Novartis data finds relapsing MS patients on Gilenya® had greater treatment retention and satisfaction rates vs. injectable DMTs

Stuart SchlossmanMS Drug Therapies, MS Research Study and Reports


                                                                  

  


Click here to receive MS news via e-mail






·       In a well-controlled, randomized,
open-label study, Gilenya® patients had higher treatment retention rates at one
year, 81.3% vs. those on injectable DMTs, 29.2%
·       Throughout the study almost 10 times
more patients switched from injectable DMTs to Gilenya® vs. Gilenya® to
injectable DMTs (90.5% vs. 9.5%, respectively)
·       At the end of randomized
treatment, patients on Gilenya® had higher treatment satisfaction and less brain
volume loss vs. patients on injectable DMTs
·       In a separate post hoc
subgroup analysis of African-American patients, treatment retention was greater
with Gilenya® vs. injectable DMTs
EAST
HANOVER, N.J., September 16, 2016 –
Novartis announced new data today from the Prospective, Randomized,
active-controlled, open-label study to Evaluate patient retention of Fingolimod
0.5 mg vs. approved first-line injectable disease-modifying therapies
(interferon ß or glatiramer
acetate), over a period of 12 months
in adults with Relapsing-remitting
Multiple Sclerosis (PREFERMS). PREFERMS included
875 patients and is the largest, prospective, randomized, active-controlled,
open-label study to evaluate patient retention in relapsing-remitting multiple
sclerosis (RRMS) patients.
These data, which included findings from a pre-planned analysis of
the impact of treatment switches and a post hoc analysis of the study’s
African-American patient subgroup, were presented at the annual Congress of the
European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)
in London, UK, September 14-17, 2016. 
Throughout
the study, patients were given the opportunity to switch treatments, and a
substantial number of patients, nearly 10 times as many patients, who were
randomized to injectable disease-modifying therapies (DMTs), switched treatment
to Gilenya® (fingolimod) (90.5%, n=257) than from Gilenya to
injectable DMTs (9.5%, n=27). It’s important to note the study was not powered
to detect the treatment difference in the secondary efficacy endpoints or
treatment effects related to switching study medication.
End
of Randomized Treatment Results
In the
pre-planned analysis at the end of randomized treatment (when patients either
switched or discontinued randomized treatment), significantly more patients
were satisfied with treatment in the Gilenya group compared to the group
receiving injectable DMTs, 77.4% vs. 47.7%, respectively (p<0.0001). Gilenya
also reduced brain volume loss compared with injectable DMTs. At the end of
randomized treatment, the exposure-adjusted mean percentage of brain volume
loss in the Gilenya compared to the injectable DMT group was 0.48% vs. 0.75%,
respectively (p<0.001).
At the end of
randomized treatment, the between-group differences in patient satisfaction and
brain volume loss favored Gilenya over injectable DMTs. By the end of the
study, a high number of patients switched from injectable DMTs to Gilenya
(90.5%, n=257) and the between-group differences became similar. This is
potentially due to the high number of patients who switched from the injectable
DMT group to Gilenya.
“These
additional analyses from our large well-controlled study demonstrate our
ongoing commitment to help improve patient outcomes in MS and address some of
the key challenges healthcare providers face on a day-to-day basis,” said
Marcia Kayath, MD, Vice President and Head of US Clinical Development and
Medical Affairs, Novartis Pharmaceuticals Corporation. “As a leader in
neuroscience, Novartis is committed to advancing research in MS to increase
understanding of our current medicines and bring additional innovative
therapies to patients and physicians.”
Safety
Results
Among the
patients who changed therapy from injectable DMTs to Gilenya, the rates of
overall adverse events (AEs)/per patient-year decreased from 10.854 at end of
randomization to 6.438 at end of study; rates for AEs/per patient-year leading
to discontinuation (1.652 vs. 0.657) and rates of serious AEs/per patient year
remained similar (0.06). Overall, the Gilenya safety
profile was consistent with data from previous studies.
African-American
Patient Subgroup Analysis
While
rates of MS are generally low among African-Americans, the disease course can
be aggressive.
PREFERMS had the largest
African-American cohort of any RRMS study with 136 of 875 patients or 16% of
