Comparison of Therapies in MS Patients After the First Demyelinating Event in Real Clinical Practice in the Czech Republic: Data From the National Registry ReMuS
Status PubMed-not-MEDLINE Jazyk angličtina Země Švýcarsko Médium electronic-ecollection
Typ dokumentu časopisecké články
PubMed
33510704
PubMed Central
PMC7835499
DOI
10.3389/fneur.2020.593527
Knihovny.cz E-zdroje
- Klíčová slova
- DMD, clinical practice, long-term therapy, multiple sclerosis, treatment,
- Publikační typ
- časopisecké články MeSH
Background: Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system. Well-established drugs used for MS patients after the first demyelinating event in the Czech Republic include glatiramer acetate (GA), interferon beta-1a (IFNβ-1a), IFN beta-1b (IFNβ-1b), peginterferon beta-1a (peg-IFNβ-1a), and teriflunomide. Objective: The objective of this observational study was to compare the effectiveness of the abovementioned drugs in patients with MS who initiated their therapy after the first demyelinating event. Patients were followed for up to 2 years in real clinical practice in the Czech Republic. Methods: A total of 1,654 MS patients treated after the first demyelinating event and followed up for 2 years were enrolled. Evaluation parameters (endpoints) included the annualized relapse rate (ARR), time to next relapse, change in the Expanded Disability Status Scale (EDSS) score, and time of confirmed disease progression (CDP). When patients ended the therapy before the observational period, the reason for ending the therapy among different treatments was compared. Results: No significant difference was found among the groups of patients treated with IFNβ-1a/1b, GA, or teriflunomide for the following parameters: time to the first relapse, change in the EDSS score, and the proportion of patients with CDP. Compared to IFNβ-1a (44 mcg), a significant increase in the percentage of relapse-free patients was found for GA, but this treatment effect was not confirmed by the validation analysis. Compared to the other drugs, there was a significant difference in the reasons for terminating GA therapy. Conclusion: Small differences were found among GA, IFNβ and teriflunomide therapies, with no significant impact on the final outcome after 2 years. Therefore, in clinical practice, we recommend choosing the drug based on individual potential risk from long-term therapy and on patient preferences and clinical characteristics.
Clinic of Neurology University Hospital Ostrava Ostrava Czechia
Department of Neurology Hospital of Jihlava Jihlava Czechia
Department of Neurology KZ a s Hospital Teplice Teplice Czechia
Department of Neurology Thomayer Hospital Prague Czechia
Department of Neurology Tomas Bata Regional Hospital Zlín Czechia
Department of Neurology University Hospital and Masaryk University Brno Czechia
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Tintoré M. Rationale for early intervention with immunomodulatory treatments. J Neurol. (2008) 255:37–43. 10.1007/s00415-008-1006-4 PubMed DOI
Schirmer L, Albert M, Buss A, Schulz-Schaeffer WJ, Antel JP, Brück W, et al. . Substantial early, but nonprogressive neuronal loss in multiple sclerosis (MS) spinal cord. Ann Neurol. (2009) 66:698–704. 10.1002/ana.21799 PubMed DOI
Hartung HP. Early treatment and dose optimization BENEFIT and BEYOND. J Neurol. (2005) 252:44–50. 10.1007/s00415-005-2017-z PubMed DOI
Comi G, De Stefano N, Freedman MS, Barkhof F, Polman CH, Uitdehaag BM, et al. . Comparison of two dosing frequencies of subcutaneous interferon beta-1a in patients with a first clinical demyelinating event suggestive of multiple sclerosis (REFLEX): a phase 3 randomized controlled trial. Lancet Neurol. (2012) 11:33–41. 10.1016/S1474-4422(11)70262-9 PubMed DOI
Jacobs L, Beck RW, Simon JH, Kinkel RP, Brownscheidle CM, Murray TJ, et al. . Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group N Engl J Med. (2000) 343:898–904. 10.1056/NEJM200009283431301 PubMed DOI
Kappos L, Freedman MS, Polman CH, Edan G, Hartung HP, Miller DH, et al. . Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3 - year follow-up analysis of the BENEFIT study. Lancet. (2007) 370:389–97. 10.1016/S0140-6736(07)61194-5 PubMed DOI
Comi G, Martinelli V, Rodegher M, Moiola L, Bajenaru O, Carra A, et al. . Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomized, double-blind, placebo-controlled trial. Lancet. (2009) 374:1503–11. 10.1016/S0140-6736(09)61259-9 PubMed DOI
Miller AE, Wolinsky JS, Kappos L, Comi G, Freedman MS, Olsson TP, et al. . Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis (TOPIC): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. (2014) 13:977–86. 10.1016/S1474-4422(14)70191-7 PubMed DOI
