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.

Základní údaje

Originální název

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

Autoři

POTUZNIK, Pavel (203 Česká republika), Jiri DRAHOTA (203 Česká republika), Dana HORAKOVA (203 Česká republika), Marek PETERKA (203 Česká republika), Aneta MAZOUCHOVA (203 Česká republika), David MATYAS (203 Česká republika), Zbysek PAVELEK (203 Česká republika), Marta VACHOVA (203 Česká republika), Eva RECMANOVA (203 Česká republika), Ivana STETKAROVA (203 Česká republika), Jana LIBERTINOVA (203 Česká republika), Jan MARES (203 Česká republika), Pavel ŠTOURAČ (203 Česká republika, domácí), Marketa GRUNERMELOVA (203 Česká republika), Alena MARTINKOVA (203 Česká republika), Jana ADAMKOVA (203 Česká republika), Pavel HRADILEK (203 Česká republika), Radek AMPAPA, Michal DUFEK (203 Česká republika, domácí), Eva HAVRDOVA KUBALA (203 Česká republika) a Dominika STASTNA (203 Česká republika)

Vydání

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

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30210 Clinical neurology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 4.800 v roce 2022

Organizační jednotka

Lékařská fakulta

DOI

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

UT WoS

001275614400001

Klíčová slova anglicky

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

Štítky

14110127, 14110221, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 15. 8. 2024 12:13, Mgr. Tereza Miškechová

Anotace

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 a 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, roč. 16, June 2024, s. 1-11. ISSN 1179-5735. Dostupné z: 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 a 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, roč.~16, June 2024, s.~1-11. ISSN~1179-5735. Dostupné z: https://dx.doi.org/10.1177/11795735241262743.

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