the overall study population. In a separate post hoc analysis of this
African-American patient subgroup, the treatment retention rate
for Gilenya was 80.6% (54 of
67 patients) compared with 30.4% (21 of 69 patients) for injectable DMTs
(p<0.0001) at the end of randomized treatment. Proportionately more patients
expressed satisfaction with Gilenya than with injectable DMTs, 80.6% vs. 49.3%
(p<0.0001).
Study Design
PREFERMS was a 12-month, Phase IV,
open-label, active-controlled, randomized, multicenter study conducted at 117
sites in the US. At enrollment, patients with RRMS were treatment-naïve or had
received only one
injectable DMT class (IFNβ-1a, IFNβ-1b or
glatiramer acetate). In the study a total of 875 patients were randomized (1:1)
to Gilenya 0.5 mg (n=433) or to a pre-selected injectable DMT (n=428), and
followed up quarterly for 12 months. After a minimum of 3 months of treatment,
a single on-study treatment switch was allowed, however, switches due to
efficacy or safety were allowed (based on patient-doctor consultation) at any
month following randomization. The primary endpoint was to compare the patient
retention on randomized treatment over 12 months. This study was powered for
the primary endpoint (retention rate). The study was not powered to detect the
treatment difference in the secondary efficacy endpoints or treatment effects
related to switching study medication.
About Multiple Sclerosis
Multiple
sclerosis, a chronic disease of the central nervous system, affects around
400,000 people in the US. Approximately 85 percent of people with MS have
relapsing-remitting MS, where the immune system attacks healthy tissue. This
form of MS is a potentially debilitating condition characterized
by relapses with worsening neurological
function, followed by periods of remission where patients partially or fully
recover, during which the disease remains stable.
About Gilenya
Gilenya was the
first once-a-day pill approved to treat relapsing forms of multiple sclerosis
(RRMS). Approved for first-line use, Gilenya is a disease-modifying therapy
(DMT) that offers freedom from injections, which may fit many patients’
lifestyles. Gilenya helps slow down the physical problems caused by RRMS and
decreases the frequency of MS flare-ups (relapses).
Gilenya is the
most prescribed oral once-daily DMT. In the US, more than 64,000 patients have
been exposed to Gilenya. Worldwide,
Gilenya has been used
to treat approximately 155,000 patients in both clinical trials and the
post-marketing setting, with approximately 343,000 years of patient experience
.
Indication
Gilenya
is a prescription medicine
used to treat relapsing forms of multiple sclerosis (MS) in adults. Gilenya can
decrease the number of MS flare-ups (relapses). Gilenya does not cure MS, but
it can help slow down the physical problems that MS causes.
Important
Safety Information
You
should not take Gilenya if in the last 6 months you experienced heart attack,
unstable angina, stroke or warning stroke, or certain types of heart failure.
Do not take Gilenya if you have an irregular or abnormal heartbeat
(arrhythmia), including a heart finding called prolonged QT as seen on an ECG,
or if you take medicines that change your heart rhythm. Do not take Gilenya if
you are allergic to fingolimod or any of the other ingredients.
Gilenya
may cause side effects such as:
  • Slow
    heart rate, especially after first dose. You will be monitored by a health
    care professional for at least 6 hours after your first dose. Your pulse
    and blood pressure will be checked hourly. You’ll get an ECG before and 6
    hours after your first dose. If any heart problems arise or your heart
    rate is still low, you’ll continue to be monitored. If you have any
    serious side effects, especially those that require treatment with other
    medicines, or if you have certain types of heart problems, or if you’re
    taking medicines that can affect your heart, you’ll be watched overnight.
    If you experience slow heart rate, it will usually return to normal within
    1 month. Call your doctor, or seek immediate medical attention if you have
    any symptoms of slow heart rate, such as feeling dizzy or tired or feeling
    like your heart is beating slowly or skipping beats. Symptoms can happen
    up to 24 hours after the first dose. Do not stop taking Gilenya without
    consulting with your doctor. Call your doctor if you miss 1 or more doses
    of Gilenya—you may need to repeat the 6-hour monitoring.
  • Increased
    risk of serious infections. Gilenya lowers the number of white blood cells
