Today I am pleased to have a guest contributor, Kathy Bolen, RN, MSCN.  Many of you know Kathy who is a certified MS nurse and director of the infusion center here at MSCT.Vitamin D

Thank you, Dr. Rice for allowing me in on this digital adventure. The topic of Vitamin D seemed like a good place to start.

Over the last several years Vitamin D, has become a topic widely discussed. Many experts in the field of medicine and research are gathering more information on Vitamin D and its benefits. It has been found that Vitamin D deficiency is widely epidemic with approximately 75-80% of adults showing deficient or insufficient levels. 

Vitamin D is referred to as the “Sunshine” vitamin because sun exposure is crucial for the body to change it to the active form of vitamin D. Studies have shown that people who live in the northern latitudes (farther way from the equator) have less sun exposure, lower levels of Vitamin D and a higher incidence of MS.   Invention of sunscreen, sun-protective clothing, geographic location, season, high skin pigmentation, decrease dietary intake, aging and obesity are also common causes for deficiency. We have known for years that Vitamin D helps regulate calcium absorption, which is important in maintaining bone health. Recent studies show that the benefit on the body is more widespread. Most cells and tissues in the body respond to Vitamin D and in relationship to the immune system it has an anti-inflammatory and immune regulatory effect.

So what does Vitamin D deficiency mean for the MS patient?

Since we know that most of our MS patients need to avoid the sun at all costs more than likely many will show inadequate levels just by that fact alone. We know that deficiency may cause myopathy (disease of the skeletal muscle), muscle weakness and increased risk of falls. It is also thought that Vitamin D has a neuro-protective benefit, which could help to slow progression.  MS patients with high levels of Vitamin D have shown decreased risk for attacks and less severe disability. The main concern for MS patients is that low Vitamin D levels can make the MS associated weakness worse. Research is looking into the possibility that adequate levels of Vitamin could possibly prevent MS.

Will my doctor automatically check my Vitamin D levels?

This may vary among physicians. We check our MS patients regularly and supplement with various doses according to their levels. Levels may require a daily maintenance dose of 2000-4000 IU daily and in some cases a higher dose for 2 months may be required followed by the maintenance dose. While approaches for supplementing have not been established, evidence based on our experience has shown no down side and many patients with extremely low levels have often expressed that they feel much better when Vitamin D levels are increased.

As with any information presented we always encourage you to talk with your physician and we will do our best to keep you updated on the latest and greatest news. Thanks for reading.

Kathy Bolen, RN

MS Nurse

OK, we have discussed the available and the soon to be available oral medications for MS. The next obvious question is who should consider switching or beginning oral medications, and when.

There are several types of patients for whom I would consider an early switch.

1) patients experiencing frequent or serious relapses while taking the first line injectable drugs (Copaxone, Betaseron, Rebif, Avonex), especially if they have risk factors for PML with Tysabri.

2) patients having significant side effects, including injection site reactions, from these drugs. This includes the “needle-phobic” patients.  

3) Tysabri patients who become allergic or develop neutralizing antibodies, or who have risk factors for PML.

Other patients who may be good candidates for oral meds include newly diagnosed patients, especially relapsing remitting patients. 

Patients doing well on whatever therapy they are currently may be smart to continue as they are doing for now.  While the medications expected next year appear to be safe so far, we know that serious side effects sometimes do not appear until a drug has been in more widespread use for a longer time.

Patients with progressive MS, either primary or secondary, will of course be interested in these medications, but we just don’t have any information yet as to whether or not they will help in that situation. 

There may not be any absolute right or wrong answers to some of these questions until a little more time goes by, but it is at least exciting to have more options to look forward to.

Next:  Tysabri update — safety data, risk assessment

Ever since the very first Betaseron needles appeared in 1993, the one question I have heard more than any other is “when will we have a pill for MS?”  Now that that day has arrived I thought I would update you on what is now available and what is expected in the next year or so.

As most of you know, there is already one pill on the market for relapsing MS.  It was approved by the FDA in September, 2010 and is called fingolimod, brand name Gilenya, made by Novartis.  It is taken once a day and in the research studies appeared to be quite effective.  Relapses were reduced by >50% compared to both placebo and to beta-interferon, and disability progression was also reduced relative to placebo (but not to interferon).  New lesions on MRI were also reduced.

The drug does have side effects, of course, and has not been in widespread use for as long as some of the others.  In the research trials it was tested at 2 doses, 1.25 mg/day(high dose) and 0.5 mg/day(low dose).  The low dose did as well as the high dose as far as treating the MS, but had fewer side effects, and so only the low dose was approved by the FDA.

Gilenya tends to cause slowing of the heart rate when first given, so patients have heart monitoring for 6 hours after the first dose.  It can also cause swelling of the macula in the back of the eye.  This is reversible but monitoring by an eye doctor is required.  Other problems include low white blood counts, high blood pressure, and liver inflammation.  Also,  a patient recently died shortly after his first dose of Gilenya.  Autopsy results are not yet known, but it may be that more extensive cardiac monitoring and/or screening will be required in the future.  

