Half-dose fingolimod for treating relapsing-remitting multiple sclerosis: Observational study

2017 ◽  
Vol 24 (2) ◽  
pp. 167-174 ◽  
Author(s):  
Chiara Zecca ◽  
Arianna Merlini ◽  
Giulio Disanto ◽  
Mariaemma Rodegher ◽  
Letizia Panicari ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Observational Study ◽  
Clinical Laboratory ◽  
Significant Proportion ◽  
Lower Baseline ◽  
Neuroimaging Data ◽  
Demyelinating Lesions ◽  
Magnetic Resonance Imaging Mri ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

Objectives: To investigate the efficacy and safety of fingolimod (FTY) 0.5 mg administered every other day (FTY-EOD) compared to every day (FTY-ED) in multiple sclerosis patients. Methods: Multicentre retrospective observational study. Clinical, laboratory and neuroimaging data were consecutively collected from 60 FTY-EOD and 63 FTY-ED patients. Baseline characteristics were compared using logistic regression. Efficacy in preventing occurrence of relapses and demyelinating lesions was tested using propensity score–adjusted Cox and linear regressions. Results: Weight was inversely associated with risk of switch to FTY-EOD because of any reason (odds ratio (OR) = 0.94, 95% confidence interval (95% CI) = 0.89–0.99, p = 0.026), and female sex and lower baseline lymphocyte count were positively associated with switch because of lymphopenia. Compared to FTY-ED patients, FTY-EOD patients were at higher risk of developing relapses (hazard ratio (HR) = 2.98, 95% CI = 1.07–8.27, p  = 0.036) and either relapses or new magnetic resonance imaging (MRI) demyelinating lesions (combined outcome, HR = 2.07, 95% CI = 1.06–4.08, p  = 0.034). Within FTY-EOD, treatment with natalizumab before FTY and lower age were positively associated with risk of developing relapses and combined outcome, respectively (HR = 25.71, 95% CI = 3.03–217.57, p = 0.002 and HR = 0.85, 95% CI = 0.77–0.96, p  = 0.005). FTY-EOD was overall well tolerated. Conclusion: Disease reactivation was observed in a significant proportion of patients treated with FTY-EOD. Neurologists should be cautious when reducing FTY administration to every other day, especially in younger patients and those previously treated with natalizumab.

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

Withdrawal of fingolimod treatment for relapsing–remitting multiple sclerosis: report of six cases

2012 ◽  
Vol 18 (11) ◽  
pp. 1636-1639 ◽  
Author(s):  
Bahia Hakiki ◽  
Emilio Portaccio ◽  
Marta Giannini ◽  
Lorenzo Razzolini ◽  
Luisa Pastò ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Laboratory ◽  
Management Strategies ◽  
Effective Management ◽  
Imaging Data ◽  
Relapsing Remitting ◽  
Pre Treatment ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis ◽  
Systematic Collection

The objective of this article is to report our experience on fingolimod suspension in multiple sclerosis patients. We evaluated clinical and magnetic resonance (MR) outcomes in six patients after fingolimod discontinuation. Within three months from fingolimod suspension, five subjects returned to pre-treatment disease activity; one patient, however, exhibited a clear rebound of clinical and MR activity. Our findings suggest that clinical and MR outcomes after fingolimod suspension can vary among patients. Systematic collection of clinical, laboratory and imaging data is highly advisable to identify subjects who are at higher risk of rebound and to define effective management strategies in these subjects.

Disability progression markers over 6–12 years in interferon-β-treated multiple sclerosis patients

2017 ◽  
Vol 24 (3) ◽  
pp. 322-330 ◽  
Author(s):  
Jordi Río ◽  
Àlex Rovira ◽  
Mar Tintoré ◽  
Susana Otero-Romero ◽  
Manuel Comabella ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Activity ◽  
Clinical Activity ◽  
Cox Models ◽  
Clinical Cohort ◽  
T2 Lesions ◽  
Magnetic Resonance Imaging Mri ◽  
Multiple Sclerosis Patients ◽  
Relapsing Remitting Multiple Sclerosis

Objective: To investigate the association between activity during interferon-beta (IFNβ) therapy and disability outcomes in patients with relapsing–remitting multiple sclerosis (RRMS). Methods: A longitudinal study based on two previously described cohorts of IFNβ-treated RRMS patients was conducted. Patients were classified according to clinical activity after 2 years (clinical cohort) or to clinical and radiological activity after 1 year (magnetic resonance imaging (MRI) cohort). Multivariate Cox models were calculated for early disease activity predicting long-term disability. Results: A total of 516 patients from two different cohorts were included in the analyses. Persistent clinical disease activity during the first 2 years of therapy predicted severe long-term disability (clinical cohort). In the MRI cohort, modified Rio score and no or minimal evidence of disease activity (NEDA/MEDA) did not identify patients with risk of Expanded Disability Status Scale (EDSS) worsening. However, a Rio score ≥ 2 (hazard ratio (HR): 3.3, 95% confidence interval (CI): 1.7–6.4); ≥3 new T2 lesions (HR: 2.9, 95% CI: 1.5–5.6); or ≥2 Gd-enhancing lesions (HR: 2.1, 95% CI: 1.1–4) were able to identify patients with EDSS worsening. Conclusion: Although early activity during IFNβ therapy is associated with poor long-term outcomes, minimal degree of activity does not seem to be predictive of EDSS worsening over 6.7-year mean follow-up.

scholarly journals Efficacy of alemtuzumab over 6 years in relapsing–remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies

2019 ◽  
Vol 26 (13) ◽  
pp. 1719-1728 ◽  
Author(s):  
Bart Van Wijmeersch ◽  
Barry A Singer ◽  
Aaron Boster ◽  
Simon Broadley ◽  
Óscar Fernández ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Post Hoc Analysis ◽  
Brain Volume Loss ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Magnetic Resonance Imaging Mri ◽  
Multiple Sclerosis Patients ◽  
Post Hoc ◽  
Relapsing Remitting Multiple Sclerosis

Background: Alemtuzumab is administered as two annual courses for relapsing–remitting multiple sclerosis (MS). Patients may relapse before completing the two-course regimen. Objective: The objective was to evaluate 6-year outcomes in patients who relapsed between alemtuzumab Courses 1 and 2 (early relapsers). Methods: Post hoc analysis of patients from the Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis (CARE-MS) studies who enrolled in the extension. Results: Early relapsers (CARE-MS I: 15%; CARE-MS II: 24%) had more relapses in 1–2 years pre-alemtuzumab and higher mean baseline Expanded Disability Status Scale score than patients without relapse. Their annualized relapse rate declined from Year 1 (CARE-MS I: 1.3; CARE-MS II: 1.2) to Year 2 following Course 2 (0.3; 0.5) and remained low thereafter. Over 6 years, 60% remained free of 6-month confirmed disability worsening; 24% (CARE-MS I) and 34% (CARE-MS II) achieved 6-month confirmed disability improvement. During Year 6, 69% (CARE-MS I) and 68% (CARE-MS II) were free of magnetic resonance imaging (MRI) disease activity. Median percent yearly brain volume loss (Year 1: −0.67% (CARE-MS I); −0.47% (CARE-MS II)) declined after Course 2 (Year 6: −0.24%; −0.13%). Conclusion: Early relapsers’ outcomes improved after completing the second alemtuzumab course. These findings support administering the approved two-course regimen to maximize clinical benefit. ClinicalTrials.gov registration numbers: CARE-MS I, II, extension: NCT00530348, NCT00548405, NCT00930553.

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