ORAL Laquinimod Halted MS Disability But Not Relapses

The BRAVO trial also included an open comparator arm against interferon beta-1a (IFNB-1a, Avonex), which proved to reduce brain lesions on MRI to a significantly greater extent relative to placebo than did laquinimod. But even though laquinimod’s effect against active brain inflammation did not appear to be as strong as that of IFNB-1a, it appeared to be potentially neuroprotective because it significantly halted loss of brain volume relative to placebo, whereas IFNB-1a did not.

The 1,331-patient BRAVO (Benefit-Risk Assessment of Avonex and Laquinimod) study is the second of two global phase III trials with laquinimod in patients with relapsing-remitting multiple sclerosis. The first was the 1,106-patient ALLEGROstudy, completed earlier this year, in which laquinimod significantly reduced the annualized relapse rate (ARR), the risk of disability progression, and the percentage of total brain volume lost compared with placebo.

Patients in BRAVO had a mean age of about 37 years and were randomized to oral laquinimod 0.6 mg/day (n = 434), daily oral placebo (n = 450), or intramuscular IFNB-1a 30 mcg once per week (n = 447). Only the comparison between oral treatments was conducted in a double-blind fashion, said Dr. Timothy L. Vollmer, professor and director of clinical research in the neurology department at the University of Colorado, Aurora. He presented the study at the joint congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS).