INCB28050: Final Phase IIa data

Final data from the dose-ranging, double-blind Phase IIa Study 28050-201 trial in 125 patients with active RA with an inadequate response to any DMARD therapy showed that once-daily 4, 7 and 10 mg LY3009104 improved the primary endpoint of ACR20 response rate at week 12 vs. placebo (52%, 59% and 53%, respectively, vs. 32%). ACR50 response rates at week 12 were 35%, 31% and 30% for low-, mid- and high-dose LY3009104, respectively, vs. 13% for placebo, while ACR70 response rates were 16%, 9% and 10%, respectively, vs. 3% for placebo. Additionally, the proportion of patients who achieved Disease Activity Scores using C-reactive protein (DAS-CRP) of <3.2, which corresponds to mild disease, were higher for low-, mid- and high-dose LY3009104 compared to placebo at week 12 (45%, 34% and 33%, respectively, vs. 26%).

At week 12, patients randomized to placebo were switched to once-daily 7 or 10 mg LY3009104. At week 24, ACR20 rates were 67%, 67% and 72% for low-, mid- and high-dose LY3009104, respectively. ACR50 response rates at week 24 were 33%, 37% and 44%, respectively, while ACR70 response rates were 26%, 30% and 28%. The proportion of patients achieving DAS-CRP of <3.2 at week 24 was 48%, 53% and 65% for low-, mid- and high-dose LY3009104, respectively. The most common adverse events were headache, upper respiratory tract infection and diarrhea. Data were presented at the American College of Rheumatology/Association of Rheumatology Health Professionals meeting in Atlanta. ...