How important is it to start treatment for relapsing MS?

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The short answer is: You should start treating relapsing multiple sclerosis (MS) as soon as possible after you are diagnosed. Research has shown that this is the best way to slow disease progression.1 With many disease-modifying treatments (DMTs) on the market,2 narrowing down what is important in your journey early on with your healthcare provider (HCP) is critical to feeling confident in your treatment decision.1 Making a plan with your doctor from the start makes good sense, for many reasons.2

The sooner you and your HCP can agree on the appropriate treatment for you, the sooner you can try to slow the progression of relapsing MS.1 The following are things to discuss with your doctor when beginning any DMT.

TAKE NEW LESIONS INTO ACCOUNT3
New lesions can be a “silent” sign that relapsing MS may be getting worse. You may not have symptoms, but your disease may still be active.1 The Consortium of Multiple Sclerosis Centers (CMSC) recommends that people living with relapsing MS have regular MRIs.4 MRI stands for magnetic resonance imaging.5 An MRI can be used to help diagnose relapsing MS and to monitor disease activity.6

Use your first MRI as a baseline and then compare to any MRIs performed after that.5 The MSAA MRI Access Fund [link to www.mymsaa.org] may be able to help eligible patients cover the cost of regular MRIs. Your doctor will use your results to discuss decisions about treatment with you.6

SLOW THE PROGRESSION OF DISABILITY3
Doctors measure disability progression using a test called the Expanded Disability Status Scale, or EDSS.7 Your first score—or your “baseline”—will determine how your disability is gauged moving forward. Changes in your EDSS will show if your relapsing MS is progressing.*8 When your level of disability remains stable that means you may continue doing the things you enjoy for as long as possible.

SMALL CHANGES COULD SIGNAL A NEED7
Disability progression can appear in different ways in the body, such as motor, sensory, bowel and bladder function, vision, speech, balance and mood.1 The goal of relapsing MS treatment should be to slow disability progression.3 Whether you are newly diagnosed or currently on a treatment — talk to your healthcare provider about making this a priority if you are seeing changes in your abilities.9

REDUCING RELAPSES IS KEY3
Staying ahead of relapses is important. All relapses, whether mild or severe, are signs that relapsing MS is active.6 Relapsing MS therapies are unique and each address relapses differently.2 When choosing a DMT, you and your HCP should discuss reducing relapses and the clinical data available for each treatment option.9

AUBAGIO IS A ONCE-DAILY PILL WITH A 15+ YEAR HISTORY THAT’S BEEN STUDIED OVER TIME10,12,13

  • AUBAGIO 14 mg was effective against placebo (pills with no medicine) in 3 key measures: reduced relapses, decreased number of new lesions, and slowed disability progression.†10

WHAT A SMALL CHANGE OVER 7.5 YEARS MEANS

In the original and extension study of Clinical Trial 1, the majority of people taking AUBAGIO 14 mg remained free of disability progression for up to 7.5 years.*†11

Visit AUBAGIO.com for more information and how to prevent relapses and new lesions and prioritize slowing disability progression.

*If your baseline score is ≤5.5, you’re considered to have sustained disability progression if that score goes up by 1 point (lasting at least 12 weeks). If your baseline score is >5.5, you’re considered to have sustained disability progression if that score goes up by at least 0.5 points (lasting at least 12 weeks).8

Clinical Trial 1 (TEMSO) included 1088 people over 2 years. Clinical Trial 2 (TOWER) included 1165 people over 2 years. AUBAGIO 14 mg and 7 mg achieved a significant relative risk reduction in relapse rate in TEMSO (31%, 31%) and TOWER (36%, 22%) versus placebo. AUBAGIO 14 mg and 7 mg significantly decreased the number of new lesions in TEMSO (80%, 57%) versus placebo. 80% of patients in TEMSO and 84% of patients in TOWER remained free from disability progression with AUBAGIO 14 mg versus placebo (73% and 80%, respectively) over 108 weeks. AUBAGIO 7 mg did not achieve statistical significance in either trial. The most common side effects include: headache (16%, 18%, 15%), diarrhea (14%, 13%, 8%), nausea (11%, 8%, 7%), hair thinning or loss (13%, 10%, 5%), and abnormal liver test results (15%, 13%, 9%) for 14 mg, 7 mg, and placebo, respectively.10

INDICATION

AUBAGIO® (teriflunomide) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

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 18007454447, 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.

