- Continuous Kesimpta® treatment for up to six years showed
sustained efficacy in recently diagnosed (≤3 years)
treatment-naïve people living with relapsing multiple sclerosis
(RMS) in an analysis of the ALITHIOS open-label extension
study1
- Similar efficacy outcomes were demonstrated in a separate
analysis of continuous Kesimpta treatment for up to six years in
the overall ALITHIOS study population2
- Switch from teriflunomide to Kesimpta resulted in
significant improvements across several efficacy outcomes such as
annualized relapse rate and MRI lesion activity in both
analyses1,2
- Treatment with Kesimpta for up to six years continues to be
well tolerated with consistent safety outcomes, supporting the
favorable benefit-risk profile of Kesimpta in
RMS2
EAST
HANOVER, N.J., April 17,
2024 /PRNewswire/ -- Novartis today announced data
from the ALITHIOS open-label extension study showing sustained
efficacy of first-line, continuous Kesimpta® (ofatumumab) treatment
for up to six years in recently diagnosed – defined as starting
treatment within three years of initial diagnosis – treatment-naïve
people living with relapsing multiple sclerosis (RMS).1
These efficacy outcomes included 44% fewer relapses; 96.4% and
82.7% reductions in MRI lesions (Gd+ T1 and neT2), respectively;
and 24.5% and 21.6% fewer 3- and 6-month confirmed disability
worsening (CDW) events, respectively, versus those who switched to
Kesimpta from teriflunomide.1 A separate analysis of the
overall ALITHIOS population showed similar efficacy with continuous
Kesimpta treatment, which was also well-tolerated with a consistent
safety profile up to six years.2 These data will be
presented at the American Academy of Neurology (AAN) 2024 Annual
Meeting held in Denver, Colorado
and virtually on April 13-18,
2024.
"Our analysis of treatment-naïve people who were recently
diagnosed with relapsing multiple sclerosis found that first-line
use of Kesimpta for up to six years provided long-term benefits,
including fewer relapses, profoundly suppressed MRI lesion
activity, and fewer disability worsening events," said principal
investigator Gabriel Pardo, M.D.,
Founding Director of the Multiple Sclerosis Center of Excellence at
Oklahoma Medical Research Foundation. "While measurable
improvements were also seen in patients switching to Kesimpta later
on, the delay in irreversible disability worsening was not fully
realized in the switch group compared to those starting on Kesimpta
first, reinforcing the value of introducing the treatment to
patients earlier."
"We are extremely pleased to share the new data from ALITHIOS,
which adds to the growing body of evidence of Kesimpta as an
efficacious and well-tolerated option for people living with RMS,"
said Norman Putzki, M.D., Development Unit Head, Neuroscience &
Gene Therapy, Development, Novartis Pharmaceuticals Corporation.
"Novartis is committed to addressing the biggest challenges for
people living with MS through relentless discovery, development,
and delivery of potentially transformative medicines with the goal
of achieving complete disease control."
