TITLE

Placebo-Controlled Trial of Oral Laquinimod for Multiple Sclerosis

AUTHOR(S)
Comi, Giancarlo; Filippi, Massimo; Rocca, Maria A.; Jeffery, Douglas; Kappos, Ludwig; Montalban, Xavier; Boyko, Alexey
PUB. DATE
March 2012
SOURCE
New England Journal of Medicine;3/15/2012, Vol. 366 Issue 11, p1000
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Background: Two proof-of-concept clinical trials have provided evidence that laquinimod reduces disease activity in patients with relapsing�remitting multiple sclerosis. Methods: We conducted a randomized, double-blind, phase 3 study at 139 sites in 24 countries. A total of 1106 patients with relapsing�remitting multiple sclerosis were randomly assigned in a 1:1 ratio to receive oral laquinimod at a dose of 0.6 mg once daily or placebo for 24 months. The primary end point was the annualized relapse rate during the 24-month period. Secondary end points included confirmed disability progression (defined as an increase in the score on the Expanded Disability Status Scale that was sustained for at least 3 months) and the cumulative number of gadolinium-enhancing lesions and new or enlarging lesions on T2-weighted magnetic resonance imaging. Results: Treatment with laquinimod as compared with placebo was associated with a modest reduction in the mean (�SE) annualized relapse rate (0.30�0.02 vs. 0.39�0.03, P=0.002) and with a reduction in the risk of confirmed disability progression (11.1% vs. 15.7%; hazard ratio, 0.64; 95% confidence interval, 0.45 to 0.91; P=0.01). The mean cumulative numbers of gadolinium-enhancing lesions and new or enlarging lesions on T2-weighted images were lower for patients receiving laquinimod than for those receiving placebo (1.33�0.14 vs. 2.12�0.22 and 5.03�0.08 vs. 7.14�0.07, respectively; P<0.001 for both comparisons). Transient elevations in alanine aminotransferase levels to greater than three times the upper limit of the normal range were observed in 24 patients receiving laquinimod (5%) and 8 receiving placebo (2%). Conclusions: In this phase 3 study, oral laquinimod administered once daily slowed the progression of disability and reduced the rate of relapse in patients with relapsing�remitting multiple sclerosis. (Funded by Teva Pharmaceutical Industries; ClinicalTrials.gov number, NCT00509145.)
ACCESSION #
73354515

 

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