Over 2.3 million people worldwide are living with relapsing multiple sclerosis (RMS), and close to half of those are in the US. Unlike some other debilitating diseases, RMS impacts every patient differently, creating a snowflake disease with a wide range of symptoms that are unpredictable and often invisible to others.
“Sometimes it’s a very clear algorithm for certain diseases,” says Ann Cabot, Doctor of Osteopathic Medicine, Director of Specialty MS Care Clinic, Concord Hospital. “But it’s not a very clear algorithm for multiple sclerosis because everybody’s MS is so different.”*
The Most Common Relapsing Multiple Sclerosis Symptoms
RMS affects the central nervous system (CNS), compromising the normal function of the brain, spinal cord, and optic nerves. While every patient’s RMS experience is unique, there are some physical and cognitive symptoms that are more common than others. The most typical physical symptoms include: fatigue; numbness and tingling in the body, face, and extremities; muscle weakness; mobility issues; and vision problems. Cognitively, patients may feel like they have “brain fog” or difficulty concentrating, problem-solving, and processing new information. They can also experience memory problems and struggle with verbal fluency, like finding the right word or slurring speech.
Despite the fact that RMS is a chronic condition, symptoms aren’t necessarily consistent or persistent throughout the progression of the disease. Many patients experience fatigue and report some kind of numbness and tingling, often as some of the earliest symptoms. About half are affected by cognitive changes, which usually manifest later on. Because symptoms may come and go, or increase and decrease in severity, it can be difficult to diagnose and manage RMS.
Diagnosing and Monitoring Relapsing Multiple Sclerosis
There are a number of ways to diagnose and monitor RMS and its physical and cognitive symptoms. One of the most effective diagnostic tools for RMS is magnetic resonance imaging (MRI). MRIs help healthcare providers see what's going on inside the CNS, which is where nearly all RMS symptoms originate. In patients with RMS, immune cells cross into the brain, optic nerve, and spinal cord, and attack the protective tissue (myelin) that surrounds nerve fibers. These attacks result in scarring, or sclerosis, that shows up as lesions. These lesions disrupt the body's ability to send signals between nerve cells. When this communication is disrupted, RMS symptoms and nerve damage can develop.
Although further studies are needed, measuring brain volume loss may be another way to monitor RMS. One key factor that MRIs can help detect is changes in the grey and white matter of the brain. Grey matter is where communication signals start, and white matter carries messages from one area to another. Researchers long assumed RMS primarily affected the white matter, but recently it has become increasingly clear that RMS lesions in the grey matter can have a significant impact on RMS symptoms as well. Brain matter naturally decreases over time for everyone, but RMS can accelerate this process, resulting in loss of volume in the brain.
Physical symptoms and their progression are often measured using the Expanded Disability Status Scale (EDSS). This scale helps quantify the physical effects of RMS and gives healthcare providers a reference from which to monitor changes in function over time. Cognitive assessments, along with self-reported daily trackers, can be used to help patients and healthcare providers monitor symptoms. But these tests aren’t always used, and may not be implemented by some healthcare providers.
“Often there are people with MS who experience physical disability and are uncertain of their future," says Jean Cain, MSN, CRNP, MSCN, Director of Disease Modifying Therapies at MS Center of Lehigh Valley. "We must provide them with treatment options that can give them hope.”*
Regular communication with healthcare providers is also important. As RMS symptoms change and progress, sharing both cognitive and physical symptoms in a timely manner helps providers recommend the best course of treatment.
Finding the Right Treatment When Each Patient's RMS Experience Is Different
While there’s no cure for RMS, there are treatments that can slow down the progression of the disease and reduce both brain lesions and relapses of acute symptoms. Just like each person’s RMS symptoms are unique, RMS treatments come in a variety of forms.
“An important thing to tell MS patients is that not only do we have multiple therapies, but they work on the immune system in different ways,” says Cabot.*
Treatments include injectables, IV infusions, and oral pills. Different treatments may be used over time as patients experience changes in both lifestyle and disease progression.
