Multiple Sclerosis

BG-12 (Tecfidera) Approved

marcusrice — Wed, 27 Mar 2013 16:52:37 -0400

As expected, the FDA today approved dimethyl fumarate (aka BG-12), to be marketed as Tecfidera. As with most of the other drugs for MS, it has been approved only for the relapsing-remitting type of MS.

We will be meeting with the company, Biogen Idec, soon and will try to obtain details on the rollout.

BG-12 (oral MS drug) Update

marcusrice — Thu, 14 Mar 2013 15:48:15 -0400

The latest news on BG-12 is that the FDA will decide about it on March 27, 2013. It is widely expected that it will be approved, but you can never be 100% sure with the FDA.

Biogen Idec, the manufacturer, has decided to market the drug under the brand name Tecfidera. I have no idea where that name came from but it does have the advantage of not sounding like anything else.

As you recall from earlier posts, this will be a pill given twice a day, and for some patients will likely take the place of injection therapies such as Avonex, Betseron, Rebif, and Copaxone. Some Tysabri patients will also switch over. Common side effects include flushing in 1/3 of patients, but serious problems have not been seen so far.

If it is approved it will still take some time to get rolled out - a few months would be my guess but it could be sooner.

I will keep you posted.

Progressive MS

marcusrice — Wed, 30 Jan 2013 17:04:55 -0500

As many of you know, most cases of MS begin with relapses followed by remissions - so called relapsing-remitting MS (RRMS). After a number of years, however, many patients evolve into a progressive phase during which the disease slowly worsens without sudden relapses or exacerbations. This is known as secondary progressive MS (SPMS). There are a few patients for whom the disease is progressive from the outset, a situation we call primary progressive MS (PPMS).

Most of the drugs we have in our arsenal are effective only in the RRMS patients. That is, they prevent relapses but are not necessarily effective against the slow underlying disease progression. There is one drug, novantrone, which is approved for progressive MS, but it is quite toxic and no longer used by most MS doctors as a result.

There are a number of reasons for this. Most drugs that have been tested for SPMS and PPMS have not been effective. Also, research in this area may take longer and hence be more costly to perform because of the slow nature of progressive MS. Drug trials in RRMS normally run 2-3 years at most, but trials in SPMS/PPMS may need to run for much longer before any effects of the drugs can be detected.

I do have on bit of good news. I recently attended the National MS Society Annual Meeting in Dallas, and the president of the society pledged a new commitment to funding for research into progressive MS in the years ahead. Also, there is a new clinical trial at the NIH in Bethesda, MD looking at a new therapy, Rituxan, for SPMS. This does include spinal taps, just in case you might be interested. If you are, let us know and we will pass along the contact information. Eligible patients must have SPMS, be between 18 & 65 years old, and be able to walk 25 feet with assistance.

Pregnancy & MS

marcusrice — Thu, 06 Dec 2012 11:12:00 -0500

MS and Pregnancy

Its Kathy Bolen, your MS nurse hoping to answer some questions about one of life’s most exciting events. This summary will address some of your questions and for information only, not designed to replace talking to your doctor.

MS is commonly diagnosed in women of childbearing age. Years ago most women were counseled to avoid pregnancy with belief that it might make their MS worse. The most often asked questions are; “will MS effect my ability to get pregnant?” “Will I have a normal pregnancy?” “Will my MS get worse?” “ What about my medication?” Studies that have involved hundreds of women over many years have led to the belief that pregnancy no longer needs to be avoided. Evidence indicates that there is no increase in risk of miscarriage, stillbirths or congenital malformations in women with MS. There is also no indication that women with MS experience any increased risk of infertility. That is all good news, but there are still many things to consider and discuss.

It is commonly thought that early and ongoing treatment with one of the disease modifying therapies available is important in controlling the disease. However, due to safety reasons, studying the effects of these drugs during pregnancy cannot be done. There is some information to suggest a slight risk of miscarriage or fetal malformation while on interferons. This information was obtained from women who accidentally became pregnant while on these medications. Data on the other medications such as Copaxone so far shows no increase risks but doctors generally recommend that you stop before becoming pregnant. Data is limited so Tysabri is not considered safe for use during pregnancy. Some of the newer medications are showing significant risk in regards to birth defects. Therefore, consistent and effective birth control while on medication is important. Your doctor will recommend that you stop your medication at least a month before trying to conceive. In the event you should become pregnant while on medication, contact your doctor immediately.

