Real-World Evidence for Favourable Quality-of-Life Outcomes in Hungarian Patients with Relapsing-Remitting Multiple Sclerosis Treated for Two Years with Oral Teriflunomide: Results of the Teri-REAL Study

被引:5
|
作者
Bencsik, Krisztina [1 ]
Dobos, Eniko [2 ]
Jobbagy, Zita [3 ]
Birkas, Adrienne Jori [4 ]
Kovacs, Krisztina [5 ]
Satori, Maria [6 ]
Lencses, Gyula [7 ]
Bartok, Gabor [8 ]
Losonczi, Erika [8 ]
Vecsei, Laszlo [1 ]
机构
[1] Univ Szeged, Albert Szent Gyorgyi Hlth Ctr, Dept Neurol, H-6720 Szeged, Hungary
[2] Szent Imre Univ Teaching Hosp, Dept Neurol, H-1115 Budapest, Hungary
[3] Bacs Kiskun Cty Teaching Hosp, Dept Neurol, H-6300 Kecskemet, Hungary
[4] Natl Inst Clin Neurosci, Dept Neurol, H-1145 Budapest, Hungary
[5] Peterfy Hosp & Jeno Manninger Natl Inst Traumatol, Dept Neurol, H-1081 Budapest, Hungary
[6] Szent Borbala Hosp, Dept Neurol, H-2800 Tatabanya, Hungary
[7] Univ Szeged, Fac Humanities & Social Sci, Dept Sociol, H-6720 Szeged, Hungary
[8] Sanofi Aventis Zrt, H-1045 Budapest, Hungary
关键词
teriflunomide; multiple sclerosis; quality-of-life; cognition; fatigue; efficacy; real-world study; disability; INTERNATIONAL COGNITIVE ASSESSMENT; SUBCUTANEOUS INTERFERON BETA-1A; REPORTED OUTCOMES; DISEASE STEPS; FATIGUE; VALIDATION; INDIVIDUALS; IMPAIRMENT; IMPACT;
D O I
10.3390/ph15050598
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
Relapsing-remitting multiple sclerosis (RRMS) is a degenerative, inflammatory disease of the central nervous system in which symptoms and disability progression vary significantly among patients. Teri-REAL was a prospective, real-world observational study that examined quality-of-life (QoL) and treatment outcomes in a Hungarian cohort of RRMS patients treated with once-daily oral teriflunomide. QoL was assessed at baseline, 12, and 24 months with the Multiple Sclerosis Quality of Life-54 (MSQoL-54) questionnaire. Other measurements included disease progression (Patient Determined Disease Steps [PDDS]), clinical efficacy (relapses), fatigue (Fatigue Impact Scale [FIS]), depression (Beck Depression Inventory [BDI]), cognition (Brief International Cognitive Assessment in MS [BICAMS]), persistence and safety. 212 patients were enrolled (69.1% female, 50.5% treatment naive), with 146 (69%) completing the study. Statistically significant improvements in subscales of the MSQoL-54 versus baseline were found at Month 12 and Month 24. Significant improvements were also observed for individual components of the BICAMS score at 24 months, while PDDS, FIS and BDI scores remained stable. The mean annualised relapse rate was 0.08 +/- 0.32. There were 93 safety events, most of which were mild to moderate. Improved QoL and cognitive outcomes in teriflunomide-treated patients over 2 years offer a unique perspective to this real-world study.
引用
收藏
页数:15
相关论文
共 50 条
  • [21] Effect of alemtuzumab on fatigue, quality of life, and patient/ caregiver-reported outcomes in relapsing-remitting multiple sclerosis-A real-world evidence study
    Frederiksen, Jette Lautrup
    Massacesi, Luca
    Nielsen, Helle Hvilsted
    Rini, Augusto
    Baldi, Eleonora
    Mirabella, Massimiliano
    Antonella, Falzone Francesca Maria
    Lush, Giacomo
    Paolicelli, Damiano
    Kant, Matthias
    Salemi, Giuseppe
    Aguglia, Umberto
    Comi, Cristoforo
    De Riz, Milena
    Barcella, Valeria
    Flemmen, Heidi o.
