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 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...
Elmentve itt :
| Szerzők: | |
|---|---|
| Dokumentumtípus: | Cikk |
| Megjelent: |
2022
|
| Sorozat: | PLOS ONE
17 No. 4 |
| Tárgyszavak: | |
| doi: | 10.1371/journal.pone.0267346 |
| mtmt: | 32791478 |
| Online Access: | http://publicatio.bibl.u-szeged.hu/24472 |
| LEADER | 03587nab a2200481 i 4500 | ||
|---|---|---|---|
| 001 | publ24472 | ||
| 005 | 20221015145207.0 | ||
| 008 | 220602s2022 hu o 0|| Angol d | ||
| 022 | |a 1932-6203 | ||
| 024 | 7 | |a 10.1371/journal.pone.0267346 |2 doi | |
| 024 | 7 | |a 32791478 |2 mtmt | |
| 040 | |a SZTE Publicatio Repozitórium |b hun | ||
| 041 | |a Angol | ||
| 100 | 1 | |a Biernacki Tamás | |
| 245 | 1 | 4 | |a The safety and efficacy of fingolimod |h [elektronikus dokumentum] : |b Real-world data from a long-term, non-interventional study on the treatment of RRMS patients spanning up to 5 years from Hungary / |c Biernacki Tamás |
| 260 | |c 2022 | ||
| 300 | |a 21 | ||
| 490 | 0 | |a PLOS ONE |v 17 No. 4 | |
| 520 | 3 | |a 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.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.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%.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. | |
| 650 | 4 | |a Általános orvostudomány | |
| 650 | 4 | |a Klinikai orvostan | |
| 700 | 0 | 1 | |a Sandi Dániel |e aut |
| 700 | 0 | 1 | |a Füvesi Judit |e aut |
| 700 | 0 | 2 | |a Fricska-Nagy Zsanett |e aut |
| 700 | 0 | 2 | |a Kincses Zsigmond Tamás |e aut |
| 700 | 0 | 2 | |a Ács Péter |e aut |
| 700 | 0 | 2 | |a Rózsa Csilla |e aut |
| 700 | 0 | 2 | |a Dobos Enikő |e aut |
| 700 | 0 | 2 | |a Cseh Botond |e aut |
| 700 | 0 | 2 | |a Horváth László |e aut |
| 700 | 0 | 2 | |a Nagy Zsuzsanna |e aut |
| 700 | 0 | 2 | |a Csányi Attila |e aut |
| 700 | 0 | 2 | |a Kovács Krisztina |e aut |
| 700 | 0 | 2 | |a Csépány Tünde |e aut |
| 700 | 0 | 2 | |a Vécsei László |e aut |
| 700 | 0 | 2 | |a Bencsik Krisztina |e aut |
| 700 | 0 | 2 | |a Sandi Dániel |e aut |
| 700 | 0 | 2 | |a Füvesi Judit |e aut |
| 700 | 0 | 2 | |a Bencsik Krisztina |e aut |
| 700 | 0 | 2 | |a Biernacki Tamás |e aut |
| 700 | 0 | 2 | |a Kincses Zsigmond Tamás |e aut |
| 700 | 0 | 2 | |a Fricska-Nagy Zsanett |e aut |
| 856 | 4 | 0 | |u http://publicatio.bibl.u-szeged.hu/24472/1/32791478Biernacki-2022-The-safety-and-efficacy-of-fingolim.pdf |z Dokumentum-elérés |