You do not need to panic about being off your medications. Evidence shows that the elevations of pregnancy hormones help suppress the immune system, which can help to keep your MS stable and quiet. Many women feel their best during pregnancy. The relapse rate is reduced similar to what your medication would do. As the hormone levels return to normal in the 3-6 months following delivery the risk for relapse increases significantly. Some doctors may prescribe medications after pregnancy to help reduce your risk of relapse. So discussion with your doctor about your MS activity is important. How active your MS is prior to pregnancy needs to be considered when deciding how long you would want to be without medication while trying to conceive and how soon you should go back on therapy after delivery. If your MS is pretty stable you may even postpone resuming medication until after breastfeeding.

Family planning decisions are never easy so a heart to heart discussion with your partner, evaluation of support networks, healthy lifestyle and close communication with your doctor is important. In a nutshell pregnancy is definitely an exciting time for anyone and women with MS are no exception.

BG-12 Update

marcusrice — Wed, 14 Nov 2012 18:37:00 -0500

From what we hear, it now appears that the approval of BG-12 (aka DMF, dimethyl fumarate, or just fumarate) has been pushed back to March 2013. Apparently the FDA has requested more information.

As many of you recall, BG-12 is the oral MS medication which is made by Biogen Idec, the same company that makes Avonex and Tysabri. It is a twice daily pill which at least so far seems to have a good safety profile and also seems to be more effective than the current “ABCR” drugs. It is already being used for psoriasis in Europe.

I am still optimistic that it will be approved, and that it will be a good choice for some patients. Remember though, even if it is approved in March it may be several months before it is actually available to use.

I will keep you posted.

Teriflunomide (Aubagio) - a new pill for MS

marcusrice — Mon, 17 Sep 2012 08:41:39 -0400

Last week the FDA approved teriflunomide, a second oral medication for relapsing forms of MS. It comes in 2 doses, 7 mg/day and 14 mg/day. It is a once a day pill.

Based on the research results so far this seems to be drug with a fairly modest effect on MS, roughly equivalent to that of the interferon medications although obviously easier to take. It seems to reduce the annual relapse rate by about 30%. Most people in the trials tolerated it well, but it can cause diarrhea, hair loss, liver problems, and damage to a fetus if taken by a pregnant woman.

The recommendations right now include blood testing for liver disease before starting the drug, then monthly for 6 months. Hopefully this will change over time and become less stringent. It should not be used in any woman who is at risk of pregnancy.

The brand name will be Auregio. It is due to be available on October 1, 2012. I have no information yet concerning cost but will keep you posted.

I don’t think this drug will be a game changer, but may well find a niche role for patients with RRMS. Other oral drugs, including BG-12 or fumarate, are expected by year’s end as well. Time will tell.

Spasticity

marcusrice — Thu, 13 Sep 2012 12:17:00 -0400

Spasticity is one of the most common and most difficult of all MS symptoms. It refers to the particular kind of stiffness and weakness which gradually develops in the legs and arms of people after injury to the brain or spinal cord. It can be painful and it can interfere with all motor skills and dexterity. When your reflexes jump quickly after a tap on the knee, or when your foot keeps bouncing on the floor after you touch it, that is spasticity. It can affect the bladder muscles as well, causing constant urgency to urinate.

In severe cases, spasticity may make it impossible even for someone else to bend a leg at the knee, or the arm at the elbow. It can make wheelchair transfers difficult and can even make sitting in a chair almost impossible. In milder cases, however, it can sometimes actually be helpful, particularly when it allows a person with a weak but stiff (spastic) leg to stay upright.

What causes spasticity? In normal people, continuous inhibitory nerve impulses travel down the spinal cord to keep the muscles relaxed. The neurotransmitter or chemical which helps these impulses flow is called gamma amino butyric acid, GABA for short. If there is an injury to the brain or cord, whether from trauma, stroke, MS, or other cause, the inhibitory impulses are blocked and the muscles become stiff due to continuous involuntary contraction.

Treatment of spasticity can be difficult. First of all, it has to be recognized for what it is, and that can be half the battle. We have a number of medications which help, and I will discuss each one briefly.

