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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\u003EConsiderable progress has been made in multiple sclerosis (MS) therapy in the 20 years since the first successful trial. Although several agents are now available for treating patients with MS, many issues remain regarding treatment of individual patients. This article discusses initiating MS therapy, and addressed the issues of switching and escalating therapy and of discontinuing therapy.\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\u003EExclusive Article - For home page\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDemyelinating Diseases\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EExclusive Article - For home page\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EConsiderable progress has been made in multiple sclerosis (MS) therapy in the 20 years since the first successful trial. Although several agents are now available for treating patients with MS, many issues remain regarding treatment of individual patients. Fred D. Lublin, MD, Icahn School of Medicine at Mount Sinai, New York, New York, USA, opened the session with his presentation on initiating therapy. B. Mark Keegan, MD, and Brian G. Weinshenker, MD, both of the Mayo Clinic, Rochester, Minnesota, USA, addressed the issues of switching and escalating therapy and of discontinuing therapy, respectively.\u003C\/p\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EINITIAL CHOICE OF THERAPY\u003C\/h2\u003E\n         \u003Cp id=\u0022p-3\u0022\u003ESince the first MS therapy became available 20 years ago, treatment of MS has been initiated earlier and earlier. Dr. Lublin addressed the difficult questions of who to treat, when to treat, and what drug should be used to initiate therapy.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EThe greatest strides have been made in treating patients with clinically active relapsing MS. All of the current US Food and Drug Administration (FDA)-approved disease-modifying therapies (DMT) have been tested in clinical trials of patients with relapsing MS. These studies have demonstrated a benefit in reducing relapses and magnetic resonance imaging (MRI) activity, and in some cases, reducing accumulation of disability. Earlier treatment results in better outcomes. Initial treatment of patients with secondary progressive (SP) or primary progressive (PP) MS is more problematic, as little evidence for successful therapy exists unless activity is present. [Tullman MJ. \u003Cem\u003EAm J Manag Care\u003C\/em\u003E 2013; Miller AE et al. \u003Cem\u003ECurr Opin Neurol\u003C\/em\u003E 2012].\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003ETreatment for patients with clinically isolated syndrome (CIS)\u2014an acute single episode\u2014is a challenge if the MRI is normal [Miller DH et al. \u003Cem\u003ELancet Neurol\u003C\/em\u003E 2012]. Such patients have only a 20% chance of another clinical event over the next 2 decades if their brain MRI is normal, but patients with \u22651 MRI lesions have an 80% chance. Thus, if the MRI is abnormal, the evidence shows that initiating treatment will reduce the risk of additional attacks. Patients with radiologically isolated syndrome (RIS) present the greatest challenge. These patients may experience subsequent clinical or radiologic events, but little evidence exists regarding treatment in this population [Okuda DT et al. \u003Cem\u003ENeurology\u003C\/em\u003E 2009].\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EDisease modifying therapy (DMT) agents with 7 different anti-inflammatory mechanisms are approved for relapsing MS in the United States (see \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E) [Tullman MI. \u003Cem\u003EAm J Manag Care\u003C\/em\u003E 2013; Miller AE et al. \u003Cem\u003ECurr Opin Neurol\u003C\/em\u003E 2012]. All have good clinical trial data to support their use. Head-to-head comparative studies provide the best evidence for assessing efficacy, but few have been done.\u003C\/p\u003E\n         \u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/15901\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/15901\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15901\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\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003EFood and Drug Administration Approved DMTs for Multiple Sclerosis\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EFactors considered in choosing an initial therapy include comparative trial data, mechanism of action, efficacy, safety, disease characteristics, biomarkers, prior therapies, comorbidities, and patient convenience. Further studies are needed to obtain long-term and good comparative efficacy data, as well as data on defining inadequate response and switching therapies.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ESWITCHING AND ESCALATING THERAPY\u003C\/h2\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EAccording to Dr. Keegan, the optimal therapeutic management strategy for MS, including switching and escalating therapy, relies on an accurate diagnosis of MS and identifying the clinical course. Therapeutic goals include reducing clinical relapses and MRI inflammatory lesions, reducing short-and long-term disability, achieving a tolerable side effect profile, and meeting safety-monitoring requirements. Patients should be assessed to determine if these goals have been achieved and if therapy should be switched or escalated (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E) [Keegan BM. \u003Cem\u003ESemin Neurol\u003C\/em\u003E 2013].\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\/14\/6\/18\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Algorithm for Assessing Multiple Sclerosis Therapy\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1578296336\u0022 data-figure-caption=\u0022Algorithm for Assessing Multiple Sclerosis Therapy\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\/14\/6\/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\/14\/6\/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\/14\/6\/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\/15899\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-11\u0022 class=\u0022first-child\u0022\u003EAlgorithm for Assessing Multiple Sclerosis Therapy\u003C\/p\u003E\n            \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EAb=antibody; BG-12=dimethyl fumarate; JCV=!ohn Cunningham virus; Nab=neutralizing antibody.