Real-world effectiveness of fingolimod in Polish group of patients with relapsing-remitting multiple sclerosis

Walczak, Agata; Kurkowska‐Jastrzębska, Iwona; Zakrzewska-Pniewska, Beata; Brola, Waldemar; Zajdel, Radosław; Bartosik-Psujek, Halina; Stasiołek, Mariusz; Kułakowska, Alina; Rusek, Stanislaw; Tutaj, Andrzej; Głąbiński, Andrzej; Włodek, Agata; Kochanowski, Jan; Ciach, Agnieszka; Siger, Małgorzata; Kurowska, Katarzyna; Wicha, W.; Nojszewska, Monika; Podlecka-Piętowska, Aleksandra; Czajka, Anna; Kapica-Topczewska, Katarzyna; Bielecki, Bartosz; Maciągowska-Terela, Marzena; Stępień, Adam

doi:10.1016/j.clineuro.2019.105453

Cited by 5 publications

(9 citation statements)

References 18 publications

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“…Studies are emerging with longer follow-up time, however [52]. The most informative, recently published studies supplying real-world information about the efficacy of fingolimod with at least 3 years of treatment come from Poland [32], Spain [37], Germany [57] and Turkey [52]. In our cohort, fingolimod was capable of reducing the incidence of relapses by up to 90% already from after the first year of treatment.…”

Section: Discussionmentioning

confidence: 79%

“…Studies assessing the demographic and clinical profile, quality of life, and disease activity of patients receiving fingolimod at the same time in a reallife clinical setting are even scarcer. Furthermore, apart from a select few [32,37,38], most of the studies examining fingolimod in a real-world practice published so far are heterogeneous in terms of the methodologies and/or the cohorts used. 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].…”

Section: Discussionmentioning

confidence: 99%

“…Real-life studies also frequently employ patient-reported outcomes (PROs), which can provide a glimpse into the everyday life of the patients and reveal the influence of the administered treatment on it, aspects which otherwise would be left unrecognised [21][22][23][24]. In recent years several long-term observational studies assessed the sustained efficacy of fingolimod, but excluding very few exceptions, many of these trials were either conducted on the patients participating in the pivotal trials (extension studies and various post hoc analyses), or have included only a relatively small amount of patients, and/or followed the patients only for a brief period [25][26][27][28][29][30][31][32][33][34].…”

Section: Introductionmentioning

confidence: 99%

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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: 79%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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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“…In multicenter studies, variable cohort number of cases and fingolimod exposure time were reported. The following are examples of data on countries, case numbers and follow-up periods from a selection of studies: UK 209, 12 months; Poland 253, 42 months; Germany 4229, 7 years; Spain 804, 26.4 months; Italy 414, 22.7 months; Hungary 570, up to 5 years; Czech Republic 237, 3.5 years [6][7][8][9][10][11][12][13]. In our country, there are multicenter studies evaluating the 5-year effect on cognition, comparing natalizumab (NTZ) and ocrelizumab treatment in the first and second year, and reporting two-year efficacy and safety results [14][15][16].…”

Section: Discussionmentioning

confidence: 99%

“…Their average usage time was 48.97±32.1 (5-189) months. The mean total number of attacks was 2.64±1.32 (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12), and the number of attacks was 1.33±0.92(0-5) when using DMT at the last use (at least six months). The ARR was 0.61±0.50 (0.11-3), and the ARR in the latest DMT was 0.47±0.48 (0-2.4).…”

Section: Population and Pre-fingolimod Datamentioning

confidence: 99%

Fingolimod real life experience in non-naive multiple sclerosis patients

Sarıdaş,

Koç,

Özkaya

et al. 2024

The European Research Journal

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Objectives: Fingolimod is approved in Turkey or the treatment of cases of multiple sclerosis (MS) which cannot be controlled with first-line treatments. There is limited information about its efficacy and safety in clinical practice in Turkey. The aim of this study was to evaluate the efficacy and safety of fingolimod treatment in patients with relapsing-remitting multiple sclerosis who were prescribed fingolimod by the Multiple Sclerosis specialists of Bursa Uludağ University Department of Neurology. Methods: This is a single-center observational study evaluating 142 patients using fingolimod who were followed up for at least 12 months in our center between April 2015 and October 2022. Efficacy results were evaluated in terms of mean number of attacks, annualized relapse rate, relapse-free patient rate, disease progression, clinical and radiological disease activity, and no evidence of disease activity (NEDA-3). The safety outcomes are the rates of treatment-related severe adverse events and patients' continuation rates. Results: Over 12 months of treatment with fingolimod, the average number of attacks decreased by 94.6%, the annual relapse rate decreased by 87%, and most patients did not relapse (83.1%). Alongside this, in 76.4% of cases, there was no disability progression and in 83.3% of cases, magnetic resonance imaging (MRI) activation was not observed. Excluding replacement due to ineffectiveness, 89.4% of patients continued fingolimod therapy. Cardiac events, treatment-related infections and a decreased lymphocyte count were observed as side effects. Conclusion: In our center, switching from first-line treatments to fingolimod was effective in reducing disease activity in patients with multiple sclerosis.

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Early use of fingolimod is associated with better clinical outcomes in relapsing–remitting multiple sclerosis patients

et al. 2022

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Real-world effectiveness of fingolimod in Polish group of patients with relapsing-remitting multiple sclerosis

Cited by 5 publications

References 18 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

Fingolimod real life experience in non-naive multiple sclerosis patients

Early use of fingolimod is associated with better clinical outcomes in relapsing–remitting multiple sclerosis patients

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