Update on ECTRIMS: Multiple Sclerosis Medication Advancements

One of the greatest recent accomplishments in neurology has been the explosion of research in Multiple Sclerosis. The biggest annual meeting for MS takes place in Europe and is called ECTRIMS (European Committee for Treatment and Research in Multiple Sclerosis). The research presentations are a mix of lectures and posters. There were the usual symposia by the big pharmaceutical companies presenting data supporting their disease modifying medications one monthly infusion for , there were preliminary presentations on new forms of therapy for relapsing-remitting MS, such as oral medications, monoclonal antibodies, and therapeutic vaccines. This is very exciting, because before 1993 there were no FDA approved medications for MS, now there are four injectable medications approved for relapsing-remitting MSrelapsing MS and one infusion for worsening or secondary-progressive MS (Novantrone or Mitoxantrone).

As you probably know, there are still no medications FDA approved for primary-progressive MS, but hopefully with newer research this will change in the next few years. Next year at the American Academy of Neurology Annual Meeting in Chicago we will hear about the results of Rituximab (Rituxan) in primary-progressive MS. Rituximab is a monoclonal antibody to CD20, which means that giving this IV medication will reduce B cells. When discussing the immunology of MS, we usually talk about T cells a lot, but we are learning more about how B cells (they make antibodies, which bind usually to "foreign invaders") are important in MS as well, and especially in progressive MS. Rituximab is being studied in relapsing-remitting MS and neuromyelitis optica (Devic's disease) as well.

As you probably know, we are finally entering the era of oral medicines for MS, but it will still be a number of years before these medicines are available outside of clinical trials. One of the oral medicines being studied is called FTY720 (Fingolimod), and the exciting news is that hopefully we will start studying it not only in relapsing-remitting MS, but in primary-progressive MS as well. It would be exciting to have one medicine for both relapsing and progressive MS.

While there is so much hope with all these new advances, I think we also have to be careful in ensuring that our new medicines are safe. One of the great things about the injectable medicines is that they are safe over the long-term, with the newer medicines (oral and monoclonal antibodies) we are seeing side effects that raise some concerns, like the development of other autoimmune diseases, infections, and potentially cancers.

So, how are we going to treat MS in the future? MS patients are all unique, and that's what makes it great to be an MS doctor. It's also what makes it tough sometimes. Eventually we hope to have a blood test where we could know what medicine is going to be right for a specific individual. This will probably be a "genomics" blood test - which will tell us doctors the specific gene expression of an individual patient's MS - and also what medicine makes sense to treat that individual with.

TREATMENT TRENDS

TreatmentTrends®, Multiple Sclerosis Study Uncovers Early Impact Of Gilenya On Perceptions And Anticipated Use Of Products Within The MS Market

Main Category: Multiple Sclerosis
Article Date: 02 Dec 2010 - 7:00 PST

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BioTrends recently published TreatmentTrends®: Multiple Sclerosis, a syndicated biannual report that provides a comprehensive view of the current and expected future management of multiple sclerosis (MS) based on primary research fielded with 103 neurologists in the U.S. A parallel report covering the European market (EU5) will be published later this month. These reports cover the use of disease-modifying agents (DMAs) for the treatment of MS, as well as attitudes and perceptions toward these products, advantages and disadvantages, ideal patient types, barriers to growth, and expected future use. In addition, respondents were queried about their awareness of and interest in MS-related DMA and symptomatic products in development.

The U.S. study, based on feedback gathered in late October/early November 2010, found that the recent commercial availability of Novartis's Gilenya, the first oral DMA, has already had significant impact on neurologists' perceptions of the traditional injectable DMAs. At one month post launch, over two-fifths of neurologists report use of the product in RRMS patients and even more anticipate trial among RRMS patients within the next six months. The uptake of Gilenya will be explored further in LaunchTrends®: Gilenya, a three wave report series which will track the product at one, three and six months post commercial availability. Neurologists' uptake of Extavia, Novartis's other recently launched DMA, continues to be limited with only about four out of 10 survey respondents reporting trial one year after availability. With the recent bout of market activity, neurologists' anticipate significant changes in their use of DMAs in the next six months.