“I believe in using different medications for different patients, and sometimes even different medications for patients at different stages in their lives,” says Regina Berkovich, MD, PhD, Director of the West Hollywood MS Center.*
One Option to Consider
It's important for each patient to work closely with their RMS specialist to figure out which treatment will work best for them. One option is ZEPOSIA® (ozanimod), a once-daily prescription pill for adults with relapsing RMS. ZEPOSIA is a prescription medicine used to treat relapsing forms of RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is not known if ZEPOSIA is safe and effective in children.
Clinical studies and trials have shown ZEPOSIA to be an effective treatment with positive results for reducing both relapses and lesions.
Clinical Results Point to Fewer Relapses
Relapses are a hallmark of RMS and are characterized by new or worsening symptoms that last at least 24 hours and present after a period of stable RMS disease activity. Relapses were measured in clinical studies for people who took ZEPOSIA and others who took a leading injectable medicine, Avonex.†
In a two-year study, those who took ZEPOSIA saw a 38% reduction in relapses compared to those who took a leading injectable medicine.‡ The two-year study also found that 76% of the people taking ZEPOSIA were relapse-free versus 64% of those taking a leading injectable.
Lesions, or the scarring left behind by immune cells that enter the brain and damage the myelin coating on nerve fibers, are one indicator of active or progressing RMS. A specific type of MRI scan known as T2-weighted imaging can be used to identify the total number of lesions a person has. Another type of MRI scan shows T1 Gadolinium-enhancing lesions, which illustrates evidence of active inflammation. Identifying these lesion areas can help when monitoring RMS activity and progression.
SELECTED IMPORTANT SAFETY INFORMATION
ZEPOSIA can cause serious side effects, including: infections that can be life-threatening and cause death, slow heart rate, liver problems, increased blood pressure, breathing problems, a problem with your vision called macular edema, PRES (Posterior Reversible Encephalopathy Syndrome): swelling and narrowing of blood vessels in your brain, and severe worsening of RMS after stopping ZEPOSIA compared to before or during treatment, and allergic reactions. For more information, please read the Important Safety Information below.
ZEPOSIA was found to be effective at reducing both new or enlarging (T2) lesions and T1 Gadolinium-enhancing lesions. In a two-year study, people who took ZEPOSIA had 42% fewer new or enlarging lesions (T2) and 53% fewer T1 Gadolinium-enhancing lesions than those who took a leading injectable.§
Physical disability progression, such as mobility or vision issues, is also a concern for those with RMS. This was also measured in the ZEPOSIA clinical studies. Among all participants, 9 out of 10 people showed no progression of physical symptoms or disability, regardless of the medication used as defined by the clinical studies. THERE WAS NO SIGNIFICANT DIFFERENCE in disability progression between people who took ZEPOSIA (7.6% of people) and those who took a leading injectable medicine (7.8% of people).❘❘
Finding the right way to manage and treat RMS is complicated. Understanding symptoms and how they progress helps patients communicate effectively with healthcare providers, which makes it easier to find the most viable treatment.
“Shared decision making is very important,” says Cabot. “I always tell patients, you’re the one who is ultimately going to be taking the medication. Patients need to understand their medication and have an opportunity to learn about it and understand the information that healthcare providers share with them.”*
Discover more now about once-daily ZEPOSIA and talk to your doctor to see if it might be the right treatment for you.
INDICATION
ZEPOSIA® (ozanimod) 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.
It is not known if ZEPOSIA is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not take ZEPOSIA if you:
- have had a heart attack, chest pain (unstable angina), stroke or mini-stroke (transient ischemic attack or TIA), or certain types of heart failure in the last 6 months
- have or have had a history of certain types of an irregular or abnormal heartbeat (arrhythmia) that is not corrected by a pacemaker
- have untreated, severe breathing problems during your sleep (sleep apnea)
- take certain medicines called monoamine oxidase (MAO) inhibitors (such as selegiline, phenelzine, linezolid)
Talk to your healthcare provider before taking ZEPOSIA if you have any of these conditions or do not know if you have any of these conditions.
