A comparison of efficacy of subcutaneous interferon β-1a 44 μg, dimethyl fumarate and fingolimod in the real-life clinical practise – a multicenter observational study
Authors:
Z. Pavelek 1; L. Sobíšek 2,3; D. Horáková 4; M. Vališ 1
Authors‘ workplace:
Neurologická klinika LF UK a FN Hradec Králové
1; Nadační fond IMPULS, Praha
2; Katedra statistiky a pravděpodobnosti, Vysoká škola ekonomická v Praze
3; Neurologická klinika a Centrum klinických neurověd 1. LF UK a VFN v Praze
4
Published in:
Cesk Slov Neurol N 2018; 81(4): 457-465
Category:
Original Paper
doi:
https://doi.org/10.14735/amcsnn2018457
Overview
Introduction:
Multiple sclerosis is a chronic inflammatory demyelinating and neurodegenerative disease affecting the CNS. Interferon (IFN) β-1a 44 μg, dimethyl fumarate (DMF) and fingolimod are established medications for the treatment of relapsing-remitting MS (RR MS). The aim of the project (analysis from registry ReMuS) was a comparison of the efficacy of IFN β-1a 44 μg, DMF and fingolimod in patients with RR MS in real world evidence in the Czech Republic. This treatment was started within 90 days after relapse.
Patients and methods:
A total of 279 patients with RR MS who experienced one relapse during the first line treatment (IFN β-1a 22 μg given 3× weekly, IFN β-1a 30 μg given 1× weekly, IFN β-1b 250 μg given each other day, teriflunomid 14 mg given daily, glatiramer acetate 20mg given daily or glatiramer acetate given 40mg given 3× weekly) and who were switched to the treatment with IFN β-1a 44 μg, DMF or fingolimod were included into the study. The observed parameters were annualized relapse rate (ARR), time to next relapse, proportion of relapse free patients and change in Expanded Disability Status Scale (EDSS) at 1-year after treatment.
Results:
We found out significant improvement in observed outcomes during 1-year observation after treatment change in all particular medications. Comparison of IFN β-1a 44 μg group (83 patients) vs. DMF or fingolimod group (196 patients) showed more significant improvement in observed parameters (ARR and change of EDSS) in DMF or fingolimod group. When we used propensity score matching method (83 patients from IFN β-1a 44 μg group vs. 83 patients from DMF or fingolimod group), the sustained improvement in observed parameters has persisted before and after change of treatment in both groups but no significant differences were observed between groups.
Conclusion:
IFN β-1a 44 μg, DMF and fingolimod proved the effectivness in escalation of treatment in the selected group of patients in observed parameters – change of EDSS and time to next relapse).
Key words:
multiple sclerosis – interferon β-1a 44 μg – dimethyl fumarate – fingolimod
The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study.
The Editorial Board declares that the manuscript met the ICMJE “uniform requirements” for biomedical papers.
Sources
1. Lu G, Beadnall HN, Barton J et al. The evolution of „No Evidence of Disease Activity“ in multiple sclerosis. Mult Scler Relat Disord 2018; 20: 231– 238. doi: 10.1016/ j.msard.2017.12.016.
2. Parks NE, Flanagan EP, Lucchinetti CF et al. NEDA treatment target? No evident disease activity as an actionable outcome in practice. J Neurol Sci 2017; 383: 31– 34. doi: 10.1016/ j.jns.2017.10.015.
3. Broadley SA, Barnett MH, Boggild M et al. A new era in the treatment of multiple sclerosis. Med J Aust 2015; 203(3): 139– 141.
4. Montalban X, Gold R, Thompson AJ et al. ECTRIMS/ EAN Guideline on the pharmacological treatment of people with multiple sclerosis. Mult Scler 2018; 24(2): 96– 120. doi: 10.1177/ 1352458517751049.
5. Trojano M, Liguori M, Paolicelli D et al. Interferon beta in relapsing-remitting multiple sclerosis: an independent postmarketing study in southern Italy. Mult Scler 2003; 9(5): 451– 457.
6. Waubant E, Vukusic S, Gignoux L et al. Clinical characteristics of responders to interferon therapy for relapsing MS. Neurology 2003; 61(2): 184– 189.
