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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

Z. Pavelek, L. Sobíšek, J. Šarláková, P. Potužník, M. Peterka, I. Štětkárová, P. Štourač, J. Mareš, P. Hradílek, R. Ampapa, M. Grünermelová, M. Vachová, E. Recmanová, F. Angelucci, S. Halúsková, M. Vališ

. 2020 ; 11 (-) : 593527. [pub] 20210112

Language English Country Switzerland

Document type Journal Article

Persistent link   https://www.medvik.cz/link/bmc21010691

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.

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$a 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.
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$a Sobíšek, Lukáš $u Department of Neurology, Faculty of Medicine and University Hospital Hradec Králové, Charles University in Prague, Hradec Králové, Czechia
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$a Šarláková, Jana $u Department of Neurology, Faculty of Medicine and University Hospital Hradec Králové, Charles University in Prague, Hradec Králové, Czechia
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$a Potužník, Pavel $u Department of Neurology, Faculty of Medicine and University Hospital Plzen, Charles University in Prague, Plzeň, Czechia
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$a Peterka, Marek $u Department of Neurology, Faculty of Medicine and University Hospital Plzen, Charles University in Prague, Plzeň, Czechia
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$a Štětkárová, Ivana $u Third Faculty of Medicine, Charles University and Hospital Kralovské Vinohrady, Charles University in Prague, Prague, Czechia
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$a Štourač, Pavel $u Department of Neurology, University Hospital and Masaryk University, Brno, Czechia
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$a Mareš, Jan $u Department of Neurology, Faculty of Medicine, Palacky University and University Hospital Olomouc, Olomouc, Czechia
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$a Hradílek, Pavel $u Clinic of Neurology, University Hospital Ostrava, Ostrava, Czechia
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$a Ampapa, Radek $u Department of Neurology, Hospital of Jihlava, Jihlava, Czechia
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$a Grünermelová, Markéta $u Department of Neurology, Thomayer Hospital, Prague, Czechia
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$a Vachová, Marta $u Department of Neurology, KZ a.s., Hospital Teplice, Teplice, Czechia
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$a Recmanová, Eva $u Department of Neurology, Tomas Bata Regional Hospital, Zlín, Czechia
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$a Angelucci, Francesco $u Department of Neurology, Faculty of Medicine and University Hospital Hradec Králové, Charles University in Prague, Hradec Králové, Czechia $u Memory Clinic, Department of Neurology, Second Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czechia
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$a Halúsková, Simona $u Department of Neurology, Faculty of Medicine and University Hospital Hradec Králové, Charles University in Prague, Hradec Králové, Czechia
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$a Vališ, Martin $u Department of Neurology, Faculty of Medicine and University Hospital Hradec Králové, Charles University in Prague, Hradec Králové, Czechia
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