TY - JOUR
T1 - Finnish multiple sclerosis patients treated with cladribine tablets
T2 - a nationwide registry study
AU - Rauma, Ilkka
AU - Viitala, Matias
AU - Kuusisto, Hanna
AU - Atula, Sari
AU - Sipilä, Jussi O.T.
AU - Ryytty, Mervi
AU - Soilu-Hänninen, Merja
AU - Järvinen, Elina
N1 - Funding Information:
IR has received research grants from The Finnish Medical Foundation, The Finnish MS Foundation, The Hospital District of South Ostrobothnia, the Orion Research Foundation sr, and the Pirkanmaa Regional Fund of The Finnish Cultural Foundation; a consultancy fee from Merck; support for meetings and/or travel from Novartis, Sanofi Genzyme, and Teva; and honoraria for lectures or for serving as an investigator in clinical trials from Novartis and Sanofi. MV has nothing to disclose. HK has received honoraria for lectures, advisory boards or for serving as an investigator for clinical trials from Biogen, BMS, Celgene, Novartis, Merck, Roche, and Sanofi. SA has received support for meetings and/or travel from Merck; and honoraria for lectures or for serving as an investigator in a clinical trial from Novartis, Merck, Biogen, and Roche. JOTS has received research grants from The Finnish Parkinson Foundation and Maire Jokinen Foundation; support for meetings and travel from the Finnish Neurological Association; honorarium for participating in an advisory board from Medaffcon; and holds Orion Corporation shares. MR has received honoraria for lectures, advisory boards or for serving as an investigator in clinical trials from Biogen, Celgene, Merck, Novartis, Roche, Sanofi, and Teva. MS-H has received honoraria for lectures, advisory boards or for serving as an investigator for clinical trials from Biogen, BMS, Celgene, Genzyme, Novartis, Merck, Roche, Sanofi and Teva. EJ is an employee of Merck Oy, Espoo, Finland, an affiliate of Merck KGaA.
Funding Information:
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.
Publisher Copyright:
© 2022
PY - 2022/5
Y1 - 2022/5
N2 - 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%). Conclusion: 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.
AB - 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%). Conclusion: 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.
KW - cladribine tablets
KW - Finland
KW - multiple sclerosis
KW - real-world data
KW - registries
KW - treatment outcome
U2 - 10.1016/j.msard.2022.103755
DO - 10.1016/j.msard.2022.103755
M3 - Article
C2 - 35483129
AN - SCOPUS:85129543204
SN - 2211-0348
VL - 61
JO - Multiple Sclerosis and Related Disorders
JF - Multiple Sclerosis and Related Disorders
M1 - 103755
ER -