Darmstadt, Germany (ots/PRNewswire) - MAGNIFY-MS retrospective
analysis demonstrates patients develop protective antibody levels for
at least six months following seasonal influenza and varicella zoster
vaccines, irrespective of vaccine timing relative to MAVENCLAD dosing
Initial findings from the CLOCK-MS vaccine sub-study show protective
influenza antibody levels at four weeks post-vaccination in MS
patients taking MAVENCLAD
In both studies, protective antibody levels were maintained or
increased independent of lymphocyte counts
Not intended for UK and U.S. based media
Merck, a leading science and technology company, today announced the
presentation of a new analysis from the MAGNIFY-MS study on
MAVENCLAD® (cladribine tablets) in patients with relapsing multiple
sclerosis (RMS) at the Americas Committee for Treatment and Research
in Multiple Sclerosis (ACTRIMS) Forum 2021, being held virtually
25-27 February 2021. The data indicate that RMS patients receiving
MAVENCLAD are able to mount a response to seasonal influenza and
varicella zoster vaccination.
"Understanding vaccine efficacy in MS patients is particularly
important in the face of the current pandemic and the growing
availability of COVID-19 vaccines," said Klaus Schmierer, Professor
of Neurology at Queen Mary University of London and The Royal London
Hospital, UK. "Whilst this new information is based on a small cohort
of patients receiving influenza and varicella zoster vaccines, it
provides physicians with preliminary evidence that patients taking
MAVENCLAD are able to mount and maintain effective vaccine
The retrospective analysis was conducted to evaluate the protective
antibody response to seasonal influenza (n=12) and varicella zoster
virus (VZV) vaccination (n=3) in patients treated with MAVENCLAD.
Blood samples taken before and after vaccination were examined. In
patients who received the seasonal influenza vaccine, protective
antibody levels were maintained or increased for at least six months
independent of lymphocyte counts measured at the time of vaccination
in year 1 or 2 of MAVENCLAD treatment. In patients who received the
VZV vaccine before year 1 initiation of MAVENCLAD, protective VZV
antibody levels were maintained over six months post-initiation with
MAVENCLAD, despite lymphocyte depletion. These results were
consistent irrespective of when the patients received the vaccine
relative to their MAVENCLAD treatment.
In the CLOCK-MS vaccine sub-study analysis, three relapsing remitting
multiple sclerosis (RRMS) patients had received at least one dose of
MAVENCLAD prior to receiving an influenza vaccine. Protective
antibody levels were increased at four weeks post-vaccination in all
three patients. Two of these patients, who had received treatment
with MAVENCLAD two and four months prior to vaccination, were
experiencing lymphopenia around the time of vaccination.
"In an ever changing world where a pandemic will likely be present
for the foreseeable future, it is critical to assess the impact of
common non-live vaccinations in those taking disease modifying
therapies," said Maria Rivas, MD, Chief Medical Officer, Healthcare
business of Merck. "We are committed to communicating timely
real-world evaluations of our therapies to help answer relevant
questions raised by the MS community."
MAVENCLAD® is a short-course oral therapy that selectively and
periodically targets lymphocytes thought to be integral to the
pathological process of relapsing MS (RMS). In August 2017, the
European Commission (EC) granted marketing authorization for
MAVENCLAD® for the treatment of relapsing forms of multiple sclerosis
(RMS) in the 28 countries of the European Union (EU) in addition to
Norway, Liechtenstein and Iceland. MAVENCLAD® has since then been
approved in over 80 countries, including Canada, Australia and the
U.S. Refer to the respective prescribing information for further
The clinical development programme for cladribine tablets includes:
* The CLARITY (Cladribine Tablets Treating MS Orally) study: a
two-year Phase III placebo-controlled study designed to evaluate
the efficacy and safety of cladribine tablets as a monotherapy in
patients with RRMS.
* The CLARITY extension study: a Phase III placebo-controlled study
following on from the CLARITY study, which evaluated the safety
and exploratory efficacy of cladribine tablets over two
years beyond the two-year CLARITY study, according to the
treatment assignment scheme for years 3 and 4.
* The ORACLE MS (Oral Cladribine in Early MS) study: a two-year
Phase III placebo-controlled study designed to evaluate the
efficacy and safety of cladribine tablets as a monotherapy in
patients at risk of developing MS (patients who have experienced
first clinical event suggestive of MS).
* The ONWARD (Oral Cladribine Added ON to Interferon beta-1a in
Patients With Active Relapsing Disease) study: a Phase II
placebo-controlled study designed primarily to evaluate the
and tolerability of adding cladribine tablets treatment to
patients with relapsing forms of MS, who have experienced
breakthrough disease while on established interferon-beta
* PREMIERE (Prospective Observational Long-term Safety Registry of
Multiple Sclerosis) study: a long-term observational follow-up
safety registry of MS patients who participated in cladribine
tablets clinical studies.
In the two-year CLARITY study, the most commonly reported adverse
event (AE) in patients treated with cladribine tablets was
lymphopenia (26.7% with cladribine tablets and 1.8% for placebo). The
incidence of infections was 48.3% with cladribine tablets and 42.5%
with placebo, with 99.1% and 99.0% respectively rated
mild-to-moderate by investigators. Adverse Events reported in other
clinical studies were similar.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the
central nervous system and is the most common non-traumatic,
disabling neurological disease in young adults. It is estimated
approximately 2.8 million people have MS worldwide. While symptoms
can vary, the most common symptoms of MS include blurred vision,
numbness or tingling in the limbs and problems with strength and
coordination. The relapsing forms of MS are the most common.
Merck in Neurology and Immunology
Merck has a long-standing legacy in neurology and immunology, with
significant R&D and commercial experience in multiple sclerosis (MS).
The company`s current MS portfolio includes two products for the
treatment of relapsing MS - Rebif® (interferon beta-1a) and
MAVENCLAD® (cladribine tablets). Merck aims to improve the lives of
patients by addressing areas of unmet medical needs. In addition to
Merck's commitment to MS, the company also have a pipeline focusing
on discovering new therapies that have the potential in other
All Merck Press Releases are distributed by email at the same time
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Merck, a leading science and technology company, operates across
healthcare, life science and performance materials. Around 58,000
employees work to make a positive difference to millions of people's
lives every day by creating more joyful and sustainable ways to live.
From advancing gene editing technologies and discovering unique ways
to treat the most challenging diseases to enabling the intelligence
of devices - the company is everywhere. In 2019, Merck generated
sales of EUR 16.2 billion in 66 countries.
Scientific exploration and responsible entrepreneurship have been key
to Merck's technological and scientific advances. This is how Merck
has thrived since its founding in 1668. The founding family remains
the majority owner of the publicly listed company. Merck holds the
global rights to the Merck name and brand. The only exceptions are
the United States and Canada, where the business sectors of Merck
operate as EMD Serono in healthcare, MilliporeSigma in life science,
and EMD Performance Materials.
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