Evaluation of the Expanded Disability Status Scale and the Multiple Sclerosis Functional Composite as clinical endpoints in multiple sclerosis clinical trials: quantitative meta-analyses

Sawad, Aseel Bin; Seoane‐Vazquez, Enrique; Rodríguez-Monguió, Rosa; Turkistani, Fatema

doi:10.1080/03007995.2016.1222516

Cited by 26 publications

(14 citation statements)

References 24 publications

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“…This comparative approach would be greatly facilitated by the increased use of existing symptom and disability assessment scales and the validation of new ones. The Expanded Disability Status Scale (4) is the most widely used neurological exam scale in clinical trial settings, but focuses primarily on mobility, while the Multiple Sclerosis Functional Composite (5) scale is considered more sensitive (6), however, both are time consuming. In contrast, the assessing relapse in multiple sclerosis (ARMS) questionnaire (7) is a less rigorous, but more practical method.…”

Section: Determining the Validity And Severity Of A Relapsementioning

confidence: 99%

Emerging Approaches for Validating and Managing Multiple Sclerosis Relapse

2017

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The autoimmune disease multiple sclerosis (MS) is characterized by relapses in the majority of patients. A definitive clinical diagnosis of relapse in MS can be complicated by the presence of an infection or comorbid disorder. In this mini-review, we describe efforts to develop enhanced imaging techniques and biomarker detection as future tools for relapse validation. There is emerging evidence of roles for meningeal inflammation, sex hormones, comorbid metabolic or mood disorders, and a dysregulated immune profile in the manifestation and severity of relapse. Specific subsets of immune cells likely drive the pathophysiology of relapse, and identification of a patient’s unique immunological signature of relapse may help guide future diagnosis and treatment. Finally, these studies highlight the diversity in terms of relapse presentation, immunological signature, and response in patients with MS, indicating that going forward the best approach to assessment and treatment of relapse will be multifactorial and highly personalized.

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Section: Determining the Validity And Severity Of A Relapsementioning

confidence: 99%

Emerging Approaches for Validating and Managing Multiple Sclerosis Relapse

2017

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“…The standardized assessment tools currently used for ambulation are the gait component of the Expanded Disability Status Scale (EDSS) 1 and the Timed 25-Foot Walk (T25FW) test, a component of the Multiple Sclerosis Functional Composite. [2][3][4] Limita-tions have been reported with both the EDSS gait component and the T25FW test. [5][6][7][8] The gait component of the EDSS is an ordinal scale with criteria for ambulation limited to the distance walked and use of a unilateral or bilateral assistive device.…”

mentioning

confidence: 99%

Validity and Reliability of Four Clinical Gait Measures in Patients with Multiple Sclerosis

Bennett¹,

Bromley²,

Fisher³

et al. 2017

International Journal of MS Care

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“…However, the EMA does acknowledge that there is a need for alternative measures (see below for information on the Multiple Sclerosis Outcome Assessments Consortium [ 68 , 69 ]), and research in this area has been active for many years. The MSFC was first introduced almost 20 years ago to address some of the limitations of the EDSS [ 17 ], and a recent meta-analysis has shown it to be more sensitive than the EDSS for detecting progression of MS [ 70 ]. The MSFC was included in over half (9/16) of the phase III RRMS trials identified in the current evaluation, although it was a primary endpoint in only one [ 43 ].…”

Section: Discussionmentioning

confidence: 99%

Disability Outcome Measures in Phase III Clinical Trials in Multiple Sclerosis

Uitdehaag

2018

CNS Drugs

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Accumulating neurological disability has a substantial impact on the lives of patients with multiple sclerosis (MS). As well as the established Expanded Disability Status Scale (EDSS), several other outcome measures are now available for assessing disability progression in MS. This review extends the findings of a previous analysis of relapsing-remitting MS (RRMS) trials published up to 2012, to determine whether there has been a shift in outcome measures used to assess disability in phase III clinical trials in RRMS and progressive MS. Forty relevant trials were identified (RRMS, n = 16; progressive MS, n = 18; other/mixed phenotypes, n = 6). Sustained EDSS worsening, particularly over 3 months, was included as an endpoint in almost all identified trials. Other disability-related endpoints included the Multiple Sclerosis Functional Composite z-score and scores for the physical component summary of the Multiple Sclerosis Impact Scale and Medical Outcomes Study Short-Form (36-item) Health Survey. Tests assessing manual dexterity, ambulation, vision and cognition were also employed, and in some trials, composite endpoints were used. However, there was no obvious trend in choice of disability outcome measures over time. Sustained EDSS worsening over short time periods continues to be the most widely used measure of disability progression in pivotal MS trials, despite its well-recognised limitations. A new tool set is needed for use in MS clinical trials that detects the benefit of potential treatments that slow (or reverse) progressive disability.Electronic supplementary materialThe online version of this article (10.1007/s40263-018-0530-8) contains supplementary material, which is available to authorized users.

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Evaluation of the Expanded Disability Status Scale and the Multiple Sclerosis Functional Composite as clinical endpoints in multiple sclerosis clinical trials: quantitative meta-analyses

Abstract: There is controversy about the sensitivity of the EDSS and MSFC in detecting the progression of MS disease. The EDSS and MSFC are effective tools to assess the clinical severity and progression of MS disease. MSFC is more sensitive than EDSS in detecting the progression of MS disease.

Cited by 26 publications

References 24 publications

Emerging Approaches for Validating and Managing Multiple Sclerosis Relapse

Emerging Approaches for Validating and Managing Multiple Sclerosis Relapse

Validity and Reliability of Four Clinical Gait Measures in Patients with Multiple Sclerosis

Disability Outcome Measures in Phase III Clinical Trials in Multiple Sclerosis

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