Multiple Sclerosis: What’s New in MS Treatment Options?

Medically reviewed by L. Anderson, PharmD. Last updated on Apr 27, 2018.

Multiple sclerosis (MS) is a disease that affects the brain, spinal cord, and optic (eye) nerve, all part 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.

There are four different patterns for MS:

RRMS is the most common form of MS, with periods of worsening (also called relapses, flare-ups, or exacerbations) and full recovery (remissions).

SPMS usually develops over time and follows RRMS; relapses can occur, but not remissions.

In PPMS, there is no eventual recovery - symptoms slowly worsen with no distinct relapses or remissions.

In PRMS, the disease progresses with intermittent relapses, but no remissions.

Anyone can get MS, but it occurs most frequently in white women 20 to 40 years old. In fact, young 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.

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.

A neurologist will typically diagnose multiple sclerosis.

Diagnosis of MS involves a clinical exam by the physician (neurologist), as well as diagnostic tests such as a magnetic resonance imaging (MRI) of the brain and spinal cord. 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:

Early multiple sclerosis (MS) is often characterized by specific attacks or relapse, which may be followed by periods of remission.

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.

can bring on flare-ups, so avoid these triggers.

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:

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.

Just over 20 years ago there were no drug treatment options for MS at all, but today there is a wide variety of FDA-approved medications.

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:

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 was the first therapy to be approved for the treatment of relapsing-remitting MS (RRMS).

The beta interferons include:

and all are approved for the relapsing forms of MS.

Betaseron was first approved in 1993. Peginterferon beta-1a (Plegridy) was approved in 2014 and has a longer duration of action.

These drugs 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.

Side effects with interferons can be difficult, and may make you less likely to finish treatment.

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.

Teva's Copaxone, and Sandoz's Glatopa are both glatiramer products, considered a disease-modifying agent for RRMS.

Glatopa is a substitutable generic version of Copaxone and only available in the 20 mg/mL dose. The generic agent may save you thousands of dollars.

Common side effects with glatiramer include:

Injection side effects typically last 15 to 30 minutes, subside without treatment, and have no known long-term effects.

Beta interferon preparations or glatiramer (Copaxone) may be the initial multiple sclerosis (MS) therapy chosen by many doctors. 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 RRMS.

Gilenya (fingolimod) was the first FDA-approved oral treatment for MS in 2010.

Other oral therapies that have become available since Gilenya include:

The following slides outline benefits and possible side effects with these oral agents.

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 clincial 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.

Gilenya has also been shown to slow disease progression and the number of brain lesions on an MRI.

Gilenya is manufactured by Novartis.

According to the 2018 American Academy of Neurology guidelines, clinicians should prescribe fingolimod for people with highly active MS.

Common side effects with Gilenya may include:

Macular edema, a swelling of an area of the retina responsible for central vision has been reported, as well, but this is an uncommon side effect.

First -Dose Monitoring

Patients with a history of heart disease may not be able to use Gilenya; initiation of treatment can lead to a decrease in heart rate (bradycardia). In 2012, Gilenya prescribing information was revised to require patients to be monitored with a heart ECG before and 6 hours after the first dose of Gilenya, in addition to hourly measurements of blood pressure and pulse. Additional monitoring may be needed based on specific circumstances outlined in the labeling.

Reinitiation of Therapy Following Discontinuation

If a patient stops taking Gilenya for more than 14 days after their first month of treatment, they will need to repeat this first dose monitoring observation. If treatment is stopped within the first 4 weeks of treatment, additional monitoring is also needed as outlined in the product label.

Aubagio works by decreasing inflammation, lowering the number of white blood cells in the CNS, and protecting nerves in MS.

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.

The manufacturer of Aubagio, Genzyme, warns not to take Aubagio if:

Common side effects with Aubagio include:

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 is it verified that plasma concentrations of teriflunomide are less than 0.02 mg/L (0.02 mcg/mL).

Exactly how Tecfidera 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:

Over a 2-year study, 27% of people taking Tecfidera experienced relapse compared with 46% of people taking placebo. 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.

