Quatro"s Medical: Multiple Sclerosis

Living with multiple sclerosis means struggles and triumphs

2012-09-28T07:25:00.002-07:00

(CNN) -- It started in May of last year for Beth Ulibarri, as she would go on the occasional long run. "I would experience a tingling sensation throughout my lower legs. I described it as feeling like something was tickling my legs from the inside and just figured it was my muscles firing away from the exertion of the run." Less than a year and many medical tests later, the Albuquerque, New Mexico, resident was diagnosed with multiple sclerosis, or MS. "My biggest struggle has been dealing with the unknown -- questions that do not have answers," she said. "Concern for my children -- will they get this disease as well? Concern for my future. Will I end up in a wheelchair? Concern for how my husband will handle everything to come." Multiple sclerosis affects about 400,000 Americans and 2 million people worldwide, according to the National Multiple Sclerosis Society. It can damage the protective outer lining of nerve cells, making it difficult to control muscular activity. Ann Romney overcomes health struggles Jack Osbourne on living with MS Following MS diagnosis, the beat goes on Montel Williams' MS diet Ann Romney, scheduled to speak on Tuesday night at the Republican National Convention, has spoken often about her experiences with the disease during the presidential campaign. Jack Osbourne's recent diagnosis has received a lot of attention as well. Ulibarri is one of many who shared their stories of struggle and triumph with the iReport community. She confessed that she worried that the disease would affect her ability to take part in athletic activity. "One of the first things I did was research athletes who have MS," she said. "I was relieved to find many runners and triathletes who have MS who continue to train and even do amazing things like run marathons and do Ironmans." Dr. Timothy Vollmer, the director of Neurology Clinical Research at the University of Colorado-Denver, even says that such activity can be beneficial. "We encourage patients to really think about lifestyle issues, to maximize their activity and exercise, and also to maximize healthy diet, because we now know those things do impact the amount of residual disability people have." Since she was diagnosed, Ulibarri has completed one marathon and has qualified for the Boston marathon. "I know that eventually this disease may prevent me from doing things like running marathons, and I will have to accept that as it comes," she said. "For now, I am incredibly grateful for each day I can get out of bed and head out the door." Beat goes on for music producer diagnosed with MS As CNN's iReporters showed, no two people afflicted with MS have exactly the same symptoms, and no two people will react to it the same way. While Ulibarri lives her life publicly with MS, others have felt the need to hide their disease. One such person is an Ohio man who wanted to go by the name of Michael Taylor for this story. "All I want is to build a career (and) a family, work out and golf. Pretty normal for an active and ambitious 25-year-old," he said. "But I find myself attempting to plan for the future and ask questions. I find myself injecting my leg with medication I know little of, and asking questions on a daily basis." Taylor has had MS for years but only found out about it earlier this month. So far, he has hidden his MS, over worries that it could hurt his career. "The fact is that most adult Americans know someone with MS, they just don't know they have MS because they keep it quiet," Vollmer said. "The fear is that they will have relapses, they won't be able to work, they're not reliable. That's actually not true for the majority of them." As for Taylor, he says he has been able to get by with the occasional bout of numbness or loss of strength. "I just recently completed a rigorous ropes course that many healthy non-MSers could not." Helen Solinski found herself in the same boat as Taylor in 2003. "The first few years, I tried to hide my disease and pushed myself as hard as I could, but there was a point when I simply let go," said the Saratoga, California, resident. "I realized I couldn't bear to stand on the sidelines, hoping for better MS drugs." Solinski left her job in Silicon Valley to work with the Myelin Repair Foundation, an organization searching for a cure for MS. MS drug Gilenya under safety review "My goal is to prevent future generations from having to make important life decisions around a chronic disease -- it's not what I want for my son," she said. Christina Lamb Sidell of Williston, Vermont, wasn't sure she would be able to have a son. "I had similar symptoms as Jack Osbourne, but was lucky that my doctor figured out within just a few days of my seeing him that I had MS." At 35, she was told she could either wait a minimum of two years to have children or have children right away. "During pregnancy, there is a decrease in having an attack of MS," Vollmer said. "But there's a rebound effect after delivery. There's an increased risk in having a relapse three to six months after delivery. "If you look at populations with more pregnancies or less pregnancies, the women with less pregnancies actually have more disability. We do not recommend that women delay pregnancy because of MS." A year and a half later, Sidell's son was born. She and her husband call him their "free gift with disease." And yes, "he is perfect." Carol Sadrozinske was told she might not be able to raise her son when she was diagnosed while pregnant in 1987, at the age of 23 (many people with MS are diagnosed quite early in life, with the peak of the disease coming at 29 or 30, according to Vollmer). "I was encouraged to put the child up for adoption, since at the time stress from childbearing and child rearing were thought to be detrimental to the health of a woman with a diagnosis of multiple sclerosis," she explained. She ignored the advice, and by 1996 was a mother of three boys. She has had her ups and downs with the disease, included a devastating fall earlier this year that left her bruised with a broken arm. MS activity may vary with seasons "The worst part of the disease is not knowing what each day will bring," she said. "Will I be able to see? Will I be able to walk? Am I making any sense when I speak?" Even so, her three sons -- now 24, 21 and 19 -- have brought her tremendous joy. "Their joys, triumphs and struggles make my life worthwhile. Not to mention that their love alone gives me the courage to survive. I believe that the best thing I have done is ignore the advice to not have children!" On the flip side, Beth McCann's daughter, Molly, just had to share how proud she is of her mother, who has suffered the debilitating effects of MS for 17 years. "The worst form of MS is primary progressive, and my mother is one away from the worst. You can do the math. She lost her beautiful singing voice and her memory is declining to the point where she is forgetting even my cousins' names." Now 20, McCann, of Eagan, Minnesota, said that she has had to grow up quickly and gained a sense of independence. "It's the hardest thing in the world watching the person you love and admire the most in this world slowly, slowly decline to more and more disability and losses in her life. It is like a death sentence of my mother, but in slow motion to me." Even so, she has always admired how her mother handled it. "Throughout her progression, she is so positive, never complains, is always joking and refuses to let this disease get the best of her." Like so many who spoke to CNN, McCann has found that little things can help conquer the disease at the worst moments. "This is all I've known of my mother. I love her regardless of this disease. Despite being sick, she still loves life; and sees the beauty in all of its challenges. She is the best mother a girl could ask for." By Henry Hanks, CNN updated 7:22 AM EDT, Tue August 28, 2012