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Please click here for full Prescribing Information, including boxed WARNING and Medication Guide.

1. Giovannoni G, Butzkueven H, Dhib-Jalbut S, et al. Brain health: time matters in multiple sclerosis. Mult Scler Relat Disord. 2016;9 Suppl 1:S5‐S48. doi: 10.1016/j.msard.2016.07.003. 2. Pardo G, Jones DE. The sequence of disease-modifying therapies in relapsing multiple sclerosis: safety and immunologic considerations. J Neurol. 2017;264(12):2351‐2374. doi:10.1007/s00415-017-8594-9. 3. Giovannoni G, Rhoades RW. Individualizing treatment goals and interventions for people with MS. Curr Opin Neurol. 2012;25(suppl 1):S20‐S27. 4. The Consortium of Multiple Sclerosis Centers. Consortium of MS centers MRI protocol and clinical guidelines for the diagnosis and follow-up of MS. 2018 revised guidelines. https://cdn.ymaws.com/mscare.site-ym.com/resource/collection/9C5F19B9-3489-48B0-A54B-623A1ECEE07B/2018MRIGuidelines_booklet_with_final_changes_0522.pdf. Published February 2018. Accessed May 21, 2020. 5. Edelman RR. The history of MR imaging as seen through the pages of Radiology. Radiology. 2014;273(suppl 2):S181‐S200. doi:10.1148/radiol.14140706. 6. Multiple Sclerosis: Hope Through Research. National Institute of Neurological Disorders and Stroke. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Multiple-Sclerosis-Hope-Through-Research. Published January 7, 2020. Accessed May 21, 2020. 7. Multiple Sclerosis Trust. Expanded Disability Status Scale (EDSS). https://www.mstrust.org.uk/a-z/expanded-disability-status-scale-edss. Updated January 2020. Accessed May 12, 2020. 8. Healy BC, Engler D, Glanz B, Musallam A, Chitnis T. Assessment of definitions of sustained disease progression in relapsing-remitting multiple sclerosis. Mult Scler Int. 2013;2013(189624):1-9. http://dx.doi.org/10.1155/2013/18962. 9. Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2018;90(17):777‐788. doi:10.1212/WNL.0000000000005347. 10. AUBAGIO (teriflunomide) [prescribing information]. Cambridge, MA: Genzyme Corporation. 11. O’Connor P, Comi G, Freedman MS, et al; TEMSO Trial Group and the MRI-AC in Houston, Texas. Long-term safety and efficacy of teriflunomide: nine-year follow-up of the randomized TEMSO study. Neurology. 2016;86(10):920-930. doi:10.1212/WNL.0000000000002441. 12. O’Connor P, Wolinsky JS, Confavreux C, et al; TEMSO Trial Group. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011;365(14):1293-1303. doi:10.1056/NEJMoa1014656. 13. Coyle PK, Khatri B, Edwards KR, et al; Teri-PRO Trial Group. Patient-reported outcomes in relapsing forms of MS: real-world, global treatment experience with teriflunomide from the Teri-PRO study. Mult Scler Relat Disord. 2017;17:107-115. doi:10.1016/j.msard.2017.07.006. 14. Confavreux C, O’Connor P, Comi G, et al; TOWER Trial Group. Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13(3):247-256. doi:10.1016/S1474-4422(13)70308-9. 15. Miller AE, Wolinsky JS, Kappos L, et al; TOPIC Study Group. Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis (TOPIC): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13(10):977-986. doi:10.1016/S1474-4422(14)70191-7.

MAT-US-2007992-v1.0-09/2020
Last Updated: 09/20

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