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Title: | Safety and effectiveness of cladribine tablets for multiple sclerosis: Results from a single-center real-world cohort | Authors: | AERTS, Sofie KHAN, Hamza SEVERIJNS, Deborah POPESCU, Veronica PEETERS, Liesbet VAN WIJMEERSCH, Bart |
Issue Date: | 2023 | Publisher: | ELSEVIER SCI LTD | Source: | Multiple Sclerosis and Related Disorders, 75 (Art N° 104735) | Abstract: | Background: Cladribine tablets are a highly effective immune reconstitution therapy licensed for treating re-lapsing multiple sclerosis (RMS) in Europe since 2017. Currently, there is a high demand for real-world data from different clinical settings on the effectiveness and safety profile of cladribine in MS. Methods: Within this report, we retrospectively evaluated the outcomes of RMS patients who received cladribine between August 2018 and November 2021 at our Belgian institute. Patients with data for three effectiveness endpoints, more specifically, relapses, MRI observations, and confirmed disability worsening were incorporated into the analysis of 'no evidence of disease activity' (NEDA-3) re-baselined at 3 months. Safety endpoints included lymphopenia, liver transaminases, and adverse events (AEs) during follow-up. Descriptive statistics and time-to-event analysis were performed, including subgroup analysis by pre-treatment. Results: Of the 84 RMS patients included in this study (age 42 [33-50], 64.3% female, diagnosis duration 6 [2-11] years, baseline EDSS 2.5 [1.5-3.6]), 14 (16.7%) patients experienced relapses, while disability pro-gression and brain MRI activity occurred in 8.5% (6/71) and 6.3% (5/79). This resulted in 72.6% (n = 69, standard error 6%) retaining NEDA-3 status at the mean follow-up time of 22.6 +/- 11.5 months. During the first year after cladribine initiation, disease activity prevailed more in patients with >= 2 prior DMTs and those switching from fingolimod, although both trends were not statistically significant. In terms of safety, 67.9% reported at least one AE during follow-up, the most frequent being fatigue (64.9%) and skin-related problems (38.6%). Conclusion: Overall, our research results confirm cladribine's safety and effectiveness among RMS patients in real-world conditions. After the re-baseline, we observed high rates of NEDA-3-retention, and no new safety signals were noted. | Notes: | Aerts, S (corresponding author), Univ MS Ctr UMSC Hasselt Pelt, Boemerangstr 2, B-3900 Pelt, Belgium. sofie.aerts@uhasselt.be |
Keywords: | Cladribine tablets;Multiple sclerosis;NEDA-3;Safety;Real-world | Document URI: | http://hdl.handle.net/1942/40542 | ISSN: | 2211-0348 | e-ISSN: | 2211-0356 | DOI: | 10.1016/j.msard.2023.104735 | ISI #: | 001008379800001 | Rights: | 2023 Elsevier B.V. All rights reserved. | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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Safety and effectiveness of cladribine tablets for multiple sclerosis_ Results from a single-center real-world cohort.pdf Restricted Access | Published version | 1.24 MB | Adobe PDF | View/Open Request a copy |
Cladribine publicatie_versie voor UHasselt BIB.pdf | Peer-reviewed author version | 644.2 kB | Adobe PDF | View/Open |
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