In terms of new DMAs, neurologists report a high unmet need for products with long term safety data. In fact, this attribute has become more important compared to results from the prior wave of research fielded in Q1 2010, while oral formulations and less frequent dosing have decreased in importance in terms of areas of unmet need. Among seven therapies in development that were profiled in the research, interest was highest for Teva's laquinimod and Biogen Idec's BG-12. Recent market news has negatively impacted perceptions of EMD Serono's Movectro (oral cladribine).

Trial of Acorda's Ampyra (dalfampridine), the first symptomatic agent approved for MS patients, continues to be high seven months post-launch. With greater familiarity and usage, a clearer picture is emerging about the average discontinuation rate and anticipated uptake of Ampyra. While awareness of the five surveyed MS-related symptomatic products is low, neurologists report moderate levels of interest in the products and believe products impacting spasticity (i.e. Otsuka's Sativex) or walking impairment (i.e. Sanofi-Aventis' nerispirdine) would provide the greatest clinical value to their practice.

All company, brand, or product names contained in this document may be trademarks of their respective hol

hase III Results of AVP-923 (formerly called Zenvia) Published, Showing It Can Reduce Episodes of Uncontrollable Laughing or Crying in MS and Other Di

Oct 08, 2010

The results of a Phase III trial of an oral drug designed to treat uncontrollable laughing and/or crying (known as pseudobulbar affect), a troubling symptom experienced by some people with MS, ALS, and other neurological disorders, have now been published. AVP-923 (Avanir Pharmaceuticals) significantly reduced the rate of laughing and crying episodes and appeared to be safe and well tolerated. (Annals of Neurology, published online September 13, 2010)

According to an Avanir press release dated August 5, the U.S. Food and Drug Administration set a date to complete its review of this drug by October 30, 2010. The company also has submitted trade names to the FDA for consideration after receiving notice that the agency did not accept the name “Zenvia” for marketing use.

Background: A small percentage (around 10%) of persons with MS experience episodes of uncontrollable laughing and/or crying that are unpredictable and seem to have little or no relationship to actual events or the individual’s actual feelings. This condition is thought to result from lesions – damaged areas – in emotional pathways in the brain. It is important for family members and caregivers to know this, and realize that people who experience these episodes may not always be able to control their expression of emotions. Some medications have shown benefit in small clinical trials, but there is no medication approved specifically to treat this symptom.

Avanir Pharmaceuticals has been conducting trials of AVP-923 in its current and related formulations for several years as a treatment for pseudobulbar affect in a number of disorders, including MS, ALS, Alzheimer’s disease and stroke. AVP-923 is a patented, orally-administered combination of dextromethorphan and an enzyme inhibitor known as quinidine; quinidine is a drug that inhibits the metabolism of dextromethorphan which results in a sustained elevation of dextromethorphan in the brain. In 2006, Avanir received a letter from the FDA indicating that the drug was “approvable” and requesting that additional studies be conducted, leading to the current study.

Study Details: This trial, called the STAR trial, involved 326 individuals (197 with ALS and 129 with MS) across the U.S. and Latin America who were experiencing pseudobulbar affect. Participants either received one of two doses of AVP-923 or inactive placebo twice a day for twelve weeks.

The primary endpoint established for this trial was the rate of self-reported laughing or crying episodes over the course of the trial. Both doses significantly reduced episode rates by about 47-49 percent compared to placebo. Secondary outcomes, including patient diaries and episode-free days, also suggested significant benefit among groups taking AVP-923, and those on the higher dosage also showed improved measures of social functioning and mental health.

The medication was relatively well tolerated. The adverse events more frequently reported by those on therapy (especially the higher dose) versus those on placebo were dizziness, nausea and diarrhea. There were seven deaths in the study, all occurring in participants who had ALS, and all of which were classified by an independent committee as being likely due to progression of respiratory problems related to the disease.

Follow-up: In an extension of this study, 253 people took the higher dose of AVP-923 for 12 more weeks, during which safety and tolerability were assessed. The drug continued to be well tolerated. (Abstract #P06.128, American Academy of Neurology Annual Meeting, 2010)

Comment: “The availability of a therapy that could safely and effectively treat uncontrollable laughing and crying would be a real breakthrough for those with MS and other neurological conditions who experience this troubling symptom,” said Dr. Nicholas LaRocca, a clinical psychologist who directs the National MS Society’s research programs in patient management and health care delivery and policy.

Read more about MS and emotional changes.

A Clinical Bulletin for physicians, providing details about pseudobulbar affect and its treatment in MS is available on the National MS Society’s Professional Resource Center.

