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Lilly and Incyte's Oral JAK1 and JAK2 Inhibitor, Baricitinib, Showed Positive Results in Phase IIb Study in Patients with Active Rheumatoid Arthritis
Date:6/8/2012

not significant)
  • 1 mg: 57 percent (p<0.05)
  • Placebo: 41 percent
  • ACR50

    • 8 mg: 40 percent (p<0.001)
    • 4 mg: 35 percent (p<0.001)
    • 2 mg: 17 percent (not significant)
    • 1 mg: 31 percent (p<0.05)
    • Placebo: 10 percent

    ACR70

    • 8 mg: 20 percent (p<0.001)
    • 4 mg: 23 percent (p<0.001)
    • 2 mg: 8 percent (not significant)
    • 1 mg: 12 percent (p<0.05)
    • Placebo: 2 percent

    Safety Results

    The most common treatment-emergent adverse event class was infections, with a similar rate observed among patients in the placebo group (12 percent) and patients receiving baricitinib (14 percent). One patient in the placebo group was diagnosed with an opportunistic infection of toxocariasis. No deaths or opportunistic infections occurred in the active treatment groups.

    There were seven serious adverse events reported in six patients (two events in the placebo group, four in the 2 mg group and one in the 8 mg group). Dose-dependent changes in laboratory tests (hemoglobin, neutrophil, serum creatinine, LDL and HDL) were observed, with greater changes being observed in the 8 mg baricitinib group. 

    A copy of the EULAR oral presentation can be accessed at:  Link to Presentation.

    Trial Design and Status

    This Phase IIb trial consists of three parts: Part A, Part B and an open-label extension. Part A was randomized, double-blind and placebo-controlled. Patients randomized to baricitinib received one of four doses administered once daily for 12 weeks.

    In Part B, patients initially randomized to placebo or the 1 mg baricitinib dose were re-randomized to receive either 4 mg once da
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    SOURCE Eli Lilly and Company; Incyte Corporation
    Copyright©2012 PR Newswire.
    All rights reserved

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