Study Results
In the first analysis, the low
annualized relapse rate (ARR) experienced by recently diagnosed
treatment-naïve (RDTN) people living with RMS receiving continuous
Kesimpta during the core Phase III trials was further reduced in
the ALITHIOS open-label extension study, from 0.104 to 0.050
(52.0% reduction), corresponding to an adjusted ARR of one relapse
per 20 years.1 Rates of 3- and 6-month progression
independent of relapse activity (PIRA) with first-line Kesimpta
were also lower versus switch.1 The observed rapid
increase in the proportion of participants with no evidence of
disease activity (NEDA-3) with continuous first-line Kesimpta
treatment was maintained up to six years.1
In RDTN people living with RMS initially randomized to
teriflunomide, improvements across several efficacy outcomes
were seen after switching to Kesimpta, including significant
reductions in ARR (71.3%) and in MRI lesion activity (Gd+ T1: 98.5%
reduction; neT2: 93% reduction), and rapid increase in rates of
NEDA-3.1 However, rates of 3- and 6-month CDW events
remained higher compared to patients receiving continuous Kesimpta,
indicating that the efficacy benefit of first-line Kesimpta on
delaying disability worsening was not fully achieved in the switch
group.1 Across both continuous and switch groups, nine
out of 10 participants achieved NEDA-3 at Year
6.1
Similar results were seen in the second analysis, which looked
at the overall ALITHIOS population.2 Data showed
sustained efficacy of continuous Kesimpta up to six years,
including low ARR (49.9% reduction between core Phase III trials
and extension phase), suppression of MRI lesion activity (Gd+ T1:
56.7% reduction; neT2: 89.3% reduction), sustained reduction of
6-month CDW events (14.1%, relative to the switch group), lower
rates of 6-month PIRA, and sustained high rates of
NEDA-3.2 People switching from teriflunomide to Kesimpta
experienced reductions in ARR (73.8%) and MRI lesion activity (Gd+
T1: 97.7% reduction; neT2: 91.8% reduction) and a rapid increase in
NEDA-3 rates during the extension period.2 Six-month CDW
rates remained higher compared to patients receiving continuous
Kesimpta, again highlighting an efficacy benefit of first-line
Kesimpta on delaying disability worsening that was not fully
achieved in the switch group.2 At Year 6, NEDA-3 status
was achieved in nine out of 10 participants in both the continuous
and switch groups.2
The study also found that treatment with Kesimpta for up to six
years was well-tolerated with no unexpected safety signals
identified.2 The rates of adverse events (AEs), serious
AEs, serious infections, and malignancies remained stable with no
increased risks over six years.2
The overall rates of AEs and serious AEs up to six years of
Kesimpta treatment were consistent between the core Phase III
trials and the ALITHIOS extension study.2 The most
common AEs were infections (COVID-19 [34.3%], nasopharyngitis
[20.6%], upper respiratory tract infection [14.9%], and urinary
tract infection [14.4%]).2 The incidence of serious
infections remained stable over time and did not increase with
Kesimpta treatment up to six years.2
Mean serum immunoglobulin G (IgG) levels remained stable up to
six years of treatment and the majority of patients (97.2%) had lgG
levels above the lower limit of normal (LLN).2 Mean
serum immunoglobulin M (IgM) levels decreased over time but
remained above the LLN for the majority of patients
(65.9%).2 No clinically meaningful association was
observed between IgG/IgM levels below the LLN and risk of serious
infections.2
About Multiple Sclerosis
Multiple sclerosis (MS) is a
chronic inflammatory disease of the central nervous system
characterized by myelin destruction and axonal damage in the brain,
optic nerves and spinal cord.3 MS, which affects around
2 million people worldwide, can be characterized into four main
types: clinically isolated syndrome (CIS), relapsing-remitting
(RRMS), secondary progressive (SPMS) and primary progressive
(PPMS).4,5 The various forms of MS can be distinguished
based on whether a patient experiences relapses (clearly defined
acute inflammatory attacks of worsening neurological function),
and/or whether they experience progression of neurologic damage and
disability from the onset of the disease.3
About Kesimpta® (ofatumumab)
Kesimpta is a targeted,
precisely dosed and delivered B-cell therapy that provides the
flexibility of self-administration for adults with relapsing forms
of multiple sclerosis (RMS). Kesimpta is the first fully human
anti-CD20 monoclonal antibody (mAb) self-administered by a
once-monthly injection, delivered subcutaneously (SC) in
RMS.6, 7, 8
The treatment regimen was designed and tested to enhance safety
and tolerability and minimize the risk of systemic
injection-related reactions.6 Initial doses of Kesimpta
are at Weeks 0, 1 and 2, with the first injection performed under
the guidance of a healthcare professional. Monthly Kesimpta 20 mg
doses are associated with rapid reduction and near-complete
peripheral B-cell depletion, with no significant effect on
pharmacokinetics due to body weight.6 As shown in
preclinical studies, Kesimpta is thought to work by binding to a
distinct epitope on the CD20 molecule inducing potent B-cell lysis
and depletion.9 The selective mechanism of action and SC
administration of Kesimpta allows precise delivery to the lymph
nodes, where B-cell depletion in MS is needed, and preclinical
studies have shown that it may preserve the B-cells in the
spleen.10
Data from the ASCLEPIOS I/II core studies demonstrate Kesimpta's
efficacy and favorable safety and tolerability profile in RMS
participants and the ALITHIOS open-label extension study provides
additional support with up to 6 years of data.2,11 The
at-home administration of Kesimpta by monthly doses of 20 mg/0.4mL
with an autoinjector (Sensoready®) also matches the preferences of
many people living with MS due to its ease of use and supports
patients to be compliant with, and persistent on the therapy over
time.6 Kesimpta was originally developed by Genmab and
licensed to GlaxoSmithKline; Novartis obtained rights for
ofatumumab from GlaxoSmithKline in all indications, including RMS,
in December 2015.12
Kesimpta has been approved for the treatment of relapsing forms
of multiple sclerosis in over 90 countries worldwide with more than
100,000 patients treated as of March
2024.
