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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

cine and co-chief, division of immunology and rheumatology at Stanford University School of Medicine in Palo Alto, Calif., and steering committee member for the study. "Also of note is that the percentage of patients achieving ACR50 and ACR70 increased over time and no unexpected safety findings emerged with continued dosing."

Also Presented: MRI Findings
The study also included a large sub-study of 154 patients using Magnetic Resonance Imaging to examine the effect of different doses of baricitinib on joint changes in a subgroup of patients with erosive RA and inadequate response to treatment with methotrexate. There was statistically significant improvement in both the Total Inflammation Score and the Total Joint Damage Score for both 4 mg and 8 mg baricitinib doses compared with placebo at 12 weeks. The effects persisted through 24 weeks.

"This sub-study illustrates not only the efficacy of oral baricitinib in suppressing joint damage in RA, but also the power of MRI to demonstrate therapeutic effects in RA on synovitis, osteitis, bone erosion and even articular cartilage loss far more quickly (within only 12 weeks) and with far fewer patients than would be needed with conventional radiography," said Charles Peterfy, M.D., Ph.D., president and CEO of Spire Sciences LLC, who performed the image analyses.

"We believe the janus kinase inhibitors are an innovative class of molecules which we hope have the potential to improve outcomes for patients with diseases such as rheumatoid arthritis. We are very encouraged about the results for baricitinib, which represent the first 24-week clinical data for a selective JAK1 and JAK2 inhibitor in RA," said Eiry Roberts, M.D., vice president of autoimmune product development at Lilly. "Based on the benefit/risk data from the Phase II program for baricitinib, we recently moved ahead with Phase III clinical trials in RA."

Safety Results
In the 12-week portion of the study, the most common trea
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SOURCE Eli Lilly and Company; Incyte Corporation
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