ZEPOSIA may cause serious side effects, including:
- Infections. ZEPOSIA can increase your risk of serious infections that can be life-threatening and cause death. ZEPOSIA lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 3 months of stopping treatment. Your healthcare provider may do a blood test of our white blood cells before you start taking ZEPOSIA.
Call your healthcare provider right away if you have any of these symptoms of an infection during treatment with ZEPOSIA and for 3 months after your last dose of ZEPOSIA:
- fever
- feeling very tired
- flu-like symptoms
- cough
- painful and frequent urination (signs of a urinary tract infection)
- rash
- headache with fever, neck stiffness, sensitivity to light, nausea, or confusion (these may be symptoms of meningitis, an infection of the lining around your brain and spine)
Your healthcare provider may delay starting or may stop your ZEPOSIA treatment if you have an infection.
Progressive multifocal leukoencephalopathy (PML). ZEPOSIA can increase your risk for PML, which is a rare brain infection that usually leads to death or severe disability. If PML happens, it usually happens in people with weakened immune systems but has happened in people who do not have weakened immune systems. Symptoms of PML get worse over days to weeks. Call your doctor right away if you have any new or worsening symptoms of PML that have lasted several days, including: weakness on one (1) side of your body, changes in your vision, changes in your thinking or memory, confusion, changes in your personality, loss of coordination in your arms or legs, decreased strength, and/or problems with balance.
Slow heart rate (also known as bradyarrhythmia) when you start taking ZEPOSIA. ZEPOSIA may cause your heart rate to temporarily slow down, especially during the first 8 days. You will have a test to check the electrical activity of your heart called an electrocardiogram (ECG) before you take your first dose of ZEPOSIA. Call your healthcare provider if you experience the following symptoms of slow heart rate:
- dizziness
- lightheadedness
- feeling like your heart is beating slowly or skipping beats
- shortness of breath
- confusion
- chest pain
- tiredness
Follow directions from your healthcare provider when starting ZEPOSIA and when you miss a dose.
Continue reading for additional possible serious side effects of ZEPOSIA.
Before taking ZEPOSIA, tell your healthcare provider about all of your medical conditions, including if you:
- have a fever or infection, or are unable to fight infections due to a disease, or take or have taken medicines that lower your immune system
- received a vaccine in the past 30 days or are scheduled to receive a vaccine. ZEPOSIA may cause vaccines to be less effective
- before you start ZEPOSIA, your healthcare provider may give you a chickenpox (Varicella Zoster Virus) vaccine if you have not had one before
- have had chickenpox or have received the vaccine for chickenpox. Your healthcare provider may do a blood test for the chickenpox virus. You may need to get the full course of the vaccine and wait 1 month before taking ZEPOSIA
- have a slow heart rate
- have an irregular or abnormal heartbeat (arrhythmia)
- have a history of stroke
- have or have had heart problems, including a heart attack or chest pain
- have high blood pressure
- have liver problems
- have breathing problems, including during your sleep
- have eye problems, especially an inflammation of the eye called uveitis
- have diabetes
- are or plan to become pregnant or if you become pregnant within 3 months after you stop taking ZEPOSIA. ZEPOSIA may harm your unborn baby. If you are a female who can become pregnant, talk to your healthcare provider about what birth control method is right for you during your treatment with ZEPOSIA and for 3 months after you stop taking ZEPOSIA. If you become pregnant while taking ZEPOSIA, tell your healthcare provider right away and enroll in the ZEPOSIA Pregnancy Registry by calling 1-877-301-9314 or visiting www.zeposiapregnancyregistry.com
- are breastfeeding or plan to breastfeed. It is not known if ZEPOSIA passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you take ZEPOSIA
Tell your healthcare provider about all the medicines you take or have recently taken, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using ZEPOSIA with other medicines can cause serious side effects. Especially tell your healthcare provider if you take or have taken:
- medicines that affect your immune system, such as alemtuzumab
- medicines to control your heart rhythm (antiarrhythmics), or heartbeat
- CYP2C8 inducers such as rifampin
- CYP2C8 inhibitors such as gemfibrozil (medicine to treat high fat in your blood)
- opioids (pain medicine), medicines to treat depression, and medicines to treat Parkinson’s disease
- medicines to control your heart rate and blood pressure (beta blocker medicines and calcium channel blocker medicines)
You should not receive live vaccines during treatment with ZEPOSIA, for at least 1 month before taking ZEPOSIA and for 3 months after you stop taking ZEPOSIA. Vaccines may not work as well when given during treatment with ZEPOSIA.
