Savient reports additional favorable Puricase Phase III results

According to Savient, results were favorable for the treatment effect on clinical outcomes assessed by the reduction in the number of tender and swollen joints, and in improvement in patient reported outcomes (PRO) as measured by short form-36 (SF-36) and the health assessment questionnaire-disability index (HAQ-DI). These endpoints were assessed in a prespecified pooled analysis from the two replicate studies and are reported for the intent-to-treat population. The improvement reported in these outcomes was clinically meaningful as determined by the prespecified definitions, the company said.

The results of the Phase III trials show that in the prespecified pooled analysis, both treatment arms attained statistical significance for improvement versus placebo for the SF-36 physical component scores. The arthritis-specific health index form SF-36 also demonstrated statistically significant improvement versus placebo for both treatment arms and again showed that even the plasma uric acid non-responders had improvement versus placebo.