Glatiramer Acetate three times per week: Commissural Connections
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`Glatiramer Acetate three times per week
`Samuel Pleasure, MD, Neurology, 02:52PM Aug 20, 2013
`
`As those of us who treat MS patients know, Copaxone (glatirimer acetate - GA) is one of the more easily
`tolerated first line therapies for MS. One of the chief problems is the need for daily subcutaneous injections,
`which are both wearisome and associated with injection site reactions. Many patients express frustration with this
`over time. The typical dose is 20mg per day but previous studies showed that 40mg per day was safe, although
`didn't confer major advantages. A recent study published in Annals of Neurology (Khan et al., June 2013) shows
`that 40mg injections 3x week are an effective therapy for RRMS. Clearly, the makers of GA are positioning
`themselves to try to keep a portion of the market that they see as imperiled with the advent of dimethyl fumarate
`(Tecfidera).
`
`The study is only modestly interesting and really not terribly surprising but the reason why I am mentioning it here
`is that on reading it I was reminded of one of the real shortfalls in the way these studies are done. By way of
`disclosure, I am a neurologist who treats MS patients and a basic researcher, I am not significantly involved in
`clinical trials at this time.
`
`What alarmed me about this study is that 3x weekly GA was compared to placebo in patients with RRMS who
`have been having at least 1-2 attacks in the previous 1-2 years. It seems fairly unethical to me to compare 3x
`weekly GA to placebo, when clearly the intention of the authors is to ask if 3x weekly is comparabe to daily 20mg
`dosing. There could easily have been a design to compare 3x weekly to daily (using dummy injections, as were
`done for the placebo) to maintain blinding. I find it difficult to understand why it is sensible to have an inactive arm
`for patients who clearly need treatment. I personally think that the design of MS trials should be overhauled a bit
`to compare putative active drugs to proven active drugs and in particular in this case where the question is just
`one of dosing, it seems a bit disingenous to compare to placebo. The real question is whether it is similarly active
`to daily GA.
`
`Am quite curious whether others feel the same.
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`ABOUT THIS BLOG
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`Commissural Connections will discuss issues of
`interest to neurologists, focusing on basic science
`with significant translational implications for
`neurologists.
`
`Disclosure: Samuel J. Pleasure, MD, PhD, has
`disclosed no relevant financial relationships.
`
`Samuel Pleasure
`Samuel Pleasure, MD, PhD, is
`Professor of Neurology at UCSF. He
`got his MD and PhD (Neuroscience)
`degrees at the University of
`Pennsylvania and then trained in
`neurology and neuroscience at UCSF. He has
`authored numerous scientific papers on the basic
`mechanisms of brain development and how they
`relate to human neurodevelopmental disorders. He
`has clinical interests in epilepsy and multiple
`sclerosis.
`
`The content of this blog does not necessarily reflect the viewpoints of
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`10/18/2016 9:38 AM
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`Biogen Exhibit 2386
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