Detection of disability worsening in relapsing‐remitting multiple sclerosis patients: a real‐world roving Expanded Disability Status Scale reference analysis from the Italian Multiple Sclerosis Register

2020 ◽  
Author(s):  
V. Lepore ◽  
C. Bosetti ◽  
C. Santucci ◽  
P. Iaffaldano ◽  
M. Trojano ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Real World ◽  
Expanded Disability Status Scale ◽  
Reference Analysis ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

No evidence for an effect on brain atrophy rate of atorvastatin add-on to interferon β1b therapy in relapsing–remitting multiple sclerosis (the ARIANNA study)

2016 ◽  
Vol 22 (9) ◽  
pp. 1163-1173 ◽  
Author(s):  
Roberta Lanzillo ◽  
Mario Quarantelli ◽  
Carlo Pozzilli ◽  
Maria Trojano ◽  
Maria Pia Amato ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Brain Atrophy ◽  
Composite Score ◽  
Expanded Disability Status Scale ◽  
Functional Composite ◽  
Multiple Sclerosis Functional Composite ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Background: A previous phase 2 trial has suggested that statins might delay brain atrophy in secondary progressive multiple sclerosis. Objectives: The objective of this study was to evaluate the effect of atorvastatin add-on therapy on cerebral atrophy in relapsing–remitting multiple sclerosis. Methods: This randomised, placebo-controlled study compared atorvastatin 40 mg or placebo add-on therapy to interferon β1b for 24 months. Brain magnetic resonance imaging, multiple sclerosis functional composite score, Rao neuropsychological battery and expanded disability status scale were evaluated over 24 months. Results: A total of 154 patients were randomly assigned, 75 in the atorvastatin and 79 in the placebo arms, with a comparable drop-out rate (overall 23.4%). Brain atrophy over 2 years was not different in the two arms (−0.38% and −0.32% for the atorvastatin and placebo groups, respectively). Relapse rate, expanded disability status scale, multiple sclerosis functional composite score or cognitive changes were not different in the two arms. Patients withdrawing from the study had a higher number of relapses in the previous 2 years ( P=0.04) and a greater probability of relapsing within 12 months. Conclusions: Our results suggest that the combination of atorvastatin and interferon β1b is not justified in early relapsing–remitting multiple sclerosis and adds to the body of evidence indicating an absence of significant radiological and clinical benefit of statins in relapsing–remitting multiple sclerosis.

Simvastatin treatment in patients with relapsing-remitting multiple sclerosis receiving interferon beta 1a: a double-blind randomized controlled trial

2010 ◽  
Vol 16 (7) ◽  
pp. 848-854 ◽  
Author(s):  
Mansoureh Togha ◽  
Sanaz Ahmadi Karvigh ◽  
Masoud Nabavi ◽  
Nahid Beladi Moghadam ◽  
Mohammad Hossein Harirchian ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Placebo Group ◽  
Scale Score ◽  
Expanded Disability Status Scale ◽  
T2 Lesions ◽  
Simvastatin Group ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Objectives: This study was conducted to evaluate the effect of simvastatin (40 mg/day) as an adjuvant therapy to interferon beta (IFNb 1a, 30 µg once weekly) in relapsing—remitting multiple sclerosis patients, compared with placebo. Methods: We enrolled 85 patients with relapsing—remitting multiple sclerosis (71% female) who were already receiving IFNb 1a (Avonex), with Expanded Disability Status Scale score of less than 5.0. The patients were assigned (in random and double-blinded fashion) into the two groups of simvastatin and placebo. All patients continued to receive their current IFNb treatment. The outcome measures were total relapse rate, Expanded Disability Status Scale score, and the number of gadolinium-enhanced (Gd+) and new T2 lesions in magnetic resonance imaging after a 1-year follow-up. We used Mann—Whitney and one-way multivariate analysis of variances to analyze the data. Results: Four patients in the placebo and two in the simvastatin group prematurely withdrew from the study due to experiencing two attacks. The total attack number in the simvastatin group was significantly lower than placebo group (moderate effect size r = 0.29) ( p = 0.01). The final Expanded Disability Status Scale scores were lower in the simvastatin group (1.01 ± 1.40, mean ± SD) than in the placebo group (1.73 ± 1.49, mean ± SD), but this difference was not significant after controlling the baseline Expanded Disability Status Scale score ( p = 0.07). In the simvastatin group, the mean ± SD of gadolinium-enhanced and new T2 lesions were 0.66 ± 1.18 and 3.39 ± 3.55, respectively, (compared with 0.74 ± 1.21 and 3.39 ± 3.55 in the placebo group). Although there was a decreasing trend in lesions on magnetic resonance imaging, this difference was not statistically significant ( p = 0.62). The combination therapy was safe and well tolerated, and no serious adverse effect was noted. Conclusion: Our study supports the safety and efficacy of simvastatin as an add-on therapy to INFb 1a in patients with relapsing—remitting multiple sclerosis. TRIAL REGISTRATION: ClinicalTrials.gov NCT00668343. This interventional study provides Class I evidence stating that adding simvastatin 40 mg/day to IFNb 1a 30 µg a week in patients with relapsing—remitting multiple sclerosis may reduce the relapse rate (moderate effect size r = 0.29) ( p = 0.01) compared with treatment with IFNb 1a alone.

