BERLIN, June 8, 2012 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (Nasdaq: INCY) 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). The results were presented as a late-breaking oral presentation at the European League Against Rheumatism's (EULAR) Annual European Congress of Rheumatology [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.
Primary Endpoint Achieved
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 percent) compared with placebo (41 percent) 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.Summary of Secondary Endpoints A statistically significant difference in response for the ACR20, ACR50 and ACR70 secondary endpoints was observed with the 1 mg, 4 mg and 8 mg dose groups compared with placebo. ACR20
- 8 mg: 78 percent (p<0.001)
- 4 mg: 75 percent (p<0.001)
- 2 mg: 54 percent (not significant)
- 1 mg: 57 percent (p<0.05)
- Placebo: 41 percent
- 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
- 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
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