Novartis in Neuroscience
At Novartis, in Neuroscience,
we are committed to understanding and solving some of the most
burdensome neurological conditions to improve the quality of life
for patients and their caregivers, and to make a positive impact on
society. We aim to lead the discovery, development and delivery of
innovative medicines to create a transformational impact for people
living with severe neurological conditions by changing the course
of disease progression.
Through innovation, partnerships and community engagement, we
have been tackling neurological conditions for >80 years,
launching transformative treatments which have made meaningful
differences to millions of people worldwide. We continue to
collaborate on the development of industry-leading innovative
medicines for multiple sclerosis, and in the areas of
neuroimmunology, neurodegeneration, and neuromuscular/rare
diseases.
To ensure patients everywhere can benefit from these
life-changing therapies, we work closely with key stakeholders
across the world to ensure rapid access and sustainable
accessibility to our medicines, with the aim of providing the best
treatment choices for each person's unique journey.
KESIMPTA
Indication
KESIMPTA is a prescription medicine used to
treat adults with relapsing forms of multiple sclerosis (MS)
including clinically isolated syndrome (CIS), relapsing-remitting
disease, and active secondary progressive disease.
It is not known if KESIMPTA is safe or effective in
children.
Important Safety Information
Who should not take
KESIMPTA?
Do NOT take KESIMPTA if you:
- have an active hepatitis B virus (HBV) infection.
- have had an allergic reaction to ofatumumab or life-threatening
injection-related reaction to KESIMPTA.
What is the most important information I should know about
KESIMPTA?
KESIMPTA can cause serious side effects such
as:
- Infections. Serious infections, which can be
life-threatening or cause death, can happen during treatment with
KESIMPTA. If you have an active infection, your health care
provider (HCP) should delay your treatment with KESIMPTA until your
infection is gone. KESIMPTA taken before or after other medicines
that weaken the immune system may increase your risk of getting
infections. Tell your HCP right away if you have any infections or
get any symptoms including painful and frequent urination, nasal
congestion, runny nose, sore throat, fever, chills, cough, or body
aches.
- HBV reactivation. If you have ever had HBV infection, it
may become active again during or after treatment with KESIMPTA
(reactivation). If this happens, it may cause serious liver
problems including liver failure or death. Before starting
KESIMPTA, your HCP will do a blood test to check for HBV. They will
also continue to monitor you during and after treatment with
KESIMPTA for HBV. Tell your HCP right away if you get worsening
tiredness or yellowing of your skin or the white part of your
eyes.
- Progressive Multifocal Leukoencephalopathy (PML). PML
may happen with KESIMPTA. PML is a rare, serious brain infection
caused by a virus that may get worse over days or weeks. PML can
result in death or severe disability. Tell your HCP right away if
you have any new or worsening neurologic signs or symptoms. These
may include weakness on one side of your body, loss of coordination
in arms and legs, vision problems, changes in thinking and memory,
which may lead to confusion and personality changes.
