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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EDMTs for multiple sclerosis (MS) carry potentially serious risks, including opportunistic infections, altered response to vaccinations, development of cancer, and the appearance of autoimmune disorders. This article reviews safety data from clinical studies and post-marketing surveillance of DMTs for MS, as well as discusses the risks associated with such new therapies.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDemyelinating Diseases\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurological Autoimmune Diseases\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatological Autoimmune Disorders\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EAdequately Assessing Risk Management of New Disease Modifying Therapies (DMT) is Difficult\u003C\/h2\u003E\n         \u003Cp id=\u0022p-2\u0022\u003EDMTs for multiple sclerosis (MS) carry potentially serious risks, including opportunistic infections, altered response to vaccinations, development of cancer, and the appearance of autoimmune disorders. Jacek Losy, MD, PhD, Pozna\u0144 University School of Medical Sciences, Pozna\u0144, Poland, reviewed safety data from clinical studies and post-marketing surveillance of DMTs for MS.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EPhase 3 safety data from the AFFIRM [Polman CH et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2006] and SENTINEL [Rudick RA et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2006] studies of natalizumab show that the most common adverse events (AEs)\u2014headache, fatigue, urinary tract infection, and arthralgia\u2014were mild. Serious AEs were comparable to those observed with placebo. The rate of hypersensitivity reactions was 4% (0.8% serious reactions), and 6% of patients were persistently positive for antibodies to natalizumab. There was no increased risk of malignancies or depression. Two cases of progressive multifocal leukoencephalopathy (PML) and other opportunistic infections were reported. The risk of PML was 1\/1000 over 18 months. Among all patients treated with natalizumab through January 2012 (n=96,582), 201 cases of PML have been reported. These data show that the key safety issues with natalizumab are hypersensitivity, immunogenicity, and PML and other opportunistic infections.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EAEs associated with alemtuzumab include infusion reactions, infections, and malignancies. Autoimmune diseases have developed with long-term use in patients with diseases other than MS. Rituximab treatment in MS patients is associated with infusion reactions, infections, and grade IV ischemic coronary artery syndrome, malignant thyroid neoplasm, and symptoms of acute and progressive MS. Increased risk of PML and enteroviral infections is possible.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EAEs reported with fingolimod are shown in \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E. ECG abnormalities were reported in more patients treated with fingolimod versus placebo or interferon beta-1a. Other potential complications of fingolimod therapy are latent DNA virus activation, bacterial infections, reversible posterior encephalopathy, and macular edema.\u003C\/p\u003E\n         \u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/2\/18\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022AEs: Fingolimod 0.5 mg Compared with Placebo.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-865756731\u0022 data-figure-caption=\u0022AEs: Fingolimod 0.5 mg Compared with Placebo.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/2\/18\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/2\/18\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/2\/18\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/13970\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-6\u0022 class=\u0022first-child\u0022\u003EAEs: Fingolimod 0.5 mg Compared with Placebo.\u003C\/p\u003E\n            \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EReproduced with permission from J. Losy, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EProf. Losy concluded that clinical trials are of limited value for evaluating the safety of these drugs because of their limited duration and small numbers of strictly selected subjects. The full risk is better evaluated in post-marketing surveillance studies under actual clinical conditions.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EAdequately Assessing Risk Management of New Disease-Modifying Therapies is Possible\u003C\/h2\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EA challenge with new DMTs for MS is determining the risk of AEs and weighing them against the benefits of treatment. According to Eva Havrdova, MD, Charles University, Prague, Czech Republic, risks of these new therapies can be assessed by discussing their risks and benefits, sharing information about prognostic factors, and creating risk management plans (RMPs) based on what has been learned about preventing AEs.\u003C\/p\u003E\n         \u003Cp id=\u0022p-9\u0022\u003ECurrently, DMT is started early in patients with MS. However, the effectiveness of these drugs is only 30% to 60%; 62% to 75% of patients relapse and 20% to 27% worsen by \u22651 EDSS point within 2 years. Sormani et al. [\u003Cem\u003ENeurology\u003C\/em\u003E 2011] showed that 2-year disability progression is entirely mediated by treatment-induced reduction in the number of MRI active lesions and relapses during the first year of therapy.\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EAs of June 1, 2011, the Tysabri\u00ae (natalizumab) Observational Program [TOP Registry; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00477113\u0026amp;atom=%2Fspmdc%2F12%2F2%2F18.atom\u0022\u003ENCT00477113\u003C\/a\u003E] had amassed data on 3484 patients from 15 countries. Overall, the patients received a mean (SD) of 14.6 (11.21) and a median of 13.0 (range, 1 to 53) natalizumab infusions. A PML risk stratification tool developed through analysis of TOP registry data uses anti-JCV antibody status, prior immunosuppressant use, and treatment duration to determine the risk of developing PML (\u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E). This tool shows that the risk for developing PML ranges from \u0026lt;0.10\/1000 (95% CI, 0 to 0.56) in patients without anti-JCV antibodies to 10.6\/1000 (95% CI, 7.7 to 14.2) in patients with anti-JCV antibodies, prior immunosuppressant use, and 25 to 48 months\u0027 exposure to natalizumab.\u003C\/p\u003E\n         \u003Cdiv id=\u0022F2\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/2\/18\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022PML Risk Stratification Tool.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-865756731\u0022 data-figure-caption=\u0022PML Risk Stratification Tool.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 2.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/2\/18\/F2.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/2\/18\/F2.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 2.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/2\/18\/F2.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/13971\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 2.\u003C\/span\u003E \n               \u003Cp id=\u0022p-11\u0022 class=\u0022first-child\u0022\u003EPML Risk Stratification Tool.\u003C\/p\u003E\n            \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from E. Havrdova, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-12\u0022\u003EA registry has not yet been established to track fingolimod safety issues, but the EMEA has recently issued additional security measures [\u003Ca href=\u0022http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Medicine_QA\/2012\/04\/WC500125689.pdf\u0022\u003Ehttp:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Medicine_QA\/2012\/04\/WC500125689.pdf\u003C\/a\u003E]. A change in RMP is expected from the European Medicines Agency. With respect to alemtuzumab, an RMP will be developed to avoid occurrences of idiopathic thrombocytopenic purpura. The RMP will include a recommendation on how to check thyroid function. PML has been shown to occur in 1\/28,000 patients treated with rituximab.\u003C\/p\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EProf. Havrdova concluded that physicians should have a balanced discussion with their patients regarding the risks of untreated MS versus the risks of therapy. Well informed patients are better equipped to decide what risks they are willing to take. The risks of DMTs can be minimized by carefully following the RMP and monitoring patient adherence, treatment effects, and AEs.\u003C\/p\u003E\n         \u003Cdiv id=\u0022F3\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/2\/18\/F3.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022The editors would like to thank the many members of the 6th World Congress on Controversies in Neurology presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-865756731\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;The editors would like to thank the many members of the 6\u0026amp;lt;sup\u0026amp;gt;th\u0026amp;lt;\/sup\u0026amp;gt; World Congress on Controversies in Neurology presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u0026amp;lt;\/div\u0026amp;gt;\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure3\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/2\/18\/F3.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/2\/18\/F3.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure3\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/2\/18\/F3.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/13972\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\n               \u003Cp id=\u0022p-14\u0022 class=\u0022first-child\u0022\u003EThe editors would like to thank the many members of the 6\u003Csup\u003Eth\u003C\/sup\u003E World Congress on Controversies in Neurology presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/12\/2\/18.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nznig1\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nznig1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}