Table 1.

Clinical efficacy of laquinimod in MS clinical trials

Study	Design and drug regimen	Primary endpoint	Results
Phase II29	24-week, randomized, double-blind, multicenter Three arms: LAQ 0.1 mg/day, LAQ 0.3 mg/day and placebo (n=209)	Mean cumulative number of GdE MRI lesions over 24 weeks	Significant reduction by 44% in the group treated with LAQ (0.3 mg/day) when compared to placebo ARR: no significant difference between groups
Phase IIb30 (LAQ/5062)	36-week, randomized, double-blind, multicenter Three arms: LAQ 0.3 mg/day, LAQ 0.6 mg/day, and placebo (n=308)	Cumulative number of GdE MRI lesions at weeks 24, 28, 32, and 36	Significant reduction by 40.4% and 44% in cumulative number of GdE MRI lesions and new T2 lesions, respectively, for LAQ (0.6 mg/day) as compared to placebo. LAQ 0.3 mg/day showed no significant effects ARR: no significant difference between groups
Phase IIb31 (LAQ/5063)	36-week, multicenter, double-blind extension of LAQ/5062. Subjects on placebo were switched to LAQ 0.3 or 0.6 mg/day, while the treatment arm subjects were continued on LAQ (n=257)	Number of GdE MRI lesions, new T2 lesions, volume of T2 lesions, and new hypointense T1 lesions over the length of the study. MRI scans were performed at baseline and at week 36	Subjects switched to LAQ showed a significant reduction by 52% in the mean number of GdE MRI lesions between the start and the end of the extension phase. Treatment effect was more significant in subjects switched to LAQ 0.6 mg/day. Subjects that continued on the treatment group showed sustained benefit throughout the extension. ARR: no significant difference between groups
ALLEGRO32 (Phase III)	24-month, randomized, double-blind, multicenter Two arms: LAQ 0.6 mg/day and placebo (n=1,106) (LAQ: 550 vs placebo: 556)	ARR at 24 months	Significant but modest reduction in ARR for the treatment group compared to placebo (0.30 vs 0.39, respectively; P=0.002)
BRAVO33 (Phase III)	24-month, randomized, double-blind, multicenter Three arms: LAQ 0.6 mg/day, IFN-β1a im and placebo (n=1,331) (LAQ: 434 vs placebo: 450 vs IFN-β: 447)	ARR at 24 months	No significant effect. Treatment with LAQ 0.6 mg/day showed a trend to reduction in ARR (P=0.075). Following an adjustment for imbalance of baseline MRI disease activity between groups, LAQ (0.6 mg/day) significantly reduced ARR when compared to placebo

Abbreviations: MS, multiple sclerosis; ARR, annualized relapse rate; GdE, gadolinium enhancing; IFN, interferon; MRI, magnetic resonance imaging; LAQ, laquinimod.