Real-world effectiveness of cladribine as an escalation
strategy for MS: Insights from the Czech nationwide ReMuS
registry

J 2024

Real-world effectiveness of cladribine as an escalation strategy for MS: Insights from the Czech nationwide ReMuS registry

POTUZNIK, Pavel, Jiri DRAHOTA, Dana HORAKOVA, Marek PETERKA, Aneta MAZOUCHOVA et. al.

Basic information

Original name

Real-world effectiveness of cladribine as an escalation strategy for MS: Insights from the Czech nationwide ReMuS registry

Authors

POTUZNIK, Pavel (203 Czech Republic), Jiri DRAHOTA (203 Czech Republic), Dana HORAKOVA (203 Czech Republic), Marek PETERKA (203 Czech Republic), Aneta MAZOUCHOVA (203 Czech Republic), David MATYAS (203 Czech Republic), Zbysek PAVELEK (203 Czech Republic), Marta VACHOVA (203 Czech Republic), Eva RECMANOVA (203 Czech Republic), Ivana STETKAROVA (203 Czech Republic), Jana LIBERTINOVA (203 Czech Republic), Jan MARES (203 Czech Republic), Pavel ŠTOURAČ (203 Czech Republic, belonging to the institution), Marketa GRUNERMELOVA (203 Czech Republic), Alena MARTINKOVA (203 Czech Republic), Jana ADAMKOVA (203 Czech Republic), Pavel HRADILEK (203 Czech Republic), Radek AMPAPA, Michal DUFEK (203 Czech Republic, belonging to the institution), Eva HAVRDOVA KUBALA (203 Czech Republic) and Dominika STASTNA (203 Czech Republic)

Edition

JOURNAL OF CENTRAL NERVOUS SYSTEM DISEASE, LONDON, SAGE PUBLICATIONS LTD, 2024, 1179-5735

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30210 Clinical neurology

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 4.800 in 2022

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1177/11795735241262743

UT WoS

001275614400001

Keywords in English

Cladribine; high-efficacy disease-modifying therapy; multiple sclerosis; annualised relapse rate; expanded disability status scale; adherence

Abstract

V originále

BackgroundCladribine, a selective immune reconstitution therapy, is approved for the treatment of adult patients with highly active multiple sclerosis (MS).ObjectivesProvide experience with cladribine therapy in a real-world setting.MethodsThis is a registry-based retrospective observational cohort study. First, using data from the Czech nationwide registry ReMuS, we analysed patients who initiated cladribine from September 1, 2018 to December 31, 2021. Second, we analysed a subgroup of patients who initiated cladribine between September 1, 2018 to June 30, 2020, thus possessing a follow-up period of at least 2 years. We evaluated demographic and MS characteristics including disease-modifying therapies (DMTs) before and after cladribine administration, relapses, Expanded Disability Status Scale (EDSS), and adherence.ResultsIn total, 617 patients (335 with follow-up of at least 2 years) started cladribine therapy in the study period (mean age 37.0, mean disease duration 8.4 years, 74.1% females). In most cases, cladribine was administered as a second-line drug, a total of 80.7% had been escalated from a platform DMT. During 2 years before cladribine initiation, the average annualised relapse rate (ARR) was .67. Following cladribine initiation, the ARR decreased to .28 in the first year and .22 in the second year. Overall, across the entire two-year treatment period, 69.0% of patients were relapse-free and the average ARR was .25. As for EDSS development, the median baseline EDSS was 2.5 and remained stable even after 24 months. The adherence to treatment ranged of around 90%.ConclusionThis nationwide study confirms the efficacy of cladribine in real-world settings, especially in patients who are not treatment-na & iuml;ve. In addition, the study shows an exceptionally high adherence rate, a finding that underscores the invaluable role of cladribine, but also the value of registry-based studies in capturing real-world clinical practice.

Citovat

POTUZNIK, Pavel, Jiri DRAHOTA, Dana HORAKOVA, Marek PETERKA, Aneta MAZOUCHOVA, David MATYAS, Zbysek PAVELEK, Marta VACHOVA, Eva RECMANOVA, Ivana STETKAROVA, Jana LIBERTINOVA, Jan MARES, Pavel ŠTOURAČ, Marketa GRUNERMELOVA, Alena MARTINKOVA, Jana ADAMKOVA, Pavel HRADILEK, Radek AMPAPA, Michal DUFEK, Eva HAVRDOVA KUBALA and Dominika STASTNA. Real-world effectiveness of cladribine as an escalation strategy for MS: Insights from the Czech nationwide ReMuS registry. JOURNAL OF CENTRAL NERVOUS SYSTEM DISEASE. LONDON: SAGE PUBLICATIONS LTD, 2024, vol. 16, June 2024, p. 1-11. ISSN 1179-5735. Available from: https://dx.doi.org/10.1177/11795735241262743.