Clinical Trial Shows Teriflunomide Pill Reduces Relapses in Relapsing-Remitting MS

2012-07-11T05:44:00.001-07:00

Jun 04, 2012

In a clinical trial involving 1,169 people with relapsing-remitting multiple sclerosis, oral teriflunomide (Genzyme/Sanofi-Aventis) reduced relapses compared with placebo over at least 48 weeks, according to a company press release dated June 1, 2012. Of two different doses tested during the TOWER trial, the higher dose also slowed progression of disability. This is the third completed of five phase III studies involving teriflunomide in multiple sclerosis. An application for marketing approval of teriflunomide was accepted for review by the U.S. Food and Drug Administration in October 2011.

Background: Multiple sclerosis occurs when the immune system attacks the brain and spinal cord. Teriflunomide is a novel oral compound that inhibits the function of specific immune cells. In the TEMSO study reported in 2011, teriflunomide reduced the average number of MS relapses and disease activity on MRI scans significantly more than inactive placebo in 796 people with relapsing forms of MS. Read more about this study.

In the TENERE study, compared with Rebif® (interferon beta-1a, EMD Serono and Pfizer), teriflunomide did not significantly reduce the primary endpoint of “risk of failure,” meaning the first occurrence of a relapse, or permanent discontinuation of the study treatment, whichever came first. Read more about this study.

Other phase III studies of teriflunomide are ongoing, including the TOPIC study in 780 people at high risk for developing MS (teriflunomide vs. placebo); and the TERACLES study in 1455 people with relapsing MS (teriflunomide vs. placebo added on to interferon beta).

The Study: For the TOWER trial, investigators worldwide recruited 1,169 people with relapsing MS, and randomly assigned them to receive teriflunomide 7 mg or 14 mg, once daily by mouth, or placebo for 48 weeks. The primary endpoint was whether the study drug reduced the average number of relapse per year significantly more than placebo. Secondary endpoints included the time to disability progression confirmed for at least 12 weeks.

According to the press release, Teriflunomide 14 mg reduced relapses by 36.3% versus placebo and 7 mg reduced relapses by 22.3% versus placebo. In the 14 mg-group, the time to disability progression was reduced by 31.5%; the lower dose did not significantly reduce progression.

Three deaths occurred in the teriflunomide groups – from sepsis, suicide, and motor vehicle accident. Participants in the teriflunomide groups experienced more headache, nausea, diarrhea, hair thinning, and low levels of white blood cells.

Comment: These and results from additional phase III studies of teriflunomide that have been completed or are now underway should help define the short-term safety and promise of teriflunomide as a potential new therapy for relapsing MS.

Rebif is a registered trademark of EMD Serono and Pfizer.

National MS Society Partners to form "Everyday Matters"

2012-06-18T09:59:00.002-07:00

The National MS Society and Genzyme have partnered to create Everyday Matters, a unique online initiative to tell important stories of everyday challenges from regular people afflicted with MS from across the nation and use positive psychology to help address those challenges head-on.

Over the next five months, Everyday Matters will feature the stories of real people meeting some of the everyday challenges that multiple sclerosis can bring on the path to one's "best life" - and provide tools for you to travel along too!

Please click on the link below and be a part in sharing and to experience the stories voted on by you.. Share this link on your Social Media, lets spread the word to make this venture a successful one..

Everyday Matters

I will bring more info your way as it becomes available, with the exchange of ideas, stories that inspire, new advanced methodology, and medical advances we can and will make a difference in the fight against Multiple Sclerosis..

Thank you for visiting, if you find this site is a help, please share on your social media, leave comments and or suggestions to better improve. We are adding information monthly to better enhance our helping capabilities, so bookmark us or follow our RSS feed. Links to share this site are located to the right or below..

Thanks again, and smiles sent your way from the southern shores of the lake they call Ackerson... Peace Y'all

Bill "Chef Willy" Ong

Memories Never Fade; a MS story of Love, a Granddaughter and her Grandfather

2012-04-23T16:45:00.002-07:00

I try mostly to put up information dealing with medical aspects of MS, but as of late I went out on my face book wall and asked my friends if they had any stories dealing with MS that they would be willing to share. One of my friends stepped up to the plate and hit a home run. Her story of she and her grandfather nearly brought this tough old guy to tears.. It is a honor to publish this and I so thank you for sharing, Jen...

