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. 2022 May 13;15(5):598.
doi: 10.3390/ph15050598.

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

Krisztina Bencsik  1 , Enikő Dobos  2 , Zita Jobbágy  3 , Adrienne Jóri Birkás  4 , Krisztina Kovács  5 , Mária Sátori  6 , Gyula Lencsés  7 , Gabor Bartok  8 , Erika Losonczi  8 , László Vécsei  1 , On Behalf Of The Teri-Real Investigators
Affiliations

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

Krisztina Bencsik et al. Pharmaceuticals (Basel). .

Abstract

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.

Keywords: cognition; disability; efficacy; fatigue; multiple sclerosis; quality-of-life; real-world study; teriflunomide.

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Conflict of interest statement

K.B.: Consulting, principal investigator and/or speaking fees (Biogen, Novartis, Sanofi, Merck, Teva, Roche). E.D.: Consulting and principal investigator (Roche, Merck, Novartis, Teva, Sanofi, Actelion, AbbVie). Z.J.: Consulting, principal investigator, and speaker honoraria (Biogen, Roche, Novartis, Sanofi, Teva, Merck). A.J.B.: Consulting and principal investigator (Biogen, Novartis, Sanofi, Merck). K.K.: Consulting and principal investigator (Novartis, Sanofi). M.S.: Consulting, principal investigator and/or speaking fees (Bayer, Biogen Idec, BMS, Receptos, Celgene, EMD Serono, Genentech/Roche, Novartis, Sanofi, Teva, Sun Pharma, Actelion and TG Therapeutics). G.L.: Nothing to declare. G.B. and E.L.: Employees of Sanofi. May hold shares and/or stock options in the company. L.V.: Consulting, principal investigator and speaking fees (Biogen, Genentech/Roche, Merck, Novartis, Sanofi, Teva).

Figures

Figure 1
Figure 1
Patient enrolment and outcomes in Teri-REAL.
Figure 2
Figure 2
MSQoL-54 scores at Month 12 (A) and Month 24 (B) compared with baseline. Graphed values show mean ± SEM for each component of the MSQoL-54 test. Statistically significant outcomes from paired sample t-test results at 12 months (A) and 24 months (B) versus baseline are shown. SEM: standard error of the mean.
Figure 2
Figure 2
MSQoL-54 scores at Month 12 (A) and Month 24 (B) compared with baseline. Graphed values show mean ± SEM for each component of the MSQoL-54 test. Statistically significant outcomes from paired sample t-test results at 12 months (A) and 24 months (B) versus baseline are shown. SEM: standard error of the mean.
Figure 3
Figure 3
Percentages of patients at each PDDS level from baseline to 2 years.
See this image and copyright information in PMC

References

    1. Multiple Sclerosis International Federation . Atlas of MS. 3rd ed. Multiple Sclerosis International Federation; London, UK: 2020. pp. 1–37.
    1. Giovannoni G., Butzkueven H., Dhib-Jalbut S., Hobart J., Kobelt G., Pepper G., Sormani M.P., Thalheim C., Traboulsee A., Vollmer T. Brain health: Time matters in multiple sclerosis. Mult. Scler. Relat. Disord. 2016;9:S5–S48. doi: 10.1016/j.msard.2016.07.003. - DOI - PubMed
    1. Benedict R.H., Wahlig E., Bakshi R., Fishman I., Munschauer F., Zivadinov R., Weinstock-Guttman B. Predicting quality of life in multiple sclerosis: Accounting for physical disability, fatigue, cognition, mood disorder, personality, and behavior change. J. Neurol. Sci. 2005;231:29–34. doi: 10.1016/j.jns.2004.12.009. - DOI - PubMed
    1. Mitchell A.J., Benito-León J., González J.M.M., Rivera-Navarro J. Quality of life and its assessment in multiple sclerosis: Integrating physical and psychological components of wellbeing. Lancet Neurol. 2005;4:556–566. doi: 10.1016/S1474-4422(05)70166-6. - DOI - PubMed
    1. Hoogs M., Kaur S., Smerbeck A., Weinstock-Guttman B., Benedict R.H.B. Cognition and Physical Disability in Predicting Health-Related Quality of Life in Multiple Sclerosis. Int. J. MS Care. 2011;13:57–63. doi: 10.7224/1537-2073-13.2.57. - DOI - PMC - PubMed

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