@article{2423183,
   author = {Potuznik, Pavel and Drahota, Jiri and Horakova, Dana and Peterka, Marek and Mazouchova, Aneta and Matyas, David and Pavelek, Zbysek and Vachova, Marta and Recmanova, Eva and Stetkarova, Ivana and Libertinova, Jana and Mares, Jan and Štourač, Pavel and Grunermelova, Marketa and Martinkova, Alena and Adamkova, Jana and Hradilek, Pavel and Ampapa, Radek and Dufek, Michal and Havrdova Kubala, Eva and Stastna, Dominika},
   article_location = {LONDON},
   article_number = {June 2024},
   doi = {http://dx.doi.org/10.1177/11795735241262743},
   keywords = {Cladribine; high-efficacy disease-modifying therapy; multiple sclerosis; annualised relapse rate; expanded disability status scale; adherence},
   language = {eng},
   issn = {1179-5735},
   journal = {JOURNAL OF CENTRAL NERVOUS SYSTEM DISEASE},
   title = {Real-world effectiveness of cladribine as an escalation strategy for MS: Insights from the Czech nationwide ReMuS registry},
   url = {https://journals.sagepub.com/doi/10.1177/11795735241262743},
   volume = {16},
   year = {2024}
}

TY  - JOUR
ID  - 2423183
AU  - Potuznik, Pavel - Drahota, Jiri - Horakova, Dana - Peterka, Marek - Mazouchova, Aneta - Matyas, David - Pavelek, Zbysek - Vachova, Marta - Recmanova, Eva - Stetkarova, Ivana - Libertinova, Jana - Mares, Jan - Štourač, Pavel - Grunermelova, Marketa - Martinkova, Alena - Adamkova, Jana - Hradilek, Pavel - Ampapa, Radek - Dufek, Michal - Havrdova Kubala, Eva - Stastna, Dominika
PY  - 2024
TI  - Real-world effectiveness of cladribine as an escalation strategy for MS: Insights from the Czech nationwide ReMuS registry
JF  - JOURNAL OF CENTRAL NERVOUS SYSTEM DISEASE
VL  - 16
IS  - June 2024
SP  - 1-11
EP  - 1-11
PB  - SAGE PUBLICATIONS LTD
SN  - 11795735
KW  - Cladribine
KW  - high-efficacy disease-modifying therapy
KW  - multiple sclerosis
KW  - annualised relapse rate
KW  - expanded disability status scale
KW  - adherence
UR  - https://journals.sagepub.com/doi/10.1177/11795735241262743
N2  - BackgroundCladribine, a selective immune reconstitution therapy, is approved for the treatment of adult patients with highly active multiple sclerosis (MS).ObjectivesProvide experience with cladribine therapy in a real-world setting.MethodsThis is a registry-based retrospective observational cohort study. First, using data from the Czech nationwide registry ReMuS, we analysed patients who initiated cladribine from September 1, 2018 to December 31, 2021. Second, we analysed a subgroup of patients who initiated cladribine between September 1, 2018 to June 30, 2020, thus possessing a follow-up period of at least 2 years. We evaluated demographic and MS characteristics including disease-modifying therapies (DMTs) before and after cladribine administration, relapses, Expanded Disability Status Scale (EDSS), and adherence.ResultsIn total, 617 patients (335 with follow-up of at least 2 years) started cladribine therapy in the study period (mean age 37.0, mean disease duration 8.4 years, 74.1% females). In most cases, cladribine was administered as a second-line drug, a total of 80.7% had been escalated from a platform DMT. During 2 years before cladribine initiation, the average annualised relapse rate (ARR) was .67. Following cladribine initiation, the ARR decreased to .28 in the first year and .22 in the second year. Overall, across the entire two-year treatment period, 69.0% of patients were relapse-free and the average ARR was .25. As for EDSS development, the median baseline EDSS was 2.5 and remained stable even after 24 months. The adherence to treatment ranged of around 90%.ConclusionThis nationwide study confirms the efficacy of cladribine in real-world settings, especially in patients who are not treatment-na & iuml;ve. In addition, the study shows an exceptionally high adherence rate, a finding that underscores the invaluable role of cladribine, but also the value of registry-based studies in capturing real-world clinical practice.
ER  -

POTUZNIK, Pavel, Jiri DRAHOTA, Dana HORAKOVA, Marek PETERKA, Aneta MAZOUCHOVA, David MATYAS, Zbysek PAVELEK, Marta VACHOVA, Eva RECMANOVA, Ivana STETKAROVA, Jana LIBERTINOVA, Jan MARES, Pavel ŠTOURAČ, Marketa GRUNERMELOVA, Alena MARTINKOVA, Jana ADAMKOVA, Pavel HRADILEK, Radek AMPAPA, Michal DUFEK, Eva HAVRDOVA KUBALA and Dominika STASTNA. Real-world effectiveness of cladribine as an escalation strategy for MS: Insights from the Czech nationwide ReMuS registry. \textit{JOURNAL OF CENTRAL NERVOUS SYSTEM DISEASE}. LONDON: SAGE PUBLICATIONS LTD, 2024, vol.~16, June 2024, p.~1-11. ISSN~1179-5735. Available from: https://dx.doi.org/10.1177/11795735241262743.

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