The oral immunomodulatory agent laquinimod significantly reduces MRI-measured disease activity in relapsing–remitting multiple sclerosis (RRMS) patients, according to results from a phase IIb study in humans. Laquinimod appears to act by modulating the Th1/Th2 balance and inducing the Th3 cytokine transforming growth factor (TGF)-ß. The efficacy of this agent at a dose of 0.3 mg/d was previously established in a 24-week phase II trial in RRMS patients. To assess the effects of 2 different doses of this agent on MRI-monitored disease activity, Giancarlo Comi, University Hospital San Raffaele, Milan, Italy, and colleagues randomized 306 RRMS patients to daily placebo (n=102) or daily doses of laquinimod 0.3 mg/d (n=98) or 0.6 mg/d (n=106) over a period of 36 weeks. All patients were required to have had 1 or more relapses in the year prior to study entry and at least 1 enhancing lesion at screening. Baseline demographic, clinical, and MRI characteristics were comparable for all patient groups. No significant treatment differences were seen for the 0.3 mg dose, reported Dr. Comi. However, significant differences in favor of the 0.6 mg dose over placebo were found for the cumulative number of enhancing lesions/scan in the last 4 scans (2.6±5.3 vs 4.2±9.2; P=0.0048) and for most secondary and exploratory MRI-based outcome measures. In addition, trends in favor of the 0.6 mg dose over placebo were demonstrated for annual relapse rate (0.52±0.92 vs 0.77±1.25; P=0.21), relapse-free patients (70.8% vs 62.7%; P=0.33), and time to first relapse ( P=0.14). Both doses of laquinimod were well tolerated, with only some transient and dose-dependent increases in liver enzymes. Overall, these results support the continued study of the 0.6 mg dose of laquinimod for the treatment of RRMS, concluded Dr. Comi.
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