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Thursday, February 20, 2014

Copaxone Tops the List of Ten Most Profitable Multiple Sclerosis Drugs

Copaxone multiple sclerosis drugA list of the top-ten FDA-approved drugs for patients with multiple sclerosis was compiled byGenetic Engineering & Biotechnology News according to sales in 2013. Coming in at number one with $4.328 billion was Copaxone, which is approved for patients with relapse-remitting multiple sclerosis, the most common form of the disease. Copaxone (glatiramer acetate) was developed by Teva and is an immunomodulator that prevents hyperactive immune cells from attacking neurological cells and nerves in the brain and spinal cord by acting as a decoy for the myelin sheath. It is a preferred treatment, and a more concentrated three-times-per-week formulation received FDA approval earlier this month.
Not far behind, with a 2013 market share of $3 billion, is Avonex from Biogen Idec. Although it, too, is indicated to treat relapse-remitting multiple sclerosis, there is some evidence that Avonex may help to slow the progression of secondary-progressive multiple sclerosis. The recommended treatment regimen involves a gradual increase in dose from 7.5 mcg each week to 30 mcg each week in order to ameliorate flu-like symptoms that may occur with full 30 mcg at the start of therapy.
Continue reading with information about the other MS medications

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Wednesday, February 19, 2014

Stony Brook Medicine Conducting Six-Month Research Study on Multiple Sclerosis Relapse

Published on February 18, 2014


(Stony Brook, NY) Stony Brook Medicine will be conducting an IRB-approved research study in conjunction with Hyperbaric Medical Solutions to determine whether hyperbaric oxygen therapy when added to conventional steroid therapy will improve recovery from multiple sclerosis relapse. Stony Brook MS Comprehensive Care Center Director Dr. Patricia Coyle will be the Principal Investigator for this first research study of its kind. Dr. Coyle will work with Hyperbaric Medical Solutions’ (HMS) Medical Director Dr. Henry Prince.
The six-month study will include 30 volunteer patients who have suffered an MS relapse. It will include steroid therapy, physical exams, neurological exams, questionnaires, MRIs and possible hyperbaric oxygen therapy. Participants will be asked to visit Stony Brook MS Comprehensive Care Center for six study visits and offsite facilities for MRI and possible hyperbaric treatments. Fifteen patients will be randomized to receive hyperbaric oxygen therapy and 15 will not.
Multiple sclerosis is an autoimmune disorder that attacks the central nervous system. Symptoms of the disease include numbness and weakness in extremities that can disable a person. According to the National Multiple Sclerosis Society, there are approximately 400,000 people living with MS in the United States. Women are almost three times more likely to have the disease.
Notes Stony Brook’s Dr. Coyle, “This is the first time hyperbaric oxygen is being examined to determine whether it can, when used acutely, lessen the damage associated with an MS attack”.
READ More of this study, found here



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For People Newly Diagnosed with Multiple Sclerosis (MS)

If you or someone close to you has recently been given a diagnosis of multiple sclerosis, you probably have a lot of questions and concerns. Or, you may be feeling so overwhelmed by the diagnosis that you aren’t sure what kinds of questions to ask. The National MS Society has developed programs to give you the information and support you need to live comfortably and confidently with this change in your life.




Taking the First Steps
The above information is provided by the National MS Society


In addition to what they do, Register with MS Views and News, to begin receiving OUR bi-monthly MS e-Newsletters that will help to keep you EMPOWERED with information.   Register here



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Multiple Sclerosis (MS) Heat & Temperature Sensitivity

Many people with MS experience a temporary worsening of their symptoms when the weather is very hot or humid or they run a fever, sunbathe, get overheated from exercise, or take very hot showers or baths. For example, some people notice that their vision becomes blurred when they get overheated—a phenomenon known as Uhthoff's sign. 
These temporary changes can result from even a very slight elevation in core body temperature (one-quarter to one-half of a degree) because an elevated temperature further impairs the ability of a demyelinated nerve to conduct electrical impulses.

The ‘Hot Bath’ Test Used for Years to Diagnose MS

For many years, the “Hot Bath” test was used to diagnose MS. A person suspected of having MS was immersed in a hot tub of water, and the appearance of neurologic symptoms or their worsening was taken as evidence that the person had MS.

