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Saturday, May 1, 2010

Statins a Possible Treatment to Slow the Progression of MS

Source: MSFYi - April e-newsletter

A study examining the impact of statins on the progression of MS found a lower incidence of new brain lesions in patients taking the cholesterol-lowering drug in the early stages of the disease as compared to a placebo. Study participants received an 80 milligram daily dose of atorvastatin, marketed by Pfizer as Lipitor®.

The study was small, with 81 participants. Though its primary endpoint (designed to evaluate MS progression in people following their first attack) was not met, the researchers found over the 12-month course that about 55 percent of participants did not develop new brain lesions when administered statins compared with about 27 percent of the placebo group.

Study findings were presented by University of California, San Francisco (UCSF) researchers during the recent annual American Academy of Neurology scientific meeting in Toronto.

The trial was a phase II, multi-center, randomized, placebo-controlled follow up to a landmark study published by principal investigator Scott S. Zamvil, M.D., PhD, associate professor of neurology at UCSF. His laboratory first observed that statins cause T cell immune modulation that could be beneficial in MS and other autoimmune diseases. That study tested whether the drug could be used to prevent conversion to definite MS in individuals who have had a first attack.

"Our data is preliminary, and we need a larger study to confirm the effects of the drug and its magnitude. It is important that we understand how statins impact the progression of multiple sclerosis in order to better inform physicians and patients of their effect since these drugs are so broadly used throughout the United States and the world, and to learn whether a relatively inexpensive oral therapy can slow the course of disease," said Waubant.


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MS Caregivers Share Needs in Study

Source: MS Foundation's MSFYi e-Newsletter

A recent study from Mississippi State University (MSU) points to ways that improved health insurance measures can assist caregivers of people with MS. In a national survey of 530 informal caregivers of people with MS who have greater levels of physical dependency, about 70 percent of informal caregivers responded that assisting the person with MS perform daily activities or personal care took up the largest amount of their caregiving time. The scientists reported their findings in the journal Disability and Rehabilitation.

"Caregivers also reported a range of home and community-based services that would make caregiving easier or improve the care provided. However, informal caregivers generally reported low satisfaction with health insurance coverage of these services, especially coverage by health maintenance organizations and other managed care plans," wrote R. Buchanan and colleagues at MSU.

The researchers concluded: "Lack of health insurance coverage of needed home and community-based services can reduce the quality of informal care provided, as well as increase the burden of informal caregiving."


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New Drug Combination Targets Pseudobulbar Affect

Source: MS Foundation

Involuntary crying or laughing, known as pseudobulbar affect (PBA) can be a common symptom in people with MS. However, researchers are exploring a combination of drugs that could be the first effective long-term treatment for the problem.

The new treatment for curbing these unwanted crying and laughing episodes uses two drugs, dextromethorphan and low-dose quinidine. Early indications are that the two drugs do reduce the incidence and severity of these episodes and improve quality of life.

"There's no FDA-approved therapy for pseudobulbar affect," notes study lead author Erik P. Pioro, M.D., director of the section for ALS and related disorders at the Cleveland Clinic in Ohio, and a member of the American Academy of Neurology (AAN). "The off-label medications that are being used have their own set of side effects and problems. So from a medical and patient care point of view, it would be very worthwhile to have an approved medication that is both safe and effective," he says.

The study results were presented at the recent AAN annual meeting in Toronto.

The study authors note that PBA typically manifests in people with an underlying neurological illness, including those with MS. Dr. Pioro says that conservative estimates put the number of Americans with PBA at close to 2 million, although he said the figure might actually be as high as 6 million to 7 million.

In the study, Dr. Pioro and his colleagues enlisted 283 people with PBA in an initial drug trial, during which some participants received one of two dosage levels of the two medications, while others received placebos.

After a two-week break, this was followed by a second phase involving 253 of the original study participants. During the study's second part, participants were exposed to daily doses of the two-drug regimen for 12 weeks.

Dr. Pioro and his colleagues observed "significant improvement" among all the participants — particularly among those who had not been exposed to the drug combo until the second part of the study.

Overall, Dr. Pioro noted that "there was an improvement of probably about 30 to 40 percent of symptoms" on average.


