Tasocitinib: Phase III data

The double-blind Phase III ORAL Solo (1045) trial in 611 patients with RA who had an inadequate response to >=1 DMARD showed that twice-daily 5 and 10 mg oral tasocitinib each met the co-primary endpoints of significantly improving ACR20 response rate and mean HAQ-DI scores from baseline to 3 months vs. placebo, but missed the third co-primary endpoint of a significantly greater proportion of patients achieving a DAS28 score of <2.6 vs. placebo. Specifically, ACR20 response rates at 3 months were 59.8% and 65.7% for low- and high-dose tasocitinib, respectively, vs. 26.7% for placebo (p<0.0001 for both), and HAQ-DI scores were reduced by 0.5 and 0.57 points from baseline to 3 months for each dose of tasocitinib, respectively, vs. 0.19 points for placebo (p<0.0001 for both). Additionally, 6% and 9.6% of patients receiving low- and high-dose tasocitinib, respectively, achieved a DAS28 score of <2.6 vs. 4.4% for placebo (p=0.505 and p=0.056, respectively). ...