Real-world effectiveness of dimethyl fumarate versus fingolimod in a cohort of patients with multiple sclerosis using standardized, quantitative outcome metrics

Hersh, Carrie M.; Altincatal, Arman; Belviso, Nicholas; Kapadia, Shivani; Moor, Carl de; Rudick, Richard A.; Williams, James R.; Miller, Catherine; Koulinska, Irene

doi:10.1177/20552173211069852

Cited by 4 publications

(11 citation statements)

References 41 publications

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“…Some of them were conducted solely in a single centre [30,[39][40][41][42][43], some of them were posthoc analyses of the pivotal studies [44][45][46], some used a relatively small cohort [30,39,40,43,47,48]. Meanwhile, others have focused only on a single objective [49][50]; except a few studies [51,52], the follow-up period was surprisingly brief [43,[53][54][55] in several reports. Furthermore, some studies employed patients with both progressive and relapsing-remitting disease type [37].…”

Section: Discussionmentioning

confidence: 99%

The safety and efficacy of fingolimod: Real-world data from a long-term, non-interventional study on the treatment of RRMS patients spanning up to 5 years from Hungary

et al. 2022

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Background Fingolimod was approved and reimbursed by the healthcare provider in Hungary for the treatment of highly active relapsing-remitting multiple sclerosis (RRMS) in 2012. The present study aimed to assess the effectiveness, safety profile, and persistence to fingolimod in a real-life setting in Hungary in RRMS patients who were either therapy naïve before enrollment or have changed to fingolimod from another disease-modifying therapy (DMT) for any reason. Methods This cross-sectional, observational study with prospective data collection was performed nationwide at 21 sites across Hungary. To avoid selection bias, sites were asked to document eligible patients in consecutive chronological order. Demographic, clinical, safety and efficacy data were analysed for up to 5 years from 570 consenting adult patients with RRMS who had received treatment with fingolimod for at least one year. Results 69.6% of patients remained free from relapses for the whole study duration; in the first year, 85.1% of patients did not experience a relapse, which rose to 94.6% seen in the 5th year. Compared to baseline at study end, 28.2% had higher, and 9.1% had lower, meanwhile, 62.7% of the patients had stable EDSS scores. Overall, the annualized relapse rate decreased from 0.804 observed at baseline to 0.185, 0.149, 0.122, 0.091, and 0.097 (77.0%, 82.1%, 85.2%, 89.7%, and 89.0% relative reduction, respectively) after 1, 2, 3, 4, and 5 years of treatment. The greatest reduction rate was seen in the group of therapy naïve patients. Treatment persistence on fingolimod after 60 months was 73.4%. Conclusion In this nationwide Hungarian cohort, most patients under fingolimod treatment were free from relapses and disability progression. In addition, fingolimod has proven to be a well-tolerated DMT that has sustained its manageable safety profile, high efficacy, and positive benefit/risk ratio for up to 5 years in a real-life setting.

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Section: Discussionmentioning

confidence: 99%

The safety and efficacy of fingolimod: Real-world data from a long-term, non-interventional study on the treatment of RRMS patients spanning up to 5 years from Hungary

et al. 2022

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“…Four studies reported a better performance of S1P modulators compared to an injectable DMT (two studies with IFN; one with GA; and one with both IFN and GA) [39,43,46,50]. Other DMTs were used as comparisons such as Natalizumab (NTZ) (three studies) [41,47,56], Alemtuzumab (ATZ) (one study) [56], DMF (two studies) [56,57], and TFL (two studies) [45,56]. In these studies, no significant differences were found with these DMTs, with the exception of the study by Glasmacher et al [56] where TFL and DMF were associated with significant worsening over time in cognitive assessment scores compared to FTY and CLAD.…”

Section: Sphingosinte-1-phosphate Modulatorsmentioning

confidence: 99%

“…Only two studies include data on neurofilaments (sNFL) [54,57]. In one of these studies, higher levels of sNFLs correlated with greater CI and BVL, and patients treated with S1P modulators had a significant reduction in sNFL levels compared to placebo [54].…”

