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1.
001-es BibID:
BIBFORM103020
035-os BibID:
(cikkazonosító)e0267346 (Wos)000792887700036 (Scopus)85128608221
Első szerző:
Biernacki Tamás
Cím:
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 / Biernacki Tamás, Sandi Dániel, Füvesi Judit, Fricska-Nagy Zsanett, Kincses Tamás Zsigmond, Ács Péter, Rózsa Csilla, Dobos Enikő, Cseh Botond, Horváth László, Nagy Zsuzsanna, Csányi Attila, Kovács Krisztina, Csépány Tünde, Vécsei László, Bencsik Krisztina, Study investigators
Dátum:
2022
ISSN:
1932-6203
Megjegyzések:
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.
Tárgyszavak:
Orvostudományok
Klinikai orvostudományok
idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:
Plos One. - 17 : 4 (2022), p. 1-21. -
További szerzők:
Sandi Dániel
Füvesi Judit
Fricska-Nagy Zsanett
Kincses Zsigmond Tamás
Ács Péter
Rózsa Csilla
Dobos Enikő
Cseh Botond
Horváth László
Nagy Zsuzsanna
Csányi Attila
Kovács Krisztina
Csépány Tünde (1956-) (neurológus, pszichiáter)
Vécsei László (1954-) (neurológus)
Bencsik Krisztina
Study investigators
Internet cím:
Szerző által megadott URL
DOI
Intézményi repozitóriumban (DEA) tárolt változat
Borító:
Saját polcon:
2.
001-es BibID:
BIBFORM103016
035-os BibID:
(cikkazonosító)e0264328 (Scopus)85125687513 (Wos)000776002200027
Első szerző:
Kokas Zsófia
Cím:
Do Hungarian multiple sclerosis care units fulfil international criteria? / Kokas Zsófia, Sandi Dániel, Fricska-Nagy Zsanett, Füvesi Judit, Biernacki Tamás, Köves Ágnes, Fazekas Ferenc, Birkás Adrienne Jóri, Katona Gabriella, Kovács Krisztina, Milanovich Dániel, Dobos Enikő, Kapás István, Jakab Gábor, Csépány Tünde, Bense Erzsébet, Mátyás Klotild, Rum Gábor, Szolnoki Zoltán, Deme István, Jobbágy Zita, Kriston Dávid, Gerócs Zsuzsanna, Diószeghy Péter, Bors László, Varga Adrián, Kerényi Levente, Molnár Gabriella, Kristóf Piroska, Nagy Zsuzsanna Ágnes, Sátori Mária, Imre Piroska, Péntek Szilvia, Klivényi Péter, Kincses Zsigmond Tamás, Vécsei László, Bencsik Krisztina
Dátum:
2022
ISSN:
1932-6203
Megjegyzések:
A patients Because of the past 3 decades' extensive research, several disease modifying therapies became available, thus a paradigm change is multiple sclerosis care was necessary. In 2018 a therapeutic guideline was created recommending that treatment of persons with multiple sclerosis should take place in specified care units where the entire spectrum of disease modifying therapies is available, patient monitoring is ensured, and therapy side effects are detected and treated promptly. In 2019 multiple sclerosis care unit criteria were developed, emphasizing personnel and instrumental requirements to provide most professional care. However, no survey was conducted assessing the real-world adaptation of these criteria. Objective To assess whether Hungarian care units fulfil international criteria. Methods A self-report questionnaire was assembled based on international guidelines and sent to Hungarian care units focusing on 3 main aspects: personnel and instrumental background, disease-modifying therapy use, number of people living with multiple sclerosis receiving care in care units. Data on number of persons with multiple sclerosis were compared to Hungarian prevalence estimates. Descriptive statistics were used to analyse data. Results Out of 27 respondent care units, 3 fulfilled minimum requirements and 7 fulfilled minimum and recommended requirements. The least prevalent neighbouring specialties were spasticity and pain specialist, and neuro-ophthalmologist and oto-neurologist. Only 15 centres used all available disease modifying therapies. A total number of 7213 people with multiple sclerosis received care in 27 respondent centres. Compared to prevalence estimates, 2500 persons with multiple sclerosis did not receive multiple sclerosis specific care in Hungary. Conclusion Less than half of Hungarian care units provided sufficient care for people living with multiple sclerosis. Care units employing fewer neighbouring specialties, might have difficulties diagnosing and providing appropriate care for persons with multiple sclerosis, especially for people with progressive disease course, contributing to the reported low number of persons living with multiple sclerosis.
Tárgyszavak:
Orvostudományok
Klinikai orvostudományok
idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:
Plos One. - 17 : 3 (2022), p. 1-15. -
További szerzők:
Sandi Dániel
Fricska-Nagy Zsanett
Füvesi Judit
Biernacki Tamás
Köves Ágnes
Fazakas Ferenc (1969-) (molekuláris biológus)
Birkás Adrienne Jóri
Katona Gabriella
Kovács Krisztina
Milanovich Dániel
Dobos Enikő
Kapás István (1965-) (neurológus, pszichiáter)
Jakab Gábor
Csépány Tünde (1956-) (neurológus, pszichiáter)
Bense Erzsébet
Mátyás Klotild
Rum Gábor
Szolnoki Zoltán
Deme István
Jobbágy Zita
Kriston Dávid
Gerócs Zsuzsanna
Diószeghy Péter (1948-) (ideg- és elmeszakorvos)
Bors László (Neurológus, Pécs)
Varga Adrián
Kerényi Levente
Molnár Gabriella
Kristóf Piroska
Nagy Zsuzsanna Ágnes
Sátori Mária
Imre Piroska
Péntek Szilvia
Klivényi Péter
Kincses Zsigmond Tamás
Vécsei László (1954-) (neurológus)
Bencsik Krisztina
Internet cím:
Szerző által megadott URL
DOI
Intézményi repozitóriumban (DEA) tárolt változat
Borító:
Saját polcon:
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