Updates in Multiple Sclerosis: What Does the Future Hold for Injectable Therapies?

Course Director

Gary A. Thomas, MD

Gary A. Thomas, MD
Assistant Professor of Neurology
Penn State Milton S. Hershey Medical Center
Penn State College of Medicine
Hershey, Pennsylvania

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Part 1 of a 3-part series

Dr. Thomas provides expert feedback to the questions submitted by your peers during a recent survey on this topic.


The current trend in multiple sclerosis is to treat earlier and more aggressively. In addition to recently approved agents, a number of emerging therapies are being studied in an effort to add to the armamentarium. Understanding how and when to incorporate these agents into practice is critical to ensuring that patients derive the greatest benefit with minimal risk. In this activity, Dr. Gary Thomas provides clinical insights on recently approved and emerging therapies and explores their potential role in the management of patients with MS.

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What are the future options for injectable therapies for MS?

Dr. Thomas: Doctors are now faced with a variety of different options for patients newly diagnosed with MS or existing MS patients. One new medication, alemtuzumab—it's very interesting to a neurologist. If that were to be approved, I think people will look at alemtuzumab as they do with natalizumab: It's clearly more effective [than current first-line injectables], but it clearly has safety issues.1-3

Narrator: Indeed, recently presented data from the CARE-MS I trial in treatment-naïve patients with relapsing-remitting MS, show 55% greater reductions in relapse rate compared with interferon β-1a (P < .0001), but a higher incidence of infections (67.3% of alemtuzumab patients versus 45.5% of interferon β-1a patients)—of predominantly mild-to-moderate severity; and a higher rate of autoimmune thyroid-related adverse events, 18.1% versus 6.4% with interferon β-1a.3

Dr. Thomas: The original studies looked wildly more effective even than natalizumab. Then the follow-up studies showed it was a little closer to natalizumab. I think neurologists are going to look for a safe alternative with a long track record first with a patient, if they can.

There isn't really one specific treatment which is appropriate for all patients. A large number of neurologists have a long experience with available injectable therapy. They feel comfortable with the monitoring requirements and the safety of the injectable therapies. So because of this, neurologists will continue to write for [current] injectable therapy as a first-line option for patients.

It's important that, as new treatments for MS come out, we don't forget about well-established treatments.4-9 The tried-and-true injectables still have a place, especially in a young patient, maybe of child-bearing age. Glatiramer acetate, in fact, is pregnancy category B. And certainly as time goes on, we'll have a better understanding of the safety issues associated with the newest medications.  I think that there will be a lot of options in the future to continue with these injectable therapies.

Obviously, patients have to be willing to take an injectable therapy, but the new auto-injectors and smaller needle options help.

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What are the recommendations for a patient who presents with worsening imaging studies (a large increase in MRI lesions) while on interferon therapy?

Dr. Thomas: This is a challenge because neurologists were really taught to treat the patient: We want to reduce the number of exacerbations; we want to reduce disability over time—we don't specifically treat the MRI. Some neurologists looking at the studies on interferon therapy would expect strong suppression of MRI activity, and so sometimes when somebody comes with new MRI activity it triggers them to think about whether or not this treatment is working. In general, doctors will not immediately switch a patient because a single MRI has a new MS lesion; if a patient is doing well, if physically and symptom-wise they haven't changed, this might be a patient that doctors would follow for a little bit longer before they would make a decision to switch. They likely would follow-up with questions, a more careful exam, and then probably a repeat MRI in three to six months.

Narrator: A study by Rudick and colleagues suggests that the development of new gadolinium-enhancing lesions and new T2 lesions within the first two years of interferon therapy correlates with poor responses to treatment.10 Therefore, new activity on a repeat MRI may be a prompt to switch therapy in order to minimize the risk of disability progression.

Dr. Thomas: When you come to a decision point about whether or not you switch treatment, you really want to make sure that you're making a decision you're comfortable with, and the patient is comfortable with as well. If a patient is doing well on a treatment and they're tolerating it well, it may not be a time when you want to switch just reflexively.

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What is optimal therapy for a 34-year-old woman with newly diagnosed relapsing and remitting MS? She has experienced visual disturbance and paresthesias, but no significant disability.

Dr. Thomas: I think the key to multiple sclerosis is that we do not right now have a way to heal damage that's done; and all of our treatments are geared towards preventing future damage and preventing future disability. It is clear from all the studies that the sooner you treat a patient, the better they do—even sometimes when the patient has a first event, [and] they don't technically qualify for multiple sclerosis, but they qualify as a clinically isolated syndrome.11,12 Specifically, three of the injection therapies have been approved for clinically isolated syndrome—interferon β-1b, interferon β-1a, and glatiramer acetate. In our practice, we would include the Monday/Wednesday/Friday version [of] interferon β-1a as well, for clinically isolated syndrome. I think that this has become standard of care that once the diagnosis is made or clinically isolated syndrome diagnosis is made, we really need to start initiating therapy very quickly.  

In a recent survey, 83% [of] neurologists indicated that they would start a therapy with either interferon or glatiramer or a second-line agent such as natalizumab early in a patient to prevent disability. It is a belief among neurologists—and the studies would indicate—that natalizumab is the strongest FDA-approved medication to treat MS, to prevent future relapses and disability in MS.13 But it clearly has safety issues, and most doctors do not use natalizumab as first line. There have been more opportunistic infections, most notably PML, progressive multifocal leukoencephalopathy—a brain infection due to a virus called the JC virus. So those doctors who are willing to use natalizumab in first line, typically they will check to see if the patient has JC virus antibodies or [has] been exposed to JC virus before.14

This is probably the most important of the three questions because we want to emphasize to doctors to treat early and treat consistently.

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  1. The Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis. Available at: http://care-ms.com/carems-program.aspx. Accessed May 2, 2013.
  2. Cohen J et al. 64th Annual Meeting of the American Academy of Neurology (AAN 2012). Abstract S01.004.
  3. Coles A et al. AAN 2012. Abstract S01.006.
  4. Cadavid D et al. Neurology. 2009;72:1976‐1983.
  5. O'Connor P et al. Lancet Neurol. 2009;8:889‐897.
  6. Koch‐Henriksen N et al. Neurology. 2006;66:1056‐1060.
  7. Panitch H et al. Neurology. 2002;59;1496‐1506.
  8. Durelli L et al. Lancet. 2002;359:1453‐1460.
  9. Mikol DD et al. Lancet Neurol. 2008;7;903‐914.
  10. Rudick RA et al. Ann Neurol. 2004;56:548-555.
  11. Comi G et al. Mult Scler. 2012. Published online ahead of print December 12, 2012.
  12. Kappos L et al. Lancet Neurol. 2009;8:987-997. doi: 10.1016/S1474-4422(09)70237-6.
  13. Polman CH et al. N Engl J Med. 2006;354:899-910.
  14. Bloomgren G et al. N Engl J Med. 2012;366:1870-1880.

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