According to http://www.mayoclinic.com/health/multiple-sclerosis/DS00188,

“Multiple sclerosis (MS) is a potentially debilitating disease in which your body's immune system eats away at the protective sheath that covers your nerves. This interferes with the communication between your brain and the rest of your body. Ultimately, this may result in deterioration of the nerves themselves, a process that's not reversible.

Symptoms vary widely, depending on the amount of damage and which nerves are affected. People with severe cases of multiple sclerosis may lose the ability to walk or speak. Multiple sclerosis can be difficult to diagnose early in the course of the disease because symptoms often come and go — sometimes disappearing for months.

There's no cure for multiple sclerosis. However treatments can help treat attacks, modify the course of the disease and treat symptoms.”

According to me, Multiple sclerosis (MS) is the disease that stole my grandfather’s identity.

I was the youngest and only girl out of a family of four. My three older brothers were my whole world, my own personal bodyguards, and turned out to be amazing men. Yet, they had something I never had and whereas I was jealous of this growing up, I now realize that at least someone got to experience the good side of grandpa.

I, however, do not ever remember the grandpa who took them for rides in the car, went fishing with them, etc. I remember the grandpa who slowly, but surely disappeared before my eyes because of MS. I spent so many weekends, long breaks from school, and weeks on end in the summer at my grandparent’s house. My mom’s parents weren’t just grandparents’ to be, but a second set of parents, the fun parents so to speak. However, like I said I watched my grandpa fade before my eyes.

When I was really little, it was him grabbing my feet and tickling them until I was screaming with laughter and going for walks on the country roads. Then as I got a little older it was all about swinging on the front porch while he did his word searches and I wrote in my journal or read the latest Ann Martin, Beverly Cleary, or Judy Blume book.

However, there were always signs of the MS … him eating like a child at the dinner table, difficulty remembering things, lack of concentration, and his rage because it took everything he had to convey his emotions. Things that were once so easy for him became difficult tasks and it just got worse and worse.

He began walking in the middle of the road with his walker because he was confused, he would go to the bathroom in the front yard, and he just withered away. I lived with my grandparents when I was a teenager and witnessed him forgetting conversations we had the day before, my name, and just struggle with everyday activities of daily living.

He was in and out of the VA hospital for a few years and finally ended up in the VA hospital for good right around the time I was 21 and by the time I was 22, we lost him for good. I’ll never forget the day we lost him …

Its 20 degrees out, a cold December day, and I’m running barefoot down my street to get the few blocks over to my mom who was babysitting my niece and nephew. I collapsed in tears in the middle of the street and luckily, my ex-husband showed up, lifted me into the car, and took me to my mom. It broke my heart to know that this disease had taken away a man who had a Purple Heart from the Korean War, who loved fishing, and who was just amazing. It robbed him of himself, but to be honest I appreciate the memories I do have of my grandpa even with the MS.

It taught me to be compassionate, to treat others with respect, and gave me a special relationship with him that nobody else had. I still tear up thinking about the last time I saw him and how he couldn’t remember my name, but sure enough, he knew I was “His girl.”

So, here’s my advice to anyone who has someone in their life that has MS or is diagnosed with MS. Don’t stop living, don’t stop loving, and don’t stop believing. Make memories that last a lifetime and appreciate what you have while you have it.

Jen H.

Study shows hotter days may worsen the ability to perform mental tasks in some people with MS

2012-04-17T07:02:00.000-07:00

Apr 12, 2012

People with multiple sclerosis often report worse symptoms when the weather is hot. A recent study concludes that hot weather may also worsen the ability to perform mental tasks in some people with MS. The research, which needs further exploration, may help people plan activities and may improve the design of future clinical trials. Victoria Leavitt, PhD, John DeLuca, PhD (Kessler Foundation Research Center, West Orange, NJ) and colleagues conducted the study with funding by the National MS Society and National Institutes of Health. The report was published early online March 7, 2012 in Neurology.

Background: Warmer weather tends to worsen many people’s neurological symptoms of MS. Recent research also suggests that relapses are more likely to occur in warmer months, and some people may have more MRI-detected active MS brain lesions during these months. This study examined a possible link between outside temperature and the ability of people with MS to perform various mental tasks.

The study: Researchers compared 40 people with MS and 40 people without MS or any other condition that might have affected the results. Each participant was tested for their ability to process a mental task and for learning and memory. The average outside temperature on the testing day was recorded. The results showed that people with MS tended to perform worse when the weather was hotter than when it was cooler. People without MS performed equally as well regardless of the outside temperature.

The investigators also examined the performance of a separate group of 45 people with MS on these same mental tasks, measured at two time points that were six months apart. The outside temperature was recorded on each testing day. Again, the researchers noted poorer performance when the outside temperature was higher on the day of testing.

Comment: This study has several implications. For one, awareness of heat-related problems with mental tasks may impact lifestyle decisions; for example, whether to take a mentally challenging college course in the summer or winter. The results also suggest that clinical trials involving people with MS should take temperature into consideration both when designing the study and interpreting the results, especially when cognitive testing is used as a treatment outcome measure.

