Evidence-based guideline update: Plasmapheresis in neurologic disorders
Bhupendra O.Khatri, Director, Center for Neurological Disorders, Aurora Health Care, St. Luke's Medical Center, Milwaukee WIbokhatri@aol.com
Submitted July 05, 2011
I have dedicated my professional career to caring for patients with chronic and debilitating neurological diseases and have come to appreciate and respect the meaning of the Hippocratic Oath statement: “First do no harm.” The American Academy of Neurology (AAN) guideline update on plasmapheresis in neurological disorders [1] is inaccurate and may cause harm to patients.
I have successfully treated more than a hundred myasthenia gravis (MG) patients with therapeutic plasma exchange (TPE) not only for Myasthenic crises but also on an ongoing basis (maintenance plasmapheresis) to prevent further worsening. This has allowed me to drastically reduce the use of long-term immunosuppressive drugs in such patients. Insurance companies will now cite these guidelines to deny TPE for such patients. Just as it is unnecessary to conduct a double-blind, placebo-controlled study to justify ongoing insulin therapy for diabetics, there should be no need to do such a study in MG. The pathogenesis of MG [2] itself lends support to the use of long-term TPE, which unequivocally removes pathogenic circulating antibodies.
With reference to secondary or chronic progressive multiple sclerosis (MS), the authors’ interpretation of our trial study is erroneous. [3] This study, heralded by Dr. George Ellison as "an exemplary study for others to match or exceed" [4], showed a significant (p less than .007) improvement in disability in the TPE group over the placebo group. A long-term follow-up study [5] in 200 chronic progressive patients confirmed the earlier report and further identified the clinical characteristics of those who should respond to TPE. In light of this report, it would be impossible to provide TPE to SPMS in whom there are data to show efficacy when conventional therapies have failed.
As the organization that represents those who care for patients with chronic and debilitating neurological diseases like MG and progressive MS, the AAN cannot allow these Guidelines to cause such patients irreparable harm.
References
1. Cortese I, Chaudhry V, So YT, et al. Evidence-based guideline update: Plasmapheresis in neurologic disorders. Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2011;76;294-300.
2. Lindstrom J, Dau PC. Biology of MG. Annu Rev Pharmacol Toxicol 1980;20;337-362.
3. Khatri B, McQuillen MP, Harrington GJ, et al. Chronic progressive multiple sclerosis: Double-blind controlled study of plasmapheresis in patients taking immunosuppressive drugs. Neurology 1985;312-319.
4. Ellison G. Therapy aimed at slowing the rate of progression in multiple sclerosis. McDonald WI, Silberger D, editors. London: Butterworth and Co Publishers; 1986. 158.
5. Khatri BO, McQuillen MP, Hoffmann RG, et al. Plasma exchange in chronic progressive multiple sclerosis: A long term study. Neurology 1991; 409-414.
I have dedicated my professional career to caring for patients with chronic and debilitating neurological diseases and have come to appreciate and respect the meaning of the Hippocratic Oath statement: “First do no harm.” The American Academy of Neurology (AAN) guideline update on plasmapheresis in neurological disorders [1] is inaccurate and may cause harm to patients.
I have successfully treated more than a hundred myasthenia gravis (MG) patients with therapeutic plasma exchange (TPE) not only for Myasthenic crises but also on an ongoing basis (maintenance plasmapheresis) to prevent further worsening. This has allowed me to drastically reduce the use of long-term immunosuppressive drugs in such patients. Insurance companies will now cite these guidelines to deny TPE for such patients. Just as it is unnecessary to conduct a double-blind, placebo-controlled study to justify ongoing insulin therapy for diabetics, there should be no need to do such a study in MG. The pathogenesis of MG [2] itself lends support to the use of long-term TPE, which unequivocally removes pathogenic circulating antibodies.
With reference to secondary or chronic progressive multiple sclerosis (MS), the authors’ interpretation of our trial study is erroneous. [3] This study, heralded by Dr. George Ellison as "an exemplary study for others to match or exceed" [4], showed a significant (p less than .007) improvement in disability in the TPE group over the placebo group. A long-term follow-up study [5] in 200 chronic progressive patients confirmed the earlier report and further identified the clinical characteristics of those who should respond to TPE. In light of this report, it would be impossible to provide TPE to SPMS in whom there are data to show efficacy when conventional therapies have failed.
As the organization that represents those who care for patients with chronic and debilitating neurological diseases like MG and progressive MS, the AAN cannot allow these Guidelines to cause such patients irreparable harm.
References
1. Cortese I, Chaudhry V, So YT, et al. Evidence-based guideline update: Plasmapheresis in neurologic disorders. Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2011;76;294-300.
2. Lindstrom J, Dau PC. Biology of MG. Annu Rev Pharmacol Toxicol 1980;20;337-362.
3. Khatri B, McQuillen MP, Harrington GJ, et al. Chronic progressive multiple sclerosis: Double-blind controlled study of plasmapheresis in patients taking immunosuppressive drugs. Neurology 1985;312-319.
4. Ellison G. Therapy aimed at slowing the rate of progression in multiple sclerosis. McDonald WI, Silberger D, editors. London: Butterworth and Co Publishers; 1986. 158.
5. Khatri BO, McQuillen MP, Hoffmann RG, et al. Plasma exchange in chronic progressive multiple sclerosis: A long term study. Neurology 1991; 409-414.
Disclosure: The author reports no disclosures.