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    Real-world effectiveness of cladribine for Australian patients with multiple sclerosis: An MSBase registry substudy

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    Author
    Lizak, N; Hodgkinson, S; Butler, E; Lechner-Scott, J; Slee, M; McCombe, PA; Shaw, C; Skibina, O; Vucic, S; Shuey, N; ...
    Date
    2020-06-12
    Source Title
    Multiple Sclerosis Journal
    Publisher
    SAGE PUBLICATIONS LTD
    University of Melbourne Author/s
    Kalincik, Tomas; Butzkueven, Helmut
    Affiliation
    Medicine and Radiology
    Metadata
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    Document Type
    Journal Article
    Citations
    Lizak, N., Hodgkinson, S., Butler, E., Lechner-Scott, J., Slee, M., McCombe, P. A., Shaw, C., Skibina, O., Vucic, S., Shuey, N., Barnett, M. H., Parratt, J., Butzkueven, H., Jack, D., Fabris, J. & Kalincik, T. (2020). Real-world effectiveness of cladribine for Australian patients with multiple sclerosis: An MSBase registry substudy. MULTIPLE SCLEROSIS JOURNAL, 27 (3), pp.465-474. https://doi.org/10.1177/1352458520921087.
    Access Status
    Open Access
    URI
    http://hdl.handle.net/11343/252090
    DOI
    10.1177/1352458520921087
    Abstract
    BACKGROUND/OBJECTIVE: Observational clinical data from cladribine-treated patients with relapsing forms of multiple sclerosis (MS) were recorded in the Australian MS registry powered by the MSBase registry platform (5-year follow-up) and analysed to complement information from the pivotal cladribine clinical trials in MS. METHODS: A cohort of 90 cladribine-treated patients with follow-up data reported by treating physicians and recorded in the Australian MSBase registry (database lock February 2016) were examined. Clinical data included Expanded Disability Status Scale (EDSS) scores, relapses and other disease-modifying drugs (DMDs) administered before and after cladribine treatment. RESULTS: Mean age on starting cladribine was 47 years; mean age at MS onset was 34 years, and median baseline EDSS score was 5.25. Disability trajectories in patients with sufficient follow-up suggested an overall increasing trend prior to cladribine treatment which was reduced during the 2-year post-treatment. Approximately 80% of patients were EDSS progression-free, 65% remained relapse-free after 2 years and median time to next DMD was 1.7 years. CONCLUSION: These observational data suggest a disease-modifying effect in this cohort of relapsing MS patients characterised by older and more disabled patients. Since these data represent a single-arm cohort, clinical trials and larger comparative post-marketing studies are needed to validate and extend these findings.

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