Rationale For Advancing Laquinimod For Progressive MS: Evidence From Large Clinical Trials In RRMS (S4.001)
Abstract
OBJECTIVE: To assess laquinimod’s potential to treat progressive forms of MS (PMS) based on RRMS clinical trial data.
BACKGROUND: Currently there is no effective treatment for PMS (i.e., PPMS or SPMS), and all tested disease-modifying therapies currently used in RRMS have failed to show efficacy. Based on its neuroprotective preclinical profile and the clinical effect of slowing disability progression, and reducing brain volume loss and black hole evolution, the large clinical trial data set from RRMS cohorts was further analyzed for the effects of laquinimod on various aspects of the disease that may contribute to its effect on slowing of disability progression.
DESIGN/METHODS: In post hoc analyses, laquinimod effect versus placebo on confirmed disability progression (CDP) was evaluated in patient subgroups based on relapse rate during the study, baseline Expanded Disability Status Scale (EDSS) scores, and Multiple Sclerosis Functional Composite (MSFC) z-score quartiles. The correlation between relapse rate and EDSS worsening with laquinimod was assessed using the Sormani meta-analysis.
RESULTS: In pooled ALLEGRO/BRAVO data (laquinimod n=984, placebo n=1006), compared with placebo, laquinimod reduced CDP by 38.9% (P=.036) in patients who were relapse-free throughout the studies, by 34.6% (P=.12) in patients with baseline EDSS scores 蠅4, and by 38.6% (P=.023) in the 25% quartile of MSFC z-score (denoting patients with the least favorable changes in MSFC). Per the Sormani…
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