– In the Phase 4 Teri-PRO study, patients
switching to Aubagio from other disease-modifying treatments
reported a significant increase in treatment satisfaction –
Sanofi Genzyme, the specialty care global business unit of
Sanofi, today announced positive new real-world data from the Phase
4 Teri-PRO (Patient Reported Outcomes) study of
Aubagio® (teriflunomide), a once-daily, oral treatment
for relapsing forms of multiple sclerosis (MS). These results will
be presented today at the 32nd Congress of the European Committee
for Treatment and Research in Multiple Sclerosis (ECTRIMS) in
London.
Teri-PRO was a prospective, global, multicenter, single-arm,
open-label study, with a primary outcome measure of global
satisfaction of Aubagio as measured by the TSQM (Treatment
Satisfaction Questionnaire for Medication) Version 1.4 at Week 48.
The TSQM 1.4 includes 14 questions intended to assess patients’
satisfaction with a medication, providing scores between 0 – 100 in
four domains: global satisfaction, effectiveness, side effects, and
convenience. A higher TSQM score indicates greater patient-reported
treatment satisfaction in that domain.
Patients with relapsing forms of MS were recruited from the
United States, Canada, Europe and Latin America. A total of 1,000
patients were treated in the study; 928 patients received Aubagio
14 mg, and 72 patients received Aubagio 7 mg (U.S. only). TSQM
scores were assessed at Week 4 and at Week 48 in all patients; and
at baseline, at Week 4 and at Week 48 in patients switching to
Aubagio from another disease-modifying treatment (DMT).
- At Week 4 and at Week 48, high mean
treatment satisfaction scores were observed with Aubagio for all
patients in the study, across all four domains: global satisfaction
72.3 / 68.2; effectiveness 67.1 / 66.3; side effects 88.4 / 84.1;
and convenience 92.3 / 90.4.
- In patients switching to Aubagio from
other DMTs, significant improvements in patient treatment
satisfaction were observed from baseline to Week 4 in all four
domains (p< 0.0001 for all domains), and these improvements were
maintained at Week 48. Mean scores at baseline / Week 48 were:
global satisfaction 53.4 / 69.7; effectiveness 58.4 / 68.5; side
effects 65.2 / 84.8 and convenience 58.4 / 90.4 (all
p<0.0001).
Most patients in the study also reported stable or improved
quality of life, as measured by the Multiple Sclerosis
International Quality of Life (MusiQoL) questionnaire. The MusiQoL
consists of 31 questions, divided into nine dimensions. Higher
scores reflect higher quality of life in that dimension. The total
MusiQoL score reflecting all nine dimensions significantly improved
compared to baseline (baseline: 67.7; Week 48: 69.2; p=0.0029).
“Teri-PRO provides important real-world data from 1,000 patients
globally. Patients taking Aubagio experienced high treatment
satisfaction, whether they were treatment-naïve or switching from
another DMT,” said Patricia K. Coyle, M.D., Director of the MS
Comprehensive Care Center at Stony Brook, New York. “In addition,
the secondary outcome finding of the study suggesting stable or
improved quality of life is very promising.”
In the Phase 4 Teri-PRO study, the real-world safety and
tolerability data for Aubagio were consistent with those previously
observed in the clinical development program. Hair thinning,
diarrhea, and alanine aminotransferase increases were reported in
230 (23 percent), 173 (17.3 percent), and 63 (6.3 percent)
patients, respectively. Most cases were mild to moderate, occurred
in the first few months of treatment, resolved or stabilized over
the course of the study and generally did not lead to treatment
discontinuation. Serious adverse events (SAEs) were reported in
12.7 percent of patients; the only SAE occurring in ≥1 percent of
patients was MS relapse (2.1 percent). Adverse events leading to
treatment discontinuation were reported in 10.9 percent of
patients; of these, diarrhea and MS relapse led to discontinuation
in >1 percent of patients (1.7 percent and 1.2 percent of
patients, respectively.)
About Aubagio® (teriflunomide)Aubagio
is approved in more than 60 countries, with additional marketing
applications under review by regulatory authorities globally. More
than 60,000 people have been treated with Aubagio worldwide.
Aubagio is an immunomodulator with anti-inflammatory properties.
Although the exact mechanism of action for Aubagio is not fully
understood, it may involve a reduction in the number of activated
lymphocytes in the central nervous system (CNS). Aubagio is
supported by one of the largest clinical programs of any MS
therapy, with more than 5,000 trial participants in 36
countries.
Aubagio® (teriflunomide) U.S.
INDICATIONAUBAGIO® (teriflunomide) is a prescription medicine
used to treat relapsing forms of multiple sclerosis (MS).
