Multiple Sclerosis: What's New in MS Treatment Options?
Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on March 24, 2021.
What is Multiple Sclerosis (MS)?
There's good news if you're living with multiple sclerosis (MS): new and easier treatments for MS are being approved at record speeds. In fact, since 2019, six new options have cleared the FDA.
Multiple sclerosis (MS) is a disease that affects the brain, spinal cord, and optic (eye) nerve -- all parts of the central nervous system (CNS).
MS has features of a disease in which the body's immune system attacks the myelin sheaths, which are the protective covering of the nerves. When the myelin is damaged and forms scar tissue -- also called sclerosis -- nerve signals that travel through the CNS are disrupted and lead to the symptoms seen in MS.
The nerve damage that occurs with MS is not reversible, and MS is not curable. However, early treatment with medicine and lifestyle changes can make a positive impact on one's quality of life.
Are There Different Types of MS?
There are four different patterns for MS:
Relapsing-Remitting MS (RRMS)
- RRMS is the most common form of MS, with periods of worsening (also called relapses, flare-ups, or exacerbations) and perioids of full recovery (remissions).
Secondary-Progressive MS (SPMS)
- SPMS typically develops over time and follows RRMS; relapses can occur, but remissions (full recovery periods) do not.
Primary-Progressive MS (PPMS)
- In PPMS, there is no eventual recovery - symptoms slowly worsen with no distinct relapses or remissions. About 15% of people have PPMS.
Progressive-Relapsing MS (PRMS)
- With PRMS, the disease progresses with intermittent relapses, but no remissions. This is the rarest form.
Eventually, over half of RRMS patients will advance into a progressive course.
Am I at Risk for Multiple Sclerosis?
Anyone can get MS, but it occurs most frequently in white women 20 to 40 years old. Overall, younger adults are most at risk, but it can occur in young children and older adults, too.
MS is not a contagious disease and is not directly inherited through the genes; however, some people may have a genetic make-up that causes them to be more susceptible. In general, the risk for MS is greater if you have a strong family history.
Not everyone who gets MS develops severe symptoms; roughly 20% to 40% of patients with MS do not have significant disability 10 years after their diagnosis.
What's Involved with Diagnosis and Treatment of MS?
A neurologist, a specialist doctor that treats disorders of the nervous system, will typically diagnose multiple sclerosis.
- Diagnosis of MS involves a clinical exam by the physician (neurologist).
- Diagnostic tests such as a magnetic resonance imaging (MRI) of the brain and spinal cord will be performed.
- An evaluation of the cerebrospinal fluid (CSF) and certain blood tests may also take place.
Most patients initially present with Relapsing Remitting MS (RRMS), meaning symptoms may come and go over time. Eventually, over half of these RRMS patients will advance into a progressive course, where symptoms worsen with no remission.
Treatment of MS involves three distinct components:
- treatment of the acute attack
- prevention of future attacks
- treatment of symptoms such as bladder dysfunction or depression.
What is an MS Attack or Relapse?
Early multiple sclerosis (MS) is often characterized by specific attacks or relapse, which may be followed by periods of remission (full recovery).
According to the National Multiple Sclerosis Society, an MS attack is defined as the worsening of MS symptoms, and/or the appearance of new symptoms, which lasts at least 24 hours and is separated from a prior exacerbation by at least one month. These flare-ups may come and go; you may go for a year or more without symptoms.
You can tell you are having a flare up if MS symptoms get suddenly worse -- for example, maybe your vision in one eye becomes blurred, or a numbness or tingling in your body may return.
New symptoms can last days, weeks or months, but eventually subside in RRMS. Certain triggers can bring on flare-ups, so avoid these common triggers:
- lack of rest
- alcohol use
- hot weather
More About RRMS and Its Symptoms
Relapsing-Remitting MS (RRMS) is the most common form of multiple sclerosis; a large majority of people are initially diagnosed with this form.
Relapses (attacks) of worsening neurologic functioning are followed by periods of remission in which partial or complete recovery occurs. Some people with RRMS might have just one symptom, while others may have many.
Common symptoms you might have with RRMS include:
- vision problems
- walking problems
- bladder/bowel or sexual dysfunction
- problems with thinking clearly.
