Mayo Clinic in Rochester

      Monday, August 30, 2004
      Mayo Clinic Study Indicates Patients with Multiple Sclerosis
      May Want to Take Wait-and-See Approach to Medications
      ROCHESTER, Minn. — Rather than taking medication to ward off a future
      potential attack, patients diagnosed with multiple sclerosis (MS) may want
      to take a conservative approach and wait watchfully with their doctors for
      the first few years to see how the disease progresses over time, according
      to a new Mayo Clinic study published in the August Annals of Neurology
      “Our study demonstrates that the longer the duration of MS and the lower
      the disability, the more likely a patient is to remain stable and not
      progress to a greater level of disability,” says Sean Pittock, M.D., lead
      author of the paper. “This isn’t a small issue; it’s a big issue.”
      Moses Rodriguez, M.D., Mayo Clinic neurologist and senior author of the
      paper, adds, “The documentation of benign MS does exist, and this
      condition can be identified during an analysis of the patient at even five
      years with MS.”
      The investigators propose a definition of benign MS as patients who have
      MS for 10 years or more who have an Expanded Disability Status Scale
      (EDSS) score of 2 or less, because they have less than 10 percent
      likelihood of developing significant disability in the future. The EDSS
      quantifies the amount of disability in MS patients from zero (normal
      neurological exam) to 10 (death due to MS). On this scale, a score of 2
      indicates minimal disability, 4 indicates moderate disability but able to
      walk unassisted, 6 indicates requirement of an aid or cane to walk, and 8
      indicates need for a wheelchair.
      Patients who have benign MS can have ongoing attacks, but they do not
      accrue any disability from the attacks, says Dr. Rodriguez. “You have
      symptoms, but they go away, and if they come back, they go away again,
      typically after a week or so. You might have a bad week or an attack —
      like the loss of vision in one eye — but you completely recover. Most of
      the time, however, there would be no outward sign of the disease, and the
      patients themselves would say that they are normal.”
      Drs. Pittock, Rodriguez and colleagues found that only 7 percent of
      patients who had minimal or no disability (EDSS score equal to or less
      than 2) after 10 years with MS progressed to a greater level of disability
      (EDSS score greater than 4), and none needed a wheelchair after 20 years
      with MS. However, for those MS patients studied who had an EDSS score of
      2.5 to 4 after 10 years of the disease, 12 of 21 patients’ disabilities
      increased to a score greater than 4 after 20 years with the disease.
      Another Mayo Clinic neurologist and author, Brian Weinshenker, M.D., says
      of the study: “This confirms some other studies, but it flies in the face
      of the commonly held belief that MS is never benign and that every person
      should be started on lifelong interferon therapy before we get a feel of
      how the natural course of their illness will behave.”
      The investigators indicate that this news is particularly important for
      patients who have had benign MS for 10 years or longer, for whom
      physicians can make a reasonable prediction that they will not develop
      progressive disability. However, forecasting the course of a patient’s MS
      prior to the five-year mark remains difficult, the investigators indicate.
      These findings have potential impact for the 17 percent of all U.S.
      multiple sclerosis patients who have benign disease. Dr. Rodriguez
      indicates that this percentage represents as many as approximately 70,000
      benign MS patients, assuming the total of MS patients in the United States
      to be 400,000.
      The current approach prevalent in the MS treatment community to
      prescribing drugs for MS patients is “the earlier the better,” according
      to Drs. Rodriguez and Pittock. “There is an overwhelming drive to start
      all patients with a diagnosis of MS on immunomodulatory medications,” says
      Dr. Pittock.
      However, the Mayo Clinic study calls this drive into question. “This study
      raises questions about the current dogma out there that all patients
      should be started on medications as soon as possible,” says Dr. Rodriguez.
      “If we treat everyone early, we would treat some people who never needed
      treatment. And, if they don’t need treatment, we can save society hundreds
      of millions of dollars, and the patients with benign MS can avoid major
      side effects.”
      Dr. Rodriguez elaborates on the costs, monetary and physical, of
      prescribing medications to MS patients who may turn out to have benign
      disease. “Medications are expensive, about $10,000 per year,” he says.
      “The injections [of immunomodulatory medications] are painful, and they
      cause side effects like nausea, vomiting, fatigue, and achiness. You may
      have to lie down in bed for the day. It can be like having the flu every
      day of your life. In addition, the drugs are only partly effective, and
      their effectiveness over the long course of the disease has not been
      demonstrated.”
      Mayo Clinic Department of Neurology’s philosophy in working with MS
      patients is to share the therapeutic decision-making process between
      physician and patient, weighing the pros and cons of starting medication
      with the predictive data on hand, as well as the patient’s personality and
      personal wishes, to arrive at a customized determination of appropriate
      treatment for each patient. The investigators on this study believe that
      their findings will be helpful in this process.
      Though the concept of benign MS is not new, the study represented in
      August Annals of Neurology manuscript is the most extensive population
      study of MS to date, says Dr. Rodriguez. The Olmsted County population of
      MS patients has been studied since 1905. The study included all people in
      the population, not just those who sought a doctor for MS. This is notable
      in that patients who have benign MS may not seek medical attention.
      For MS patients who have concerns or questions regarding whether they have
      benign MS or whether they should be on immunomodulatory medications, Dr.
      Rodriguez stresses that it is important for them to contact their personal
      physicians to discuss their diseases and make decisions customized to
      their personal situations.