    (lymphocytes) in your blood. This will usually go back to normal within 2
    months of stopping Gilenya. Your doctor may do a blood test before you
    start Gilenya. Gilenya may decrease the way vaccines work in your body,
    especially the chicken pox vaccine. Increased risk of infection was seen
    with doses higher than the approved dose (0.5 mg). Two patients died who
    took higher-dose Gilenya (1.25 mg) combined with high-dose steroids. Call your
    doctor right away if you have fever, tiredness, body aches, chills,
    nausea, vomiting, or headache accompanied by fever, neck stiffness,
    sensitivity to light, nausea, and/or confusion. These may be symptoms of
    meningitis.
  • Progressive multifocal leukoencephalopathy
    (PML). PML is a rare brain infection that usually leads to death or severe
    disability. If PML happens, it usually happens in people with weakened
    immune systems. It is important that you call your doctor right away if
    you have any new or
    worsening medical problems that
    have lasted several days, including problems with thinking, eyesight,
    strength, balance, weakness on 1 side of your body, or using your arms and
    legs.
  • Macular edema, a vision problem that can cause some of
    the same vision symptoms as an MS attack (optic neuritis), or no symptoms.
    If it happens, macular edema usually starts in the first 3 to 4 months
    after starting Gilenya. Your doctor should test your vision before you
    start Gilenya; 3 to 4 months after you start Gilenya; and any time you
    notice vision changes. Vision problems may continue after macular edema
    has gone away. Your risk of macular edema may be higher if you have
    diabetes or have had an inflammation of your eye (uveitis). Call your
    doctor right away if you have blurriness, shadows, or a blind spot in the
    center of your vision; sensitivity to light; or unusually colored vision.
  • Swelling and narrowing of the blood vessels in your
    brain. A condition called PRES (Posterior reversible encephalopathy
    syndrome) has occurred rarely in patients taking Gilenya. Symptoms of PRES
    usually get better when you stop taking Gilenya. However, if left
    untreated, it may lead to a stroke. Call your doctor right away if you
    experience any symptoms, such as sudden headache, confusion, seizures, loss
    of vision, or weakness.
  • Breathing problems. Some patients have shortness of
    breath. Call your doctor right away if you have trouble breathing.
  • Liver problems. Your doctor should do blood tests to
    check your liver before you start Gilenya. Call your doctor right away if
    you have nausea, vomiting, stomach pain, loss of appetite, tiredness, dark
    urine, or if your skin or the whites of your eyes turn yellow.
  • Increases in blood pressure (BP). BP should be
    monitored during treatment.
  • A type of skin cancer called basal cell carcinoma
    (BCC). Talk to your doctor if you notice any skin nodules (shiny, pearly
    nodules), patches or open sores that do not heal within weeks. These may
    be signs of BCC.
Gilenya may harm your unborn baby. Talk to your doctor if you are pregnant
or planning to become pregnant. Women who can become pregnant should use
effective birth control while on Gilenya, and for at least 2 months after
stopping. If you become pregnant while taking Gilenya, or within 2 months after
stopping, tell your doctor right away. Women who take Gilenya should not
breastfeed, as it is not known if Gilenya passes into breast milk. A pregnancy
registry is available for women who become pregnant during Gilenya treatment.
For more information, contact the Gilenya Pregnancy Registry by calling
Quintiles at 1-877-598-7237, by e-mailing
gpr@quintiles.com, or by going to www.gilenyapregnancyregistry.com.
Tell your doctor about all your medical conditions, including if
you had or now have an irregular or abnormal heartbeat; heart problems; a
history of repeated fainting; a fever or infection, or if you are unable to
fight infections due to a disease or are taking medicines that lower your
immune system, including corticosteroids, or have taken them in the past; eye
problems; diabetes; breathing or liver problems; or uncontrolled high blood
pressure. Also tell your doctor if you have had chicken pox or have received
the chicken pox vaccine. Your doctor may test for the chicken pox virus, and
you may need to get the full course of the chicken pox vaccine and wait 1 month
before starting Gilenya.
If you take too much Gilenya, call your doctor or go to the nearest
hospital emergency room right away.