Tecfidera appears to be tolerable from a side effect standpoint; common side effects include:

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 the white blood cell count. If a serious infection develops, the provider may withhold treatment until resolved.

Tecfidera is manufactured by Biogen Idec.

Tysabri (natalizumab), and Lemtrada (alemtuzumab) are generally reserved for relapsing patients who cannot tolerate or have had a poor response to other MS drugs.

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). Clinicians may initiate natalizumab treatment in people with MS with positive anti-JCV antibody indexes above 0.9 only when there is a reasonable chance of benefit compared with the low but serious risk of PML, based on 2018 American Academy of Neurology guidelines.

Other drugs that may be associated with PML include: fingolimod (Gilenya), rituximab (Rituxan), ocrelizumab (Ocrevus), and dimethyl fumarate (Tecfidera).

Natalizumab may also be linked with antibodies in people with MS and may lead to allergies or to reduced effectiveness of the medication. Stopping natalizumab results in an increased risk of MS relapse or MRI-detected disease activity within six months of discontinuation; however, switching to other agents may be possible.

Lemtrada has a unique dosing schedule of two annual IV infusion treatments, but contains a boxed warning for serious side effects, including:

According to the 2018 American Academy of Neurology guidelines, clinicians should prescribe natalizumab or alemtuzumab for people with highly active MS.

Zinbryta (daclizumab) was used to treat relapsing forms of multiple sclerosis. However, in March 2018, Biogen and AbbVie announced the voluntary worldwide withdrawal for Zinbryta for relapsing multiple sclerosis due to serious adverse events.

Mitoxantrone, a cancer drug available generically since 2006, is an option for patients with worsening RRMS, progressive-relapsing MS, or secondary-progressive MS to help reduce the number of flare-ups and to lessen disability. However, the American Academy of Neurology in 2018 noted that because of the high frequency of severe side effects, clinicians should not prescribe mitoxantrone to people with MS unless the potential therapeutic benefits greatly outweigh the risks.

Possible severe side effects include:

Mitoxantrone is given 4 times a year by IV infusion in a medical clinic, and heart function must be tested regularly. The total lifetime dose is limited due to potential heart damage.

Common side effects may also include stomach upset and fatigue.

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); its also indicated for relapsing disease (RMS). Ocrevus is given as an intravenous (IV) infusion into a vein.

In 2018 guidelines, the American Academy of Neurology stated that clinicians should offer ocrelizumab to people with PPMS who are likely to benefit from this therapy unless there are risks of treatment that outweigh the benefits.

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:

Not really. Disease-modifying drugs may not help you feel better once an attack begins -- but they work to help reduce the chances for an MS attack to start and to slow progression 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.

Plasma exchange (plasmapheresis) has been used to treat severe symptoms in patients who do not respond to corticosteroids.

Ampyra is an oral potassium channel blocker from Acorda Therapeutics, Inc. approved in 2010. Ampyra (dalfampridine) is an MS medication 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.

There are several investigational drugs in late-phase studies for the treatment of patients with relapsing or progressive multiple sclerosis. They cover a variety of mechanisms of action, and have demonstrated encouraging results in some, but not all, clinical trials.

Laquinimod (Teva Pharmaceutical Industries Ltd. and Active Biotech)

Ozanimod (Celgene Corporation)

Anti-LINGO-1 (Biogen)

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 physicians, nurses, pharmacists, physical therapists, and other healthcare providers:

Ask your doctor for the latest vitamin D information in MS. Several clinical trials are now testing vitamin D against MS. One small study of only 40 people has shown that high dose vitamin D (~10,000 IU per day) for six months reduced immune cells linked to relapsing MS. A clinical effect, like slowing progression or reducing relapses, was not evaluated.

Plus, a another study suggests (but does not prove) that newborns with low levels of vitamin D may be at greater risk of developing multiple sclerosis (MS) later in life.

Many treatments for multiple sclerosis (MS) are extremely costly, often running $30,000 to $50,000 per year. However, you may be able to get help paying for your medications if you do not have adequate insurance coverage.

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:

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Multiple Sclerosis: What's New in MS Treatment Options?