Baclofen is the first line drug of choice in most cases. It is usually well tolerated as long as you titrate the dose up slowly. I like to begin low, at 5mg 3 times a day, and work up to 20mg 3 times a day at a minimum. Some patients will tolerate up to 120mg a day or more, but unfortunately it may not be as effective as we would like in cases of severe spasticity. It may cause mild drowsiness but serious side effects are rare. Baclofen is thought to work by mimicking the action of GABA in the spiinal cord.

Tizanidine (Zanaflex) is the next one to try. Maximum dose is usually 8 mg 3 times aday, but drowsiness can be a problem. Liver tests have to be monitored, and there are some serious drug interactions (Cipro) to be aware of.

Dantrolene is another option, up to 400 mg/day maximum. It works more directly on the muscle, so weakness is a problem. Also sometime toxic to liver.

Diazepam (valium) works as well. Obvious drawbacks with sedation and it is habit forming, but if dose is increased gradually it can be a helpful add-on drug.

Botox injections are becoming increasingly popular for spasticity of the arms and legs. These injections were work by weakening the muscles involved. This requires the skills of a physician who is experienced in its use.It is also expensive and insurance reimbursement can be a problem

If patients have very severe spasticity which limits

their ability to sit in a chair or to transfer, then a baclofen pump should be considered. This is a surgical procedure. A small device, about the size of a hockey puck, is implanted into the abdomen with a tube which is threaded into the lower spine. In this way, tiny amounts of baclofen are delivered directly to the spinal cord where they are most effective. It is usually allows for excellent control of the spasticity in the legs without causing any sedation.

In summary, treating spasticity can be quite challenging but there are a number of options available

. The most important thing is probably to recognize the spasticity in the first place, because it is distinctly different from other types of muscle pain or cramping.

What is NMO?

marcusrice — Fri, 06 Jul 2012 14:40:11 -0400

Once in a while a patient with apparent MS receives a surpise diagnosis - it is not MS at all, but rather NMO. NMO stands for neuromyelitis optica, and it used to be called Devic’s disease. It is quite similar to MS, and used to be considered a subtype of MS, but in the past decade we have learned that it is in fact a distinct disease and it requires different treatment entirely. There is now a blood test called an NMO-IgG test, which accurately diagnoses NMO in most cases.

NMO is like MS but the attacks are usually limited to the spinal cord (neuromyelitis) and to the optic nerves (optica) and only rarely affect the rest of the brain. The attacks are often quite severe, however, and the recovery that we often see in MS patients is usually less pronounced in NMO. In other words, NMO patients with optic neuritis may not recover as much vision, and those with spinal cord attacks (myelitis) may be more likely to have permanent paralysis.

We treat the acute attacks in a similar fashion to MS attacks, that is, with high dose steroids. We may then go to plasmapheresis, which replaces the body’s plasma with artificial plasma, if steroids don’t work.

Long term, the drugs for MS, Avonex, Rebif, Tysabri etc do not work in NMO patients. We usually have to rely on immunosupressant drugs such as Imuran and CellCept. If those do not work we then use Rituxan, an intravenous medication which is a monoclonal antibody which depletes certain types of white blood cells. Rituxan is usually given every 6-8 months or so depending on blood counts. It may cause significant infusion reactions, and there are very rare reports of PML, the viral infection also seen as a complication of therapy with Tysabri.

To sum up, NMO is a serious disease which is now understood to be similar to, but distinct from MS. It requires aggressive treatment in order to prevent disability. There is a lot of current research interest in NMO, and I suspect that new therapies will be developed before long.

For those of you who want to learn more, the Guthy-Jackson Foundation is devoted to the cause and cure of NMO and can be reached at www.guthyjacksonfoundation.org or by phone at 858-638-7638.

Post #6 MS Fatigue

marcusrice — Tue, 22 May 2012 18:34:12 -0400

Sorry for the delay with this post, but have been crazy busy lately. Today I want to discuss MS-related fatigue and what can be done for it.

Each patient with MS has a unique set of symptoms. This is because MS can affect many different areas of the nervous system including the brain, spinal cord, or optic nerves. Because of this, one patient may have mostly visual problems, another may have trouble walking, and yet another may have memory problems.

There is one symptom, however, which is nearly universal, and that is MS-related fatigue. Perhaps as many as 90% of MS patients will experience fatigue at some point, and for some it can be a major problem. You will read about the different kinds of fatigue - physical, mental, emotional, etc. - but for most people tired is just tired.

There are a number of suspected causes of MS fatigue:

1) there are chemical changes in the brain, not visible by MRI, which almost certainly play a role.

