Multiple Sclerosis Drug Reduces Active Lesions

Laquinimod at specific dosage reduces MRI-measured disease activity and is well tolerated

FRIDAY, June 20 (HealthDay News) -- In patients with relapsing-remitting multiple sclerosis, treatment with a higher dosage of laquinimod reduces the formation of active lesions and is well tolerated, according to the results of a study published in the June 21 issue of The Lancet.

Giancarlo Comi, M.D., of the University Vita-Salute, Scientific Institute San Raffaele in Milan, Italy, and colleagues randomly assigned 306 patients aged 18-50 to receive laquinimod at a dosage of either 0.3 mg or 0.6 mg per day, or placebo, for 24 weeks.

Compared to placebo, the researchers found that laquinimod at a dosage of 0.6 mg/day was associated with a 40.4 percent reduction of the baseline adjusted mean cumulative number of gadolinium enhancing lesions per scan on the last four scans. They also found that laquinimod at a dosage of 0.3 mg/day had no significant effects compared to placebo.

"With any new drug, safety is paramount," state the authors of an accompanying comment. "One patient in Comi and colleagues' study developed Budd-Chiari syndrome, a potentially serious thrombotic venous-outflow obstruction of the liver. Others developed increased liver enzymes that, for interferon-based drugs, need ongoing biochemical monitoring. Fortunately, the investigators did not encounter the serious safety issues seen in the clinical trial of the structurally related linomide, which was abandoned after major events including myocardial infarction and systemic inflammatory syndromes."

This study was supported by Teva Pharmaceutical Industries, and several study authors disclosed financial ties to Teva and other pharmaceutical companies.

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