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

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posted on 2020-03-01, 00:00 authored by N Lizak, S Hodgkinson, E Butler, J Lechner-Scott, M Slee, P A McCombe, Cameron ShawCameron Shaw, O Skibina, S Vucic, N Shuey, M H Barnett, J Parratt, H Butzkueven, D Jack, J Fabris, T Kalincik
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.

History

Journal

Multiple sclerosis journal

Volume

27

Issue

3

Pagination

465 - 474

Publisher

Sage

Location

London, Eng.

ISSN

1352-4585

eISSN

1477-0970

Language

eng

Publication classification

C1 Refereed article in a scholarly journal