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Lilly and Incyte Announce Baricitinib Efficacy and Safety Data from the Open-Label, Long-Term Extension of the Phase 2b JADA Study in Patients with Rheumatoid Arthritis
Date:6/13/2013

tal Sciences in the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford, and steering committee member for the study.

A copy of the EULAR oral presentation can be accessed at:  2013 EULAR - JADA 52-Week Presentation  

Trial DesignThis randomized, open-label, long-term extension of Phase 2b JADA study included 201 (95 percent) of the eligible 212 patients. Of the 201 patients, 184 completed 52 weeks of treatment, 15 discontinued treatment, and two patients had not yet completed the full 52 weeks of treatment. Patients received either 4 mg or 8 mg once-daily doses of baricitinib beginning at week 24 through week 52.

In the initial 12-week treatment duration, patients received one of four doses of baricitinib (1 mg, 2 mg, 4 mg or 8 mg) or placebo, administered once daily. 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 who completed week 24 were eligible to receive either the 4- or 8-mg once daily dose through week 52. The study is ongoing, with all patients who are continuing in the study receiving baricitinib 4 mg once daily.

About JAK InhibitionThere are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2.[3] These enzymes are critical components of signaling mechanisms used by a number of cytokines and growth factors, including several that are elevated in patients with RA. Cytokines such as interleukin-6, -12 and -23 and both type 1 and type 2 interferons signal through these pathways. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoi
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SOURCE Eli Lilly and Company; Incyte Corporation
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