With one exception, the investigational oral drug laquinimod was more effective than placebo, and possibly better than interferon-beta-1a (Avonex), in reducing clinically relevant aspects of multiple sclerosis (MS), a researcher said here.
But that exception was a doozy: on the phase III BRAVO trial's primary efficacy endpoint, annualized relapse rate, laquinimod failed to show significantly better efficacy than placebo, reported Timothy Vollmer, MD, of the University of Colorado in Denver.
According to the two-year trial's prespecified method for measuring annualized relapse rates in the primary analysis, laquinomid produced a rate of 0.28 relapses, versus 0.34 for placebo (risk ratio 0.82, 95% CI 0.66 to 1.02, P=0.075).
On the other hand, when the data were adjusted for baseline clinical factors associated with relapse rate that were imbalanced between treatment groups in the randomized trial -- also planned in the BRAVO protocol -- annualized relapse rates rose enough in the placebo group to give laquinimod a statistically significant advantage (0.37 placebo, 0.29 laquinimod, P=0.03).... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1735