In summary, the drug is well tolerated by most, and it does seem to be effective, but there are certainly enough safety concerns to warrant caution in its use.

So what’s on the horizon?  The most exciting drug is called BG-12 (aka dimethyl fumarate).  This is a pill made by Biogen (Avonex, Tysabri) which is taken 2 or 3 times a day.  It also seems to be quite effective, reducing the relapse rate by about 51% and the rate of disability progression by 24%.  It did significantly better than Copaxone in the head to head trial as well.  How does it work?  That’s not entirely known yet but it seems to reduce inflammation and protect both nerve cells and myelin in the brain.

So far the safety profile seems good, but about 38% of patients have had facial flushing and some have had gastrointestinal symptoms.  Because this drug is approved in Europe for psoriasis, there is a longer period of safety data available and so far no serious effects have turned up.  The timetable for possible FDA approval is unclear, as it is with all of these, but I will keep you posted.

Two other oral medications are currently being studied as well, teriflunomide and laquinimod.  Teriflunomide (Aubagio) is the active metabolite of leflunomide (Arava) which is approved for use in rheumatoid arthritis, another autoimmune disease.  It is made by Genzyme/Sanofi and has already been submitted to the FDA for approval.  It prevents proliferation of T-lymphocytes, inflammatory cells which cause the myelin damage in the brain.  Studies so far show that it reduces relapses by 31%, disability progression by 30%.  In the trials so far the side effects have been very mild, but Arava, which is similar, has been associated with rare cases of fatal liver failure and at least one case of PML in a patient with lupus.  In addition, it is a type of medication known to have the ability to cause birth defects, so great care will be needed treating patients with childbearing potential.

Laqinimod, made by Teva, has shown somewhat more modest effects compared to the two drugs above, although the safety and tolerability have been good so far.  It may have a  neuroprotective effect on the brain.  Relapse rate was down by 23% and rate of progression by 36%.  It also slowed brain shrinkage by 33%.  The dose is 0.6 mg daily. 

These new drugs will present a challenge to all of us.  Who should stay with their current drug and who should consider one of these newer ones?  What about Tysabri patients?  Stay tuned, I will address these issues soon.

The idea for writing an MS blog came to me out of the blue recently, but I might have never really started had it not been for the expert help of my computer-savvy daughter-in-law Sarah, who understands all things digital in a way that someone my age probably never will.  So hats off to her, and to my son Teddy who also added his considerable expertise - not to mention the rest of my family who have long encouraged me to sit down and write, whatever it might be.  

Since the majority of MS related blogs seem to be patient initiated,  I thought it might be helpful to start one from the neurologist’s point of view.  What I would like to accomplish here is to share some of my 30+ years of experience caring for, listening to, and treating patients with MS.  In those years we have come a long way, from almost no treatment at all to our current remarkable array of treatments for many aspects of the disease.  But of course as most readers of this are aware, there is still a very long way to go.  While we have made progress in diagnosis and treatment of relapsing MS, we still do not have adequate therapy for progressive forms of MS and we are just beginning to understand how we might be able to someday repair myelin and other brain structures already damaged by MS.

I will try to keep my posts fairly brief, topical, and informal.  I don’t know yet how often my schedule will allow me to write but I will try my best to keep current.  I also plan to ask others in the field to contribute periodically to provide a change of pace and to address other topics of interest.

For the immediate future I will plan to update you on several important areas of interest including the new oral drugs expected for MS soon, new advances in understanding the risks and benefits of treating with Tysabri, and current treatment of MS symptoms, including fatigue, spasticity, and others.  I will also update you periodically on the research projects in which we are participating. Other “hot” topics such as CCSVI, the so- called “liberation therapy”, as well as stem cell research, are on my radar screen as well.

A couple of other things to mention.  First, when I say MS I am generally also including patients with NMO (Neuromyelitis Optica, formerly known as Devic’s disease), transverse myelitis, optic neuritis, ADEM and any other of the rare immune disorders of the nervous system.  For patients with NMO in particular, there have been major advances in our understanding and treatment of their disease in the past 5 years, and I hope to be able to discuss some of those from time to time as well.

Secondly I would like to let you know that my opinions will always be mine alone.  I don’t accept money or gifts from pharmaceutical companies, except for specific research work done with them.  I’m actually one of the few docs around who does not talk to drug reps,  not because I don’t like them but because I believe it’s best to get information about new drugs or other treatments only from independent sources.

So I hope this will turn out to be an exciting and educational venture.  Bear with me if we hit any technical glitches - but I can always call on Sarah to the rescue!  I will be back soon.

MR

PS:  Please remember that what I say here is my opinion only and is not medical advice.  For your own specific concerns please contact your own physician.