scholarly journals The real-world effectiveness and safety of fingolimod in relapsing-remitting multiple sclerosis patients: An observational study

PLoS ONE ◽  
2017 ◽  
Vol 12 (4) ◽  
pp. e0176174 ◽  
Author(s):  
Guillermo Izquierdo ◽  
Fátima Damas ◽  
Maria Dolores Páramo ◽  
Juan Luis Ruiz-Peña ◽  
Guillermo Navarro
Keyword(s):  
Multiple Sclerosis ◽  
Observational Study ◽  
Real World ◽  
The Real ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

scholarly journals A voxel-based morphometry study of disease severity correlates in relapsing— remitting multiple sclerosis

2009 ◽  
Vol 16 (1) ◽  
pp. 45-54 ◽  
Author(s):  
A. Prinster ◽  
M. Quarantelli ◽  
R. Lanzillo ◽  
G. Orefice ◽  
G. Vacca ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
White Matter ◽  
Grey Matter ◽  
Disease Duration ◽  
Expanded Disability Status Scale ◽  
Lesion Load ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Previous studies have shown a preferential loss of grey matter in fronto-temporal regions in patients with multiple sclerosis. Studies of correlates of disease severity are more controversial, because some studies have suggested an association between sensorimotor cortex atrophy and Expanded Disability Status Scale score, while others did not find such a correlation. The objective of this study was to assess the correlation of regional loss of grey matter and white matter with indexes of clinical and radiological severity in relapsing—remitting multiple sclerosis, including the Expanded Disability Status Scale and lesion load. Correlations between Expanded Disability Status Scale, lesion load and disease duration were assessed in 128 patients with relapsing—remitting multiple sclerosis (Expanded Disability Status Scale range 1.0—6.0) using optimized voxel-based morphometry. Bilateral loss of grey matter in sensorimotor cortices was correlated with Expanded Disability Status Scale, and tissue loss also involved adjacent white matter, extending along pyramidal tracts to the brainstem. Increasing lesion load was correlated with loss of deep grey matter and white matter. No specific region of grey matter or white matter showed a significant correlation with disease duration. These findings support the hypothesis that motor neuron involvement plays a major role in the progression of physical disability. Lesion load accrual affects mainly highly interconnected subcortical structures, while disease duration has a less significant impact on brain atrophy, probably owing to the inter-subject heterogeneity of the clinical course of the disease.

scholarly journals Spanish real-world experience with fingolimod in relapsing-remitting multiple sclerosis patients: MS NEXT study

PLoS ONE ◽  
2020 ◽  
Vol 15 (4) ◽  
pp. e0230846
Author(s):  
Francisco Barrero ◽  
Javier Mallada-Frechin ◽  
María Luisa Martínez-Ginés ◽  
María Eugenia Marzo ◽  
Virginia Meca-Lallana ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Real World ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

scholarly journals Fingolimod Treatment in Relapsing-Remitting Multiple Sclerosis Patients: A Prospective Observational Multicenter Postmarketing Study

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Rocco Totaro ◽  
Caterina Di Carmine ◽  
Gianfranco Costantino ◽  
Roberta Fantozzi ◽  
Paolo Bellantonio ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Activity ◽  
Real World ◽  
Convincing Evidence ◽  
Clinical Relapse ◽  
Disability Progression ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

