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

Totaro R, Di Carmine C, Costantino G, Fantozzi R, Bellantonio P, Fuiani A, Mundi C, Ruggieri S, Marini C, Carolei A - Mult Scler Int (2015)

Bottom Line: Results.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Neurology, University of L'Aquila, L'Aquila, Italy.

ABSTRACT
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.

No MeSH data available.


Related in: MedlinePlus

Kaplan-Meyer plot of cumulative proportion of patients remaining free from any disease activity over time from start of fingolimod therapy.
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Related In: Results  -  Collection


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fig6: Kaplan-Meyer plot of cumulative proportion of patients remaining free from any disease activity over time from start of fingolimod therapy.

Mentions: As shown in Figure 6, the cumulative proportion of patients free from any disease activity was 41.9%. Multivariate regression analysis revealed lower EDSS score at baseline as the only predictor of disease activity recurrence after fingolimod start (p = 0.018).


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

Totaro R, Di Carmine C, Costantino G, Fantozzi R, Bellantonio P, Fuiani A, Mundi C, Ruggieri S, Marini C, Carolei A - Mult Scler Int (2015)

Kaplan-Meyer plot of cumulative proportion of patients remaining free from any disease activity over time from start of fingolimod therapy.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4526215&req=5

fig6: Kaplan-Meyer plot of cumulative proportion of patients remaining free from any disease activity over time from start of fingolimod therapy.
Mentions: As shown in Figure 6, the cumulative proportion of patients free from any disease activity was 41.9%. Multivariate regression analysis revealed lower EDSS score at baseline as the only predictor of disease activity recurrence after fingolimod start (p = 0.018).

Bottom Line: Results.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Neurology, University of L'Aquila, L'Aquila, Italy.

ABSTRACT
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.

No MeSH data available.


Related in: MedlinePlus