Subgroups of multiple sclerosis patients with larger treatment benefits: a meta‐analysis of randomized trials

Signori, Alessio; Schiavetti, Irene; Gallo, Fabio; Sormani, Maria Pia

doi:10.1111/ene.12690

Cited by 72 publications

(79 citation statements)

References 15 publications

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“…58 Statements and recommendations ■ T2 weighted and contrast enhanced T1 weighted brain MRI are the modalities of choice for MS disease monitoring, revealing acute and active inflammation, and clinically silent disease progression 24 Early prediction Some evidence suggests that certain baseline demo graphic variables (for example, age at treatment initi ation), clinical factors (including disease duration at treatment initiation and pretreatment relapse rate) and MRI measures related to disease activity (such as base line lesion load) can help to indicate which patients will benefit most from a first line DMD, and who will have a poor response. 66,[71][72][73][74] However, the relevant studies mainly analysed cohorts receiving different IFN β formulations, produced preliminary or inconsistent results, and have failed to satisfactorily predict treatment response in clinical practice. 70 Other MRI derived metrics-such as global or regional brain volume, or the number of spinal cord lesions-have shown value for predicting relapses or disability progression, 35-37,39,75-77 but have not been specifically analysed for treatment response predictions.…”

Section: Focal Lesionsmentioning

confidence: 99%

MAGNIMS consensus guidelines on the use of MRI in multiple sclerosis—establishing disease prognosis and monitoring patients

2015

Nat Rev Neurol

404

147

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Section: Focal Lesionsmentioning

confidence: 99%

MAGNIMS consensus guidelines on the use of MRI in multiple sclerosis—establishing disease prognosis and monitoring patients

2015

Nat Rev Neurol

404

147

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“…However, there were relevant baseline differences across subgroups of patients defined by previous treatment history that are known to act as treatment effect modifiers [36]. We found indeed that fingolimod may lead to a better control of the disease if started in patients with a less aggressive disease, i.e.…”

Section: Discussionmentioning

confidence: 67%

Baseline characteristics associated with NEDA-3 status in fingolimod-treated patients with relapsing-remitting multiple sclerosis

Giuliani

Logoteta

Prosperini

et al. 2017

Mult Scler Demyelinating Disord

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Background: Fingolimod is an efficacious treatment for relapsing-remitting multiple sclerosis (RRMS) and there is class I evidence that it is superior to standard care in reducing relapse rate. However, real-world data investigating its effectiveness and potential predictors of response are still scarce. Objective: To estimate (i) the proportion of fingolimod-treated patients who achieved the no evidence of disease activity (NEDA-3) status; and (ii) to determine which baseline (i.e. at treatment start) clinical and magnetic resonance imaging (MRI) variables were associated with better outcomes. Methods: We collected clinical and MRI data of RRMS patients treated with fingolimod and followed-up for 24 months. The proportion of patients who had NEDA-3 -i.e. absence of relapses, sustained Expanded Disability Status Scale (EDSS) worsening and radiological activity on MRI -was estimated. A Cox proportional hazard model was carried out to investigate which baseline characteristics were associated with the NEDA status at follow-up. Results: We collected data of 201 patients who started fingolimod. Of them, 24 (12%) were treatment-naïve, 115 (58%) were switched after failing a self-injectable drug, and 60 (30%) switching from natalizumab. Five patients who discontinued fingolimod early (within 3 months) (bradycardia, n = 2; leukopaenia, n = 2; macular oedema, n = 1) were removed from the analysis. At follow-up, 118 (60%) patients achieved the NEDA-3 status, while 78 experienced clinical and/or MRI activity. The risk of not achieving the NEDA-3 status was associated with higher baseline EDSS score (hazard ratio [HR] = 1.18, p = 0.024) and more relapses in the 12 months prior to fingolimod start (HR = 1.61, p = 0.014). Conclusion: Our findings suggest that fingolimod may lead to a better control of the disease if started in patients with a less aggressive disease (i.e. fewer pre-treatment relapses and milder disability level), thus supporting its possible role as an early treatment for MS.

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“…Comorbidities are also highly prevalent in the MS population, and comorbid disease is recognized as a critical issue in MS given the breadth of adverse impacts with which it is associated [5]. The identification of patients with varying levels of overall disease status is important to help select patient populations most likely to benefit from interventions and to assess the value and effectiveness of treatments [6]. …”

Section: Introductionmentioning

confidence: 99%

Development and validation of a claims-based measure as an indicator for disease status in patients with multiple sclerosis treated with disease-modifying drugs

Munsell¹,

Frean²,

Menzin³

et al. 2017

BMC Neurol

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BackgroundAdministrative healthcare claims data provide a mechanism for assessing and monitoring multiple sclerosis (MS) disease status across large, clinically representative “real-world” populations. The estimation of MS disease status using administrative claims can be a challenge, however, due to a lack of detailed clinical information. Retrospective claims analyses in MS have traditionally used rates of MS relapses to approximate disease status. Healthcare costs may be alternate, broader claims-based indicators of disease activity because costs reflect multiple facets of care of patients with MS, and there is a strong correlation between quality of life of patients with MS and costs of the disease. This study developed, tested, and validated a healthcare cost-based measure to serve as an indicator of overall disease status in patients with MS treated with disease-modifying drugs (DMDs) utilizing administrative claims.MethodsUsing IMS Health Real World Data Adjudicated Claims – US data (January 2006–June 2013), a negative binomial regression predicted annual all-cause medical costs. Coefficients reaching statistical significance (p < 0.05) and increasing costs by ≥5% were selected for inclusion into an MS-specific severity score (scale of 0 to 100). Components of the score included rehabilitation services, altered mental state, pain, disability, stiffness, balance disorder, urinary incontinence, numbness, malaise/fatigue, and infections. Coefficient weights represented each predictor’s contribution. The predictive model was derived using 50% of a random sample and tested/validated using the remaining 50%.ResultsAverage overall predicted annual total medical cost was $11,134 (development sample, n = 11,384, vs. $10,528 actual) and $11,303 (validation sample, n = 11,385, vs. $10,620 actual). The model had consistent bias (approximately +$600 or +6% of actual costs) for both samples. In the validation sample, mean MS disease status scores were 0.24, 8.95, and 21.77 for low, medium, and high tertiles, respectively. Mean costs were most accurately predicted among less severe patients ($5243 predicted vs. $5233 actual cost for lowest tertile).ConclusionThe algorithm developed in this study provides an initial step to helping understand and potentially predict cost changes for a commercially insured MS population.Electronic supplementary materialThe online version of this article (doi:10.1186/s12883-017-0887-1) contains supplementary material, which is available to authorized users.

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Subgroups of multiple sclerosis patients with larger treatment benefits: a meta‐analysis of randomized trials

Abstract: This study formally shows that in RRMS higher treatment effects are associated with characteristics of earlier (lower age and Expanded Disability Status Scale) and more active (higher gadolinium activity) disease.

Cited by 72 publications

References 15 publications

MAGNIMS consensus guidelines on the use of MRI in multiple sclerosis—establishing disease prognosis and monitoring patients

MAGNIMS consensus guidelines on the use of MRI in multiple sclerosis—establishing disease prognosis and monitoring patients

Baseline characteristics associated with NEDA-3 status in fingolimod-treated patients with relapsing-remitting multiple sclerosis

Development and validation of a claims-based measure as an indicator for disease status in patients with multiple sclerosis treated with disease-modifying drugs

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