ZEPOSIA can cause serious side effects, including:
liver problems. Your healthcare provider will do blood tests to check your liver before you start taking ZEPOSIA. Call your healthcare provider right away if you have any of the following symptoms:
- unexplained nausea
- vomiting
- stomach area (abdominal) pain
- tiredness
- loss of appetite
- yellowing of the whites of your eyes or skin
- dark colored urine
increased blood pressure. Your healthcare provider should check your blood pressure during treatment with ZEPOSIA. A sudden, severe increase in blood pressure (hypertensive crisis) can happen when you eat certain foods that contain high levels of tyramine.
breathing problems. Some people who take ZEPOSIA have shortness of breath. Call your healthcare provider right away if you have new or worsening breathing problems.
a problem with your vision called macular edema. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis. Your healthcare provider should test your vision before you start taking ZEPOSIA if you are at higher risk for macular edema or any time you notice vision changes during treatment with ZEPOSIA. Call your healthcare provider right away if you have any of the following symptoms:
- blurriness or shadows in the center of your vision
- sensitivity to light
- a blind spot in the center of your vision
- unusually colored vision
swelling and narrowing of the blood vessels in your brain. Posterior Reversible Encephalopathy Syndrome (PRES) is a rare condition that has happened with ZEPOSIA and with drugs in the same class. Symptoms of PRES usually get better when you stop taking ZEPOSIA. If left untreated, it may lead to stroke. Your healthcare provider will do a test if you have any symptoms of PRES. Call your healthcare provider right away if you have any of the following symptoms:
- sudden severe headache
- sudden confusion
- sudden loss of vision or other changes in your vision
- seizure
severe worsening of multiple sclerosis (MS) after stopping ZEPOSIA. When ZEPOSIA is stopped, symptoms of MS may return and become worse compared to before or during treatment. Always talk to your healthcare provider before you stop taking ZEPOSIA for any reason. Tell your healthcare provider if you have worsening symptoms of MS after stopping ZEPOSIA.
The most common side effects of ZEPOSIA can include:
- upper respiratory tract infections
- elevated liver enzymes
- low blood pressure when you stand up (orthostatic hypotension)
- painful and frequent urination (signs of urinary tract infection)
- back pain
- high blood pressure
- headache
These are not all of the possible side effects of ZEPOSIA. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Medication Guide.
ZEPOSIA and ZEPOSIA logo are trademarks of Celgene Corporation, a Bristol Myers Squibb company. All other trademarks are the property of their respective owners.
Endnotes:
*Paid consultants of Bristol Myers Squibb.
†Avonex (interferon beta-1a).
‡In a two-year study: People taking ZEPOSIA had an Annualized Relapse Rate (ARR) of 0.172 vs 0.276 with a leading injectable. To measure relapses, the ARR was used, which is the average number of relapses a group of people have in one year. A total of 874 people were in the two-year study (ZEPOSIA 433, a leading injectable 441).
§In a two-year study: People taking ZEPOSIA had an average of 1.84 lesions (T2) vs 3.18 with a leading injectable. People taking ZEPOSIA had an average of 0.18 lesions (T1 Gd-enhancing) vs 0.37 with a leading injectable.
❘❘The progression was confirmed after three months with predefined increases in Expanded Disability Status Scale scores and results were combined from both clinical studies.
This story was produced by WIRED Brand Lab for Bristol-Myers Squibb Company.
© 2022 Bristol-Myers Squibb Company. 2084-US-2201069 09/22
