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New Oral Drug Laquinimod Appears to Reduce Disease Activity in Patients With Relapse-Remitting MS NEW YORK -- June 20, 2008 -- A new oral treatment for multiple sclerosis (MS) appears to reduce magnetic resonance imaging (MRI) disease activity and is well tolerated in patients with relapse-remitting MS, according to promising results from a phase 2 study reported in this week's edition of The Lancet. The treatment also offers an advantage of convenience to patients when compared with conventional, injected treatments. Professor Giancarlo Comi, Institute of Experimental Neurology, University Vita-Salute, Milan, Italy, and colleagues, aimed to test the efficacy, safety, and tolerability of 2 doses of laquinimod versus placebo in a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. A total of 306 patients, aged 18 to 50 years, were enrolled. Patients were eligible if they had 1or more relapses in the year before entry and at least one gadolinium-enhancing (GdE) lesion on screening MRI. Of the patients, 102 were randomised to placebo, 98 to laquinimod 0.3 mg QD, and 106 to laquinimod 0.6 mg QD. Brain MRI scans and clinical assessments were done 4 weeks before the trial started, at baseline, then every 4 weeks for 9 months. Numbers of GdE lesions were measured at weeks 12, 16, 20, 24, 28, 32, and 36. The researchers found that, compared with placebo, laquinimod 0.6 QD showed a 40.4% reduction of the mean number of GdE lesions over the last 4 scans compared with baseline, while laquinimod 0.3 mg QD showed no statistically significant effects compared with placebo. Both doses of laquinimod were well tolerated and only 2 serious, but reversible, adverse events were reported with no clinical consequences. Two patients stopped treatment as one had persistent elevations in liver enzymes, and the other had inherited thrombophilia and experienced an event of Budd-Chiari syndrome. "Overall, the efficacy and safety profile emerging from this and from a previous phase II clinical trial, in combination with the oral route of administration, make laquinimod a promising therapeutic opportunity for patients with relapse-remitting multiple sclerosis," the authors wrote. "The benefits and risks of laquinimod treatment are now being further assessed in a large-scale phase III trial." SOURCE: The Lancet E-mail this page to a friend or colleague! To print, use this version