Heat-Related Symptoms are Temporary

It is important to remember that heat generally produces only temporary worsening of symptoms and does not cause more disease activity (demyelination or damage to the nerves themselves). The symptoms are generally rapidly reversed when the source of increased temperature is removed. People with MS who are planning to move to a very warm climate should try to visit first; plans may have to be changed if the weather seriously worsens MS symptoms.

Strategies for Easing the Effects of Heat

  • Stay in an air-conditioned environment during periods of extreme heat and humidity. [If an air conditioner is needed to help minimize the symptoms of MS, the cost of this equipment may be tax deductible if the physician has written a prescription for it.]
  • Use cooling products (vests, neck wraps, bandanas, etc.) during exercise or outdoor activity, or pre- and post-cool.
  • Wear lightweight, loose, “breathe-able” clothing.
  • Icy drinks such as “slurpees” or popsicles can provide temporary relief.
  • Use an oscillating fan during indoor exercise.
  •  Exercise in a cool pool (<85 degrees).

Source for the above material: National MS Society



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Multiple Sclerosis Among Top Research Topics For “Year of the Brain” in Europe

European Brain CouncilThe European Brain Council (EBC) has declared 2014 the “Year of the Brain,” with Multiple Sclerosis as a main research focus for the consortium. During the new year, more focus will be placed on understanding how the brain works and is affected by diseases such as MS because, as stated by Gordon Francis, head of the NeuroInflammation Clinical Science Unit at Novartis (whose FDA-approved drug Gilenya is a leading Multiple Sclerosis therapy), “we have already identified a lot of gaps in knowledge about treatments of brain diseases.”
To address these gaps, the European Commission’s DG Research and Innovative Medicines Initiative launched one of Europe’s largest public-private initiatives to churn out safer, more efficacious medicines to treat brain diseases, which cost European countries more than €798 billion in 2010–more than 37% the overall health budget. “More money is spent into brain diseases than cancer or cardiovascular diseases, said Mary Baker, president of the European Brain Council, but the intention is not to create “a race or competition against cancer, cardiovascular diseases, or diabetes.”
The EBC’s underscoring of MS is well-suited, given the prevalence of the disease in Europe. At least 600,000 Europeans are affected by the autoimmune condition, according to the European Multiple Sclerosis Platform.  Bringing more light to how the brain works could lead to a better understanding of the onset and progression of multiple sclerosis, leading to research on new ways to treat, cure, and prevent it and other diseases of the nervous system. Already, scientists, including Frederik Barkhof at the VU University Medical Centre in Amsterdam, are looking into the loss of brain tissue that occurs with the early stages of multiple sclerosis.
The need for research is driven by the toll multiple sclerosis places on patients and their family members. Multiple sclerosis is a debilitating disease, with about one-third of patients requiring a wheelchair for mobility 20 years after diagnosis and fewer than one-half of patients maintaining employment after 10 years–not to mention, younger people between 20 and 40 are being diagnosed with multiple sclerosis. Careers, relationships, and future plans can be drastically altered for young patients, and “they are the brains of future,” said Baker. “The brain is a very special organ, and we must take care of it.”

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Experimental Medications: Administered Orally - Cladribine

Company: Merck Serono, Inc.
  • Given orally, as one or two courses per year, depending on the study regimen 
  • Although the parent company is not currently seeking approval, cladribine continues to be studied in RRMS

Cladribine predominantly affects peripheral blood lymphocytes (immune-system cells produced to fight infection and disease), with relative preservation of other cell types and components. It causes a preferential and sustained depletion of certain T cells in the immune system, as well as a decrease in B cells. (T and B cells are two types of lymphocytes.) Cladribine also seems to directly influence the overall T-cell response, which is believed to play a major role in the MS process.

The two-year Phase III CLARITY trial of two levels of cladribine versus placebo involved 1,326 patients with RRMS. Each course consisted of once-daily administration for four-to-five consecutive days, and study patients took cladribine for a total of eight-to-20 days of treatment during the year. It met its primary endpoint, showing 55-to-58-percent reductions in annualized relapse rates and 31-to-33-percent reductions in disability progression, as well as a substantial reduction in lesion burden.

The ONWARD Phase II study of 200 individuals who have experienced at least one relapse while taking Rebif combines oral cladribine with Rebif. This study will determine whether the combination is more effective than Rebif alone.