Calabresi PA, Kieseier BC, Arnold DL, Balcer LJ, Boyko A, Pelletier J, et al. . Pegylated interferon β-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomized, phase 3, double-blind study. Lancet Neurol. (2014) 13:657–65. 10.1016/S1474-4422(14)70068-7 PubMed DOI
Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, et al. . Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. (2011) 69:292–302. 10.1002/ana.22366 PubMed DOI PMC
Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, et al. . Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. (2018) 17:162–73. 10.1016/S1474-4422(17)30470-2 PubMed DOI
Schwid SR, Thorpe J, Sharief M, Sandberg-Wollheim M, Rammohan K, Wendt J, et al. EVIDENCE (Evidence of Interferon Dose-Response: European North American Comparative Efficacy) Study Group; University of British Columbia MS/MRI Research Group. Enhanced benefit of increasing interferon beta-1a dose and frequency in relapsing multiple sclerosis: the EVIDENCE Study. Arch Neurol. (2005) 62:785–92. 10.1001/archneur.62.5.785 PubMed DOI
Durelli L, Verdun E, Barbero P, Bergui M, Versino E, Ghezzi A, et al. . Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomized multicentre study (INCOMIN). Lancet. (2002) 359:1453–60. 10.1016/S0140-6736(02)08430-1 PubMed DOI
Koch-Henriksen N, Sørensen P, Christensen T, Frederiksen J, Ravnborg M, Jensen K, et al. . A randomized study of two interferon- beta treatments in relapsing–remitting multiple sclerosis. Neurology. (2006) 66:1056–60. 10.1212/01.wnl.0000204018.52311.ec PubMed DOI
Limmroth V, Malessa R, Zettl UK, Koehler J, Japp G, Haller P, et al. . Quality assessment in Multiple Sclerosis Therapy (QUASIMS): a comparison of interferon beta therapies for relapsing–remitting multiple sclerosis. J Neurol. (2007) 254:67–77. 10.1007/s00415-006-0281-1 PubMed DOI
Mikol DD, Barkhof F, Chang P, Coyle PK, Jeffery DR, Schwid SR, et al. . Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomized, parallel, open-label trial. Lancet Neurol. (2008) 7:903–14. 10.1016/S1474-4422(08)70200-X PubMed DOI
Kalincik T, Jokubaitis V, Izquierdo G, Duquette P, Girard M, Grammond P, et al. . Comparative effectiveness of glatiramer acetate and interferon beta formulations in relapsing-remitting multiple sclerosis. Mult Scler. (2015) 21:1159–71. 10.1186/s12883-018-1162-9 PubMed DOI
Polman CH, Bertolotto A, Deisenhammer F, Giovannoni G, Hartung HP, Hemmer B, et al. . Recommendations for clinical use of data on neutralizing antibodies to interferon-beta therapy in multiple sclerosis. Lancet Neurol. (2010) 9:740–50. 10.1016/S1474-4422(10)70103-4 PubMed DOI
Kalincik T, Spelman T, Trojano M, Duquette P, Izquierdo G, Grammond P, et al. . Persistence on therapy and propensity matched outcome comparison of two subcutaneous interferon beta 1a dosages for multiple sclerosis. PLoS ONE. (2013) 8:e63480. 10.1371/journal.pone.0063480 PubMed DOI PMC
Kolb-Mäurer A, Goebeler M, Mäurer M. Cutaneous adverse events associated with interferon-β treatment of multiple sclerosis. Int J Mol Sci. (2015) 16:14951–60. 10.3390/ijms160714951 PubMed DOI PMC
Vukusic S, Coyle PK, Jurgensen S, Truffinet P, Benamor M, Afsar S. et al. Pregnancy outcomes in patients with multiple sclerosis treated with teriflunomide: clinical study data and 5 years of post-marketing experience. Mult Scler. (2019) 10:1352458519843055 10.1177/1352458519843055 PubMed DOI
Scott LJ. Glatiramer acetate: a review of its use in patients with relapsing-remitting multiple sclerosis and in delaying the onset of clinically definite multiple sclerosis. CNS Drugs. (2013) 27:971–88. 10.1007/s40263-013-0117-3 PubMed DOI
Rommer PS, Milo R, Han MH, Satyanarayan S, Sellner J, Hauer L, et al. . Immunological aspects of approved MS therapeutics. Front Immunol. (2019) 10:1564. 10.3389/fimmu.2019.01564 PubMed DOI PMC
Filippini G, Del Giovane C, Vacchi L, D'Amico R, Di Pietrantonj C, Beecher D, et al. Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis. Cochrane Database Syst Rev. (2013) 6:CD008933 10.1002/14651858.CD008933.pub2 PubMed DOI PMC
Thomas RH, Wakefield RA. Oral disease-modifying therapies for relapsing-remitting multiple sclerosis. Am J Health Syst Pharm. (2015) 72:25–38. 10.2146/ajhp140023 PubMed DOI
Wynn DR. Enduring clinical value of copaxone® (Glatiramer Acetate) in multiple sclerosis after 20 years of use. Mult Scler Int. (2019) 2019:7151685. 10.1155/2019/7151685 PubMed DOI PMC
Comi G, Freedman MS, Kappos L, Olsson TP, Miller AE, Wolinsky JS, et al. . Pooled safety and tolerability data from four placebo-controlled teriflunomide studies and extensions. Mult Scler Relat Disord. (2016) 5:97–104. 10.1016/j.msard.2015.11.006 PubMed DOI