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      Application of the 2017 Revised McDonald Criteria for Multiple Sclerosis to Patients With a Typical Clinically Isolated Syndrome

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          Abstract

          <div class="section"> <a class="named-anchor" id="ab-noi180052-1"> <!-- named anchor --> </a> <h5 class="section-title" id="d6956551e368">Question</h5> <p id="d6956551e370">What is the diagnostic accuracy of the 2017 criteria vs the 2010 criteria to predict clinically definite MS (CDMS) in patients with a typical clinically isolated syndrome (CIS)? </p> </div><div class="section"> <a class="named-anchor" id="ab-noi180052-2"> <!-- named anchor --> </a> <h5 class="section-title" id="d6956551e373">Findings</h5> <p id="d6956551e375">This study included 229 patients with a clinically isolated syndrome. The sensitivity of the revised McDonald 2017 criteria was higher than for the 2010 criteria, and specificity was lower for the 2017 criteria. </p> </div><div class="section"> <a class="named-anchor" id="ab-noi180052-3"> <!-- named anchor --> </a> <h5 class="section-title" id="d6956551e378">Meaning</h5> <p id="d6956551e380">The 2017 revision of the McDonald MS criteria leads to a higher number of MS diagnoses in patients with a less active disease course. </p> </div><div class="section"> <a class="named-anchor" id="ab-noi180052-4"> <!-- named anchor --> </a> <h5 class="section-title" id="d6956551e384">Importance</h5> <p id="d6956551e386">In 2017, the International Panel on Diagnosis of Multiple Sclerosis revised the McDonald 2010 criteria for the diagnosis of multiple sclerosis (MS). The new criteria are easier to apply and could lead to more and earlier diagnoses. It is important to validate these criteria globally for their accuracy in clinical practice. </p> </div><div class="section"> <a class="named-anchor" id="ab-noi180052-5"> <!-- named anchor --> </a> <h5 class="section-title" id="d6956551e389">Objective</h5> <p id="d6956551e391">To evaluate the diagnostic accuracy of the 2017 criteria vs the 2010 criteria in prediction of clinically definite MS in patients with a typical clinically isolated syndrome (CIS). </p> </div><div class="section"> <a class="named-anchor" id="ab-noi180052-6"> <!-- named anchor --> </a> <h5 class="section-title" id="d6956551e394">Design, Setting and Patients</h5> <p id="d6956551e396">A total of 251 patients at Erasmus MC, Rotterdam, the Netherlands, in collaboration with several regional hospitals, fulfilled the inclusion criteria. Thirteen patients received another diagnosis early in the diagnostic process and therefore were excluded from the analyses. Nine patients with CIS declined to participate in the study. This left 229 patients who were included between March 2006 and August 2016 in this prospective CIS cohort. Patients underwent a baseline magnetic resonance imaging scan within 3 months after onset of symptoms and, if clinically required, a lumbar puncture was performed. Data were analyzed between December 2017 and January 2018. </p> </div><div class="section"> <a class="named-anchor" id="ab-noi180052-7"> <!-- named anchor --> </a> <h5 class="section-title" id="d6956551e399">Main Outcomes and Measures</h5> <p id="d6956551e401">Sensitivity, specificity, accuracy, and positive and negative predictive value were calculated after 1, 3, and 5 years for the 2017 vs the 2010 criteria. </p> </div><div class="section"> <a class="named-anchor" id="ab-noi180052-8"> <!-- named anchor --> </a> <h5 class="section-title" id="d6956551e404">Results</h5> <p id="d6956551e406">Among the 229 patients with CIS, 167 were women (73%), and the mean (SD) age was 33.5 (8.2) years. One hundred thirteen patients (49%) were diagnosed as having CDMS during a mean (SD) follow-up time of 65.3 (30.9) months. Sensitivity for the 2017 criteria was higher than for the 2010 criteria (68%; 95% CI, 57%-77% vs 36%; 95% CI, 27%-47%; <i>P</i> &lt; .001), but specificity was lower (61%; 95% CI, 50%-71% vs 85%; 95% CI, 76%-92%; <i>P</i> &lt; .001). Using the 2017 criteria, more MS diagnoses could be made at baseline (n = 97 [54%]; 95% CI, 47%-61% vs n = 46 [26%]; 95% CI, 20%-32%; <i>P</i> &lt; .001). In the group with at least 5 years of follow-up, 33% of patients who were diagnosed as having MS using the 2017 criteria did not experience a second attack during follow-up vs 23% when using the 2010 criteria. </p> </div><div class="section"> <a class="named-anchor" id="ab-noi180052-9"> <!-- named anchor --> </a> <h5 class="section-title" id="d6956551e418">Conclusions and Relevance</h5> <p id="d6956551e420">The 2017 revised McDonald criteria are associated with greater sensitivity but less specificity for a second attack than the previous 2010 criteria. The tradeoff is that it leads to a higher number of MS diagnoses in patients with a less active disease course. </p> </div><p class="first" id="d6956551e423">This study evaluates the diagnostic accuracy of the 2017 McDonald criteria vs the 2010 criteria to predict clinically definite multiple sclerosis in patients with a typical clinically isolated syndrome. </p>

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          Clinically isolated syndromes.

