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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

MADRID, June 13, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (Nasdaq: INCY) today announced 52-week efficacy and safety data from the open-label, long-term extension of the Phase 2b JADA study of baricitinib in patients with active rheumatoid arthritis (RA). Baricitinib, formerly LY3009104 (INCB28050), is an orally available Janus kinase (JAK) inhibitor being studied for use in the treatment of certain autoimmune conditions, including RA. Among patients completing the open-label extension, clinical improvements observed at week 24 were sustained at the end of 52 weeks. The results were presented at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Madrid, Spain [EULAR abstract OP0047: Baricitinib, an Oral Janus Kinase Inhibitor, in the Treatment of Rheumatoid Arthritis: Safety and Efficacy in Open-Label, Long-Term Extension Study].

The long-term extension of the JADA study evaluated the efficacy and safety of baricitinib in 201 patients taking either 4 mg (n=108) or 8 mg (n=93) once daily for up to 52 weeks. Doses could be escalated to 8 mg once daily at 28 or 32 weeks at the investigator's discretion when the patient presented more than six tender and swollen joints.

As previously reported, in the initial 12-week portion of this study, baricitinib was associated with statistically significant improvements in the signs and symptoms of RA disease versus placebo[1] and these responses were maintained or improved during an additional 12 weeks of blinded treatment.[2]

In the long-term extension, the clinical improvements observed at week 24 were sustained through 52 weeks in RA patients. The following chart summarizes selected efficacy results:

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SOURCE Eli Lilly and Company; Incyte Corporation
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