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced from Keegan BM et al. Therapeutic decision making in a new drug era in multiple sclerosis. \u003Cem\u003ESemin Neurol\u003C\/em\u003E 2013;33(1):5\u201312. With permission from Thieme Medical Publishers.\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\u003ESwitching medications within a drug class or out of a class across the same level of therapy is called parallel switching. An example of parallel switching is switching between interferon beta (IFNb) and glatiramer acetate (GA) because of IFNb- or GA-specific side effects or IFNb neutralizing antibodies. A route switch between an oral and an injectable therapy may be made in cases of inadequate response or intolerability to an oral or injectable drug. Efficacy and side effects of the drugs should be considered when making such a switch.\u003C\/p\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EFor patients with an inadequate response to injectable or oral therapies who are John Cunningham virus (JCV) antibody negative, therapy can be escalated by switching to natalizumab, which has a strong anti-inflammatory effect. JCV causes the opportunistic infection, progressive multifocal leukoencephalopathy (PML), which results in severe disability or death [Tan et al. \u003Cem\u003ENeurology\u003C\/em\u003E 2011]. Approximately 54% of MS patients test positive for JCV, and the annual seroconversion rate is about 2% [Berger JR et al. \u003Cem\u003EAnn Neurol\u003C\/em\u003E 2013; Gorelik L et al. \u003Cem\u003EAnn Neurol\u003C\/em\u003E 2010]. \u201cDe-escalating\u201d therapy from natalizumab to an oral medication can be done after a washout period of \u0026lt;3 months [Cohen M et al. \u003Cem\u003EJAMA Neurol\u003C\/em\u003E 2014], with a low relapse risk [Jokubaitis VG et al. \u003Cem\u003ENeurology\u003C\/em\u003E 2014].\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-3\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EDISCONTINUING THERAPY\u003C\/h2\u003E\n         \u003Cp id=\u0022p-14\u0022\u003EPatients with MS may discontinue therapy for a variety of reasons. Based on data from studies of MS DMT discontinuation, Dr. Weinshenker concluded that early discontinuation, typically within 5 years of initiation of IFNb and GA is common (\u003Ca id=\u0022xref-table-wrap-2-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T2\u0022\u003ETable 2\u003C\/a\u003E). Although patients often switch to other treatments, approximately 20% permanently discontinue treatment. Lack of efficacy is the most commonly cited factor. Tolerability issues are common reasons for stopping, but serious safety reasons are relatively uncommon.\u003C\/p\u003E\n         \u003Cdiv id=\u0022T2\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/15903\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/15903\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15903\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\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 2.\u003C\/span\u003E \n               \u003Cp id=\u0022p-15\u0022 class=\u0022first-child\u0022\u003EStudies Examining Rates of Discontinuing Multiple Sclerosis DMT\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-17\u0022\u003EDr. Weinshenker categorized reasons for discontinuing as good, reasonable, or bad. Good reasons include genuine lack of efficacy, serious toxicity, and pregnancy. Reasonable reasons include high titer of IFNb neutralizing antibodies, poor tolerance, a long period of no evidence of disease activity in patients \u0026gt;50 years of age, and entry into the progressive MS phase. Bad reasons include misperceptions about treatment goals, nihilistic approach to treatment, assumption that treatment is curative rather than partially effective, inadequate education about adverse effect management and duration, and cost or insurance issues.\u003C\/p\u003E\n         \u003Cp id=\u0022p-18\u0022\u003EEarly discontinuation of therapy is common but the rate of late discontinuation is not well studied. Therapy is unsuccessful in a large proportion of patients in clinical trials, and the main reason cited for early discontinuation is lack of efficacy. Prospective studies of discontinuation of DMTs integrated with algorithms of treatment escalation based on evidence of ongoing inflammatory disease activity are needed to guide decisions on stopping or switching therapy.\u003C\/p\u003E\n         \u003Cp id=\u0022p-19\u0022\u003EWhether treatment should be stopped when MS becomes progressive is unknown, but might be inferred because all DMT\u0027s are approved for patients with relapsing forms of MS. DMTs that have been evaluated in patients with progressive MS have been shown to have limited efficacy except in those with superimposed relapses or MRI evidence of disease activity [Kappos L et al. \u003Cem\u003ENeurology\u003C\/em\u003E 2004].\u003C\/p\u003E\n         \u003Cp id=\u0022p-20\u0022\u003ESuccess rates for stopping DMT in stable patients and predictors of success have also not been studied. In the absence of evidence, Dr. Weinshenker requires a 7-year period of freedom from disease activity before approving a patient\u0027s decision to discontinue treatment, while advising the patient that the safety of discontinuation is unknown.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 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\/14\/6\/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?nzpac3\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?nzpac3\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_tables.js?nzpac3\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}