IMPORTANT SAFETY INFORMATION
DO NOT TAKE AUBAGIO IF YOU:
- Have severe liver problems. AUBAGIO
may cause serious liver problems, which can be
life-threatening. Your risk may be higher if you take other
medicines that affect your liver. Your healthcare provider should
do blood tests to check your liver within 6 months before you start
AUBAGIO and monthly for 6 months after starting AUBAGIO. Tell your
healthcare provider right away if you develop any of these symptoms
of liver problems: nausea, vomiting, stomach pain, loss of
appetite, tiredness, yellowing of your skin or whites of your eyes,
or dark urine.
- Are pregnant. AUBAGIO may harm an
unborn baby. You should have a pregnancy test before starting
AUBAGIO. After stopping AUBAGIO, continue to use effective birth
control until you have made sure your blood levels of AUBAGIO are
lowered. If you become pregnant while taking AUBAGIO or within 2
years after stopping, tell your healthcare provider right away and
enroll in the AUBAGIO Pregnancy Registry at 1-800-745-4447, option
2.
- Are of childbearing potential and
not using effective birth control.
It is not known if AUBAGIO passes into breast milk. Your
healthcare provider can help you decide if you should take AUBAGIO
or breastfeed — you should not do both at the same time.
If you are a man whose partner plans to become pregnant,
you should stop taking AUBAGIO and talk with your healthcare
provider about reducing the levels of AUBAGIO in your blood. If
your partner does not plan to become pregnant, use effective birth
control while taking AUBAGIO.
- Have had an allergic reaction to
AUBAGIO or a medicine called leflunomide
- Take a medicine called leflunomide
for rheumatoid arthritis.
AUBAGIO may stay in your blood for up to 2 years after you
stop taking it. Your healthcare provider can prescribe a
medicine that can remove AUBAGIO from your blood quickly.
Before taking AUBAGIO, talk with your healthcare provider if
you have: liver or kidney problems; a fever or infection, or if
you are unable to fight infections; numbness or tingling in your
hands or feet that is different from your MS symptoms; diabetes;
serious skin problems when taking other medicines; breathing
problems; or high blood pressure. Your healthcare provider will
check your blood cell count and TB test before you start AUBAGIO.
Talk with your healthcare provider if you take or are planning to
take other medicines (especially medicines for treating cancer or
controlling your immune system), vitamins or herbal
supplements.
AUBAGIO may cause serious side effects, including:
reduced white blood cell count — this may cause you to have more
infections; numbness or tingling in your hands or feet that is
different from your MS symptoms; allergic reactions, including
serious skin problems; breathing problems (new or worsening) and
high blood pressure. Patients with low white blood cell count
should not receive certain vaccinations during AUBAGIO treatment
and 6 months after.
Tell your doctor if you have any side effect that bothers you or
does not go away.
The most common side effects when taking AUBAGIO include:
headache; diarrhea; nausea; hair thinning or loss; and abnormal
liver test results. These are not all the side effects of
AUBAGIO. Tell your healthcare provider about any side effect that
bothers you.
Consult your healthcare provider if you have questions about
your health or any medications you may be taking, including
AUBAGIO.
You are encouraged to report 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 boxed WARNING and Medication Guide.
About SanofiSanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi is organized into five global business
units: Diabetes and Cardiovascular, General Medicines and Emerging
Markets, Sanofi Genzyme, Sanofi Pasteur and Merial.
Sanofi Genzyme focuses on developing specialty treatments for
debilitating diseases that are often difficult to diagnose and
treat, providing hope to patients and their families. Learn more
at www.sanofigenzyme.com
Sanofi® and Aubagio® are registered trademarks of Sanofi.
Genzyme® is a registered trademark of Genzyme Corporation. All
rights reserved.
Sanofi Forward-Looking StatementsThis press release
contains forward-looking statements as defined in the Private
Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates and their
underlying assumptions, statements regarding plans, objectives,
intentions and expectations with respect to future financial
results, events, operations, services, product development and
potential, and statements regarding future performance.
Forward-looking statements are generally identified by the words
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"plans" and similar expressions. Although Sanofi's management
believes that the expectations reflected in such forward-looking
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forward-looking information and statements are subject to various
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
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things, the uncertainties inherent in research and development,
future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMA,
regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
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future approval and commercial success of therapeutic alternatives,
Sanofi's ability to benefit from external growth opportunities
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and the ultimate outcome of such litigation, trends in exchange
rates and prevailing interest rates, volatile economic conditions,
the impact of cost containment initiatives and subsequent changes
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AMF made by Sanofi, including those listed under "Risk Factors" and
"Cautionary Statement Regarding Forward-Looking Statements" in
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2015. Other than as required by applicable law, Sanofi does not
undertake any obligation to update or revise any forward-looking
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Sanofi Genzyme Media RelationsErin Pascal, + 1
857-248-0874erin.pascal@genzyme.comorSanofi Media
RelationsJack Cox, +33 (0) 1 53 77 46
46mr@sanofi.comorSanofi Investor RelationsGeorge Grofik, +33
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