Objective. The aim of this prospective observational multicenter postmarketing study was to evaluate fingolimod efficacy in a real world clinical setting.Methods. One hundred forty-two subjects with relapsing-remitting multiple sclerosis (RRMS) were enrolled in three multiple sclerosis centers throughout Central and Southern Italy between January 2011 and September 2013. After enrollment, regular visits and EDSS assessment were scheduled every 3 months, and MRI scan was obtained every 12 months. Patients were followed up from 1 to 33 months (mean 14.95 ± 9.15 months). The main efficacy endpoints included the proportion of patients free from clinical relapses, from disability progression, from magnetic resonance imaging activity, and from any disease activity.Results. Out of 142 patients enrolled in the study, 88.1% were free from clinical relapse and 69.0% were free from disability progression; 68.5% of patients remained free from new or newly enlarging T2 lesions and 81.7% of patients were free from gadolinium enhancing lesions. Overall the proportion of patients free from any disease activity was 41.9%.Conclusions. Our data in a real world cohort are consistent with previous findings that yield convincing evidence for the efficacy of fingolimod in patients with RRMS.

scholarly journals Serum Anjiogenesis Factors of Neuropilin-1 and Neuropilin-2 Levels in Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis Patients

2020 ◽  
Author(s):  
Ahmet Dönder ◽  
Hasan Hüseyin ÖZDEMİR ◽  
Hamza ASLANHAN
Keyword(s):  
Multiple Sclerosis ◽  
Clinically Isolated Syndrome ◽  
Control Group ◽  
Expanded Disability Status Scale ◽  
Angiogenesis Factors ◽  
Neuropilin 1 ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Abstract Background: Several of the molecular constituent factors in the pathophysiology of Multiple Sclerosis (MS). Neuropilins are transmembrane glycoproteins which have to be receptors for the vascular endothelial growth factor (VEGF) family of angiogenesis factors. The role of angiogenesis factors of Neuropilin-1 and 2 in the pathology of MS is unknown. Methods: We aimed to investigate levels of serum Neuropilin-1 and 2 in Relapsing-Remitting Multiple Sclerosis (RRMS), and Clinically Isolated Syndrome Patients (CIS) and to investigate a correlation with, age, sex, Expanded Disability Status Scale (EDSS) and relationship with immunomodulatory therapy. Serum Neuropilin-1 and 2 concentrations of 46 RRMS patients and 28 CIS patients and 45 healthy control group were analyzed. Clinical status was evaulated using the Expanded Disability Status Scale (EDSS). Results: Neuropilin-1 and 2 concentrations matched for immumodulatuar treatment, age and sex at a group level.Neuropilin levels were found to be significantly higher in the CIS and RRMS patient’s groups compared with the control group (p˂0,001). No statistically significant difference was found between groups; age, immunmodulatuar treatment, EDSS and gender. Conclusions: Neuropilin-1 and 2 levels have been shown to increase in RRMS and CIS patients. Neuropilins, one of the factors of angiogenesis, may be effective in pathophysiology since the first period of the disease.

scholarly journals Differential disease phenotypes and progression in relapsing–remitting multiple sclerosis: comparative analyses of single Canadian and Saudi Arabian clinics

BMC Neurology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
M. Alluqmani ◽  
W. Roda ◽  
M. Qqrmli ◽  
G. Blevins ◽  
F. Giuliani ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Saudi Arabia ◽  
Severe Disease ◽  
Geographic Location ◽  
Expanded Disability Status Scale ◽  
Disease Phenotypes ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Abstract Objective Relapsing–remitting multiple sclerosis (RR-MS) phenotypes differ widely although the variables contributing to this heterogeneity remain uncertain. To assess geographic and ethnic effects on RR-MS phenotypes, we investigated RR-MS patients in Canada and Saudi Arabia. Methods A retrospective analysis of patients followed in two MS Clinics was performed in Medina, Saudi Arabia and Edmonton, Canada. Demographic and clinical data were collected for each patient and analyzed using univariable and multivariable statistics. Univariable and multivariable linear regression were used to distinguish the significant clinical and demographic features and neurological systems associated with the change in expanded disability status scale (EDSS) between clinical assessments. Results Patients with treated RR-MS were recruited (n = 51, Saudi; n = 47, Canada) although the disease duration was longer in the Canadian cohort (5.6 ± 2.2 yr.) compared to the Saudi cohort (4.4 ± 1.4 yr.) (P < 0.05), annual relapse rate and EDSS change were higher in the Saudi cohort (P < 0.05). Infratentorial lesion-associated presentation differed (Canada, n = 23; Saudi, n = 13) among groups (P < 0.05). Spinal cord lesions on MRI were more frequently detected in Canadian (n = 23) compared to Saudi (n = 1) patients (P < 0.05). Patients within the Saudi cohort displayed a significantly greater change in Expanded Disability Status Scale (EDSS) between first and second assessments. Conclusions Despite differences in geographic location, ethnicity, and predominance of infratentorial lesions in the Canadian group, the RR-MS phenotypes were similar although the Saudi cohort displayed a more severe disease course.

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