          Clinically isolated syndrome (CIS) is a term that describes a first clinical episode with features suggestive of multiple sclerosis (MS). It usually occurs in young adults and affects optic nerves, the brainstem, or the spinal cord. Although patients usually recover from their presenting episode, CIS is often the first manifestation of MS. The most notable risk factors for MS are clinically silent MRI lesions and CSF oligoclonal bands; weak or uncertain risk factors include vitamin D deficiency, Epstein-Barr virus infection, smoking, HLA genes, and miscellaneous immunological abnormalities. Diagnostic investigations including MRI aim to exclude alternative causes and to define the risk for MS. MRI findings incorporated into diagnostic criteria in the past decade enable MS to be diagnosed at or soon after CIS presentation. The course of MS after CIS is variable: after 15-20 years, a third of patients have a benign course with minimal or no disability and a half will have developed secondary progressive MS with increasing disability. Prediction of the long-term course at disease onset is unreliable. Disease-modifying treatments delay the development from CIS to MS. Their use in CIS is limited by uncertain long-term clinical prognosis and treatment benefits and adverse effects, although they have the potential to prevent or delay future tissue damage, including demyelination and axonal loss. Targets for future therapeutic progress are to achieve safe and effective long-term immunomodulation with neuroprotection and repair. Copyright © 2012 Elsevier Ltd. All rights reserved.
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            Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study.

            Several controlled studies provide evidence that treatment with interferon beta in patients with a first event suggestive of multiple sclerosis (MS) delays conversion to clinically definite MS (CDMS). Our aim was to determine whether early initiation of treatment with interferon beta prevents development of confirmed disability in MS. In the initial placebo-controlled phase of the double-blinded BENEFIT study, patients with a first event suggestive of MS and a minimum of two clinically silent lesions in MRI were randomised to receive either interferon beta-1b 250 microg (n=292) or placebo (n=176) subcutaneously every other day for 2 years, or until diagnosis of CDMS. Patients were then eligible to enter the follow-up phase with open-label interferon beta-1b. In the current prospectively planned analysis 3 years after randomisation, the effects of early interferon beta-1b treatment were compared with those of delayed treatment initiated after diagnosis of CDMS or after 2 years on the study. The primary outcomes of this ITT analysis were time to diagnosis of CDMS, time to confirmed expanded disability status scale (EDSS) progression, and score on a patient-reported functional assessment scale (FAMS-TOI). This trial is registered with ClinicalTrials.gov, number NCT00185211. Of the 468 patients originally randomised, 418 (89%) entered the follow-up phase; 392 (84%) completed 3 years' post-randomisation follow-up. After 3 years, 99 (37%) patients in the early group developed CDMS compared with 85 (51%) patients in the delayed treatment group. Early treatment reduced the risk of CDMS by 41% (hazard ratio 0.59, 95% CI 0.44-0.80; p=0.0011; absolute risk reduction 14%) compared with delayed treatment. Over 3 years, 42 (16%) patients in the early group and 40 (24%) in the delayed group had confirmed EDSS progression; early treatment reduced the risk for progression of disability by 40% compared with delayed treatment (0.60, 0.39-0.92; p=0.022; absolute risk reduction 8%). The FAMS-TOI score was high and stable in both groups over the 3-year period (p=0.31). Our data suggest that early initiation of treatment with interferon beta-1b prevents the development of confirmed disability, supporting its use after the first manifestation of relapsing-remitting MS.
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              Association of MRI metrics and cognitive impairment in radiologically isolated syndromes.

              To evaluate cognitive changes in a cohort of radiologically isolated syndromes (RIS) suggestive of multiple sclerosis (MS) and to assess their relationship with quantitative magnetic resonance (MR) measures such as white matter (WM), lesion loads, and cerebral atrophy. We assessed the cognitive performance in a group of 29 subjects with RIS recruited from 5 Italian MS centers and in a group of 26 patients with relapsing-remitting MS (RRMS). A subgroup of 19 subjects with RIS, 26 patients with RRMS, and 21 healthy control (HC) subjects also underwent quantitative MR assessments, which included WM T1 and T2 lesion volumes and global and cortical brain volumes. Cognitive impairment of the same profile as that of RRMS was found in 27.6% of our subjects with RIS. On MR scans, we found comparable levels of lesion loads and brain atrophy in subjects with RIS and well-established RRMS. In subjects with RIS, high T1 lesion volume (ρ = 0.526, p = 0.025) and low cortical volume (ρ = -0.481, p = 0.043) were associated with worse cognitive performance. These findings emphasize the importance of including accurate neuropsychological testing and quantitative MR metrics in subjects with RIS suggestive of MS. They can provide a better characterization of these asymptomatic subjects, potentially useful for diagnostic and therapeutic decisions.
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                Author and article information

                Journal
                JAMA Neurology
                JAMA Neurol
                American Medical Association (AMA)
                2168-6149
                November 01 2018
                November 01 2018
                : 75
                : 11
                : 1392
                Affiliations
                [1 ]Department of Neurology, MS Center ErasMS, Erasmus MC, Rotterdam, the Netherlands
                [2 ]Department of Neurology, Amphia Hospital, Breda, the Netherlands
                [3 ]Department of Neurology, Maasstad Hospital, Rotterdam, the Netherlands
                [4 ]Department of Neurology, Albert Schweitzer Hospital, Dordrecht, the Netherlands
                Article
                10.1001/jamaneurol.2018.2160
                6248116
                30083703
                56bbd09c-8295-43c8-8e41-20fa4a668d25
                © 2018
                History

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