Treating multiple sclerosis with monoclonal antibodies: a 2010 update

1. Expert Rev Neurother. 2010 May;10(5):791-809.  Treating multiple sclerosis with monoclonal antibodies: a 2010 update.  Buttmann M.  Department of Neurology, Julius Maximilian University, Josef-Schneider-Str. 11, Würzburg, Germany.  Treating multiple sclerosis (MS) with monoclonal antibodies (mAbs) has been marked by both progress and setbacks in the past 2 years, which are reviewed here. 
The natalizumab section of the article centers around progressive multifocal leukoencephalopathy (PML), and discusses PML risk in relation to treatment duration, bioassays for individual risk prediction, the concept of drug holidays, clinical course and treatment of PML, as well as safety-related regulatory actions. 
The rituximab section critically analyzes recent clinical trial results, discusses the clinical relevance of anti-idiotypic mAbs and makes  a short excursion to neuromyelitis optica. Following this, the newer anti-CD20 mAbs ocrelizumab and ofatumumab, which are currently being tested in Phase II for MS, are reviewed and compared. 
The alemtuzumab section highlights novel data on mechanisms of action, potentially allowing individual risk prediction, and new results from the CAMMS223 trial, as well as the current status of the pivotal MS  studies. 
The daclizumab section summarizes new open-label data, shedding more light on the adverse-effect profile of the drug in MS patients, and reports on its Phase III status. 
Subsequently, a failed ustekinumab trial and LY2127399 are  reviewed. Taking into account late Phase II and III data on novel oral agents, the final section attempts to provide a detailed perspective on disease-modifying MS therapy in the medium term.  PMID: 20420497 [PubMed - in process]

PMID: 20420497 [PubMed - in process]



A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis

N Engl J Med. 2010; 362(5):387-401 (ISSN: 1533-4406)

Kappos L ; Radue EW ; O'Connor P ; Polman C ; Hohlfeld R ; Calabresi P ; Selmaj K ; Agoropoulou C ; Leyk M ; Zhang-Auberson L ; Burtin P ;
Department of Neurology, University Hospital, University of Basel, Switzerland.

BACKGROUND: Oral fingolimod, a sphingosine-1-phosphate-receptor modulator that prevents the egress of lymphocytes from lymph nodes, significantly improved relapse rates and end points measured on magnetic resonance imaging (MRI), as compared with either placebo or intramuscular interferon beta-1a, in phase 2 and 3 studies of multiple sclerosis.

METHODS: In our 24-month, double-blind, randomized study, we enrolled patients who had relapsing-remitting multiple sclerosis, were 18 to 55 years of age, had a score of 0 to 5.5 on the Expanded Disability Status Scale (which ranges from 0 to 10, with higher scores indicating greater disability), and had had one or more relapses in the previous year or two or more in the previous 2 years. Patients received oral fingolimod at a dose of 0.5 mg or 1.25 mg daily or placebo. End points included the annualized relapse rate (the primary end point) and the time to disability progression (a secondary end point).

RESULTS: A total of 1033 of the 1272 patients (81.2%) completed the study. The annualized relapse rate was 0.18 with 0.5 mg of fingolimod, 0.16 with 1.25 mg of fingolimod, and 0.40 with placebo (P 0.001 p="0.02">

The cumulative probability of disability progression (confirmed after 3 months) was 17.7% with 0.5 mg of fingolimod, 16.6% with 1.25 mg of fingolimod, and 24.1% with placebo. Both fingolimod doses were superior to placebo with regard to MRI-related measures (number of new or enlarged lesions on T(2)-weighted images, gadolinium-enhancing lesions, and brain-volume loss; P<0.001>

Causes of study discontinuation and adverse events related to fingolimod included bradycardia and atrioventricular conduction block at the time of fingolimod initiation, macular edema, elevated liver-enzyme levels, and mild hypertension.

CONCLUSIONS: As compared with placebo, both doses of oral fingolimod improved the relapse rate, the risk of disability progression, and end points on MRI. These benefits will need to be weighed against possible long-term risks. ( number, NCT00289978.)

PreMedline Identifier:20089952

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
source: Medscape


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Friday, April 30, 2010

MSVN to host an MS education program in Ft. Lauderdale

MSV&N invites you to attend this MS Education Program

"Staying on Your MS Treatment"


“Urological Implications on MS”

Presented by:

Brian Steingo, MD – Neurology

To Discuss: The importance of staying on your MS Therapy


Bill Pintauro, MD – Urology

To Discuss: Neurologic Issues concerning the bladder

Where: The Signature Grand Catering Center

6900 W State Road 84 - Davie,FL 33317

Google Map

When: Tuesday, May 11th, 2010

6:00pm - Registration

6:30 - Program and Dinner

RSVP required: To obtain a confirmation number

Please Contact Stuart at (954) 684-1683

Or send an email to:

Limited to the MS Patient & (1) caregiver

Program Supported through an educational grant from Biogen-Idec


The Viking Hypothesis the global distribution of certain northern-European genes which appear to be present in cases of MS

Information provided by Terence in Spain.

RESEARCHERS working on the island of Sicily recently discovered that Enna has an unexpectedly high and rising incidence of MS1. This, in the warm wine/oil-growing region of the Mediterranean where the incidence of MS is supposedly lower than in northern Europe. It was Dr. Roy L. Swank, MD Ph.D in his book based on years of study, research and experience with MS patients who noticed that is was the beer-drinking, bread-eating people of northern Europe who were more susceptible to the disease and he suggested the problem was possibly due to their wheat-based diet. But is there another reason?

