New data for Roche’s OCREVUS show that after 10 years of treatment
77% of people with relapsing multiple sclerosis were free from
disability progression and 92% continue to walk unaided
- 10-year efficacy data
highlight OCREVUS’ impact on preventing disability progression and
maintaining mobility in both relapsing and progressive forms of
multiple sclerosis (MS)
- 10-year safety data from
over 6,000 patients continue to reinforce consistent long-term
safety profile of OCREVUS
- More than 3,200 women with
MS treated with OCREVUS reported no increased risk in adverse
pregnancy and infant outcomes with real-world analyses showing low
risk of relapse during and after pregnancy
- OCREVUS controlled disease
activity and progression over one year in Black and Hispanic /
Latinx people with MS
Basel, 12 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
today announced new clinical and real-world data for OCREVUS®
(ocrelizumab), demonstrating its role in continuing to transform
care for people living with relapsing or primary progressive
multiple sclerosis (RMS or PPMS) presented at the 9th Joint
ECTRIMS-ACTRIMS Meeting (European and Americas Committees for
Treatment and Research in Multiple Sclerosis). OCREVUS is the first
and only disease-modifying treatment (DMT) in MS to benefit both
people with RMS and PPMS and now has 10 years of follow-up data
from its three Phase III trials.
“OCREVUS is the first B-cell therapy approved for RMS and PPMS
and it’s remarkable to see that after 10 years of treatment, a
great majority of RMS patients remain free from disease
progression,” 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. “These results signify that people with both RMS and
PPMS have more years to spend their days living independently
without the need for walking aids or wheelchairs.”
10-year disability outcomes from Phase III OCREVUS
open-label extension (OLE) trialsAfter 10 years of
continuous OCREVUS treatment, 77% were free from disability
progression based on 48-week confirmed disability progression (CDP)
events and 92% of patients with RMS were still walking unassisted.
In patients with PPMS, 36% were free from disability progression
based on 48-week CDP events and 80% of those patients treated
continuously with OCREVUS over 10 years were still able to walk.
The long-term data reinforce the critical importance of early
treatment in preserving function across the MS spectrum, showing
a
lower risk of reaching disability events in patients with RMS
and PPMS who initiated OCREVUS treatment earlier (initiating at the
start of the double-blind studies vs. the start of the OLEs).
10-year safety profile of OCREVUSNew safety
data from 6,155 patients with 28,269 patient-years of exposure to
OCREVUS across 12 clinical trials further support the medicine’s
favourable benefit-risk profile, which has remained consistent over
10 years. The risk characteristics of OCREVUS in the all-exposure
population (RMS and PMS) remained consistent with the
characteristics observed during the controlled treatment periods.
Serious infections and malignancy rates remain within the range
reported for patients with MS in real-world registries. Longer
exposure to OCREVUS did not lead to an increased risk of serious
infections regardless of the immunoglobulin G (IgG) status of the
patients (normal levels or levels below the lower limit of normal).
No new or unexpected safety signals were seen in patients treated
with OCREVUS in ongoing clinical trials.
''Some women affected by MS may be thinking about starting a
family, so it is important to understand how their treatment prior
to pregnancy may impact them and their unborn child,'' said Levi
Garraway. ''With more than 300,000 people treated globally and 30
ongoing trials, we continue to accrue robust evidence for how
OCREVUS may benefit many underrepresented groups including pregnant
women and people of Black or Hispanic heritage.”
Real-world analyses on pregnancy & infant outcomes
and postpartum relapsesFamily planning is an essential
aspect in the care of women living with MS, many of whom are of
child-bearing age. Roche safety data from 3,253 cumulative
pregnancies in women with MS do not suggest an increased risk of
adverse pregnancy or infant outcomes in women with MS treated with
OCREVUS. Outcomes were known for 1,145 prospectively reported
pregnancies and 512 of these had in utero exposure to OCREVUS.