Less commonly, problems with speech, swallowing, or breathing may occur. The normal routines of daily life and work -- and one's quality of life -- can be interrupted.
What Treatment Options Are Available for RRMS?
Just over 25 years ago there were no drug treatment options that affected disease progression of MS at all, but today there is a wide variety of FDA-approved medications. Betaseron was approved by the FDA for relapsing‐remitting MS in 1993, becoming the first available drug that affected the underlying disease.
Disease modifying agents, such as beta interferons and newer oral drugs alter the immune system to slow disease progression and reduce attacks. Some treatments also shorten the course of an acute MS attack.
Additional medications may be added to control symptoms such as:
- bladder or bowel problems
- difficulty with movement
Symptoms of MS may come and go, but they can be managed with medications and rehabilitation. MS is not considered life-threatening as most people will live a normal life-span.
Beta Interferon: First Approved Therapy for MS
Beta interferon was the first therapy to be approved for the treatment of relapsing-remitting MS (RRMS).
The beta interferons that are approved for the relapsing forms of MS include:
- Avonex (interferon beta-1a)
- Rebif (interferon beta-1a)
- Betaseron (interferon beta-1b)
- Extavia (interferon beta-1b)
The interferons for MS are given by injection, either by intramuscular or subcutaneous (under the skin) shots, and you can be taught to do this at home for convenience. In addition, some formulations come as a prefilled syringe or autoinjector pen, to ease administration.
Injections are given as often as every other day to only once every two weeks, depending upon the specific drug and dosing directions.
Beta Interferon Side Effects
Side effects with interferons (see Avonex as an example) can be difficult for some people, and may make you less likely to finish treatment, for example:
- flu-like symptoms and injection-site reactions are common with interferons.
- allergic reactions, depression, and liver toxicity are more serious, but less common side effects with interferon beta. You'll need to have blood tests to monitor your liver function.
- some patients may develop antibodies to beta interferon in their blood and become immune to treatment, which may lessen its effect and require a treatment change.
Not every patient experiences the same side effects at the same frequency. Some reactions, like flu-like symptoms, may be more common just at the beginning of treatment.
Be sure to discuss possible treatment side effects and their frequency with your healthcare provider.
Copaxone and Glatopa: Possible First Line Agents
Teva's Copaxone, and Sandoz's Glatopa are both glatiramer products, considered a disease-modifying and immunomodulator agent for relapsing-remitting multiple sclerosis (RRMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).
Glatiramer will not cure MS, but it can make relapses occur less frequently.
Glatopa is a substitutable branded generic version of Copaxone. A generic form of glatiramer from Mylan is also on the market. The generic agents may save you thousands of dollars, especially if you are paying cash. Talk to your healthcare provider about saving options.
Common side effects of glatiramer include:
- injection site reactions
- chest pain
- post-injection reaction (anxiety, chest pain, heart palpitations, shortness of breath, throat constriction, flushing).
Injection side effects typically last 15 to 30 minutes, subside without treatment, and have no known long-term effects.
New Oral MS Medications
Beta interferon preparations or glatiramer (Copaxone) may be the initial multiple sclerosis (MS) therapy chosen by many doctors. The "ABC" drugs (Avonex, Betaseron, and Copaxone) are often the three first-line agents used for long-term treatment of multiple sclerosis (MS).
However, side effects and the inconvenience of injections are often problematic with these treatments, and new oral therapies now provide unique options for patients with relapsing-remitting disease (RRMS) and secondary progressive multiple sclerosis (SPMS).
- Gilenya (fingolimod) was the first FDA-approved oral treatment for MS in 2010.
- It is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in patients 10 years of age and older.
- In 2018, Gilenya received the first FDA approval of a drug to treat MS in pediatric patients.
Other oral therapies that have become available since approval of Gilenya include:
Gilenya is thought to work by preventing white blood cells (lymphocytes) from getting into the central nervous system (CNS) and causing inflammation and damage to nerve cells.
Gilenya has been shown in clinical studies to cut relapses by over half when compared in a one year study to using interferon beta-1a, or compared to placebo over two years. In addition, at one year, 13% more patients on Gilenya were relapse-free when compared to interferon beta-1a (such as Avonex, Rebif). Gilenya has also been shown to slow disease progression and the number of brain lesions on an MRI. Gilenya is manufactured by Novartis.