Read more about cognitive problems related to MS

Read more about heat sensitivity in MS and ways to cope

Biogen Idec Applies to FDA for Approval of BG-12 to Treat MS

2012-03-21T09:43:00.001-07:00

Feb 29, 2012

Biogen Idec announced that the company has submitted a New Drug Application to the U.S. Food and Drug Administration for approval to market oral BG-12 (dimethyl fumarate) for the treatment of MS, based on positive results from several clinical trials involving people with relapsing-remitting MS.

Multiple sclerosis involves immune system attacks against brain and spinal cord tissues. Although its exact mechanism of action is not known, BG-12 is thought to inhibit immune cells and molecules and may be protective against damage to the brain and spinal cord.

BG-12 significantly reduced the proportion of people with MS who experienced relapses in the phase 3 DEFINE study of more than 1200 people with relapsing-remitting MS and significantly reduced the average number of annual MS relapses in the phase 3 CONFIRM trial of more than 1400 people with relapsing-remitting MS. Data from the DEFINE trial were presented at the 2011 joint meeting of the European and Americas Committee for Treatment and Research in MS, and data from both trials will be presented at the Annual Meeting of the American Academy of Neurology in April 2012; abstracts can be viewed on the meeting web site.

“If the FDA’s review of oral BG-12 finds it to be safe and effective, it would represent an important treatment advance for people with MS,” said Aaron Miller, MD, Chief Medical Officer of the National MS Society.

A reprinted article from the National MS Society web site..

National MS Society Convenes Summit to Explore Vitamin D Trials to Prevent MS

2012-01-28T10:54:00.000-08:00

Jan 17, 2012

Researchers and clinicians from around the globe gathered recently in Chicago to develop strategies for testing whether vitamin D supplements can prevent the development of MS. Participants discussed the latest findings relevant to vitamin D and MS and potential clinical trial designs, taking the first steps to making these exciting studies a reality. “Vitamin D and MS Prevention: An International Workshop,” was chaired by Colleen E. Hayes, PhD (University of Wisconsin-Madison) and Anne-Louise Ponsonby, PhD (Murdoch Children’s Research Institute, Canberra Australia), and was funded by the National MS Society.

Background: Research is increasingly pointing to a reduced level of vitamin D in the blood as a risk factor for developing MS. Years ago, MS researchers wondered why MS occurs less often in regions of the world where exposure to sunlight is high. Dr. Hayes – a professor of biochemistry and microbiology – and colleagues suggested that vitamin D, which is made by cells in the skin in response to sunlight, may suppress the immune response involved in MS. She and others have since shown that in lab mice, vitamin D can reduce the effects of EAE, an MS-like disease.

Epidemiologic studies (studies of who gets MS) have backed up laboratory studies. Dr. Ponsonby – an epidemiologist and public health physician – was a co-author of the Ausimmune Study, a comprehensive Australian study that showed that higher levels of sun exposure and higher blood levels of vitamin D were both associated with decreased risk of having a first demyelinating event, often the first indicator of subsequent MS.

The National MS Society has led the way in pursuing this avenue of MS research, funding much of Dr. Hayes’ work, first funding the Ausimmune study, and now, a new clinical trial testing whether vitamin D can reduce disease activity in people who have MS. Read more on clinicaltrials.gov.

The Meeting: Participants included experts in vitamin D studies, immunology, statistics, epidemiology, clinical MS research, pediatric MS, and MS biomarkers. The group began by bringing its vast experience to bear in discussing the promise and potential pitfalls of conducting “primary prevention studies” using vitamin D to potentially prevent MS before it occurs.

“We are people from all over the world and we have one common purpose – to stop this disease,” noted Dr. Hayes. “The research that has been done by the people in this room and others provides us with strong evidence that vitamin D may help.”

Alberto Ascherio, MD, DrPH (Harvard School of Public Health) and colleagues have published pivotal studies relating to several MS risk factors. His 2006 study – supported by the Society – compared levels of vitamin D in blood serum stored from military personnel during their service, and found that those with higher levels of vitamin D were at lower risk for later developing multiple sclerosis. Dr. Ascherio noted a major concern about designing vitamin D studies, based on his research. “Compliance is likely to be a major obstacle,” he said. “You have to worry about people in the placebo group that might take vitamin D anyway, and make the study powerful enough to account for that.”

George Ebers, MD, FRCP(C) (University of Oxford) reported on findings “hot off the press” – his team recently confirmed an association between MS and a gene linked to vitamin D. Dr. Ebers cautioned that before beginning a study, “You absolutely need to know what the rate of MS is in your country,” noting that the reported rates of MS is increasing in some areas.
Dr. Hayes reviewed basic research that could have a strong impact on planned studies. For example, female mice treated with vitamin D are protected from MS-like disease, but not male mice. “Normal estrogen may be essential for vitamin D benefits,” she said. Also, her research points to the immune messenger protein interleukin-10 as being essential for vitamin D protection from MS-like disease in mice. “Anything that destroys that pathway may undermine a treatment trial,” said Dr. Hayes.