7. Nadační fond IMPULS. Pravidelný výstup z registru ReMuS – export dat ke dni 31. 12. 2017. [online]. Do-stupné z URL: http:/ / nfimpuls.cz/ images/ docs/ remus_zaverecne-zpravy/ zaverecna-zprava_2017_12_souhrnna_rocni_web_2v-1.pdf.
8. Ho DE, Imai K, King G et al. MatchIt: Nonparametric Preprocessing for Parametric Causal Inference. J Stat Soft 2011; 42(8): 1– 28.
9. Schwid SR, Thorpe J, Sharief M et al. Enhanced benefit of increasing interferon beta-1a dose and frequency in relapsing multiple sclerosis: the EVIDENCE Study. Arch Neurol 2005; 62(5): 785– 792.
10. Limmroth V, Malessa R, Zettl UK et al. Quality Assessment in Multiple Sclerosis Therapy (QUASIMS): a comparison of interferon beta therapies for relapsing-remitting multiple sclerosis. J Neurol 2007; 254(1): 67– 77. doi: 10.1007/ s00415-006-0281-1.
11. Kalincik T, Jokubaitis V, Izquierdo G et al. Comparative effectiveness of glatiramer acetate and interferon beta formulations in relapsing-remitting multiple sclerosis. Mult Scler 2015; 21(9): 1159– 1171. doi: 10.1177/ 1352458514559865.
12. Carrá A, Onaha P, Luetic G et al. Therapeutic outcome 3 years after switching of immunomodulatory therapies in patients with relapsing-remitting multiple sclerosis in Argentina. Eur J Neurol 2008; 15(4): 386– 393. doi: 10.1111/ j.1468-1331.2008.02071.x.
13. Durelli L, Verdun E, Barbero P et al. Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN). Lancet 2002; 359(9316): 1453– 1460.
14. Gajofatto A, Bacchetti P, Grimes B et al. Switching first-line disease-modifying therapy after failure: impact on the course of relapsing-remitting multiple sclerosis. Mult Scler 2009; 15(1): 50– 58. doi: 10.1177/ 1352458508096687.
15. Koch-Henriksen N, Sørensen PS, Christensen T et al. A randomized study of two interferon-beta treatments in relapsing-remitting multiple sclerosis. Neurology 2006; 66(7): 1056– 1060.
16. Prosperini L, Borriello G, De Giglio L et al. Management of breakthrough disease in patients with multiple sclerosis: when an increasing of Interferon beta dose should be effective? BMC Neurol 2011; 11: 26. doi: 10.1186/ 1471-2377-11-26.
17. Fox RJ, Miller DH, Phillips JT et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012; 367(12): 1087– 1097.
18. Miclea A, Leussink VI, Hartung HP et al. Safety and efficacy of dimethyl fumarate in multiple sclerosis: a multi-center observational study. J Neurol 2016; 263(8): 1626– 1632. doi: 10.1007/ s00415-016-8175-3.
19. Cohen JA, Barkhof F, Comi G et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med 2010; 362(5): 402– 415. doi: 10.1056/ NEJMoa0907839.
20. Trojano M, Tintore M, Montalban X et al. Treatment decisions in multiple sclerosis – insights from real-world observational studies. Nat Rev Neurol 2017; 13(2): 105– 118. doi: 10.1038/ nrneurol.2016.188.
21. Kalincik T, Butzkueven H. Observational data: Understanding the real MS world. Mult Scler 2016; 22(13): 1642– 1648.
22. Piťha J. Individualizovaný přístup k léčbě roztroušené sklerózy. Cesk Slov Neurol N 2016; 79/ 112(5): 528– 533.
Labels
Paediatric neurology Neurosurgery NeurologyArticle was published in
Czech and Slovak Neurology and Neurosurgery
2018 Issue 4
Most read in this issue
- Antiplatelet and anticoagulant therapy in carotid endarterectomies
- Imaging of peripheral nerves using diffusion tensor imaging and MR tractography
- Bilateral abducens nerve palsy after head and cervical spinal injury
- Late-onset Huntington’s disease – an overlooked diagnosis