The Phase III ORACLE MS study was designed to assess whether cladribine can delay the time to a second clinical demyelinating attack in 600 individuals who have had a first clinical demyelinating event, also referred to as clinically isolated syndrome (CIS).

In March 2011, after an increase in malignancies was observed in patients in the cladribine clinical trials, the FDA announced that it would not approve oral cladribine for MS without more safety information. In June 2011, Merck Serono announced that they will not currently pursue global approval for cladribine tablets for the treatment of RRMS, but would continue existing clinical trials. The company may consider a reapplication if safety concerns are lessened. The experience with cladribine, while a setback for MS therapy, provides an important lesson in medication development - and a reminder that risks are as important as benefits in developing medications, and in offering these medications to people with MS.

Source: MSAA

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Experimental Medications: Administered Orally

Laquinimod

Company: Teva Neuroscience, Inc. and Active Biotech
  • Oral medication taken once daily; dosing is still under investigation
  • Laquinimod is being studied in RRMS

Although its exact mechanisms of action are unknown, laquinimod is an immunomodulator, apparently through its effects on cytokines and interleukins (immune-system signaling chemicals). It enhances T-regulatory cell activity, which reduces Th1-inflammatory T-cell activity. It also appears to reduce white blood cell penetration of the central nervous system (CNS). In addition to its immunomodulatory actions, laquinimod increases levels of the brain-derived neurotrophic factor (BDNF), possibly contributing to neuroprotection (protecting the nerves and myelin from damage) in MS patients. BDNF is a protein found in the brain that helps to support nerves and their development.

The Phase III ALLEGRO study of 1,106 individuals with RRMS showed that, compared to placebo, laquinimod reduced the annualized relapse rate by 23 percent and the progression of disability by 36 percent. It also was effective on several MRI outcomes, including a reduction in brain atrophy by 33 percent.

The BRAVO Phase III trial was another global, 24-month, double-blind study with 1,300 participants designed to evaluate laquinimod's efficacy, safety, and tolerability versus placebo. In August 2011, the sponsors announced that the study had failed to achieve its primary goal of reducing the annualized relapse rate, although there was a trend in that direction if the data are adjusted for differences in MRI characteristics at the start of the study.

Because the effect of laquinimod on relapses was more modest than has been seen with other disease-modifying therapies for RRMS, the drug was not considered for approval in the United States in 2012. In 2013, the results of two separate analyses of pooled data from the Phase III ALLEGRO and BRAVO trials studying laquinimod were presented.32 The first analysis compared the expected risk of disability progression (given a particular relapse rate) with that seen in the pooled data. In this analysis, the effect of laquinimod on reducing the risk of disability progression was larger than predicted. The second analysis examined the relationship between relapses and disability by looking at disability progression in both relapsing and relapse-free patients in the two trials. About one third of the patients who progressed were relapse-free, suggesting that these two outcome measures are mediated through different pathways.

Since laquinimod may have more of an effect on disability than on relapses, a new trial looking primarily at laquinimod's disability-preventing impact was designed. This 24-month trial, The Efficacy and Safety and Tolerability of Laquinimod in Subjects With Relapsing Remitting Multiple Sclerosis (CONCERTO33), is comparing two doses of laquinimod (including a 1.2-mg dose, higher than that which was tested in prior Phase III studies) with placebo, looking at confirmed disease progression as the primary outcome. This is the first modern RRMS trial to prioritize prevention of disability over prevention of relapses. The trial began enrollment of 1,800 patients in 2013, and is expected to run into 2018.

Source: mymsaa.org


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Experimental Medications: A New Interferon

Plegridy® PEGylated interferon beta-1a, also known as BIIB017)

Company: Biogen Idec
  • Administered by subcutaneous injection once every two weeks at a dose of 125 mcg (micrograms)
  • Plegridy is being studied for relapsing forms of MS

PEGylation is a chemical modification that has been performed on the interferon beta-1a molecule that allows it to be given subcu-taneously (under the skin) every two or four weeks, in contrast to the more frequent in-jections utilized by the currently approved forms of interferon. The goal is to reduce the number of injections, while maintaining the positive effect of the drug. Studies have tested this experimental therapy for safety and effectiveness. If approved by the FDA, this would give patients the option of using a single-dose auto-injector with a prefilled syringe less frequently.