Click here to read more of this interesting story


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The most detailed genetic investigation ever of multiple sclerosis has produced more questions than answers

A Twins Study, Deepens Multiple Sclerosis Mystery

Using extremely fine-grained analytical tools, scientists compared genetic information in three sets of identical twins. One of each pair had MS, and the other didn’t — yet their genes proved essentially identical.

“We find no smoking gun on the genetic level,” said National Center for Genome Resources geneticist Stephen Kingsmore, co-author of the study published April 28 in Nature.

The research cost $1.5 million, and the scientists took 18 months to sequence 2.8 billion DNA units in each twin, and determine whether they came from the mother or father. Most genomic comparisons look for differences in a just handful of suspect genes, and even whole-genome approaches don’t differentiate between parental contributions.

The researchers also analyzed the twins’ CD4 cells, a type of white blood cell that plays a central role in the development of MS. In these cells, the researchers sequenced epigenomes — chemical instructions that turn genes on and off — and transcriptomes, or a chemical record of genes that are actively coding proteins.

These multiple layers of information represent the cutting edge of genomic analysis, and are expected to reveal what rougher tools cannot. “This was a technical tour de force, and potentially represents a new way of looking at disease states,” said Kingsmore. Nevertheless, they found no differences.

The absence of genetic differences doesn’t mean that genetics are irrelevant to multiple sclerosis. Identical twins, who are descended from the same egg, are six times more likely to develop MS than non-identical twins, who come from two different eggs.

It’s still possible that some as-yet-unknown genetic factor, undetectable by even the most advanced tools, may explain the discordance in the study. However, Kingsmore thinks the culprit is probably an unknown environmental influence. “There must be a nongenetic factor, probably environmental,” that combines with known genetic and environmental risks, he said.

The researchers would like to look at more twins, and other types of cells. Even so, the study “was a pioneering effort on a scale that hasn’t been done before,” said Kingsmore. “We’re left with this mystery.”

Read More


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Mouse DNA Stops Progression Of Multiple Sclerosis

A tiny creature could hold the key to stopping the progression of multiple sclerosis. DNA from a mouse is being infused into patients. It's FDA approved and patients are seeing results.

"I am not expecting a cure," said Violet Lotito, who suffers from MS. "I am just expecting some help."

Lotito loves being in the middle of the mix -- either substitute teaching or cutting and styling hair.

But recently she couldn't even stand, let alone work. Her MS got so bad, life wasn't fun.

"The benefit hasn't gone higher than the risk until now," said Lotito. "Now that my symptoms have increased it is time to do something."

Lotito turned to infusions of a drug called tysabri -- a monoclonal antibody that contains DNA from a mouse and a human.

"Monoclonal antibodies are designed in the lab and they are specifically targeted toward specific molecules on white blood cells," said Dr. John Corboy, of University of Colorado Hospital.

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Bill Bradbury has put his multiple sclerosis front and center in his campaign

By Anna Griffin, The Oregonian

April 29, 2010,
Let's play the "what if" game.

You're a candidate for major public office. You suffer from a debilitating physical condition. You're running against a guy who looks and acts like the Marlboro Man, if the Marlboro Man fought cancer instead of encouraging it.

Do you downplay your health problems. Highlight them?

Bill Bradbury figures he doesn't have a choice. When he was diagnosed with multiple sclerosis 30 years ago, the symptoms were barely noticeable. When he ran for the senate in 2002, the only sign was a minor limp. Bradbury scoffed then at suggestions that he talk much about it.

Today, the Democratic gubernatorial candidate has enough trouble controlling his leg muscles that he uses a Segway scooter to get around. The slow progression of the illness is obvious enough that there was almost no debate within his campaign about making the condition, in which a person's immune system attacks the insulation around their nerves, a centerpiece of his TV and radio campaigns.


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When and where people are born may affect their odds of developing multiple sclerosis

April 29, 2010, Bloomberg Business Week
Sunlight May Play Role in Multiple Sclerosis Risk

Adequate vitamin D in months before birth could be key, Australian study suggests

THURSDAY, April 29 (HealthDay News) -- When and where people are born may affect their odds of developing multiple sclerosis, according to researchers who found that children born in the early summer months in the Southern Hemisphere are more likely to develop multiple sclerosis than those born in early winter.

A similar pattern has been found in the Northern Hemisphere, where the summer and winter months are the reverse of those in the Southern Hemisphere. The researchers think the higher disease rates may have something to do with the children's mothers getting less exposure to sunlight during pregnancy.

Scientists have linked low vitamin D levels to higher rates of multiple sclerosis, and sunlight boosts vitamin D levels. Click here to continue


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