2) sleep disorders are very common in patients with MS. Spasticity, restless legs, bladder problems, and pain can all disrupt sleep and lead to daytime fatigue.

3) MS patients may need to expend more energy than normal just to move around. This can be due to muscle stiffness or spasticity, weakness, and loss of balance.

4) medications used for treating other symptoms may contribute to fatigue. Examples include baclofen, tizanidine(Zanaflex), and gabapentin(Neurontin), but there are many others as well.

5) temperature effects can be a problem. Many MS patients develop fatigue with heat, whether it is due to hot weather, an illness with fever, or any other cause.

So how do we best combat fatigue? Obviously good quality sleep at night will help a lot, and if your schedule permits daytime naps, that’s fine too as long as you limit them to no more that an hour or so. Energy preservation also helps, but only to a point. It’s OK to take the elevator instead of the stairs once in a while, but if you do it too often you will get out of condition and it will backfire. In fact, a good exercise routine will help a lot - the hard part is the getting started.

Medications can also help. I like to try amantadine first, it’s an older drug, an antiviral, antiParkinson’s medication discovered by accident to help MS fatigue. No one knows how it works but it’s very safe and inexpensive. I give it twice a day, morning and after lunch. It can cause a rash called livido reticularis, especially on fair-skinned people, but it’s not generally serious. It’s also the only prescription drug with research evidence that it really works.

Provigil and Nuvigil are two newer drugs being used for MS fatigue. They were developed for the treatment of other conditions, such as narcolepsy. Unfortunately they are not FDA-approved for MS, and are quite expensive, but some people do find them helpful. They are taken once or twice a day, and the side effects include allergic reactions which can be very severe. There is some controversy over whether or not they are habit forming.

The stimulant drugs, including Ritalin, Straterra, Adderall, Concerta, Vyvance and others can be helpful as well. These drugs are tightly controlled by the DEA and usually cannot be refilled by phone or fax. They may cause weight loss, palpitations, and high blood pressure, but their cardiac risks seem fairly small. They are also potentially habit forming, however, and like Provigil and Nuvigil they are not FDA-approved for MS.

Recently I have learned that an OTC supplement called Acetyl-L-carnitine, taken at a dose of 1000mg twice a day, has been shown to help up to 50% of patients with MS fatigue. I do not have much personal experience with it yet, but I have been recommending it and will keep you updated. Diarrhea is a possible side effect, and as with all supplements, it is not regulated as to content, purity etc..

The bottom line is that there is no magic pill or treatment for this, and each person has to figure out what works best for them. I suspect that more treatments will be coming soon, since this is a lot of research going on in the field right now.

Post #5 Tysabri update

marcusrice — Thu, 05 Apr 2012 09:14:00 -0400

As many of you are aware, Tysabri has become one of the most widely used medications for multiple sclerosis. At this time there are nearly 100,000 people taking Tysabri around the world. In our center in Norfolk we currently are treating approximately 180 patients with Tysabri each month. It has become popular for several reasons, but primarily because it seems to be more effective than anything else on the market at preventing MS relapses and slowing down disability. It is given as an intravenous infusion, which takes 2 hours overall, once a month. It is thought to work by preventing inflammatory cells which cause MS from entering the nervous system.

There have been new developments within the past year which have improved our ability to use this medication safely. Tysabri is very well tolerated by most patients, but there is a small risk that it can activate a viral infection in the brain called progressive multifocal leukoencephalopathy, or PML. PML is caused by activation of a virus called the JC virus. The symptoms may be similar to those of MS itself, but they tend to be more progressive and severe. For example, the early symptoms of PML might include progressive weakness of one side, and enlarging blind spot, difficulty with speech or language, or changes in behavior.

PML is actually not terribly difficult to diagnose. There are characteristic signs on MRI. A spinal tap required because we are able to detect to the viral DNA in the spinal fluid.

The current treatment is designed to restore the immune system to normal. To do that, we removed the Tysabri from the bloodstream using a technique called plasmapheresis. This is basically a blood washing procedure. Blood is removed from a large vein, separated into cells and plasma, and the cells are returned to the body with artificial plasma. The Tysabri therefore is removed with the plasma. The immune system returns to normal and a syndrome called the Immune Reconstitution Inflammatory Syndrome - IRIS for short - usually develops. This is similar to a very severe attack of MS, and is treated with steroids. This can last for a number of months. If all goes well, the patient will recover but will frequently have more disability than they had previously. Some patients do still die from PML, but the percentage is down to under 20% with our current treatments.