Tell your doctor about all the medicines you take or have recently
taken, including prescription and over-the-counter medicines, vitamins, and
herbal supplements. Tell your doctor if you have been vaccinated within 1 month
before you start taking Gilenya. You should not get certain vaccines, called
live attenuated vaccines, while taking Gilenya and for at least 2 months after
stopping Gilenya treatment.
The
most common side effects with Gilenya were headache, abnormal liver tests,
diarrhea, cough, flu, sinusitis, back pain, abdominal pain, and pain in arms or
legs.
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.
Disclaimer
The
foregoing release contains forward-looking statements that can be identified by
words such as “potentially,” “commitment,” “committed,” “may,” “innovative,” or
similar terms, or by express or implied discussions regarding potential new
indications or labeling for Gilenya, potential marketing approvals for any
investigational therapies for MS being developed at Novartis, or regarding
potential future revenues from Gilenya and such investigational therapies for
MS. You should not place undue reliance on these statements. Such
forward-looking statements are based on the current beliefs and expectations of
management 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 Gilenya will be submitted or
approved for any additional indications or labeling in any market, or at any
particular time. Neither can there be any guarantee that any investigational
therapies for MS being developed at Novartis will be submitted or approved for
sale in any market, or at any particular time. Nor can there be any guarantee
that Gilenya or any investigational therapies for MS being developed at
Novartis will be commercially successful in the future. In particular,
management’s expectations regarding Gilenya and such investigational therapies
for MS could be affected by, among other things, the uncertainties inherent in
research and development, including unexpected clinical trial results and
additional analysis of existing clinical data; unexpected regulatory actions or
delays or government regulation generally; the company’s ability to obtain or
maintain proprietary intellectual property protection; general economic and
industry conditions; global trends toward health care cost containment,
including ongoing pricing pressures; unexpected safety, quality or
manufacturing issues, 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
Novartis Pharmaceuticals
Corporation offers a broad range of medicines for cancer, cardiovascular
disease, endocrine disease, inflammatory disease, infectious disease,
neurological disease, organ transplantation, psychiatric disease, respiratory disease
and skin conditions. 
Located
in East Hanover, NJ Novartis Pharmaceuticals Corporation is an affiliate of
Novartis AG, which provides
innovative healthcare solutions that address the evolving needs of patients and
societies. Headquartered in Basel, Switzerland, Novartis offers a diversified
portfolio to best meet these needs: innovative medicines, eye care and
cost-saving generic pharmaceuticals. Novartis is the only global company with
leading positions in these areas. In 2015, the Group achieved net sales of USD
49.4 billion, while R&D throughout the Group amounted to approximately USD
8.9 billion (USD 8.7 billion excluding impairment and amortization charges).
Novartis Group companies employ approximately 118,000 full-time-equivalent
associates. Novartis products are available in more than 180 countries around
the world. For more information, please visit
http://www.novartis.com.
Novartis is on
Twitter. Sign up to follow @Novartis at
http://twitter.com/novartis
For Novartis
multimedia content, please visit
www.novartis.com/news/media-library
For questions about the site or required registration, please contact media.relations@novartis.com
# # #
Novartis Media Relations
Central media
line: +41 61 324 2200
Eric Althoff
Novartis
Global Media Relations
+41 61 324
7999 (direct)
+41 79 593
4202 (mobile)
Christine Cascio
Novartis Pharmaceuticals Corporation
+1 862 778 8026 (direct)
+1 862 926 7992 (mobile)
Novartis Investor Relations
Central
investor relations line: +41 61 324 7944
Central
North
America
Samir
Shah
+41
61 324 7944
Richard
Pulik
+1
212 830 2448
Pierre-Michel
Bringer
+41
61 324 1065
Sloan
Pavsner
+1
212 830 2417
Thomas
Hungerbuehler
+41
61 324 8425
Isabella
Zinck
+41
61 324 7188





MS Views and News
Providing educational information, resources and services for those affected by MS


Visit our MS Learning Channel on YouTube: http://www.youtube.com/msviewsandnews