Eli Lilly and Co. (LLY: Quote) and Incyte Corp. (INCY: Quote) announced the presentation of 12-week results from a Phase IIb study of baricitinib, formerly LY3009104 or INCB28050, an orally available janus kinase or JAK inhibitor, in patients with active rheumatoid arthritis or RA.
The company noted that the Phase IIb randomized double-blind, placebo-controlled, dose-ranging study, known as JADA, involved a total of 301 patients with active RA on stable doses of methotrexate. Patients were randomized to receive either placebo or one of four once-daily doses of baricitinib (1 mg, 2 mg, 4 mg or 8 mg) for 12 weeks.
The Phase IIb trial achieved the primary endpoint by demonstrating a statistically significant difference in the American College of Rheumatology 20 (ACR20) response between the combined 4 mg and 8 mg baricitinib groups (76 percent) compared with placebo (41 percent) after 12 weeks of treatment (p<0.001).
Statistically significant improvement was observed at the first assessment point after two weeks of treatment and was sustained through week 12.
A statistically significant difference in response for the ACR20, ACR50 and ACR70 secondary endpoints was observed with the 1 mg, 4 mg and 8 mg dose groups compared with placebo.
The company stated that the most common treatment-emergent adverse event class was infections, with a similar rate observed among patients in the placebo group (12 percent) and patients receiving baricitinib (14 percent). One patient in the placebo group was diagnosed with an opportunistic infection of toxocariasis. No deaths or opportunistic infections occurred in the active treatment groups.
The company added that there were seven serious adverse events reported in six patients (two events in the placebo group, four in the 2 mg group and one in the 8 mg group). Dose-dependent changes in laboratory tests (hemoglobin, neutrophil, serum creatinine, LDL and HDL) were observed, with greater changes being observed in the 8 mg baricitinib group.
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by RTT Staff Writer
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