Common side effects (> 10%) with Gilenya include:
- liver enzyme elevations
- back pain
- abdominal (stomach) pain
- pain in extremity
See other important warnings and side effects, including information about Gilenya use in pregnancy (in more detail).
Aubagio (teriflunomide) works in MS by decreasing inflammation, lowering the number of white blood cells in the central nervous system, and protecting the nerves. It's mechanism is inhibition of dihydroorotate dehydrogenase, an enzyme involved in pyrimidine synthesis.
In clinical trials, when the 14 mg oral dose of Aubagio was compared with placebo, a significant decrease in the three measures of MS activity -- relapses (31% decrease), disability progression (30% decrease), and MRI brain lesions (80% decrease) -- was shown.
Common side effects with Aubagio include:
- thinning hair (alopecia)
- elevated liver function tests
- flu-like symptoms
- numbness or tingling in the hands or feet (paresthesias).
Liver damage, increased risk for infections, and elevated blood pressure are other less common but more serious side effects. You will require regular blood tests to monitor liver function and blood cell counts.
Aubagio Use in Pregnancy
Aubagio effects may remain in the body for 2 years after discontinuing therapy and special treatment to remove the drug may be required. If Aubagio is discontinued, use of contraception should be continued until it is verified that plasma concentrations of teriflunomide are less than 0.02 mg/L (0.02 mcg/mL).
Aubagio can lead to severe birth defects. There are specific directions that women of reproduction potential and men should follow.
Tecfidera (dimethyl fumarate)
Exactly how Tecfidera (dimethyl fumarate) works in MS is not fully understood, but it does activate a chemical pathway in the body that helps to protect nerve cells from damage and inflammation.
Tecfidera has been shown in clinical trials to have positive benefits in MS similar to other treatments: it reduces relapses, helps to delay physical disability progression, and lowers the number of brain lesions. Tecfidera is manufactured by Biogen Idec.
- Over a 2-year study, 27% of people taking Tecfidera experienced relapse compared with 46% of people taking a placebo pill (containing no medicine).
- In addition, 38% fewer people had disability progression compared to those taking placebo, and from 72% to 90% of MRI brain lesions slowed down in development.
Common side effects (> 10%) include: flushing (redness, itching and rash), stomach pain, diarrhea, and nausea. These side effects tend to occur at the beginning of treatment and may subside over time. Taking Tecfidera with food may help to reduce the flushing.
A simple blood test will be performed prior to treatment and regularly thereafter to monitor your white blood cell count. If a serious infection develops, your doctor may withhold treatment until resolved.
In April 2020, Bafiertam (monomethyl fumarate) was cleared by the FDA. Bafiertam is a bioequivalent alternative to Tecfidera (dimethyl fumarate).
Vumerity (diroximel fumarate)
Tecfidera may be too hard on the stomach of some people with multiple sclerosis, and for those patients there's an alternative.
In October 2019 the FDA approved Vumerity (diroximel fumarate) capsules from Biogen/Alkermes to treat relapsing forms of multiple sclerosis (MS) (including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease).
Vumerity has a distinct chemical structure that may cause somewhat less stomach irritation. Once in the body, Vumerity converts to monomethyl fumarate, the same active metabolite of Biogen’s dimethyl fumarate (Tecfidera). It is considered a prodrug.
- In a head-to-head study with dimethyl fumarate (Tecfidera), Vumerity met the primary endpoint of significantly fewer days of key gastrointestinal (GI) symptoms with intensity scores ≥2 on the Individual Gastrointestinal Symptom and Impact Scale (IGISIS).
- The proportion of patients who discontinued the study due to GI side effects during the five-week treatment period were 0.8% for Vumerity and 4.8% for dimethyl fumarate.
Overall, the most common adverse events (AEs) reported in this study for both treatment groups were flushing, diarrhea and nausea (32.8%, 15.4% and 14.6% for Vumerity; 40.6%, 22.3% and 20.7% for Tecfidera).
Tysabri, Lemtrada: For Advancing MS
Tysabri is given every 4 weeks by IV infusion, and can be associated with a rare, but often fatal brain disease known as progressive multifocal leukoencephalopathy (PML).
