Perorální kladribin v léčbě roztroušené sklerózy – data z celostátního registru ReMuS®

Česká verzia

Authors: D. Horáková ¹; M. Vachová ^1,2; A. Tvaroh ^2,3; J. Drahota ^1,4; A. Mazouchová ^4,5; J. Mareš ⁶; I. Woznicová ⁷; D. Zimová ⁸; J. Libertínová ⁹; A. Martinková ¹⁰; E. Recmanová ¹¹; M. Grunermelová ¹²; M. Vališ ¹³; J. Adámková ¹⁴; R. Ampapa ¹⁵; Y. Benešová ¹⁶; M. Dufek ¹⁷; M. Peterka ^13,18; E. Kubala Havrdová ¹
Authors place of work: Neurologická klinika a Centrum klinických neurověd, 1. LF UK a VFN v Praze ¹; Neurologické oddělení, Krajská zdravotní a. s. – Nemocnice Teplice o. z. ²; Merck spol. s r. o., Praha ³; Nadační fond IMPULS, Praha ⁴; Katedra ekonomické statistiky, Vysoká škola ekonomická v Praze ⁵; Neurologická klinika LF UP a FN Olomouc ⁶; Neurologická klinika FN Ostrava ⁷; Neurologická klinika 3. LF UK a FN Královské Vinohrady, Praha ⁸; Neurologická klinika 2. LF UK FN Motol, Praha ⁹; Neurologická klinika Nemocnice Pardubického kraje, a. s., Pardubice ¹⁰; Neurologické oddělení Krajské nemocnice Tomáše Bati, a. s., Zlín ¹¹; Neurologická klinika 3. LF UK a Fakultní Thomayerovy nemocnice v Krči, Praha ¹²; Neurologická klinika LF UK a FN Hradec Králové ¹³; Neurologické oddělení, Nemocnice České Budějovice, a. s. ¹⁴; Neurologické oddělení, Nemocnice Jihlava, p. o. ¹⁵; Neurologická klinika LF UK a FN Plzeň ¹⁵; Neurologická klinika LF MU a FN Brno ¹⁶; Neurologická klinika LF MU a FN u sv. Anny, Brno ¹⁷
Published in the journal: Cesk Slov Neurol N 2021; 84(6): 555-561
Category: Original Paper
doi: https://doi.org/10.48095/cccsnn2021555

Summary

Aim: Our objective was to share our first clinical experience with oral cladribine gathered through the analysis of data of the national ReMuS® registry. Patients and methods: Our sample includes data of all patients who initiated oral cladribine treatment since September 1, 2018 till December 31, 2020. We also analyzed, in more detail, the subgroup of 222 patients who were assumed to complete the full cumulative dose. Our analyses included relapses, disability, employment status and financial social support, and also MRI activity in the subgroup. Data were obtained from all 15 centers for treatment of MS and analyzed in terms of descriptive statistics. Results: A total sample comprised of 436 patients, 75.5% of them females, mean age 37.0 years, and mean weight 71.9 kg. Mean duration since the disease onset was 8.4 years with a mean baseline EDSS (Expanded Disability Status Scale) score of 2.8. Mean annualized relapse rate was 1.07 prior to treatment initiation. After treatment initiation, the confirmed disability progression was not reached in 90% of patients until 20.8 (90th quantile) months after follow up. Approximately three quarters of patients stayed relapse-free in year one and two. In the defined subgroup, 85% of patients had no significant MRI activity. A switch to another disease-modifying drug was performed in 12 patients. Conclusion: In accordance with the pivotal trials, our data demonstrate a high proportion of patients without relapses, disability progression and MRI activity, and a very low proportion of patients with a treatment change.

Keywords:

Multiple sclerosis – oral cladribine – therapeutic response – patient registry

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