Choosing the Right Therapy for YOU

By Cherie C. Binns RN BS MSCN

I receive a quarterly publication for MS Nurses entitled “Counseling Points” which may be found on the web at www.counselingpoints.com .  It is written by MS nurses for MS nurses to assist them in patient communication in the clinical setting of the MS Clinic.   The Winter issue for 2011 was entitled , Changing Treatment Paradigms in MS and dealt the fact that as we work with disease modifying therapies (DMTs) over time, one of the findings is that most of our first line therapies (Interferon Beta 1a and 1b(Betaseron, Evista, Rebif and Avonex) and Glaterimer Acetate (GA or Copaxone)  seem to be equally effective across the Board in preventing relapses and all have a high safety record.

For CIS (Clinically Isolated Syndrome) All of the lower dose interferons seemed to work quite well and only half of those with CIS went on to develop Multiple Sclerosis within 5 years of being treated with these medications.  Rebif (the highest dose Interferon) and Copaxone (GA) worked well over a 10 year span of use to prevent relapses and progression in the majority of patients who took them faithfully.

This article also stated that “As many as one quarter of people with MS discontinue therapy within the first 6 months of treatment, with studies showing that perceived lack of efficacy accounts for 30% to 52% of therapy discontinuation.”p6  (citations are in the article in the above web link).

Given the proven effectiveness of the drugs we have had available for the past 15+ years, why are patients so hesitant to stay on therapy?  For some, as in the above statement, they feel like it is not helping.  Is the Medical community giving patients false hope when prescribing a therapy to treat MS?  These therapies are designed to slow the progression of MS by slowing the frequency of relapses thereby preventing some nerve damage over time that could ultimately cause a Person with MS (PWMS) to leave the work force or develop secondary complications that would see an overall deterioration in their health.

So the big question is, how do you choose a therapy that is right for you in your circumstances and with your lifestyle?  

Knowing that over the course of 10-15 years, all of the trusted first line drugs on the market have similar efficacy, you are free to decide on the frequency and route of administration of a medication for you.  For many, that means once daily dosing of a medication (GA) in a manner that will not let you forget (same time as brushing teeth or preparing for bed at night or work in the morning).   For others, once a week on Friday night after the work week is ended works (Avonex). Some choose an even/odd every other day of the week plan with Evista or Betaseron and others find that a Monday, Wednesday Friday routine works well for them.

Fingolimod (Gilenya) was approved by the FDA a little over a year ago as a daily oral agent and , oddly, people seem to miss more doses of the pill than of daily Copaxone.   This can be problematic as Gilenya has an idiosyncrasy of lowering heart rate (sometimes to dangerous levels) on the first dose so the user must be monitored in the Clinical setting for several hours after that dose.   More and more clinics are doing this for the same person several times over the course of treatment because the PWMS taking Gilenya will forget to take the medication or go on vacation and not have access to a replacement supply and once off the drug for an average of 10 days, the risk of severe bradycardia (lowered heart rate) is as high as it was with the initial dose.

Another factor which you personally should consider in your lifestyle choice of medication is use of alcohol or other medications that may elevate liver enzymes.   Many of the alpha and beta blockers used to treat high blood pressure can elevate liver enzymes.   Add this to an interferon or Gilenya which also have the potential to elevate them and even a few glasses of beer or wine in a week can be harmful.

You might ask about the less frequent therapy offered by Tysabri which is given in a monthly infusion.   This is NOT a lifestyle choice of therapy as this drug is ONLY to be prescribed for persons whose disease is progressing and for which nothing else has slowed the progression.   And it carries with it a risk of severe brain injury or death if the user carries the JC Virus (the FDA approved a new blood test to be used prior to initiation of therapy within the past month).

Novantrone, which is given intravenously once every three months is another medication that is reserved for those for whom nothing else has worked and since it is a chemotherapy, comes with the side effects potentially of nausea, UTI and hair loss.   Additionally, a recent finding of leukemia in up to 30% of users 5 years after stopping the drug has made this therapy fall out of favor with many of the prescribing physicians.

Monthly Pulse steroids (generally a gram of IV Solumedrol) have been found to contribute to osteoporosis (bone loss) with resultant fractures.   They also change the metabolism so high blood pressure, obesity and diabetes are frequently associated with long term use as is vision loss in the form of cataracts.

Cytoxan is generating renewed interest as an intravenous infusion which is tailored to the individual’s need, severity of disease, schedule and two year dosing with this is showing in many a halt of disease activity.   It too, is a chemotherapy and carries a higher than normal risk of infection, hair loss, anemia so is not a therapy to be entered into lightly.

Reproductive goals is another factor to consider.   Currently the only drug that has been deemed safe by the FDA for people trying to conceive is Copaxone.  Even then, once pregnancy is confirmed, if the person with MS is the pregnant mother, a drug holiday is recommended until after delivery of the child.  Males who have MS and are trying to father a child are often advised to stop therapy during the period leading up to conception then resume therapy once pregnancy has been confirmed.

To close, I would like to borrow information from Table 2 in Changing Treatment Paradigms in MS  from www.counselingpoints.com

Table 2.   Factors to Consider in Selection of Disease –Modifying Therapy

• Stage of MS (CIS, RRMS, progressive)
• Recent stability of disease course (relapse, changes in MRI lesions)
• Patient’s readiness in starting/committing to therapy
• Availability of reimbursement for therapy
• Previous therapies used and safety/efficacy/adherence
• Patient’s comfort level with Mode of Administration
• Patient’s commitment to necessary monitoring
• Reproductive goals (desire for future pregnancies)
• Co-morbid conditions or contraindications
• 
  

Within the coming 12-18 months we should see another oral medication for RRMS becoming available as well as two more monoclonal antibodies similar to Tysabri for advancing forms of MS.

Written for MS Views and News on February 15, 2012

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