If you take Tysabri, your doctor might discuss switching you to a disease-modifying MS drug with a lower PML risk if you are or become JCV antibody positive, especially with an antibody index of above 0.9 while on therapy. If you are positive for JCV antibody, it means you may have a higher risk for developing PML with certain drug treatments. Your doctor will test you for this antibody.
Other drugs used in MS that contain PML warnings include: alemtuzumab (Lemtrada), fingolimod (Gilenya), rituximab (Rituxan), ocrelizumab (Ocrevus), dimethyl fumarate (Tecfidera), diroximel fumarate (Vumerity), cladribine (Mavenclad), and siponimod (Mayzent).
Ocrevus & Kesimpta
Ocrevus (ocrelizumab) from Genentech was approved in March 2017.
Ocrevus is a monoclonal antibody that selectively targets CD20-positive B cells.
- It is the first treatment approved for primary progressive multiple sclerosis (PPMS).
- It’s also indicated for relapsing disease (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
- Ocrevus is given as an intravenous (IV) infusion into a vein. Premedication with a corticosteroid and antihistamine required. Ocrevus is given twice a year (every 6 months) dosing after the initial loading dose.
In both forms of MS, Phase III studies indicated that Ocrevus slowed disability and reduce signs of disease activity in the brain (MRI lesions). In the RMS group, annual relapses were lowered by nearly one-half.
Mild to moderate side effects include:
- infusion reactions
- respiratory tract infections
- skin infections
Kesimpta, (ofatumumab), a CD20-directed cytolytic antibody was also approved in August 2020. It is used for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Kesimpta, from Novartis, is the first B-cell therapy intended for patient self-administration at home by once-monthly subcutaneous injection.
Sphingosine-1-Phosphate Receptor Modulators
Secondary progressive MS (SPMS) is a level of MS that occurs after relapsing remitting MS, the first stage. With SPMS, disability steadily gets worse.
Since March of 2019, three new sphingosine-1-phosphate (S1P and S1P1) receptor modulators have been approved to treat relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing remitting disease, and active secondary progressive MS (SPMS). Exactly how these new drugs work is not known, but it is thought S1P and S1P1 modulators bind with key receptors on white blood cells (lymphocytes) in the immune system. This helps to keep the lymphocytes from spreading to your brain and spinal cord where they can cause nerve damage.
In March 2019, the FDA approved once-a-day Mayzent (siponimod) tablets from Novartis to treat adults with relapsing forms of multiple sclerosis (MS).
- Mayzent binds with high affinity to S1P receptors 1 and 5.
- Common side effects with Mayzent (in at least 10% of patients) in studies included headache, high blood pressure and elevated liver function tests.
In March 2020, another oral once-daily S1P receptor modulator, Zeposia (ozanimod) capsules from Bristol-Myers Squibb was approved.
- Zeposia also binds with high affinity to S1P receptors 1 and 5.
- Side effects (in at least 4% of patients) can include upper respiratory infection, liver enzyme elevation, low blood pressure when standing, urinary tract infection, back pain, and high blood pressure.
In March 2021, the FDA approved Janssen’s once-daily oral Ponvory (ponesimod), also for treatment of relapsing forms of multiple sclerosis.
- Ponvory is a S1P1 modulator that binds with high affinity to S1P receptor 1.
- Common side effects (in at least 10% of patients) may include upper respiratory tract infection, liver enzyme elevation, and high blood pressure.
Mavenclad (cladribine) was cleared by the FDA in March 2019, for both relapsing-remitting disease and active secondary progressive disease. Mavenclad is not recommended for MS patients with clinically isolated syndrome or as a first-line agent due to its safety profile.
Mavenclad, from EMD Serono, is classified as a purine antimetabolite. It is thought Mavenclad exerts cytotoxic effects on B and T lymphocytes (white blood cells) through impairment of DNA synthesis, resulting in depletion of lymphocytes. In placebo-controlled studies Mavenclad significantly decreased the number of relapses and the progression of disability.
Commonly reported side effects were upper respiratory tract infections, headache and decreased white blood cell (lymphocyte) counts. Mavenclad should not be used in patients with an active cancer or in pregnant women due to fetal harm.