- Weakened immune system. KESIMPTA taken before or after
other medicines that weaken the immune system could increase your
risk of getting infections.
Before you take KESIMPTA, tell your HCP about all your
medical conditions, including if you:
- Have or think you have an infection including HBV or PML.
- Have ever taken, currently take, or plan to take medicines that
affect your immune system. These medicines could increase your risk
of getting an infection.
- Have had a recent vaccination or are scheduled to receive any
vaccinations.
- You should receive any required 'live' or 'live-attenuated'
vaccines at least 4 weeks before you start treatment with KESIMPTA.
You should not receive 'live' or 'live-attenuated' vaccines while
you are being treated with KESIMPTA and until your HCP tells you
that your immune system is no longer weakened.
- Whenever possible, you should receive any 'non-live' vaccines
at least 2 weeks before you start treatment with KESIMPTA.
- Talk to your HCP about vaccinations for your baby if you used
KESIMPTA during your pregnancy.
- Are pregnant, think that you might be pregnant, or plan to
become pregnant. It is not known if KESIMPTA will harm your unborn
baby. Females who can become pregnant should use birth control
(contraception) during treatment with KESIMPTA and for 6 months
after your last treatment. Talk with your HCP about what birth
control method is right for you during this time.
- Are breastfeeding or plan to breastfeed. It is not known if
KESIMPTA passes into your breast milk. Talk to your HCP about the
best way to feed your baby if you take KESIMPTA.
Tell your HCP about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements.
How should I use KESIMPTA?
See the detailed
Instructions for Use that comes with KESIMPTA for information about
how to prepare and inject a dose of KESIMPTA and how to properly
throw away (dispose of) used KESIMPTA Sensoready pens or prefilled
syringes.
- Use KESIMPTA exactly as your HCP tells you to use it.
- Your HCP will show you how to prepare and inject KESIMPTA the
right way before you use it for the first time.
- Do not inject into areas where the skin is tender,
bruised, red, scaly or hard. Avoid areas with moles, scars, or
stretch marks.
KESIMPTA may cause serious side effects including:
- Injection-related reactions. Injection-related reactions
are a common side effect of KESIMPTA. Injecting KESIMPTA can cause
injection-related reactions that can happen within 24 hours (1 day)
following the first injections and with later injections. There are
two kinds of reactions:
- at or near the injection site: redness of the skin,
swelling, itching, and pain. Talk to your HCP if you have any of
these signs and symptoms.
- that may happen when certain substances are released in your
body: fever, headache, pain in the muscles, chills, tiredness,
rash, hives, trouble breathing, swelling of the face, eyelids,
lips, mouth, tongue and throat, and feeling faint, or chest
tightness. Contact your HCP right away if you experience any of
these signs and symptoms, especially if they become worse or you
have new severe signs of reactions after subsequent injections. It
could be a sign of an allergic reaction, which can be serious.
- Low immunoglobulins. KESIMPTA may cause a decrease in
some types of antibodies. Your HCP will do blood tests to check
your blood immunoglobulin levels.
The most common side effects of KESIMPTA include:
- Upper respiratory tract infection, with symptoms such as sore
throat and runny nose, and headache.
- Headache.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
Please see full Prescribing Information including Medication
Guide.
Disclaimer
This press release contains forward-looking
statements within the meaning of the United States Private
Securities Litigation Reform Act of 1995. Forward-looking
statements can generally be identified by words such as
"potential," "can," "will," "plan," "may," "could,"
"would," "expect," "anticipate," "look forward," "believe,"
"committed," "investigational," "pipeline," "launch," or similar
terms, or by express or implied discussions regarding potential
marketing approvals, new indications or labeling for the
investigational or approved products described in this press
release, or regarding potential future revenues from such products.
You should not place undue reliance on these statements. Such
forward-looking statements are based on our current beliefs and
expectations regarding future events, and are subject to
significant known and unknown risks and uncertainties. Should one
or more of these risks or uncertainties materialize, or should
underlying assumptions prove incorrect, actual results may vary
materially from those set forth in the forward-looking statements.
