Remaining Adherent
Once a DMT is initiated, evidence suggests that treatment needs to be ongoing for benefits to persist. Non-adherence and gaps in treatment have been associated with an increased rate of relapses and progression of disability.
Rather than discontinuing the medication, it is essential for individuals to talk with their doctor about recent changes in their MS and explore options to make adjustments with their current medication or switch to another DMT. The SEARCH model can be helpful in recalculating a treatment decision. MSAA also recognizes that adhering to an MS medication can present certain challenges over time, which may cause people to limit or discontinue prescribed usage. Fortunately, many of these challenges can be managed to help keep you on course with your therapy. Some helpful strategies include:
Managing Side Effects
Each of the approved treatments has side effects that are usually manageable. Initial side effects to some of the DMTs include headache and flu-like symptoms. These often dissipate after several weeks and can be easily managed with over-the-counter medications. Individuals using injectable medications can manage pain or skin reactions at the injection site by icing the area, rotating injection sites, taking over-the-counter pain relievers, and using an auto injector.
For individuals taking an oral medication, common side effects include headache, nausea, and diarrhea. These are usually mild, dissipate over time, and can often be managed by taking over-the-counter medications, as prescribed by your doctor. Taking an oral DMT while having a full stomach may also assist with reducing side effects, if advised by your doctor.
Understanding Expectations
Individuals must allow six months to one year for their prescribed medication to have an effect on their disease course. This also necessitates that patients are taking their medication as prescribed on a consistent basis and not skipping or altering doses. People often think that in order for the medication to be working they must “see” results. In fact, the opposite is true for MS. It is important to realize that if patients are not seeing an increase in relapses and/or not experiencing additional symptoms, then, most likely, their DMT is effectively treating their MS. However, individuals need to consult their neurologist and/or healthcare team to help determine the success of their current long-term treatment.
Learning to Adjust
Even with the best intentions, people can forget to take their medication. A few simple suggestions to help remember include setting a schedule and abiding to it as much as possible, utilizing memory aids such as print and electronic calendars and reminder notes, recording your dosage in a journal or mobile phone app such as My MS Manager™, and involving family members in the treatment plan.
In addition to forgetfulness, fear or anxiety related to injections has often been a concern shared by the MS community. Receiving proper training from a healthcare professional on administering the injection and using an auto injector are effective strategies in building self-confidence and reducing fear.
Staying on Course
The effectiveness of any disease-modifying therapy for MS can vary greatly from person-to-person and even change within the same individual as the disease progresses over time. All DMT’s have potential risks and some of the newer therapies require tests before and during treatment to help determine if the medication would be considered an appropriate option for the individual, and whether or not he or she can manage the potential side effects. It is important for individuals with MS to work together with their neurologist to explore new treatment options and remain committed to finding a therapy that works for them.
APPENDIX # 1: MS OVERVIEW
What is MS?
Multiple sclerosis (MS) is a neurological disorder affecting the nerves of the central nervous system (CNS), which consists of the brain, optic nerves, and spinal cord. Most individuals with MS experience their first symptoms as a young adult and are often diagnosed in the prime of their life. Although MS is not contagious, a cause and cure have yet to be discovered. As discussed later in this booklet, several effective treatment choices are available for most individuals with MS to help reduce disease activity.
Caucasians have the greatest incidence of MS and about three times as many women are diagnosed with MS than men. MS does not usually occur with populations living in warm areas near the equator; in general, the further people live from the equator (north or south), the greater their risk of developing the disease.
With MS, nerve fibers (or “axons“) and their fatty-rich protective covering (known as “myelin“) become damaged. As a result, nerve impulses along these nerve fibers are interrupted; causing the symptoms of MS. MS is believed to be an autoimmune disease, where the body’s own immune system is sending disease-fighting cells to destroy specific elements within the body. Examples of other autoimmune diseases include lupus and rheumatoid arthritis.
The symptoms of MS include a wide range of physical, mental, and emotional difficulties. Examples include: visual problems, spasticity (spasms and tightening of muscles), weakness, tremor, numbness, and dizziness; bladder, bowel, and sexual dysfunction; mobility issues; chronic, aching pain; fatigue, depression, and memory problems.
Types of MS
On average, 80 percent of people with MS begin with the relapsing-remitting form of MS (RRMS). This type of MS has temporary symptom flare-ups or “relapses” (also referred to as exacerbations, attacks, or bouts), which may last from a few days to a few months. These are followed by a complete or partial recovery (“remission“). Women are more likely to be diagnosed with RRMS than men.
Between relapses, many people may go into remission for a year or more. During this time, they may remain symptom-free, or only experience mild changes with symptoms that did not fully remit following the exacerbation.
This remission can be deceptive, however, because of the clinically silent aspect of MS. While symptoms may not appear or worsen between MS attacks, changes do continue within the CNS. Lesions (areas of inflammation along the nerves in the brain and spinal cord) can flare up within the CNS at least 10 times as often as clinical attacks (those with visible symptoms).
