New MS Treatments and the Importance of Maintaining Therapy
Looking into the future of MS treatment
The future approval of emerging therapies for multiple sclerosis (MS) is exciting, and that is just one reason to maintain control over your MS until then. Think about personal milestones your own future may hold for you. If you decide to continue with your MS therapy and wait for more data on the new therapies, how would that benefit you? How would it help you if you gave up your current MS therapy in the hope that another option is about to become available?
Physicians who care for people with MS are almost as eager to see new therapies become available as you are. The potential is out there – all that’s needed is a reasonable track record of safety and success. Your physician has a commitment to “do no harm”; that is why he or she will want to take a careful approach to prescribing new therapies.
Go with what you know
Delaying or preventing the onset of physical disability is a major goal of treating MS with a disease modifying therapy (DMT). Intramuscular (IM) (Avonex®) and subcutaneous interferon beta IFNb-1a (Rebif®), IFNb-1b (Betaseron®), and glatiramer acetate (Copaxone®) represent the main self-injectable DMTs for patients with relapsing–remitting MS (RRMS).
A second beta interferon-1b called Extavia® was approved for treatment of MS in 2009, and became available in Canada in May 2010. Extavia® is identical to Betaseron®. Natalizumab (Tysabri®) is the most recently introduced novel treatment option, and a variety of new therapies are expected to become available over the next few years. When you are looking into your treatment options, you will notice that the newer the therapy, the less we know about its long-term tolerability and benefits.
Over 15 years of experience treating MS with the IFN betas and Copaxone® has provided a good understanding of what to expect from currently approved therapies. It has been shown that taking a disease modifying therapy soon after a diagnosis of MS or CIS (Clinically Isolated Syndrome) reduces relapses by one-third. Just as importantly, DMT delays progression of the disease and the disability it leads to over the long term.
Keep up with new developments
By paying attention to treatment developments in MS, you are taking an active role in managing your MS. It’s important to stay up to date, so that you can make the best choices for your long term wellbeing. That’s where patience may be a virtue. Until we have more experience with emerging treatments, you can choose to continue with your DMT for its proven long-term benefits. All your treatment decisions should be well informed and thoroughly considered.
Aspects of MS treatments to consider
Quality of life
All drug therapies have both positive (efficacy) and negative (safety considerations and adverse events) effects. It will continue to be important to have informed conversations with your physician about treatment options best suited to you.
What’s new in MS treatment?
Several new therapies are likely to become available for the treatment of MS in Canada over the coming years. Efficacy and safety data from advanced development trials (Phase III) are now available for the two emerging oral (i.e. taken by mouth) medications, cladribine and fingolimod. Barring any unforeseen safety concerns, these two medications are expected to be approved for MS within about a year, while another oral therapy, laquinimod, is completing Phase III trials. Other emerging treatments have completed, or are in the process of completing Phase III trials.
An overview of emerging oral MS therapies
The following table is an overview of specific oral therapies based on their respective clinical development programs. Once approved, the Canadian product will be the most accurate source of information.
FINGOLIMOD
Generic names: FTY720 or fingolimod
Brand name: Gilenia®
- First of a new class of sphingosine modulators originally targeted for undergoing organ transplantation.
- Oral therapy taken once-daily.
Efficacy
- FTY720 reduced the relapse rate by 54% for the 0.5-mg dose 60% for the 1.25-mg dose compared with placebo, in the 2-year, Phase III FREEDOMS study.
- Efficacy as well as adverse effects may be dose dependent.
Adverse effects
- Slowed heart rate and irregular heart beat (which can range from mild to severe) have occurred when the medication is started; macular edema (which affects the eyes), elevated liver enzymes, and mild elevations in blood pressure.
CLADRIBINE
Generic names: Cladribine, 2-chlorodeoxyadenosine and 2-CdA
Brand name: Movectro®
- Purine nucleoside analog developed as a selective lymphocytotoxic agent for the treatment of leukemia.
- Cladribine Tablets are oral therapy, requiring as little as 2 cycles of 5 consecutive days each at the beginning of the first and second month of treatment for the first full year of therapy.
Efficacy
- Disease-activity-free status (patients with no relapses, no sustained disability progression and no new MRI lesion activity) over the 96 weeks CLARITY Study, was experienced by 46% of patients treated with a high-dose of cladribine, and 44% of patients randomized to a low- dose regimen compared with 16% of placebo patients (P<0.001) in the Phase III (CLARITY) clinical trial of an oral formulation of cladribine.
Adverse effects
- Lymphopenia (low levels of white blood cells), herpes zoster, malignancies, and infections.
LAQUINIMOD
- Modulator of key processes of the immune system, and may have an immunomodulating effect within the central nervous system (CNS); developed for treatment of RRMS.
- Two randomized, placebo controlled Phase III trials of laquinimod are currently underway.
Efficacy
- In Phase II trials, laquinimod 0.3 mg reduced the mean cumulative number of active lesions by 44% compared with placebo.
Adverse effects
- Nasopharyngitis (inflammation of the nose and throat causing cold-like symptoms), back pain, and headache; dose-dependent, reversible elevation of liver enzymes.
Keep the faith
Keep the faite in yourself and your ability to make wise choices to maximize your long-term health. If your approved DMT for MS is working for you, you can feel confident knowing that it has a proven long term record of safety and effectiveness. Medications only work when you take them as prescribed. Recent studies have shown that skipping doses or taking a “drug holiday” can lead to a setback in your control over MS. Not taking your DMT, even for a relatively short period of time, can increase the risk of having a relapse.
Perseverance has its benefits
A recent study in MS showed that greater levels of adherence to therapy (i.e. taking it as prescribed) are associated with lower chances of relapse. And in addition, increasing levels of adherence to treatment were associated with lower overall costs, even though the medication costs to the healthcare system increased along with adherence levels.
Thinking ahead
You know what it’s like to live with uncertainty when you have MS. While you look forward to the availability of new therapies, think about your own future. Try to imagine your life in one year, three years or five years, and how things might be different if you continue taking a disease modifying therapy, or if you decide to stop treating your MS. The proven benefits of our current DMTs in terms of delayed disability can not be regained – when disease modifying treatment is stopped, the disease will continue to progress. When you consider your options, be sure you understand as much as possible how they may affect not only your disease, but your overall long-term wellbeing.