Jorge Correale, MD (Raul Carrea Institute for Neurological Research Argentina) discussed his research on the immune response and vitamin D. “Vitamin D is particularly reduced during relapses in people with MS,” he said, noting that administering vitamin D to cells isolated from people with MS resulted in modulation of immune “T cells” which have been previously implicated in MS activity. He noted that cells that reduce inflammation are activated by vitamin D and those that promote inflammation are suppressed.

Reinhold Vieth, PhD, FCACB (University of Toronto) has been studying vitamin D for decades. His team’s findings show that this vitamin is associated with decreased PSA (a marker for prostate cancer), and a decreased risk of breast cancer. His experience provided numerous important considerations for conducting vitamin D prevention trials in MS. “Vitamin D binding protein [a protein that helps to transport the vitamin within the body] acts as a safety buffer to prevent toxicity,” he said. “It protects the body from having too much vitamin D.” Dr. Vieth works with the team that found vitamin D supplements to be safe in small, early study of people with MS (Neurology 2010;75(5):480).

Co-chair Dr. Ponsonby encouraged participants with her review of similar efforts undertaken to combat other diseases such as folate supplementation to mothers in pregnancy to prevent spina bifida. “I remember being at a primary prevention meeting in the early 1990’s ,like this one, to talk about sudden infant death syndrome prevention, which was taking one in 250 children in Tasmania at that time,” she said. “I thought, ‘How are we going to get this done?’ Five years later, it felt so good to be at another meeting, talking about how, after changes in health recommendation, the rate of SIDS had decreased by up to 70% in several countries.”

Future Steps: After reviewing data and hearing from statisticians and clinicians about the feasibility and expense of primary prevention studies, participants agreed to look at three study designs. The next steps are to submit a report based on the summit to a peer reviewed journal, and to begin the process of designing and seeking funding for the proposed prevention trials.

Timothy Coetzee, PhD, chief research officer of the National MS Society, complimented Drs. Hayes, Ponsonby, and colleagues on the “audaciousness” of their efforts. “Can we end MS by something as simple as vitamin D supplementation? This goal is as big as they come, but it fits right into the Society’s bold commitment to do everything possible to free the world of MS.”

New Oral Drug To Treat MS Nearing Market

2010-06-18T11:08:00.000-07:00

A U.S. Food and Drug Administration advisory committee today recommended that the agency approve marketing of fingolimod capsules (formerly called Gilenia, Novartis International AG) for the treatment of relapsing multiple sclerosis. If approved, fingolimod would be the first oral disease-modifying therapy for the treatment of MS. While the FDA is not required to follow the recommendations of its advisory committees, it usually does. According to Novartis, the agency is expected to make a final decision about whether to approve the drug in September 2010.

During an all-day meeting held June 10, 2010, the FDA advisory committee reviewed data about the effectiveness and safety of fingolimod, as well as a proposed plan designed to monitor and mitigate risks – called Risk Evaluation Mitigation Strategies (REMS) that would likely be mandated to monitor safety if the agent is approved. The committee also heard public testimony from individuals and patient advocacy groups, including the National MS Society, which testified to the unmet need for more therapies for people with MS.

Among its discussions, the advisory committee recommended that fingolimod be approved at the dose (0.5 mg once daily) recommended by Novartis and that:
• Fingolimod demonstrated substantial evidence of effectiveness for the treatment of relapsing MS to reduce the frequency of clinical relapses and to delay the accumulation of physical disability;
• the safety data currently known justify the drug’s approval, and the FDA should require a post-marketing study that would proactively gather information about adverse events and longer-term safety, the effects on a broader range of people than were included in the trials, and possible complications of taking other medications including steroids along with fingolimod;
• patients should be monitored during the first dose for possible lowering of heart rate and other potential heart effects, and that some assessments for potential adverse events related to eye (especially macular edema) and lung function be required, to an extent to be determined by the FDA;
• the FDA should consider requiring a study to evaluate whether a lower dose would be as effective as the recommended dose, with fewer adverse events;
• this therapy should be approved as a first-line therapy, meaning that patients would be eligible to take fingolimod without having to try an alternative therapy first.

About the drug: Fingolimod is a new class of therapy in development for treating multiple sclerosis. It binds to a docking site (sphingosine-1-phosphate receptor, or S1P receptor) on immune cells, including T cells and B cells, that have been implicated in causing nervous system damage in MS. The drug appears to induce immune cells to remain in lymph nodes, where they can do little harm, preventing them from migrating into the brain and spinal cord.

Positive results from two large-scale phase III clinical trials have been published showing that fingolimod significantly reduced multiple sclerosis relapse rates. One of the trials also suggested that fingolimod could slow the progression of disability. (New England Journal of Medicine January 20, 2010.) Read more about these studies on our Website. In December 2009, Novartis applied to the FDA and European regulators for marketing approval of this compound for the treatment of relapsing MS.

What Clinical Trials Found: According to the published results, a large-scale, two-year phase III trial known as FREEDOMS involved 1,272 people with relapsing-remitting MS. Over two years, fingolimod at either of two doses was able to significantly reduce relapse rates (the primary endpoint of the study) and slow disability progression (a secondary endpoint) compared to an inactive placebo. Annual relapse rates were 0.18 for the lower dose, 0.16 with the higher dose, and 0.40 for those on placebo (a reduction of 54% and 60% over placebo, respectively). Disease progression was measured by two standard MS clinical assessment tools known as the EDSS and MSFC, and after 24 months both doses showed slower progression compared to placebo. Secondary measures of disease activity and progression also favored both fingolimod doses, including MR imaging to detect tissue injury and brain atrophy.

