University of Oulu

Rauma, I., Viitala, M., Kuusisto, H., Atula, S., Sipilä, J. O. T., Ryytty, M., Soilu-Hänninen, M., & Järvinen, E. (2022). Finnish multiple sclerosis patients treated with cladribine tablets: A nationwide registry study. Multiple Sclerosis and Related Disorders, 61, 103755.

Finnish multiple sclerosis patients treated with cladribine tablets : a nationwide registry study

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Author: Rauma, Ilkka1,2; Viitala, Matias3; Kuusisto, Hanna2,4;
Organizations: 1Tampere University, Faculty of Medicine and Health Technology, Tampere, Finland
2Tampere University Hospital, Department of Neurology, Tampere, Finland
3StellarQ Ltd., Turku, Finland
4University of Eastern Finland, Department of Health and Social Management, Kuopio, Finland
5Helsinki University Hospital, Neurocenter, Helsinki, Finland
6University of Helsinki, Department of Neurosciences, Helsinki, Finland
7Siun Sote, North Karelia Central Hospital, Department of Neurology, Joensuu
8Clinical Neurosciences, University of Turku, Turku, Finland
9University of Oulu, Research Unit of Clinical Neuroscience, Neurology, Oulu, Finland
10Oulu University Hospital, Medical Research Center, Oulu, Finland
11Turku University Hospital, Neurocenter, Turku, Finland
12Merck Oy, Espoo, Finland, an affiliate of Merck KGaA
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 2.3 MB)
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Language: English
Published: Elsevier, 2022
Publish Date: 2022-10-04


Background: Cladribine tablets for adult patients with highly active relapsing multiple sclerosis (MS) have been available in Finland since 2018. Real-world data from different genetic and geographical backgrounds are needed to complement data from clinical trials.

Methods: We investigated the use of cladribine tablets in Finland in a non-interventional cohort study, based on real-world data from the nationwide Finnish MS registry. All eligible patients who had initiated treatment with cladribine tablets in 2018–2020 were included. Descriptive analyses for outcomes were conducted using summary statistics. Time-dependent endpoints were analyzed using cumulated events analysis based on 1-Kaplan–Meier estimates and curves. Subgroups were analyzed separately according to the number of previous disease-modifying therapies (DMTs) and the most common last preceding therapies.

Results: Data of 179 patients were analyzed. Median follow-up time was 19.0 months (interquartile range [IQR] 12.0–26.2). Of the 134 patients who were followed for at least 12 months, 112 patients (83.6%) remained relapse-free during follow-up. Mean annualized relapse rate (ARR) was 1.0 (standard deviation [SD] 0.89) at baseline, and 0.1 (SD 0.30) at follow-up. Patients with two or more previous DMTs had shorter time to first relapse (median 2.5 months, IQR 0.6–9.3) when compared to patients with 0–1 previous DMTs (median 11.4 months, IQR 8.7–13.1) (p=0.013). After excluding patients switching from fingolimod (n=33), a statistically significant difference in time to first relapse was no longer observed between the two groups (p=0.252). Adverse events (AEs) were reported in 30 patients (16.8%). The most frequent AE was headache (n=14, 7.8%). One patient (0.6%) died of cardiac arrest. Discontinuation of cladribine tablets was reported in nine patients (5.0%).

Conclusions: The mean ARR observed in this cohort was similar to what has been reported in clinical trials. Approximately half of the patients had used two or more previous DMTs before cladribine tablets. These patients had a shorter time to first relapse when compared to patients with 0–1 previous DMTs, mostly driven by early relapses in patients switching from fingolimod.

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Series: Multiple sclerosis and related disorders
ISSN: 2211-0348
ISSN-E: 2211-0356
ISSN-L: 2211-0348
Volume: 61
Article number: 103755
DOI: 10.1016/j.msard.2022.103755
Type of Publication: A1 Journal article – refereed
Field of Science: 3124 Neurology and psychiatry
Funding: This study was funded by Merck Oy, Espoo, Finland, an affiliate of Merck KGaA (CrossRef Funder ID: 10.13039/100009945). The funding included data collection and analysis. EJ is an employee of Merck Oy. IR received a consultancy fee from Merck Oy for the preparation of the first version of this manuscript and used his personal research grant from the Pirkanmaa Regional Fund of The Finnish Cultural Foundation (grant 50211598) to work on the final version of this manuscript. MV, HK, SA, JOTS, MR, and MS-H received no funding in the context of this study.
Copyright information: © 2022 The Author(s). This is an open access article under the CC BY license (