Vumerity for Multiple Sclerosis

9 min read

Multiple sclerosis (MS) is a chronic autoimmune disorder of the central nervous system (CNS), including the brain, spinal cord, and optic nerves. The body mistakenly attacks and damages the protective coating (called myelin) that surrounds the nerves of your CNS. The damage disrupts the flow of information and nerve signals. Symptoms from MS vary widely and have patterns of relapse (temporary worsening of symptoms) and remission. 

MS is treated with disease-modifying treatments (DMTs) to prevent relapses and manage symptoms. DMTs will not eliminate relapses but may slow progression or worsening of your MS over time. Most medicines for treating MS require an injection; however, newer oral medicines, like Vumerity, provide an easier treatment option. 

Oral options can be more convenient, but they may not be better or worse than other types of MS treatments. The best choice is the one that works well for you and your MS.

Always talk to your health care provider about your options. They can explain more about these medicines and help you decide which might be the best fit for you.

Vumerity is an oral fumarate medicine available for the treatment of MS. It has been shown to be easier on the stomach than other fumarate medicines. Vumerity contains the active ingredient diroximel fumarate. After you take Vumerity, your body changes it into the active ingredient monomethyl fumarate (MMF), which treats your MS.

MMF helps to calm down your overactive immune system. The exact way Vumerity or other fumarate medicines work for MS is not fully known. It is believed that these medicines activate a communication pathway (Nrf2) that protects your cells from oxidative stress. Inflammation in the body causes oxidative stress, which leads to more inflammation. This inflammation damages nerve cells and causes the symptoms of MS. 

Vumerity is a capsule taken twice a day. You will start at a beginning dose (one capsule) twice a day and increase to two capsules twice a day. Your health care provider will tell you when and how to increase the dose. It is important to take it as prescribed by your health care provider. 

The capsule is swallowed whole. Do not crush, chew, or sprinkle the medicine on food. If you eat a meal or snack at the same time you take Vumerity, you should not eat food that is high-fat or high-calorie.  

For medicines that have the same active ingredient, the FDA allows bioequivalence studies to show that both medicines respond the same way in the body.  Bioequivalence basically refers to how your body processes and responds to a medication. Here's a simple way to think about it: Imagine you have two different capsules: One is the original medication, and the other is a slightly different version. Bioequivalence studies compare how your body reacts to these two capsules.

Vumerity is a slightly different version of a medicine called dimethyl fumarate (DMF). The clinical studies used to approve Vumerity were completed with DMF. The results from studies on DMF are important for understanding the effectiveness  of Vumerity. That's because once Vumerity is processed in the body, it changes to the same active ingredient, MMF. Vumerity was then shown to be bioequivalent to DMF.

Two clinical studies compared DMF to placebo (no treatment) for MS. Placebo-controlled studies help researchers see differences in benefit or harm of a medicine when compared with no treatment.

Everyone in the studies had a diagnosis of relapsing-remitting MS and had experienced at least one relapse in the past 1-2 years, had an Expanded Disability Status Score (EDSS) from 0 to 5, and had brain lesions showing on magnetic resonance imaging (MRI). The EDSS tool looks at disability in people with MS and tracks changes over time. Scores of less than 5 represent mild to moderate disease. 

  • Most of the people in the studies were White (78%-85%), with 8-10% Asian, 2% Black, and 6-10% Other.
  • A majority (68%-75%) of the people were female, with the average age of 38 years. 
  • The average time since MS symptoms started was 4-5 years.
  • The average EDSS score was 2.5, which would be mild-to-moderate disease 

Efficacy was measured by the annual relapse rate (ARR) over 2 years. A relapse (also called an attack or exacerbation) is when you experience new MS symptoms or a worsening of existing symptoms that lasts for at least 24 hours. The ARR is a way to measure how often relapses occur in a year. It is like an average of how many relapses a person with MS might have each year.  This means that a treatment group with a higher ARR had more relapses and symptoms. 

The studies also measured the percentage of people with a relapse, percentage of people with worsened disability, and the number of new or newly growing brain lesions on MRI.

In both clinical studies, people who took DMF had a lower ARR compared to people who took placebo. The number of relapses decreased by about 50% compared with placebo. This means that people taking DMF had about half as many MS attacks as those not taking a medicine. The same groups saw a smaller risk of worsening disability and less MRI changes, which suggests that DMF may help slow down the worsening of MS symptoms over 2 years. 

Efficacy Measures

Study 1 (DEFINE)

Study 2 (CONFIRM)

Dimethyl Fumarate

Placebo

Dimethyl Fumarate

Placebo

Annual relapse rate (ARR)

0.172

0.364

0.224

0.401

Percentage with a relapse

27%

46%

29%

41%

Percentage with disability progressing

16%

27%

13%

17%

Average number of new or newly growing brain lesions

2.6

17

5.1

17.4

 

Bioequivalence studies were done to show that Vumerity is processed in the body the same way as DMF and to show if there were less gastrointestinal (GI) side effects.  Bioequivalence was measured by testing the levels of the active ingredient, MMF, in the body in people who took Vumerity compared to people who took DMF.  This was determined by the amount of MMF in the blood, the time it took to convert to MMF, and how long MMF was in the blood was similar.