The second paper detailed positive results from a one-year clinical trial, called the TRANSFORMS study, comparing two different doses of fingolimod with Avonex® (interferon beta-1a, Biogen Idec). That study involved 1,292 individuals with relapsing-remitting MS. Both doses of fingolimod were able to reduce relapse rates over one year (the primary endpoint of the study), and also reduced disease activity on MR brain imaging. The annualized relapse rate in those taking the lower dose of fingolimod was 0.16, compared to 0.33 in those on Avonex (a comparative reduction of 52%). Those taking the higher dose of fingolimod experienced an annualized relapse rate of 0.20 (a reduction of 38% compared with Avonex). Time to sustained disability progression was no different in the fingolimod and Avonex groups.

At the 2010 meeting of the American Academy of Neurology (Abstract P03.125), investigators reported on an extension of the TRANSFORMS study involving 1027 of the original participants. Those taking fingolimod stayed on the same dose, and those who had been on weekly interferon beta 1a received either 0.5 mg or 1.25 mg of fingolimod for one year. The annualized relapse rate (primary outcome) and inflammatory activity on MRI scans were significantly lower for those taking fingolimod for the entire two-year period compared to those switching to fingolimod at the beginning of the second year.

Safety: In the clinical trials, the lower dose was better tolerated. A few participants experienced a transient reduction in heart rate and blockage of heart conduction (atrioventricular conduction block) which generally normalized after the first dose. There was a slight elevation of blood pressure starting during the second month of therapy. Macular edema (swelling of the center of the retina inside the eye) occurred more frequently with those on the higher dose of fingolimod in both studies.

Elevations in liver enzymes, without accompanying symptoms, were common in those receiving fingolimod. In both studies, a small number of serious herpes infections occurred, including two deaths from herpes infections that occurred in the TRANSFORMS trial in people taking the higher dose of fingolimod.

Other phase III clinical trials of fingolimod, including one involving people with primary progressive MS, are still under way, as are extension studies involving those who’ve completed trials. These and other studies that may be required post-marketing should provide additional data on the safety and efficacy of fingolimod.

Comment: “If the FDA agrees that fingolimod is safe and effective, this would represent significant progress for people with MS – the first oral disease modifying therapy -- and would help address the unmet need for additional therapies,” said National MS Society Chief Medical Advisor Dr. Aaron Miller, Professor of Neurology and Medical Director of the MS Center at Mount Sinai Medical Center in New York City. Dr. Robert Lisak, MD, Chair of Neurology and Professor of Immunology and Microbiology at Wayne State University School of Medicine in Detroit, agreed. “I would welcome having another treatment option for my patients, particularly an oral medication that might make it easier for people to get on and stay on therapy. Taking a disease-modifying therapy is the best way we have of reducing MS disease activity and future deterioration. However, we will need to monitor all new therapies for any long-term safety issues.”

If approved, the decision to take an oral MS therapy should be made by people with MS in collaboration with their MS doctors, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors.

FAQ About June 10 FDA Advisory Committee’s Recommendation to
Approve Oral Fingolimod for Relapsing MS

Q. What is fingolimod?
A. Fingolimod is different than current MS therapies on the market and represents a new class of therapy, for one because it is taken orally rather than by injection or infusion, and secondly because of its mode of action. Fingolimod binds to a docking site (sphingosine-1-phosphate receptor, or S1P receptor) on immune cells, including T cells and B cells that have been implicated in causing nervous system damage in MS. The drug appears to force immune cells to remain in lymph nodes where they can do little harm, and prevents them from migrating into the brain and spinal cord. Fingolimod is considered a disease-modifying agent, and if it is approved, it would not be taken along with other disease-modifying therapies.

Q. Does this announcement mean that fingolimod is approved and available for MS?
A. No, this does not mean that fingolimod is approved and available. The FDA will take this committee’s recommendation into account as it completes its review of the clinical trials’ benefit and safety data. The agency is expected to make a decision by September 2010. The FDA is not required to follow the advice of its advisory committees, but it usually does. The Society will have updates as we learn more from FDA announcements.

Q. What is the official brand name of fingolimod?
A. At present fingolimod, or FTY 720, does not have an approved name for marketing. The name proposed by Novartis – Gilenia -- was not accepted by the FDA. The usual reason the agency might reject a proposed name is that it may be too similar to the name of an approved drug, which could cause confusion in prescribing and dispensing the medications.

Q. What types of MS might fingolimod be approved to treat?
A. The application to the FDA requested approval to market fingolimod for the treatment of relapsing forms of MS (http://www.nationalmssociety.org/about-multiple-sclerosis/relapsing-ms/index.aspx). In other words, people who experience periodic MS attacks, such as those who have relapsing-remitting MS or secondary-progressive MS with relapses. However, this agent is also being tested in people with primary-progressive MS (http://www.nationalmssociety.org/about-multiple-sclerosis/progressive-ms/primary-progressive-ms/index.aspx) who experience steady worsening without acute attacks. If the FDA approves fingolimod for relapsing MS, and if it shows significant benefit in primary-progressive trials, it is likely that the sponsor will apply to expand its labeling to include progressive forms of MS. Read more about the clinical trial of fingolimod in primary-progressive MS, which is currently recruiting participants.

