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Plasmapheresis: are bigger studies necessarily better?

Nature Reviews Neurology volume 8, page 410 (2012)Cite this article

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I read with interest the comments of Professors Hughes and Hartung regarding the use of plasmapheresis to treat neurological disorders based on the most recent American Academy of Neurology (AAN) practice guideline (Neuroimmunology: Assessing the value of plasma exchange in neurology. Nat. Rev. Neurol. 7, 309–310; 2011).1 I was disappointed to see that the authors did not cite our class II study,2 referenced in the AAN practice guideline,3 which provides strong support for the use of plasma exchange to treat acute, severe relapses of inflammatory demyelinating disease that are refractory to standard treatment with corticosteroids.

Our study was a randomized, double-blind, sham-controlled evaluation of 22 patients with severe corticosteroid-refractory attacks of inflammatory demyelinating disease.2 The study design included a crossover, allowing both intrapatient and interpatient comparisons of response to active and sham plasmapheresis treatment. The outcomes required to declare success in this study were moderate to marked improvements in neurological deficits. Largely on the basis of this study, the Therapeutics and Technology Assessment Subcommittee of the AAN reached the following recommendation: “plasmapheresis may be considered in the treatment of fulminant CNS demyelinating diseases that fail to respond to high-dose corticosteroid treatment (Level C).”3 The main concerns that limited a higher rating of the evidence were the small size of the study and the heterogeneity of the inflammatory demyelinating diseases that were included in the study. Inflammatory demyelinating diseases are notoriously difficult to accurately classify at initial presentation.4 For example, acute transverse myelitis may occur as a non-recurring entity or as part of acute disseminated encephalomyelitis or, on the basis of further follow-up, may be reclassified as an initial attack of multiple sclerosis or neuromyelitis optica.

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References

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  1. Department of Neurology, Mayo Clinic, 200 First Street SW, Rochester, 55905, MN, USA

    Brian Weinshenker

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B. G. Weinshenker receives royalties related to a patent for a test for neuromyelitis optica that has been licensed to a third party, RSR.

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Weinshenker, B. Plasmapheresis: are bigger studies necessarily better?. Nat Rev Neurol 8, 410 (2012). https://doi.org/10.1038/nrneurol.2011.59-c1

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