– In the Phase 4 Teri-PRO study, patients switching to Aubagio
from other disease-modifying treatments reported a significant increase
in treatment satisfaction –
Company Website:
http://www.sanofigenzyme.com
CAMBRIDGE, Mass. -- (Business Wire)
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. INDICATION
AUBAGIO®
(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 Sanofi
Sanofi, 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® areregistered
trademarks of Sanofi. Genzyme® is a registered trademark of
Genzyme Corporation. All rights reserved.
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Contacts:
Sanofi Genzyme Media Relations
Erin Pascal, + 1 857-248-0874
erin.pascal@genzyme.com
or
Sanofi
Media Relations
Jack Cox, +33 (0) 1 53 77 46 46
mr@sanofi.com
or
Sanofi
Investor Relations
George Grofik, +33 (0) 1 53 77 45 45
ir@sanofi.com
Source: Sanofi Genzyme
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