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Press Release

Results from 1,000-Patient, Global Real-World Patient-Reported Outcomes Study of Sanofi Genzyme’s Aubagio® (teriflunomide) in Patients with Relapsing Multiple Sclerosis Demonstrate High Levels of Treatment Satisfaction

Sanofi Genzyme
Posted on: 15 Sep 16

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.

Sanofi Forward-Looking Statements
This 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 "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that 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 statements. These risks and uncertainties include among other 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 candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation 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 thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160915005910/en/

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Last updated on: 15/09/2016

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