Respective outcomes from these two groups were: 83.6% and 84.2%
live births (1.3% and 1.6% with major congenital anomalies); 1.2%
and 0.8% ectopic pregnancy; 5.1% and 7.4% elective terminations;
10.0% and 7.4% spontaneous abortions; <0.1% and 0.2% still
birth. In utero exposure to OCREVUS did not increase the risk of
adverse pregnancy or infant outcomes compared with epidemiological
background of both the MS and general populations.
Furthermore, a real-world analysis from the international MSBase
registry based on data from 1,722 women living with MS receiving
different DMTs suggests that women who conceived during OCREVUS
treatment or soon after their last dose are at low risk for relapse
during pregnancy and postpartum. During pregnancy, the annualised
relapse rate (ARR) was 0.00 for women previously treated with
OCREVUS vs. 0.05 to 0.32 for other DMTs. The postpartum ARR was
0.09 for women treated with OCREVUS vs. 0.10 to 0.74 for other
DMTs. Roche is committed to generating further data on family
planning priorities by assessing pregnancy and infant outcomes
including infant B cell levels through routine pharmacovigilance
activities, post-marketing commitments and two ongoing Phase IV
studies, MINORE (placental transfer and infant outcomes) and
SOPRANINO (breastmilk transfer and infant outcomes).
One-year efficacy and safety outcomes from Phase IV
CHIMES studyBlack and Hispanic / Latinx people with MS
experience more severe disease, faster disease progression and
greater disability than white people living with MS. CHIMES is the
first-ever clinical trial focused exclusively on broadening
understanding of MS disease biology among Black and Hispanic /
Latinx people with MS. One-year data from the trial show that
OCREVUS controlled disease activity and disability progression in
these populations, demonstrating a safety and efficacy profile
consistent with the large body of clinical evidence from other
OCREVUS trials. Approximately half of 182 patients enrolled in the
CHIMES trial achieved no evidence of disease activity (NEDA) at one
year (46% of Black patients and 58% of Hispanic / Latinx patients
at 48 weeks), with approximately 95% of patients experiencing no
relapses (95% of Black patients and 96% of Hispanic / Latinx
patients), no 24-week CDP (95% of Black patients and 94% of
Hispanic / Latinx patients) and no T1 gadolinium-enhancing (T1-Gd+)
lesions (95% of Black patients and 97% of Hispanic / Latinx
patients). No new or enlarging T2 lesions were observed in about
half of Black patients (46%) and more than half of Hispanic /
Latinx patients (64%). No new safety signals were observed. The
results also provide new insight into the role of social
determinants of health in the recruitment and retention of diverse
patient populations for clinical research, a critical first step in
breaking the cycle of inequity.
More than 300,000 people with MS have been treated with OCREVUS
globally. OCREVUS is approved in more than 100 countries across
North America, South America, the Middle East, Eastern Europe, Asia
as well as in Australia, Switzerland, the United Kingdom and the
EU.
Roche is committed to advancing innovative clinical research
programmes to broaden the scientific understanding of MS, further
reduce disability worsening in RMS and PPMS and improve the
treatment experiences for those living with the disease. There are
more than 30 ongoing OCREVUS clinical trials designed to help us
better understand MS and its progression.
About OCREVUS (ocrelizumab)OCREVUS is the first
and only therapy approved for both RMS (including
relapsing-remitting MS [RRMS] and active, or relapsing secondary
progressive MS [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 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 – from
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
disease activity and progression 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 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 and Genentech are investigating more
than a dozen medicines for neurological disorders, including MS,
spinal muscular atrophy, neuromyelitis optica spectrum disorder,
Alzheimer’s disease, Huntington’s disease, Parkinson’s disease,
acute ischemic stroke, Duchenne muscular dystrophy and Angelman
syndrome. 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 endeavour 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.
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- 12102023_MR_ECTRIMS MS Leadership Data Release_en
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