The Phase III clinical trial (ADVANCE) enrolled patients with relapsing-remitting MS (RRMS) to determine the safety and efficacy of Plegridy as compared to placebo. Results were presented in 201331 from the first year of this Phase III study, where 1,512 patients were randomized to one of three groups: one group receiving placebo; a second group receiving Plegridy given by subcutaneous injection once every two weeks; and a third group receiving Plegridy by subcutaneous injection once every four weeks.

Plegridy dosed every two weeks significantly reduced MS disease activity versus placebo. Relapses were reduced by 36 percent, and new brain lesions by 67 percent, compared to placebo at one year. Disability outcomes were also positive in this one-year trial. In total, the proportion of disease activity-free patients over one year was significantly higher in the two treatment groups compared to placebo.

The overall incidence of serious adverse events (SAE) and adverse events (AE) was similar among the Plegridy and placebo groups. The most common serious adverse event was infection, which was balanced across all treatment groups (less than or equal to 1 percent per group). The most commonly reported adverse events with Plegridy treatment were redness at the injection site and influenza-like illness. Flu-like illness was reported in 47 percent of both treatment groups compared to 13 percent in the placebo group. These safety data are consistent with the established safety profile of interferon beta-1a therapies for MS.

After the first year, study participants who were taking the placebo were re-randomized to one of the two treatment groups (taking the active drug either once every two weeks or once every four weeks), and will continue on their new treatment for the remainder of the second year in the study. Once the study is completed, participants will be given the option to enroll in the ATTAIN open-label (no longer blinded) extensions study. Participants will be followed for up to four years in this second study.

In a subgroup of ADVANCE participants, up to 120 were enrolled in a sub-study that involves optical coherence tomography (OCT). This is a rapid, noninvasive, office-based imaging technique that allows objective evaluation of the thickness of the retinal axon (the nerve behind the eye) and nerve layers that atrophy (shrinking due to nerve cell death) in MS. Preliminary evidence supports the use of OCT as an objective tool to monitor the effectiveness of a therapy, and it is hoped that OCT may be used as an outcome measure in future studies.
In May 2013, Biogen Idec submitted a new treatment application for multiple sclerosis to the United States FDA for approval, and the application was accepted for review. A decision regarding the approval of Plegridy is expected in 2014.

Source: mymsaa.org
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MS Research Updates from the MS Association of America

MS Research Update 2014 Publication Cover 
View/Download PDF

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Tuesday, February 18, 2014

Is your healthcare team helping you achieve your goals?


Behind every great Olympian is a team of coaches and supporters—is your healthcare team helping you achieve your goals?

As the world gathers this year to watch thousands of athletes compete in the Sochi Winter Olympics, consider how they achieved this goal—through hard work, perseverance, and a team of people providing guidance and support. Your team of healthcare providers can help you achieve your goals too.

The key is learning how to work with them.
(2) TIPS to help you
#1. Track your progress. Write down any symptoms you may be experiencing to share with your healthcare provider.
Download My Relapse Report and start tracking your symptoms

#2. Bring a playbook. Come prepared for your next appointment with a list of topics you’d like to talk about or questions you may have.
Watch Dr. Randy Schapiro’s video to hear more about how to work well with your healthcare team.



                  START NOW - CREATE YOUR REPORT


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What works and what doesn't in multiple sclerosis?

What works and what doesn't in multiple sclerosis? We asked three experts in the field for their take: Jerry S. Wolinsky, MD, interim dean of the department of neurology at UTHealth/Memorial Hermann in Houston; Anthony T. Reder, MD, professor of neurology at The University of Chicago Medicine; and Barbara Giesser, MD, vice chair of the neurology department at the University of California Los Angeles. Their answers covered drug selection, new rehab strategies, the role of vitamin D, and new findings on survival rates versus relapse rates.

Watch this video: http://www.medpagetoday.com/HOTTOPICSWhatWorksWhatDoesnt/special-reports/SpecialReports-Videos/406


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Monday, February 17, 2014

Rebooting the Immune System - an MS update



Story of an experimental medical procedure to "reboot" the damaged immune system in individuals suffering severe effects of certain auto-immune diseases such as MS and Severe Aplastic Anemia, told by a recovered MS patient and the doctors who treated him.

Watch and COMMENT
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