Since Vumerity has the same active substance (MMF) as dimethyl fumarate, people taking Vumerity may see similar effects on the relapses and symptoms of MS. 

Your results may differ from what was seen in clinical studies. You and your health care provider should determine if the benefits outweigh any potential risks. 

After a few months, you may see improvements in frequency of MS symptoms or number of relapses. This means that you may function better in daily activities because of the following benefits:

  • Decrease in the number of relapses over time
  • Less symptoms or shorter duration of relapses
  • Slowed progression, like fewer new or growing lesions on MRI scans
  • Day-to-day symptoms, like tiredness, numbness, or vision changes, may be less
  • Ability to maintain daily activities in your family or social life

The long-term goal is to slow progression, so it is important to track your symptoms and relapses and review them with your health care provider.

You should not take Vumerity if you are taking another fumarate medicine or have had an allergic reaction to these medicines, like Biafiertam (monomethyl fumarate) and Tecfidera (dimethyl fumarate). 

The most common side effects are flushing and stomach issues, especially at the start of treatment. Call your health care provider if you have the following symptoms and they bother you or do not go away.

Flushing. Vumerity may cause flushing, which is redness, itching or a rash. Taking Vumerity with food may help reduce the symptoms. If you do take with food, do not take with a high-fat or high-calorie meal or snack. Taking aspirin before taking Vumerity may help reduce flushing. Before taking aspirin, talk to your health care provider to make sure that it is appropriate for you.

Stomach problems. Vumerity commonly causes nausea, vomiting, diarrhea, stomach pain, or upset stomach (indigestion). This is usually more common in the first month and should start to go away. Contact your health care provider to determine if an over-the-counter (OTC) medicine, like antacids, may reduce some of the stomach problems. If the symptoms worsen, call your health care provider right away. Signs of serious stomach problems include:

  • Severe nausea or vomiting
  • Vomit with blood that looks like coffee grounds
  • Coughing up blood or blood clots
  • Bright red, black, or tarry poop (stools)
  • Stomach pain that will not go away

These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

Your health care provider may do the following blood tests before and during your treatment due to the risk of side effects. 

Infections. Complete blood count (CBC) is a blood test that can check for infections or other blood disorders. This blood test includes checking white blood cell (WBC) levels. Vumerity may cause a decrease in your WBC levels, also called lymphocytopenia. WBC (or lymphocytes) help protect the body from infections. If you have a decrease in WBCs, you may be at more risk for infections. 

Liver tests. A liver function test (LFT) includes a group of tests that check to see if your liver is damaged. Your health care provider may do this test before starting Vumerity or during treatment. Call your health care provider right away if you have any of the following symptoms of liver damage:

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vaccines, vitamins/minerals, herbal products, and other supplements you are using. 

Do not take Vumerity at the same time as other fumarate medicines like Biafiertam (monomethyl fumarate) or Tecfidera (dimethyl fumarate). All of these have the same active medicine once in the body and could increase the risk of side effects.

Certain foods and alcohol may reduce the way Vumerity works. If you eat a meal or snack at the same time as you take Vumerity, you should not eat food that is high-fat (over 30 grams) or high-calorie (over 700 calories). Your health care provider can help you with healthy options. While taking Vumerity, you should not drink any alcohol at the same time you take Vumerity. Alcohol may decrease the effectiveness of Vumerity or cause more side effects, like flushing. 

This is not a complete list of medicines that may interact with Vumerity. Tell your pharmacist or healthcare provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them determine if there are any interactions or if you need a dosage adjustment.

Your primary care provider or neurologist will prescribe Vumerity. It is a specialty medicine, which is a high-cost medication that is taken for rare, complex, or chronic diseases. It may require a different process than picking up a prescription at your local pharmacy. This process helps you stay on track with your treatment. The manufacturer has a program to help support the process or your insurance company may require a specific pharmacy to fill the prescription. Your health care provider will work with you, your insurance company, and/or the manufacturer to start the process. 

Here are some differences that you may expect. 

Insurance approval. Your insurance may require approval for using this medicine, also called prior authorization. The insurance company reviews the prescription from your health care provider to make sure it is covered and determines the process that needs to be followed. 

Specialty pharmacy. You may be required to use a specialty pharmacy to get your medicine each month. The pharmacist works with your health care provider, insurance company, and/or manufacturer to get you started, helps with instructions on how to take and store the medicine, monitors side effects, and tracks refills. This pharmacy will also work with you on how to get you the medicine, either at a store or through the mail. Your health care provider will work with you and your insurance company on which pharmacy to use and the information that will be provided. 

Cost assistance. There is a copay assistance program from the manufacturer that may allow you to pay $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at www.vumerity.com/en_us/home/biogen-support-services/financial-support.html or by calling 800-456-2255.