Learn more: Mavenclad warnings and side effects (in more detail)
Do Disease-Modifying Drugs Help With MS Symptoms?
Disease-modifying drugs may not help you feel better once an attack begins -- but they work to help reduce the chances of an MS attack and help to slow worsening of the disease. Attacks themselves often require different treatments.
- For example, corticosteroids like oral prednisone or IV methylprednisolone (Solu-Medrol) may be used to reduce inflammation in MS.
- Plasma exchange (plasmapheresis) has been used to treat severe symptoms in patients who do not respond to corticosteroids.
- Ampyra (dalfampridine) is an oral potassium channel blocker from Acorda Therapeutics, Inc. Ampyra is shown to improve walking in those with MS, but you should not use this drug if you have a history of seizures or kidney disease. Ampyra, when given at doses greater than that recommended (10 milligrams twice a day), can cause seizures.
A Must: A Healthy Lifestyle for MS Patients
There are lifestyle behaviors and trigger avoidances that can make multiple sclerosis (MS) more manageable. All MS patients should strive towards these goals while working in conjunction with their healthcare team:
- Physical therapy
- Avoid extreme heat or cold
- Eat a healthy, balanced diet
- Don't smoke and avoid second-hand smoke
- Learn about your various medications and ask questions if you do not understand. Read the included patient information with your prescriptions
- Exercise regularly
- Reduce Stress
- Find emotional support
What About the Costs of MS Treatment?
Many treatments for multiple sclerosis (MS) are extremely costly, often running into the tens of thousands of dollars per year. However, you may be able to get help paying for your medications if you do not have adequate insurance coverage.
- Each pharmaceutical company may be able to offer direct patient assistance programs.
- If you do have insurance, be sure to check with your plan to determine their preferred treatments for MS, and the amount of your copay or co-insurance. You will most likely be referred to a specialty pharmacy that can help you with all drug-related issues.
- Plus, don't forget to discuss your financial situation with your doctor and pharmacist who may have advice on medication cost-savings or new generic approvals.
How Do You Determine Which Treatment is Right?
Multiple sclerosis is a complicated condition that requires individualized attention and treatment from a dedicated team of healthcare providers. Decisions about drug treatment are made by weighing your individual factors, for example:
- Your lifestyle
- MS history
- Work and home-life considerations
- Side effect profiles and costs of your treatment options.
Over time, you will want to continue these discussions with your healthcare provider as your condition and treatments evolve. Each person responds to MS treatments in different ways, so a personalized approach is the best way to forge a positive outcome.
While you and your doctor should only make decisions about your medical treatment, consider joining the Drugs.com MS Support Group to ask questions, express concerns, and keep up with the latest medical news.
Finished: Multiple Sclerosis: What's New in MS Treatment Options?
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- Ponvory. FDA Approval History. Drugs.com. Accessed March 24, 2021 at https://www.drugs.com/history/ponvory.html
- Naismith RT, Wundes A, Ziemssen T, et al. Diroximel Fumarate Demonstrates an Improved Gastrointestinal Tolerability Profile Compared with Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III EVOLVE-MS-2 Study. CNS Drugs. 2020;34(2):185–196. doi:10.1007/s40263-020-00700-0
- American Academy of Neurology. Practice Guideline Recommendations. Disease-modifying therapies for adults with multiple sclerosis https://n.neurology.org/content/90/17/777
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- American Academy of Neurology. Practice Guideline Recommendations. Starting Disease-modifying Therapy (DMT) Recommendations. https://www.aan.com/Guidelines/home/GetGuidelineContent/900
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- Biogen. U.S. Prescribing Information. Vumerity (diroximel fumarate). https://www.vumerity.com
- Genzyme. U.S. Prescribing Information. Aubagio (teriflumomide). https://www.aubagio.com/
- Norvartis. U.S. Prescribing Information. Gilenya (fingolimod). https://www.gilenya.com/
- Biogen Idec. U.S. Prescribing Information. Tecfidera (dimethyl fumarate) https://www.tecfidera.com/
- National Multiple Sclerosis Society. What is MS? https://www.nationalmssociety.org/What-is-MS
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.