Society Of Interventional Radiology Supports Research For New M.S. Treatments

Recognizing that venous interventions may potentially play an important role in treating some patients who suffer from multiple sclerosis -- an incurable, disabling disease -- the Society of Interventional Radiology has issued a position statement indicating its support for high-quality clinical research to determine the safety and effectiveness of interventional M.S. treatments. SIR's position statement is endorsed by the Canadian Interventional Radiology Association and will be published in the September Journal of Vascular and Interventional Radiology.

"The Society of Interventional Radiology would like to be actively involved in developing evidence-based therapies for the potential treatment of patients with multiple sclerosis," said SIR President James F. Benenati, M.D., FSIR. "Completing high-quality studies -- for example, on chronic cerebrospinal venous insufficiency (CCSVI, a reported abnormality in blood drainage from the brain and spinal cord) and interventional M.S. treatments -- should be a research priority for investigators, funding agencies and M.S. community advocates," added Benenati, who represents nearly 4,700 doctors, scientists and allied health professionals dedicated to improving health care through minimally invasive treatments.

About 500,000 people in the United States have M.S., and SIR understands the public's desire to advance treatment for M.S., generally thought of as an autoimmune disease in which a person's body attacks its own cells. Currently, medicines may slow the disease and help control symptoms. The role of CCSVI in M.S. and its endovascular treatment (through a catheter placed in a vein) by an interventional radiologist via balloon angioplasty and/or stents to open up veins "could be transformative for patients and is being actively investigated," said Benenati. "The idea that there may be a venous component to the etiology (or cause) of some symptoms in patients with M.S. is a radical departure from current medical thinking," he noted.

"SIR recognizes the challenge and the potential opportunity presented by promising early studies of an interventional approach to the treatment of M.S.," said Benenati. SIR is moving rapidly to "catalyze" the development of needed studies by bringing together expert researchers in image-guided venous interventions, neurology, central nervous system imaging, M.S. outcomes assessment and clinical trial methodology, he added. While the use of balloon angioplasty and stents cannot be endorsed yet as a routine clinical treatment for M.S., SIR is committed to assuming a national leadership role in launching needed efforts, said Benenati.

SIR's position statement agrees with M.S. advocates, physicians and other caregivers that the use of any treatment (anti-inflammatory, immunomodulatory, interventional or other) in M.S. patients should be based on an individualized assessment of the patient's disease status, his or her tolerance of previous therapies, the particular treatment's scientific plausibility, and the strength and methodological quality of its supporting clinical evidence. "When conclusive evidence is lacking, SIR believes that these often difficult decisions are best made by individual patients, their families and their physicians," notes "Interventional Endovascular Management of Chronic Cerebrospinal Venous Insufficiency in Patients With Multiple Sclerosis: A Position Statement by the Society of Interventional Radiology, Endorsed by the Canadian Interventional Radiology Association."

If interventional therapy proves to be effective, M.S. patients should be treated by doctors who have specialized expertise and training in delivering image-guided venous treatments, said Benenati. Interventional Radiologists pioneered balloon angioplasty and stent placements and use those treatments on a daily basis in thousands of patients with diverse venous conditions. "Interventional radiologists are steeped in a tradition of innovation and invention -- of pioneering modern medicine with the devices, drugs and methods to treat patients minimally invasively," said Benenati.

Source: Society of Interventional Radiology

LIFE WITH MULTIPLE SCLEROSIS

What is a typical case of multiple sclerosis like? The newly diagnosed usually ask what they should expect from a life with MS; but typical, when it comes to MS, is hard to define.

One thing is clear — life with multiple sclerosis is anything but predictable. MS doesn’t come with a road map, a GPS system, or a set of directions. There is no forgone conclusion — and despite the uncertainty, that is good news.

Plenty of people will tell you horror stories of life with MS, or of folks with MS who climb mountains and run marathons. There is truth in all of it, but none of it necessarily will reflect your experiences or point to your own future.

Are you like Lori Schneider of Bayfield, Wisconsin, who earlier this year became the first person with MS to climb Mount Everest?

Are you like Montel Williams, who was devastated by the diagnosis, suffered through depression, and now raises money for MS research, and advocates for people with MS?

