Eli Lilly And Co And Incyte Corporation Announces Results Of Baricitinib Ph2b RA Data

Eli Lilly And Co and Incyte Corporation announced the presentation of 12-week results from a Phase IIb study of baricitinib, formerly LY3009104 (INCB28050), an orally available janus kinase (JAK) inhibitor, in patients with active rheumatoid arthritis (RA). EULAR abstract LB0005: 12-Week Results of a Phase IIb Dose-Ranging Study of LY3009104 (INCB028050), an Oral JAK1/JAK2 Inhibitor, in Combination with Traditional DMARDs in Patients with Rheumatoid Arthritis. 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%) compared with placebo (41%) 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. The common treatment-emergent adverse event class was infections, with a similar rate observed among patients in the placebo group (12%) and patients receiving baricitinib (14%). One patient in the placebo group was diagnosed with an opportunistic infection of toxocariasis.