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Lilly and Incyte Announce Additional Phase IIb Baricitinib Data, Advance into Phase III Trials


Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (Nasdaq: INCY) today announced 24-week results from the continuation of an ongoing Phase IIb study of baricitinib, an orally available janus kinase (JAK) inhibitor, in patients with moderate-to-severe rheumatoid arthritis (RA) who had an inadequate response to treatment with methotrexate. Additionally, Magnetic Resonance Imaging (MRI) technology was used in a sub-study to examine the effect of baricitinib on joint erosion and other markers of structural changes in and around the joint. The findings were presented at the annual meeting of the American College of Rheumatology (ACR) in Washington, D.C.

Positive results of the placebo-controlled 12-week portion of the study were presented at the European League Against Rheumatism's (EULAR) Annual European Congress of Rheumatology in June 2012.[1] Patients taking baricitinib 4 mg or 8 mg once daily reported significant differences in ACR20, ACR50 and ACR70 responses compared with patients taking placebo. Data from the 12- to 24-week portion of the study, which did not include a placebo control, showed that patients who continued to receive 2 mg, 4 mg or 8 mg baricitinib once daily doses maintained or improved ACR20, ACR50 and ACR70 responses. The following chart defines the percentage of patients that achieved ACR20, ACR50 and ACR70 at 24 weeks of treatment with baricitinib.

Response at 24 weeks 2 mg

(n=52) 4 mg (n=52) 8 mg (n=50) ACR20 63 78 73 ACR50 20 48 55 ACR70 10 28 24

"These data are important because collectively they show patients experienced improvement with baricitinib as early as week two that was sustained through week 24," said Mark Genovese, M.D., the James Raitt professor of medicine 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

Posted-In: News FDA


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