Are you like the United Kingdom’s Debbie Purdy, who fought for the right to choose assisted suicide without fear of prosecution, so that she can control her own end-of-life issues?

Are you using a wheelchair… or living in a nursing home… or struggling with day-to-day living… or… or… or…

Trying to pin down the typical person with MS is like trying to pin down, well, the typical person with MS. We are as varied in our physical condition and our outlook on life as the rest of the human population.

I can’t climb Mount Everest or run a marathon, but I was never the outdoor athletic type, so I’m not about to bemoan my fate in that department. If I had been, my perspective would most certainly be different.

Some people with MS have amazingly positive attitudes; many suffer from deep depression. Some have obvious disabilities; others have a multitude of invisible symptoms and, yes, there are people with only minor symptoms that barely register on their radar screen. Many have additional health problems not associated with MS — we are not immune to other illnesses or symptoms of aging. Some have strong family support while others languish.

Most people with MS manage to remain employed; others are disabled and cannot work. Some have the security of good health insurance coverage; others struggle with the financial burdens associated with a chronic illness, suffering the consequences of that added stress.

It is important to meet and communicate with other people who have MS. The mutual support and kinship is priceless. But it is equally important that we not compare ourselves and the course of our condition, that we not harshly judge others for their choices or what we might view as their shortcomings.

Life is more complicated than that. We all received our diagnosis under different circumstances — our general health, age, financial status, family life, and general outlook were all uniquely ours. Add to that the many variations of relapsing/remitting and progressive forms of MS, and it’s easy to see why answering the “what can I expect of a life with MS?” question is so difficult.

A typical life with MS? Definitely challenging, rife with possibilities, and anything but predictable.

Multiple Sclerosis

People with Multiple Sclerosis often contact us to prepare compounded medications for them. MS, like many chronic conditions, is not a single disease. Instead, it is more of a description of a set of symptoms. The symptoms for MS include weakness, lack of muscle control, speech difficulties, "foggy thinking", bladder difficulties, pain, difficulties with mobility, and many more. Some people suffer greatly with many symptoms and they are diagnosed as "having" multiple sclerosis. Others experience a few of the symptoms and they too "have" MS.

MS isn't something that you can catch from another person. However, some of the information about the condition suggests to us that the symptoms of MS can often be traced to a specific situation or experience. This leads to a conclusion that MS may be a sequelae - or result of - some other condition. Some researchers are looking at bacterial and viral infections as a cause, or "trigger" for MS. The search continues but it seems reasonable that something outside a person attacks the body and begins the degeneration of nerve sheaths that is commonly identified as multiple sclerosis.

Regardless of the cause, MS is considered by most to be a degenerating condition that gets worse over time. A person will experience times when the symptoms seem less severe - only to find that at some time in the future "it" seems to get worse again. These fluctuations are sometimes called remission and exacerbation. This may suggest there are things people could do to slow and maybe halt the progression of MS. A compounding pharmacist can provide many services to the MS patient that can help keep their symptoms under control. While there are a few of "standard" compounds that people use, we are eager and ready to make something to meet your special needs.

MULTIPLE SCLEROSIS OF INDIANA

MY REASON FOR THIS WEB BLOG AND GROUP, IVE NOTICED, THERE'S NOT MANY SUPPORT GROUPS FOR PEOPLE WITH MULTIPLE SCLEROSIS, IN INDIANA, OR ACROSS THE NATION, AND THE ONES THAT DO EXSIST, ARE TO OFFICAL, AND AT HOSPITALS AND SUCH, WHAT A BORE. WE PEOPLE WITH MULTIPLE SCLEROSIS, WANNA HAVE FUN AND ENJOY LIFE TOO, MEET OTHERS WITH THE ILLNESS, TALK LAUGH, AND SHARE WHAT LIFE IS LIKE FOR US. TO OFTEN THESE GROUPS, ARE RAN BY PEOPLE WHO DO NOT HAVE M/S, AND HAVE NO IDEA WHAT IT IS LIKE TO HAVE M/S. I FEEL I NEED TO START SLOW AND SMALL, WITH THE GROUP, AND SOME DAY, IT WILL DEVELOP, INTO A MUCH BIGGER GROUP, WITH GET TOGETHERS, AND SUCH. I WELCOME ANY AND ALL SUGGESTIONS, PLEASE DON'T FORGET TO CLICK ON (FOLLOW THIS BLOG) BUTTON.