Q. How is fingolimod taken?
A. Fingolimod comes in capsules. If approved for marketing, it will likely be taken by mouth once a day, which is how it was taken during the clinical trials.

Q. How effective is fingolimod?
A. In a large-scale, two-year phase III trial known as FREEDOMS, involving 1,272 people with relapsing-remitting MS, fingolimod at either of two doses was able to significantly reduce relapse rates (the primary endpoint of the study) and slow disability progression (a secondary endpoint) compared to an inactive placebo. Annual relapse rates were 0.18 for the lower dose (which is the dose the sponsor is asking the FDA to approve) and 0.40 for those on placebo - a reduction of 54% over placebo. Disease progression was measured by two standard MS clinical assessment tools, the EDSS and the MSFC. After 24 months, both doses slowed progression compared to placebo. Secondary measures of disease activity and progression, including MR imaging to detect tissue injury and brain atrophy, also favored both fingolimod doses. Details of two large-scale clinical trials were published early online on January 20, 2010 in the New England Journal of Medicine -- the two-year placebo-controlled trial and the one-year trial comparing fingolimod to interferon beta-1a.

Q. Should I switch from my current therapy to fingolimod?
A. If fingolimod is approved, the decision about whether to take it should be made in collaboration with your MS doctor, taking into account a variety of factors including the effectiveness of any therapy you are currently using, the potential risks and benefits, as well as costs and lifestyle factors.

Q. What are the potential side effects of fingolimod?
A. In clinical trials, some participants experienced a transient reduction in heart rate and blockage of heart conduction (atrioventricular conduction block) which generally normalized after the first dose. There was a slight elevation of blood pressure starting during the second month of therapy. Macular edema (swelling of the center of the retina inside the eye) occurred more frequently with those on the higher dose of fingolimod than the dose being proposed in the sponsor’s application. Elevations in liver enzymes, without accompanying symptoms, were common in those receiving fingolimod. A small number of serious herpes infections occurred, including two deaths from herpes infections that occurred in people taking a higher dose of fingolimod than the dose that the sponsor is proposing to market.

Q. Has fingolimod been proven to be “better” than other disease-modifying therapies?
A. No, fingolimod has not been demonstrated to be “better” than other disease modifying therapies. So far, the only comparison to an existing disease-modifying therapy has been in the one-year, head-to-head “TRANSFORMS” trial against Avonex® (interferon beta-1a, Biogen Idec). This trial suggested short-term superiority of fingolimod, but the trial was too short to be definitive in terms of comparing long-term benefits of the two therapies. In this trial, fingolimod caused more serious side effects than Avonex. Fingolimod has not been compared to other available disease-modifying therapies.

Q. If it is approved, how long would a person take fingolimod?
A. Based on the advisory committee discussions, it is likely that an individual could potentially take fingolimod indefinitely.

Q. If fingolimod is approved, will people taking it have to get any special medical tests or monitoring?
A. The clinical trials showed that there is the potential for significant side effects in some patients even at the lower dose being proposed for marketing. Therefore, it is likely that monitoring would be required if fingolimod is approved for clinical use. Details of a risk management plan (“Risk Evaluation Mitigation Strategies”) that would likely be mandated to monitor safety will be negotiated between the FDA and the sponsor before the agent is approved.

Q. If it is approved, what will fingolimod cost?
A. At this point, there is no information available about what fingolimod may cost – but the actual cost to a person with MS will depend on the provisions of his or her insurance coverage.

Q. If fingolimod is approved, would it be immediately available to everyone who gets a prescription, or would there be a waiting list?
A. According to Novartis representatives, if fingolimod is approved, the company would ensure that there is an adequate supply when the drug becomes available by prescription.

Q. If fingolimod is approved by the FDA, will my health insurance cover it?
A. Coverage will depend on individual insurance plans. It is likely that fingolimod’s sponsor, Novartis, will provide support services to help patients and healthcare professionals access the therapy. Details of support services are likely to be made available by Novartis if and when the agent is approved.

Q. Where can I get additional information about the support that Novartis will provide to help people gain access to fingolimod?
UPDATE: New phone #
A. If and when fingolimod is approved for use, physicians and people with MS can contact Novartis for more information at: 888-NOW-NOVA (888-669-6682)

Q. Are there other oral disease-modifying therapies in development for MS?
A. Yes, there are others in development. Cladribine (sponsored by EMD Serono) has been shown to reduce MS relapses and slow progression in relapsing-remitting MS. It has been submitted to the FDA for marketing approval, but the application has not yet been accepted by the FDA.

Additional oral agents currently in phase III clinical trials are: teriflunomide (sponsored by sanofi-aventis), BG00012 (sponsored by Biogen Idec), and laquinimod (sponsored by Teva Pharmaceutical Industries). They are being tested in relapsing MS and in people at high risk for MS, after earlier trials suggested potential benefits against disease activity.

