,225,
respectively) and MS-related/non-DMT costs ($8,837 vs. $14,758,
respectively) compared with patients treated with second-line or
later OCREVUS.
Non-DMT costs were defined as total costs for emergency
department visits, inpatient care, outpatient care and non-DMT
prescriptions. MS-related costs were defined similarly but could
also be attributed to the disease.
The findings from the study suggest that the early initiation of
OCR, instead of escalation from lower-efficacy DMTs, can provide
benefits for both patients and the healthcare system.
These clinical and economic analyses were performed on U.S.
commercial claims data between 1 January 2015 and 30 June 2021.
Long-term safety from OCREVUS clinical trials consistent for
nine years
New safety data as of November 2021 will be presented,
representing 5,848 patients with relapsing MS (RMS) and primary
progressive MS (PPMS) and 25,153 patient-years of exposure to
OCREVUS, across all OCREVUS clinical trials. These findings further
demonstrate the consistently favourable benefit-risk profile of
OCREVUS over nine years.
“Nine-year data presented at ECTRIMS in relapsing and primary
progressive MS continue to show significant efficacy against
disease activity and progression with a consistent long-term safety
profile, which is very encouraging for patients living with this
disease and their physicians,” said Stephen Hauser, M.D., 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. “OCREVUS has significantly changed the
treatment paradigm for more than 250,000 people with MS since its
approval more than five years ago.”
More than 250,000 people with MS have now been treated with
OCREVUS globally, and data continue to show a consistent and
favourable benefit-risk profile in clinical trial and real-world
settings. OCREVUS is approved in 101 countries across North
America, South America, the Middle East, Eastern Europe, as well as
in Australia, Switzerland, the United Kingdom and the EU.
Roche safety data do not suggest increased risk of adverse
pregnancy and infant outcomes in women treated with OCREVUS
As of 31 March 2022, 2,020 cumulative MS pregnancies were
reported, of which 705 (35%) had in utero exposure to OCREVUS.
Of the 532 pregnancies with in utero exposure of OCREVUS that
were also prospectively reported, 286 had known outcomes: 79% live
births; 1% ectopic pregnancies; 12% therapeutic/elective abortions;
8% spontaneous abortions; 0.3% still birth.
In women living with MS and treated with OCREVUS who reported
pregnancies, cumulative data do not suggest an increased risk of
preterm birth, major congenital anomalies or other adverse outcomes
and are consistent with epidemiological data, and in-line with
previous reports, providing important information for women living
with MS who are or may become pregnant.
Regulatory agencies advise the use of contraception while on
treatment with OCREVUS, and for 6-12 months after the last dose.
The benefit-risk of OCREVUS in mothers and infants is being
prospectively assessed in two Phase IV studies, MINORE in pregnant
women and SOPRANINO in lactating women, both of which are currently
enrolling.
About multiple
sclerosisMultiple sclerosis (MS) is a chronic
disease that affects more than 2.8 million people worldwide. MS
occurs when the immune system abnormally attacks the insulation and
support around nerve cells (myelin sheath) in the central nervous
system (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.
People with all forms of MS experience disease progression –
permanent loss of nerve cells in the central nervous system and
gradual worsening of disability – at the beginning of their disease
even if their clinical symptoms aren’t apparent or don’t appear to
be getting worse. Delays in diagnosis and treatment can negatively
impact people with MS, in terms of their physical and mental
health, and contribute to the negative financial impact on the
individual and society. An important goal of treating MS is to
slow, stop and ideally prevent the progression of disability as
early as possible.
Relapsing-remitting MS (RRMS) is the most common form of the
disease and is characterised by episodes of new or worsening signs
or symptoms (relapses) followed by periods of recovery.
Approximately 85% 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 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% of people with MS are diagnosed with
the primary progressive form of the disease. Until the FDA approval
of OCREVUS, there had been no FDA-approved treatments for PPMS.
About OCREVUS
(ocrelizumab)OCREVUS is
the first and only therapy approved for both RMS (including RRMS
and active, or relapsing SPMS, in addition to clinically isolated
syndrome [CIS] in the U.S.) and PPMS. OCREVUS is a humanised
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 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, suggesting that 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
neuroscienceNeuroscience is a major focus of
research and development at Roche. Our goal is to pursue
ground-breaking science to develop new treatments that help improve
the lives of people with chronic and potentially devastating
diseases.
Roche has both approved and investigational medicines across
multiple sclerosis, spinal muscular atrophy, neuromyelitis optica
spectrum disorder, myasthenia gravis, Alzheimer’s disease,
Huntington’s disease, Parkinson’s disease and Duchenne muscular
dystrophy. Together with our partners, we are committed to pushing
the boundaries of scientific understanding to solve some of the
most difficult challenges in neuroscience today.
About Roche Founded in 1896 in Basel,
Switzerland, as one of the first industrial manufacturers of
branded medicines, Roche has grown into the world’s largest
biotechnology company and the global leader in in-vitro
diagnostics. The company pursues scientific excellence to discover
and develop medicines and diagnostics for improving and saving the
lives of people around the world. We are a pioneer in personalised
healthcare and want to further transform how healthcare is
delivered to have an even greater impact. To provide the best care
for each person we partner with many stakeholders and combine our
strengths in Diagnostics and Pharma with data insights from the
clinical practice.
In recognising our endeavor to pursue a long-term perspective in
all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the thirteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
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 law.
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