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AAN April 2009

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The American Academy of Neurology annual meeting was April 28-30, 2009.  Here are a few of the highlights.

There were three major clinical trials that reported initial results at this meeting.  The first was the TRANSFORMS trial which compared fingolimod with Avonex.  Fingolimod is an oral medication that interferes with the movement of white blood cells.  It had impressive results in a previous phase II study.  This was a phase III study that enrolled about 1280 patients.  Fingolimod reduced the relapse rate by about 50% compared to Avonex.  It also had some side effects.  The most concerning were two deaths in the high dose group from virus infections.  At this point fingolimod looks like a very effective treatment for relapsing MS, but safety concerns may limit its use. 


The CLARITY trial tested cladribine, a chemotherapy drug, against placebo in relapsing MS.  They followed 1300 patients for 2 years.  The number of relapses was decreased by over 50%.  Side effects were more frequent in the cladribine group, but there weren’t any that were particularly alarming.  This appears to be an effective therapy, but the side effects and long term effectiveness need further study. 


The third major trial was the rituximab in primary progressive MS study.  Preliminary results from this were presented at WCTRIMS in Montreal earlier this year.  This presentation had some more details.  The study overall was negative, but patients younger than 51 years or with enhancing lesions on MRI did better on treatment.  This is an encouraging first step to effective treatment for progressive disease. 


Biogen presented an update on Tysabri and PML.  There have now been 6 cases of PML since Tysabri was reintroduced in July 2006.  Three of these patients had previous chemotherapy treatment for immunosuppression.  One of the cases was fatal, and the others had additional deficits.  There have now been over 25,000 people treated for at least 12 months with Tysabri, so the rate seems to be somewhere around 1 per 5000 people per year.  I will continue to monitor this.  The page titled Tysabri update on this website has a link to the most up-to-date information from Biogen.


There was an interesting presentation on the use of deep-brain stimulation to treat severe tremor in MS.  This is already an established treatment for Parkinson’s disease.  The patients they treated all had disabling tremor.  The tremor and their function both improved.  This is an interesting option for treatment for people who are disabled by tremor rather than weakness. 


There were several reports of small groups of patients treated with aggressive immunosuppression.  These included studies with high dose chemotherapy followed by bone marrow transplant, alemtuzumab (a monoclonal antibody that eliminates most white blood cells), and cyclophosphamide.  The rationale of this approach is to suppress the immune system and prevent autoimmune demyelination.  These treatments all appear very effective in stopping clinical relapses and enhancing lesions on MRI scans over the first year or two of followup.  They all have worrisome side effects and their longer term effectiveness is unknown. 


In a related report, a group from Italy reported on the occurrence of leukemia after mitoxantrone treatment.  Mitoxantrone is a chemotherapy drug which I am using in people with severe MS.  Leukemia is a known complication of this, and we previously thought the risk was about 1 in 1000.  The Italian study found 21 cases in 2,854 mitoxantrone-treated patients.  This means the risk is closer to 1 in 100.  I usually use this treatment in people with severe MS, so the risk may be acceptable.  Other chemotherapy drugs may have less troublesome side effects. 

J. William Lindsey, MD
University of Texas Multiple Sclerosis Research Group
Houston, Texas

copyright 2007-2020 John William Lindsey