Section: Sphingosinte-1-phosphate Modulatorsmentioning

confidence: 99%

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Current Status of Oral Disease-Modifying Treatment Effects on Cognitive Outcomes in Multiple Sclerosis: A Scoping Review

2023

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Introduction. Cognitive impairment represents one of the most hidden and disabling clinical aspects of multiple sclerosis (MS). In this regard, the major challenges are represented by the need for a comprehensive and standardised cognitive evaluation of each patient, both at disease onset and during follow-up, and by the lack of clear-cut data on the effects of treatments. In the present review, we summarize the current evidence on the effects of the available oral disease-modifying treatments (DMTs) on cognitive outcome measures. Materials and Methods. In this systematised review, we extract all the studies that reported longitudinally acquired cognitive outcome data on oral DMTs in MS patients. Results. We found 29 studies that evaluated at least one oral DMT, including observational studies, randomised controlled trials, and their extension studies. Most of the studies (n = 20) evaluated sphingosine-1-phosphate (S1P) modulators, while we found seven studies on dimethyl fumarate, six on teriflunomide, and one on cladribine. The most frequently used cognitive outcome measures were SDMT and PASAT. Most of the studies reported substantial stability or mild improvement in cognitive outcomes in a short-time follow-up (duration of most studies ≤2 years). A few studies also reported MRI measures of brain atrophy. Conclusion. Cognitive outcomes were evaluated only in a minority of prospective studies on oral DMTs in MS patients with variable findings. More solid and numerous data are present for the S1P modulators. A standardised cognitive evaluation remains a yet unmet need to better clarify the possible positive effect of oral DMTs on cognition.

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“…The eligibility criteria were as follows: patients enrolled in the Multiple Sclerosis Partners Advancing Technology and Health Solutions network and had follow-ups in the network for more than one year. In the overall cohort, there was no significant difference noted in the neuro performance or MRI outcomes, including the brain volume loss between DMF (702 patients) and FTY (600 patients) groups [ 22 ].…”

Section: Reviewmentioning

confidence: 99%

Comparison of Pharmacological Therapies in Relapse Rates in Patients With Relapsing-Remitting Multiple Sclerosis

Etta,

Elballushi,

Kolesnyk

et al. 2023

Cureus

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Multiple sclerosis (MS) is a chronic autoimmune neurological disorder that significantly impacts the central nervous system (CNS), which includes the brain and spinal cord. Approximately 2.8 million individuals are believed to be living with MS worldwide. The management of MS has evolved considerably over the years, offering a multitude of guidelines, diverse treatment options, and different approaches to signs and symptoms. The present systematic literature review serves as a comprehensive analysis of the current therapeutic options for MS. It provides a thorough literature review of Food and Drug Administration (FDA)-approved drugs comparing their various clinical end points while concurrently assessing their risk-benefit ratio. It also provides an extensive review of current guidelines and offers an in-depth examination of the different approaches to MS. Through this multifaceted approach, this paper facilitates easy access to available treatment options and aims to aid healthcare providers in decision-making as well as providing a foundation for future research aimed at enhancing treatment options for MS.

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Real-world effectiveness of dimethyl fumarate versus fingolimod in a cohort of patients with multiple sclerosis using standardized, quantitative outcome metrics

Cited by 4 publications

References 41 publications

The safety and efficacy of fingolimod: Real-world data from a long-term, non-interventional study on the treatment of RRMS patients spanning up to 5 years from Hungary

The safety and efficacy of fingolimod: Real-world data from a long-term, non-interventional study on the treatment of RRMS patients spanning up to 5 years from Hungary

Current Status of Oral Disease-Modifying Treatment Effects on Cognitive Outcomes in Multiple Sclerosis: A Scoping Review

Comparison of Pharmacological Therapies in Relapse Rates in Patients With Relapsing-Remitting Multiple Sclerosis

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