Monday, December 20, 2010

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.

Thursday, December 2, 2010

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.

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