Q. I’ve been hearing news about other new treatments in development for MS. What are some details?
A. Oral disease-modifying therapies are only one of many exciting treatments moving through the MS pipeline and other promising research avenues that address ways to stop MS progression, restore function and end MS forever. Just a few therapies being tested include the hormone estriol, adult stem cell transplantation, and infused drugs that require infrequent dosing. The National MS Society has established a Rapid Response Fund to pursue new and unexpected research opportunities when they arise, a recent example being our expedited funding of research exploring the potential relationship between CCSVI and the MS disease process. Check our Website for information on an upcoming live Webcast on June 30 on What’s new in MS research and treatment?

Avonex is a registered trademark of Biogen Idec

Walk For MS, Multiple Sclerosis

2010-03-08T07:03:00.000-08:00

Walk MS is a simple, but incredibly powerful way for you to share in the hope for the future.
Walk MS

Walk MS is our rallying point, a time and a place for us to stand together and to be together — to help raise critical funds that support cutting edge research, drive change through advocacy, facilitate professional educations and provide programs and services to help people with MS move their lives forward.

Join the Walk MS Movement. Register Today.
Be there. Because every movement you make and every dollar you raise supports the mission to create a world free of MS.

Click on the National MS Society, or the Multiple Sclerosis Foundation links to the right to get more info on how you can help in your area. Walk, Sponsor a walker, Volunteer and help a great cause. Don't sit on the sidelines, get into the game. Make a difference in your life, it feels good helping others. Your actions will make a difference in others lives. So click on the foundations and charities listed to the right and see what you can do to help.

YOU WILL BE GLAD YOU DID...

Quatro

Multiple Sclerosis: Diagnosis, Treatment and Coping

2009-11-16T06:14:00.000-08:00

What Is Multiple Sclerosis?

Multiple sclerosis or MS is a disease that affects the brain and spinal cord resulting in loss of muscle control, vision, balance, and sensation (such as numbness). With MS, the nerves of the brain and spinal cord are damaged by one's own immune system. Thus, the condition is called an autoimmune disease.

Autoimmune diseases are those whereby the body's immune system, which normally targets and destroys substances foreign to the body such as bacteria, mistakenly attacks normal tissues. In MS, the immune system attacks the brain and spinal cord, the two components of the central nervous system. Other autoimmune diseases include lupus and rheumatoid arthritis.

The central nervous system is made up of nerves that act as the body's messenger system. Each nerve is covered by a fatty substance called myelin, which insulates the nerves and helps in the transmission of nerve impulses, or messages, between the brain and other parts of the body. These messages control muscle movements, such as walking and talking.

MS gets its name from the buildup of scar tissue (sclerosis) in the brain and/or spinal cord. The scar tissue or plaques form when the protective and insulating myelin covering the nerves is destroyed, a process called demyelination. Without the myelin, electrical signals transmitted throughout the brain and spinal cord are disrupted or halted. The brain then becomes unable to send and to receive messages. It is this breakdown of communication that causes the symptoms of MS.

Although the nerves can regain myelin, this process is not fast enough to outpace the deterioration that occurs in MS. The types of symptoms, severity of symptoms, and the course of MS vary widely, partly due to the location of the scar tissue and the extent of demyelination.

According to the National Multiple Sclerosis Society, the condition affects approximately 400,000 Americans and is, with the exception of trauma, the most frequent cause of neurological disability beginning in early to middle adulthood.

MS is two to three times as common in females as in males and its occurrence is unusual before adolescence. A person has an increased risk of developing the disease from the teen years to age 50 with the risk gradually declining thereafter.

What Causes MS?

No one is sure what causes the body's immune system to go awry. Some scientists believe that it is a combination of genetics and something in the environment to which the person was exposed to early in life.

To learn more about what causes MS, see What Causes MS?

What Are the Symptoms?

Symptoms vary from person to person and can change over time in the same person. The most common early symptoms include:

Muscle weakness
Decreased coordination
Blurred or hazy vision
Eye pain
Double vision

As the disease progresses, symptoms may include muscle stiffness (spasticity), pain, difficulty controlling urination or problems with cognition.

How Is MS Diagnosed?

Making the diagnosis of MS isn't easy because the symptoms are vague and often fleeting. Factors that a health professional considers are:

Two or more isolated episodes of symptoms that could be caused by MS. The episodes must last at least 24 hours and occur a month apart.
MRI test showing the areas of demyelination (lesions)

There are other tests that a health professional may perform.

How Is MS Treated?

There are a variety of medications available that can reduce the frequency and severity of MS symptoms in some people with MS. Some drugs can also slow the progression of certain types of MS.

There are also a variety of medications available that can:

Shorten attacks of MS (acute worsening of symptoms)
Relieve the symptoms of MS (such as pain, urinary problems and muscle stiffness)

Reviewed by the doctors at the Mellen Institute for Multiple Sclerosis research at The Cleveland Clinic.

Multiple Sclerosis Health Center
http://www.webmd.com/multiple-sclerosis/
Multiple sclerosis affects 2.5 million people worldwide, including 400,000 Americans. Get in-depth information here on multiple sclerosis symptoms and treatments. Plus, find daily help in our online support group.

To the right you will find a variety of informational links, for volunteering to help raise funds to fight this disease, to treatment possibilities and ideas on how to cope with this debilitating disease.

We will be updating periodically, with information on advances, fund raising events, and passing on true stories of remarkable individuals who have not let MS beat them, showing them to be true role models and heroes, to emmulate and to look up to.