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Therapeutic lag in reducing disability progression in relapsing-remitting multiple sclerosis: 8-year follow-up of two randomized add-on trials with atorvastatin

Lanzillo, R; Moccia, M; Russo, CV; Carotenuto, A; Nozzolillo, A; Petruzzo, M; Palladino, R; ... Brescia Morra, V; + view all (2019) Therapeutic lag in reducing disability progression in relapsing-remitting multiple sclerosis: 8-year follow-up of two randomized add-on trials with atorvastatin. Multiple Sclerosis and Related Disorders , 28 pp. 193-196. 10.1016/j.msard.2018.12.042. Green open access

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Abstract

BACKGROUND: Current treatments for relapsing remitting multiple sclerosis (RRMS) reduce inflammation, but have a partial or modest effect on disability. This effect may require a much longer follow-up than standard trial design, in particular in RRMS with relatively-preserved functional reserve. We aimed to assess the long-term clinical evolution of RRMS patients exposed to atorvastatin in two trials (ACTIVE and ARIANNA). METHODS: We retrospectively looked at 69 participants randomized with atorvastatin or placebo as add-on therapy to interferon-beta for 24 months at a single MS centre. We recorded relapses, 1-point EDSS progression and progression to EDSS 4.0. Cox regression was performed for these three questions. A Poisson regression model was used to evaluate the association between atorvastatin treatment and annualized relapse rate (ARR). RESULTS: After 8.4 ± 2.3 (3.7–11.9) years from trial, the use of atorvastatin was associated with reduced risk of 1-point EDSS progression (HR = 0.440; 95%CI = 0.225–0.861; p = 0.017), and of EDSS 4.0 (HR = 0.310; 95%CI = 0.123–0.784; p = 0.013). We found no significant association between atorvastatin and relapses. DISCUSSION: These data suggest that a delayed treatment effect may be seen with atorvastatin added to interferon-beta, eight years after entering the clinical trials. Long-term follow-up of trial cohorts should be mandated.

Type: Article
Title: Therapeutic lag in reducing disability progression in relapsing-remitting multiple sclerosis: 8-year follow-up of two randomized add-on trials with atorvastatin
Location: Netherlands
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.msard.2018.12.042
Publisher version: https://doi.org/10.1016/j.msard.2018.12.042
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Multiple sclerosis, Statin, Treatment, Clinical trial, Extension
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology
URI: https://discovery.ucl.ac.uk/id/eprint/10068909
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