There can be no guarantee that the investigational or approved
products described in this press release will be submitted or
approved for sale or for any additional indications or labeling in
any market, or at any particular time. Nor can there be any
guarantee that such products will be commercially successful in the
future. In particular, our expectations regarding such products
could be affected by, among other things, the uncertainties
inherent in research and development, including clinical trial
results and additional analysis of existing clinical data;
regulatory actions or delays or government regulation generally;
global trends toward health care cost containment, including
government, payor and general public pricing and reimbursement
pressures and requirements for increased pricing transparency; our
ability to obtain or maintain proprietary intellectual property
protection; the particular prescribing preferences of physicians
and patients; general political, economic and business conditions,
including the effects of and efforts to mitigate pandemic diseases;
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or actual data security and data privacy breaches, or disruptions
of our information technology systems, and other risks and factors
referred to in Novartis AG's current Form 20-F on file with the US
Securities and Exchange Commission. Novartis is providing the
information in this press release as of this date and does not
undertake any obligation to update any forward-looking statements
contained in this press release as a result of new information,
future events or otherwise.
About Novartis
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medicines company. Every day, we work to reimagine medicine to
improve and extend people's lives so that patients, healthcare
professionals and societies are empowered in the face of serious
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References
- Pardo G, Hauser SL, Bar-Or A, et al. Longer-term (up to 6
Years) Efficacy of Ofatumumab in People with Recently Diagnosed and
Treatment-Naïve Relapsing Multiple Sclerosis. Oral presentation at
the American Academy of Neurology (AAN) 2024 Annual Meeting;
April 13-18, 2024; Denver, CO.
- Wiendl H, Hauser SL, Nicholas J, et al. Longer-term Safety and
Efficacy of Ofatumumab in People With Relapsing Multiple Sclerosis
for Up to 6 Years. Poster presentation at the American Academy of
Neurology (AAN) 2024 Annual Meeting; April
13-18, 2024; Denver,
CO.
- Guthrie EW. Multiple sclerosis: A primer and update. Adv
Studies Pharm. 2007;4(11):313-317.
- Multiple Sclerosis International Federation. Atlas of MS
2013-Mapping Multiple Sclerosis Around the World. Accessed
August 12, 2020.
http://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf
- National MS Society. Types of MS. Accessed January 18, 2023.
https://www.nationalmssociety.org/What-is-MS/Types-of-MS
- Hauser SL, Kappos L, Bar-Or A, et al. The Development of
Ofatumumab, a Fully Human Anti-CD20 Monoclonal Antibody for
Practical Use in Relapsing Multiple Sclerosis Treatment. Neurol
Ther. 2023;12(5):1491-1515.
doi:10.1007/s40120-023-00518-0
- Kesimpta Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals
Corp; September 2022.
- Bar-Or A, Fox E, Goodyear A, et al. Onset of B-cell depletion
with subcutaneous administration of ofatumumab in relapsing
multiple sclerosis: results from the APLIOS bioequivalence study.
Poster presentation at: ACTRIMS; February
2020; West Palm Beach,
FL.
- Smith P, Kakarieka A, Wallstroem E. Ofatumumab is a fully human
anti-CD20 antibody achieving potent B-cell depletion through
binding a distinct epitope. Poster presentation at: ECTRIMS;
September 2016; London, UK.
- Smith P, Huck C, Wegert V, et al. Low-dose, subcutaneous
anti-CD20 therapy effectively depletes B-cells and ameliorates CNS
autoimmunity. Poster presentation at: ECTRIMS; September 2016; London,
UK.
- Cohen, JA, Hauser SL, Zielman R., et al. Effect of Longer-term
Ofatumumab Treatment on Disability Progression and Brain Volume
Change. Poster presentation at: AAN; April
2023; Boston, US.
- Genmab Press Release: Genmab announces completion of agreement
to transfer remaining ofatumumab rights. December 21, 2015. Accessed January 18, 2023.
https://ir.genmab.com/static-files/9d491b72-bb0b-4e46-a792-dee6c29aaf7d
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