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January 08, 2019; 92 (2) Disputes & Debates: Editors' Choice

Editors' note: Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology

View ORCID ProfileAriane Lewis, Steven Galetta
First published January 7, 2019, DOI: https://doi.org/10.1212/WNL.0000000000006733
Ariane Lewis
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Editors' note: Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology
Ariane Lewis, Steven Galetta
Neurology Jan 2019, 92 (2) 109; DOI: 10.1212/WNL.0000000000006733

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In “Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology,” Rae-Grant et al. provided recommendations for use of disease-modifying therapy in patients with multiple sclerosis. Dr. Saltonstall, for Sanofi Genzyme, identified the following 3 concerns regarding teriflunomide in the recommendations: (1) characterization of teriflunomide as being transmitted in sperm and intercalating with DNA leading to teratogenicity unless treatment with chelation therapy is administered; (2) notation that teriflunomide should be switched to another agent if a person develops malignancy; and (3) indication that teriflunomide data are not Class I evidence. With respect to the issue of teratogenicity, Dr. Rae-Grant responds and issues a correction to the recommendations acknowledging that teriflunomide is, in fact, transmitted in small quantities in seminal fluid, not sperm, and that adsorption therapy, not chelation therapy, should be administered to eliminate risk of teratogenicity. Dr. Rae-Grant supports the recommendation to change therapies if a patient develops malignancy by citing the Food and Drug Administration package insert for teriflunomide, which notes that while there was no increase in rate of malignancy in teriflunomide trials, larger and longer studies are needed to better assess its effect on malignancy. Finally, Dr. Rae-Grant notes that the teriflunomide studies were rated as Class II evidence in accordance with the American Academy of Neurology system of classification because <80% of participants completed the study. The correction appears on page 112.

In “Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology,” Rae-Grant et al. provided recommendations for use of disease-modifying therapy in patients with multiple sclerosis. Dr. Saltonstall, for Sanofi Genzyme, identified the following 3 concerns regarding teriflunomide in the recommendations: (1) characterization of teriflunomide as being transmitted in sperm and intercalating with DNA leading to teratogenicity unless treatment with chelation therapy is administered; (2) notation that teriflunomide should be switched to another agent if a person develops malignancy; and (3) indication that teriflunomide data are not Class I evidence.

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