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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.
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页数:15
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