Eli Lilly and Company and Incyte Corporation announced 24-week results from the continuation of an ongoing Phase 2b 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. 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.
"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."
Date: November 13, 2012
Source: Eli Lilly and Company