If untreated, more than 90 percent of individuals with RRMS may eventually enter a second phase of RRMS, known as secondary-progressive MS (SPMS), within 25 years of their diagnosis. This phase is reached when an individual experiences a progressive worsening of symptoms. SPMS may occur with or without superimposed relapses.
While approximately 80 percent of individuals with MS are initially diagnosed with RRMS, the majority of the other 20 percent are diagnosed with primary-progressive MS (PPMS). This form of MS presents a gradual but steady accumulation of neurological problems from the onset, without the presence of relapses and remissions. Unlike RRMS, PPMS is equally divided between the genders.
Other types of MS exist, but these are not as common. These include benign MS (with little or no change after 20 years), progressive-relapsing MS (PRMS) (a progressive course from the onset with acute relapses), and malignant or fulminant MS (a rapidly progressive disease course).
APPENDIX # 2: MS TREATMENT OVERVIEW
What drugs are approved for the long-term treatment of MS?
At the time of this publication, 13 disease-modifying treatments have been approved by the United States Food and Drug Administration (FDA), each shown to help slow disease activity for individuals with relapsing forms of MS. Since inflammation appears to be a major component in the relapsing forms of MS, these treatments are believed to reduce the inflammation within the CNS, thereby reducing the number and severity of active lesions (and also reducing the number of clinically silent flare-ups). Other immunological changes are also thought to occur with these disease-modifying therapies (DMTs).
Many experts now recommend treatment as early as possible with one of these approved DMTs. Research has shown that treating after the first attack can significantly delay the amount of time to the second attack. Early treatment is also thought to possibly limit axonal (nerve) injury, which may be irreversible, and later lead to a progressive form of MS.
The 13 FDA-approved, long-term disease-modifying therapies (DMTs) for MS (as of the printing of this booklet) are listed on pages 8 through 11. An individual with MS is usually prescribed only one of these medications during any one time period, although trials with combinations of these treatments are being conducted.
When switching from one therapy to another, doctors will often allow time between treatments for the former medication to be completely out of one’s system. This is known as a “wash-out” period. Results from several large clinical trials have found that all of these medications reduce the number and severity of relapses, as well as the development of new areas of inflammation as seen on MRI. These studies also showed some evidence of delaying disease progression.
What are the side effects of these medications?
Similar to most any medication, these DMTs are accompanied by certain side effects and/or adverse events, most of which may be managed or avoided through various precautionary actions. For instance, the interferons may cause flu-like symptoms and injection-site reactions, especially when first starting the such as smaller needles and gradually increasing from a small dose to the full dose (dose titration), can greatly help to avoid the potential side effects mentioned. Liver function is also monitored while taking an interferon. Injection-site reactions can occur with Copaxone, and for a small percentage of patients, a brief systemic reaction (such as flushing, dizziness, palpations, and/or shortness of breath) may occur following an injection.
Novantrone poses additional risks to the heart and for developing leukemia. For this reason, this medication is typically reserved for severe cases of MS that are not responding to any of the other DMTs. To avoid these adverse events, Novantrone may not be taken for more than two to three years.
Approximately 0.1 percent (or one in one thousand) of patients taking Tysabri develop a condition known as progressive multifocal leukoencephalopathy (PML), which is a potentially fatal brain infection with the JC virus (JCV), in people with weakened immune systems. About 55 percent of individuals with MS have this virus, which normally stays dormant, unless a suppressed immune system allows it to become activated. New guidelines to minimize the risk have been identified, and safety monitoring programs have been put in place for early detection and treatment, as well as to track any occurrences of this condition. A new blood test shows if a person has been exposed to the JC virus and if he or she could be at risk of developing PML if taking Tysabri.
Gilenya may cause certain heart-related issues when first starting the medication. For this reason, patients are screened in advance for heart problems and are monitored during the first six to 24 hours following the initial treatment at a treatment center.
Please note that all of these MS medications have been approved by the FDA. This agency has determined that the benefits of these medications outweigh any risks – many of which are rare. Other side effects (not listed in this booklet) may occur with these drugs. For more information on potential benefits and risks, individuals are advised to speak with their physician.
APPENDIX # 3: ASSISTANCE PROGRAMS
The following pharmaceutical companies offer patient programs to provide information, instruction, and resources for advocacy and financial assistance (listed alphabetically).
Aubagio – MS One to One
(855) 676-6326; www.aubagio.com
Avonex – Above MS
(800) 456-2255; www.avonex.com
Betaseron – BetaPlus
(800) 788-1467; www.betaseron.com
Copaxone – Shared Solutions
(800) 887-8100; www.copaxone.com
Extavia – Patient Services Program
(866) 398-2842; www.extavia.com
Gilenya – Patient Services Program
(800) 445-3692; www.gilenya.com
Glatopa – GlatopaCare
(855) GLATOPA (855-452-8672); www.glatopa.com
Lemtrada – MS One to One
(855) 676-6326; www.lemtrada.com
Plegridy – Above MS
(800) 456-2255; www.plegridy.com
Rebif – MS Lifelines
(877) 447-3243; www.rebif.com
Tecfidera – Above MS
(800) 456-2255; www.tecfidera.com
Tysabri – Above MS
(800) 456-2255; www.tysabri.com