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|Lilly and Incyte Announce Additional Phase IIb Baricitinib Data, Including MRI Results, in Patients with Rheumatoid Arthritis|
Positive results of the placebo-controlled 12-week portion of the study were presented at the European League Against Rheumatism's (EULAR) Annual
"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
Also Presented: MRI Findings
"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
"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."
Over 24 weeks in the combined 2 mg, 4 mg and 8 mg groups, the rate of TEAEs was 64 percent (36 percent mild, 23 percent moderate, 5 percent severe) and the rate of serious adverse events was 5 percent.
There were no opportunistic infections and no deaths reported through week 24. Dose-dependent changes in laboratory tests (hemoglobin, lymphocyte and neutrophil count, low-density lipoprotein and high-density lipoprotein) were observed, with greater changes being observed in the 8 mg baricitinib group than in the 2 mg and 4 mg groups.
Trial Design and Status
In the initial 12-week treatment duration, patients received one of four doses of baricitinib or placebo. In the 12- to 24-week portion of the study, patients initially randomized to placebo or the 1 mg baricitinib dose were re-randomized to receive either 4 mg once daily or 2 mg twice daily for an additional 12 weeks; patients initially randomized to the 2 mg, 4 mg and 8 mg doses continued therapy with those doses. Patients are continuing to participate in the open-label long-term extension phase of the trial.
About JAK Inhibition
Four Phase III RA studies are planned, which will investigate the safety and efficacy of baricitinib 2 mg and 4 mg once daily in patients with active RA who are methotrexate-naive, biologic-naive or biologic-experienced. Patients completing any of the four studies will be eligible for enrollment in a fifth study, a long-term extension.
About Rheumatoid Arthritis
Current treatment of RA includes the use of non-steroidal anti-inflammatory drugs, oral disease-modifying antirheumatic drugs such as methotrexate, and injectable biological response modifiers that target tumor necrosis factor, a pro-inflammatory cytokine implicated in the pathogenesis of RA.
About the Webcast
This press release contains certain forward-looking statements about baricitinib as a potential treatment for patients with rheumatoid arthritis and reflects Lilly and
 Edward Keystone, "Safety and Efficacy of LY3009104 (JAK1/JAK2 inhibitor) in RA Patients with Inadequate Response to MTX" (presented at the Annual
Lilly: Media: Sonja Popp-Stahly, +1-317-655-2993, firstname.lastname@example.org; Investors: Phil Johnson, +1-317-655-6874, email@example.com; Incyte: Media and Investors: Pam Murphy, +1-302-498-6944, firstname.lastname@example.org
The information in the press releases should be considered accurate only as of the date of the document or presentation. We disclaim any obligation to supplement or update the information in these documents or presentations.
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