057 Real world evidence (RWE) on long-term persistence of fingolimod in relapsing-remitting multiple sclerosis (RRMS) in australia

2018 ◽  
Vol 89 (6) ◽  
pp. A23.3-A24 ◽  
Author(s):  
Robert Walker ◽  
Mark Schulz ◽  
Birendra Arora ◽  
Eric Chung ◽  
Prabhjot Juneja ◽  
...  

IntroductionThis study aimed to examine and compare patient persistence of fingolimod to all reimbursed disease modifying therapies (DMTs) for relapsing-remitting multiple sclerosis (RRMS) in Australia.MethodThe Pharmaceutical Benefits Scheme (PBS) 10% sample supplied by the Department of Human Services was used in this study. Eligible patients must have received a script for a reimbursed DMT for RRMS between September 2011 and February 2016. Patient demographics were summarised using mean and standard deviation or frequency percentage. Persistence was defined as a patient that remained on a DMT with a gap in scripts of no longer than 4 months. Individual patients could be included multiple times if they initiated a new DMT during the study period. Persistence was derived using the Kaplan-Meier method and hazard ratios (HR). Persistence to individual treatments was then compared to the average persistence observed across all treatments; p-values were based on the log-rank test.Results720 unique patients were eligible for the study, contributing 1827 observations that for analysis (2.5 new initiations/patient). Overall the median persistence (MP) to therapy was 29.6 months with 67.7% of patients remaining on therapy for 12 months. The only DMT with significantly better persistence compared to the overall average was fingolimod (HR 0.65 (95%CI 0.57–0.73; p<0.001). Patients had an MP of 60 months on fingolimod with 79.5% of patients persistent at 12 months. Patients were significantly less persistent to interferon Beta-1a, interferon Beta-1b, glatiramer acetate and dimethyl fumarate (hazard ratios above 1.27 (p values all≤0.001) whilst the remaining DMTs, teriflunomide and natalizumab, showed no significant difference from the average persistence.ConclusionIn this analysis of PBS sample data, patients were most persistent to fingolimod treatment amongst all DMTs.

Author(s):  
Leila Karimi ◽  
Nahid Eskandari ◽  
Vahid Shaygannejad ◽  
Nasrin Zare ◽  
Alireza Andalib ◽  
...  

T helper type 1 (Th1) and Th17 Cells with distinct cytokine profiles including interferon-gamma (IFN-γ) and interleukin 17 (IL-17) have a pivotal role in neuroinflammation and myelin destruction in the central nervous system (CNS) in MS. MicroRNA-29b (MiR-29b) and miR-326 contribute to regulating Th1 and Th17 differentiation and altered expression of the miRNAs could be associated with response to treatment in multiple sclerosis (MS). Therefore, our study aimed to evaluate the percentage of Th1 and Th17 and determining the expression levels of miR-29b-3p and miR-326 in these lymphocyte subpopulations between responsive and non-responsive to interferon beta (IFN-β) therapy in relapsing-remitting multiple sclerosis (RRMS) patients. The present study was performed on 40 RRMS patients following treatment with IFN-β. The percentage of Th1 cells and Th17 cells were determined by flow cytometry in responsive and nonresponsive patients. The expression levels of miR-29b-3p and miR-326 were assessed in Th1 and Th17 cells by quantitative polymerase chain reaction (PCR). Enzyme-linked immunosorbent assay (ELISA) was applied to evaluate the plasma levels of IFN-γ and IL-17A. No significant difference was observed in the percentage of Th1 and Th17 cells as well as the expression levels of miR-29b-3p and miR-326 (in Th1 and Th17, respectively) in treated patients. Also, we did not find any significant difference in IFN-γ and IL-17A plasma concentration between responsive or non-responsive to IFN-β therapy in patients with RRMS. IFN-β may regulate other miRNAs in Th1 and Th17 cells than miR29b-3p and miR-326 in MS patients.


