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news.Eli Lilly and Company and Incyte's oral JAK1 and JAK2 Inhibitor, Baricitinib, has demonstrated positive results in Phase IIb study in patients with active rheumatoid arthritis.
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Baricitinib is an orally administered selective JAK1 and JAK2 inhibitor that is JAK3-sparing.
A total of 301 patients, with active RA on stable doses of methotrexate, were randomized to receive either placebo or one of four once-daily doses of baricitinib (1mg, 2mg, 4mg or 8mg) for 12 weeks in the double-blind study.
A statistically significant difference in the American College of Rheumatology 20 (ACR20) response between the combined 4mg and 8mg baricitinib groups (76%) compared with placebo (41%) after 12 weeks of treatment was observed, there by reaching the primary endpoint.
The placebo-controlled, dose-ranging study reported that a statistically significant improvement was observed at the first assessment point after two weeks of treatment and was sustained through week 12.
With the 1mg, 4mg and 8mg dose groups compared with placebo, a statistically significant difference in response for the ACR20, ACR50 and ACR70 secondary endpoints was observed.
With greater changes being observed in the 8mg baricitinib group, dose-dependent changes in laboratory tests such as hemoglobin, neutrophil, serum creatinine, LDL and HDL were observed.