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Lilly and Incyte Announce Additional Phase IIb Baricitinib Data, Including MRI Results, in Patients with Rheumatoid Arthritis
Date:11/13/2012

tment-emergent adverse event (TEAE) class was infections, with a similar rate observed among patients in the placebo group (12 percent) and patients receiving baricitinib (14 percent).

Over 24 weeks in the combined 2 mg, 4 mg and 8 mg groups, the rate of TEAEs was 64 percent (36 percent mild, 23 percent moderate, 5 percent severe) and the rate of serious adverse events was 5 percent.

There were no opportunistic infections and no deaths reported through week 24. Dose-dependent changes in laboratory tests (hemoglobin, lymphocyte and neutrophil count, low-density lipoprotein and high-density lipoprotein) were observed, with greater changes being observed in the 8 mg baricitinib group than in the 2 mg and 4 mg groups.

Trial Design and Status
This Phase IIb randomized double-blind, placebo-controlled, dose-ranging study, known as JADA, included 301 patients with moderate-to-severe RA with inadequate response to treatment with methotrexate.

In the initial 12-week treatment duration, patients received one of four doses of baricitinib or placebo. In the 12- to 24-week portion of the study, patients initially randomized to placebo or the 1 mg baricitinib dose were re-randomized to receive either 4 mg once daily or 2 mg twice daily for an additional 12 weeks; patients initially randomized to the 2 mg, 4 mg and 8 mg doses continued therapy with those doses. Patients are continuing to participate in the open-label long-term extension phase of the trial.

About JAK Inhibition
There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. These enzymes are critical components of signaling mechanisms used by a number of cytokines and growth factors, including those that are elevated in RA patients. Cytokines such as interleukin-6, -12 and -23 and both type 1 and type 2 interferons signal through the JAK/STAT pathways. Additional JAK-dependent cytokines also have been implicated in a number of inflammatory and autoimmune diseases, suggesting
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SOURCE Eli Lilly and Company; Incyte Corporation
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