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

Pharmaceuticals

on behalf of the Teri-REAL Investigators¹  Krisztina Bencsik²  László Vécsei²  Zita Jobbágy³  Adrienne Jóri Birkás⁴  Krisztina Kovács⁵  Mária Sátori⁶  Enikő Dobos⁷  Gyula Lencsés⁸  Gabor Bartok⁹  Erika Losonczi⁹ 

[1] ;Department of Neurology, Albert Szent-Györgyi Health Centre, University of Szeged, 6720 Szeged, Hungary;Department of Neurology, Bács-Kiskun County Teaching Hospital, 6300 Kecskemét, Hungary;Department of Neurology, National Institute of Clinical Neurosciences, 1145 Budapest, Hungary;Department of Neurology, Péterfy Hospital and Jenő Manninger National Institute of Traumatology, 1081 Budapest, Hungary;Department of Neurology, Szent Borbála Hospital, 2800 Tatabánya, Hungary;Department of Neurology, Szent Imre University Teaching Hospital, 1115 Budapest, Hungary;Department of Sociology, Faculty of Humanities and Social Sciences, University of Szeged, 6720 Szeged, Hungary;Sanofi-Aventis Zrt., 1045 Budapest, Hungary;

关键词: teriflunomide;    multiple sclerosis;    quality-of-life;    cognition;    fatigue;    efficacy;   

DOI  :  10.3390/ph15050598

来源: DOAJ

【 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 naïve), 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.

【 授权许可】

Unknown