    Protti, Alessandra
    Farbu, Elisabeth
    van Exel, Job
    Torkildsen, Oivind
    MULTIPLE SCLEROSIS AND RELATED DISORDERS, 2025, 93
  • [22] Impact of Alemtuzumab on Fatigue, Quality of Life, and Patient/Caregiver Reported Outcomes in Relapsing-Remitting Multiple Sclerosis: Findings from a Real-World Evidence Study
    Frederiksen, Jette
    Massaceci, Luca
    Nielsen, Helle
    Rini, Augusto
    Baldi, Eleonora
    Mirabella, Massimiliano
    Antonella, Falzone
    Lus, Giacomo
    Paumicella, Daimao
    Kant, Mathias
    Salemi, Guiseppe
    Aguglia, Umberto
    Comi, Cristoforo
    De Riz, Milena
    Barcella, Valeria
    Flemmen, Heidi
    Protti, Allessandra
    Farbu, Elisabeth
    Ruiters, Daimy
    Torkildsen, Oivind
    MULTIPLE SCLEROSIS JOURNAL, 2024, 30 (03) : 1092 - 1093
  • [23] Effectiveness of fingolimod in real-world relapsing-remitting multiple sclerosis Italian patients: the GENIUS study
    Comi, Giancarlo
    Pozzilli, Carlo
    Morra, Vincenzo Brescia
    Bertolotto, Antonio
    Sangalli, Francesca
    Prosperini, Luca
    Carotenuto, Antonio
    Iaffaldano, Pietro
    Capobianco, Marco
    Colombo, Delia
    Nica, Mihaela
    Rizzoli, Sara
    Trojano, Maria
    NEUROLOGICAL SCIENCES, 2020, 41 (10) : 2843 - 2851
  • [24] Effectiveness of fingolimod in real-world relapsing-remitting multiple sclerosis Italian patients: the GENIUS study
    Giancarlo Comi
    Carlo Pozzilli
    Vincenzo Brescia Morra
    Antonio Bertolotto
    Francesca Sangalli
    Luca Prosperini
    Antonio Carotenuto
    Pietro Iaffaldano
    Marco Capobianco
    Delia Colombo
    Mihaela Nica
    Sara Rizzoli
    Maria Trojano
    Neurological Sciences, 2020, 41 : 2843 - 2851
  • [25] Effect of teriflunomide on Epstein-Barr virus shedding in relapsing-remitting multiple sclerosis patients: Outcomes from a real-world pilot cohort study
    Gold, Julian
    Holden, David
    Parratt, John
    Yiannikas, Con
    Ahmad, Raghib
    Sedhom, Mamdouh
    Giovannoni, Gavin
    MULTIPLE SCLEROSIS AND RELATED DISORDERS, 2022, 68
  • [26] The real-world effectiveness and safety of fingolimod in relapsing-remitting multiple sclerosis patients: An observational study
    Izquierdo, Guillermo
    Damas, Fatima
    Dolores Paramo, Maria
    Luis Ruiz-Pena, Juan
    Navarro, Guillermo
    PLOS ONE, 2017, 12 (04):
  • [27] Effect of teriflunomide on Epstein-Barr virus shedding in relapsing-remitting multiple sclerosis patients: Outcomes from a real-world pilot cohort study
    Gold, Julian
    Holden, David
    Parratt, John
    Yiannikas, Con
    Ahmad, Raghib
    Sedhom, Mamdouh
    Giovannoni, Gavin
    MULTIPLE SCLEROSIS AND RELATED DISORDERS, 2022, 68
  • [28] Real-world effectiveness of fingolimod in Polish group of patients with relapsing-remitting multiple sclerosis
    Walczak, A.
    Kurkowska-Jastrzebska, I.
    Zakrzewska-Pniewska, B.
    Dorobek, M.
    Brola, W.
    Zajdel, R.
    Bartosik-Psujek, H.
    Kulakowska, A.
    Rusek, S.
    Tutaj, A.
    Glabinski, A.
    Wlodek, A.
    Kochanowski, J.
    Stepien, A.
    MULTIPLE SCLEROSIS JOURNAL, 2019, 25 : 328 - 328
  • [29] Real-world effectiveness of fingolimod in Polish group of patients with relapsing-remitting multiple sclerosis
    Walczak, Agata
    Kurkowska-Jastrzebska, Iwona
    Zakrzewska-Pniewska, Beata
    Dorobek, Malgorzata
    Brola, Waldemar
    Zajdel, Radoslaw
    Bartosik-Psujek, Halina
    Stasiolek, Mariusz
    Kulakowska, Alma
    Rusek, Stanislaw
    Tutaj, Andrzej
    Glabinski, Andrzej
    Wlodek, Agata
    Kochanowski, Jan
    Ciach, Agnieszka
    Siger, Malgorzata
    Kurowska, Katarzyna
    Wicha, Wojciech
    Nojszewska, Monika
    Podlecka-Pietowska, Aleksandra
    Czajka, Anna
    Kapica-Topczewska, Katarzyna
    Bielecki, Bartosz
    Maciagowska-Terela, Marzena
    Stepien, Adam
    CLINICAL NEUROLOGY AND NEUROSURGERY, 2019, 184
  • [30] Real-world disability improvement in patients with relapsing-remitting multiple sclerosis treated with natalizumab in the Tysabri Observational Program
    Wiendl, Heinz
    Spelman, Tim
    Butzkueven, Helmut
    Kappos, Ludwig
    Trojan, Maria
    Su, Ray
    Campbell, Nolan
    Ho, Pei-Ran
    Licata, Stephanie
    MULTIPLE SCLEROSIS JOURNAL, 2021, 27 (05) : 719 - 728