Mitigate Risk and Increase Success of Lupus Clinical Trials

The study, while exploratory and not sufficiently powered, uncovered some difference in flare rates of BILAG A. The placebo group showed more adjudicated BILAG A flares than the study drug group did, but this difference was also not statistically significant. The study found that the majority of serious adverse events, mostly exacerbated lupus symptoms, occurred during or shortly after the steroid taper. The study also found that the high dose steroids required by the protocol at entry because of the flare design, did not permit sufficient flexibility to individualize treatment according to patient response.