2002 ◽  
Vol 8 (1) ◽  
pp. 15-18 ◽  
Author(s):  
J Reeß ◽  
J Haas ◽  
K Gabriel ◽  
A Fuhlrott ◽  
M Fiola

Interferon beta-1a is an established therapy for patients with relapsing-remitting multiple sclerosis (MS). Adverse effects in the first weeks of treatment are common. This open-label, multicenter, randomized, prospective study compared treatment of flu-like symptoms (FLS) with paracetamol versus ibuprofen administered 48 h within interferon injection. The percentage of patients with FLS was comparable between both treatment groups and improved during the course of the study (baseline: paracetamol 92%, ibuprofen 90%; week 12: paracetamol 60%, ibuprofen 57%). More than 75% of patients receiving either paracetamol or ibuprofen reported no or only mild impairment of daily activities. There was no significant difference in general satisfaction or incidence of additional symptoms (weakness, nausea, headache; paracetamol 84.6% patients, ibuprofen 86.0% patients) between the two groups. A significant overall improvement from baseline to week 12 was observed for all parameters studied (paracetamol and ibuprofen groups were pooled). These results indicate that neither the paracetamol nor the ibuprofen treatment regimen is better.


2002 ◽  
Vol 8 (1_suppl) ◽  
pp. 15-18
Author(s):  
J. Reeß ◽  
J. Haas ◽  
K. Gabriel ◽  
A. Fuhlrott ◽  
M. Fiola

Interferon beta-la is an established therapy for patients with relapsing-remitting multiple sclerosis (MS). Adverse effects in the first weeks of treatment are common. This open-label, multicenter, randomized, prospective study compared treatment of flu-like symptoms (FLS) with paracetamol versus ibuprofen administered 48 h within interferon injection. The percentage of patients with FLS was comparable between both treatment groups and improved during the course of the study (baseline: paracetamol 92%, ibuprofen 90%; week 12: paracetamol 60%, ibuprofen 57%). More than 75% of patients receiving either paracetamol or ibuprofen reported no or only mild impairment of daily activities. There was no significant difference in general satisfaction or incidence of additional symptoms (weakness, nausea, headache; paracetamol 84.6% patients, ibuprofen 86.0% patients) between the two groups. A significant overall improvement from baseline to week 12 was observed for all parameters studied (paracetamol and ibuprofen groups were pooled). These results indicate that neither the paracetamol nor the ibuprofen treatment regimen is better. Multiple Sclerosis (2002) 8, 15-18


2021 ◽  
Vol 12 ◽  
pp. 204062232098312
Author(s):  
Aurora Zanghì ◽  
Emanuele D’Amico ◽  
Salvatore Lo Fermo ◽  
Francesco Patti

Aims: We aimed to examine the frequency of polypharmacy in a large cohort of patients at the time of diagnosis of relapsing–remitting multiple sclerosis (RRMS) and to explore its effects on discontinuation of first disease-modifying treatment (DMT) using survival analysis. Methods: This was a cohort ambispective single-centre study. We enrolled RRMS patients starting their first DMT between 1st January 2013 and 31st December 2015. According to the number of medicines prescribed (except DMTs), we divided the patients into three groups: no-poly RRMS, minor-poly RRMS (from one to three medications), and major-poly RRMS (more than three medications). Results: A total of 392 RRMS patients were enrolled (mean age 41.1). The minor-poly RRMS group included 61 patients (15.6%) and the major-poly RRMS group included 112 (28.6%). Individuals in these groups were older and had higher median body mass index (BMI) than patients in the no-poly RRMS group ( p < 0.05). Upon multinomial regression analysis, older age at onset was associated with minor and major polypharmacy (OR 1.050, CI 1.010–1.093, p = 0.015 and OR 1.063, CI 1.026–1.101, p = 0.001, respectively) and higher BMI was associated with major polypharmacy (OR 1.186, CI 1.18–1.29, p = 0.001). The rates of discontinuation of first DMT were similar among the three groups (50.7% for no-Poly RRMS, 50.8% for minor-Poly RRMS, and 53.3% for major-Poly RRMS, p = 0.264). At log-Rank test, there were no differences among the three groups ( p = 0.834). Conclusion: Polypharmacy was more common in older RRMS patients with high BMI.


2013 ◽  
Vol 115 ◽  
pp. S65-S69 ◽  
Author(s):  
Jelena Drulovic ◽  
Jelena Kostic ◽  
Sarlota Mesaros ◽  
Irena Dujmovic Basuroski ◽  
Nebojsa Stojsavljevic ◽  
...  

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