Because this is such a potentially serious side effect, researchers have been trying to figure out which patients are most likely to get PML. It turns out that roughly half of the population carries the JC virus in their bodies without knowing it. We now have a blood test which can tell quite accurately whether or not a person carries the virus. If he or she does have the virus, the risk of PML will be higher. If there is no virus present, the risk of PML is extremely low.

The risk of PML also increases the longer you take Tysabri. For the first couple of years, even if you have the virus, the risk is less than 1:1000. After that, for patients with the virus, the risk increases to approximately 1:240. Also, if you have previously been treated with chemotherapy, such as Novantrone, Imuran, methotrexate, or others, your risk is increased.

I realize that some of this sounds a little scary. However, you have to compare the risk of PML to the risk of other treatments for other conditions and indeed to other life events themselves. For example the lifetime risk of dying from fire or smoke is 1:1116; from a car accident, 1:100 (*). Taken in that context, the risk of PML does not seem so bad.

To summarize, Tysabri is a widely used and very effective treatment for multiple sclerosis. While it does carry some risk, we are beginning to learn which risk factors are important so that we can identify patients who are most in danger of getting PML but also we can identify patients who have an extremely low risk and who may benefit from beginning Tysabri earlier in the course of MS.

It now appears that relative risk factors for development of PML include positive JC virus antibody status, duration of treatment, and previous treatment with chemotherapy. Patient’s with those risk factors should certainly keep in close contact with their physicians and frankly discuss their own particular situation with them. Patients who do not have any of those risk factors may be eligible to consider Tysabri early in the stages of MS.

(*) this is from an article by Drs Fox and Rudick in Neurology 2012;78;436

Post #4 Vitamin D & MS

marcusrice — Mon, 19 Mar 2012 08:44:26 -0400

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

marcusrice — Tue, 06 Mar 2012 16:36:00 -0500

Post #3: Oral Therapies: should I switch? and if so, when?

marcusrice — Fri, 02 Mar 2012 16:29:00 -0500

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

Post #2 Oral Meds for MS

marcusrice — Mon, 23 Jan 2012 15:09:24 -0500

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.

Welcome to my MS blog!

marcusrice — Tue, 03 Jan 2012 09:47:13 -0500

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.

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.

"It does not matter how slow you go so long as you do not stop. Wisdom of Confucius"

marcusrice — Mon, 26 Dec 2011 10:41:06 -0500

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It does not matter how slow you go so long as you do not stop.

Wisdom of Confucius

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Photo

marcusrice — Mon, 26 Dec 2011 10:15:00 -0500

NORFOLK, Va. (WAVY) - A new pill approved by the FDA in...

marcusrice — Wed, 21 Dec 2011 21:54:00 -0500

NORFOLK, Va. (WAVY) - A new pill approved by the FDA in March may be a potential medical breakthrough for the nearly 10,000 Virginians living with Multiple Sclerosis.

MS is a disease that affects the central nervous system and stops people from moving.

Lamont Walker of Virginia Beach leans on a cane when he walks because his left foot does not move very well anymore.

He was diagnosed with MS in 1991, which was a devastating blow to this avid athlete.

“Back in ‘85 I went to Booker T and we won the state championship, and I was named Eastern district player of the year,” he said.

Eventually he had to give up basketball, but never gave up on himself.

“I know I have multiple sclerosis but it doesn’t have me,” he said.

His doctor, Marcus Rice, prescribed a new drug called Ampyra, and they are seeing dramatic results.

“It is just so amazing to me that it happens like that,” said Walker, as his foot bobbed up and down.

His Neurologist, Dr. Marcus Rice said, “What it seems to do is it helps to improve the conduction of electrical current through the spinal chord.”

Dr. Rice cautions, however, that the pill it is not a cure. Side effects can include tingling, nausea and headache, which usually go away in a few weeks. There is also a risk of seizures, and the medication does not work for everyone.

“But those who do respond well, respond remarkably well, and they’re able to walk 25 percent faster, and in some cases have been able to get rid of canes, or walkers, or even wheelchairs,” said Rice.

Lamont does not dream of getting back on the basketball court, but the new treatment is giving him a shot at a new goal.

“I just want to be able to walk with my daughter and my son to just hold hands and walk around the block, that’s my goal,” he said.