Baricitinib: Additional Phase III data

Additional data from the double-blind, international Phase III RA-BEGIN trial in 584 patients with moderately to severely active RA who had limited or no prior treatment with methotrexate and who were naive to other conventional or biologic DMARDs showed that once-daily 4 mg oral baricitinib led to an ACR20 response rate at week 24, the primary endpoint, of 77% vs. 62% for once-weekly methotrexate (p<=0.01). Baricitinib plus methotrexate led to an ACR20 response rate of 78% (p<=0.001 vs. methotrexate alone). On secondary endpoints, baricitinib alone and with methotrexate led to ACR50 response rates of 60% and 63% at week 24, respectively, vs. 43% for methotrexate alone (p<=0.01 and p<=0.001, respectively). Baricitinib alone and with methotrexate led to ACR70 response rates of 42% and 40% at week 24, respectively, vs. 21% for methotrexate alone (p<=0.001 for both).

Additionally, 57% and 60% of patients receiving baricitinib alone and with methotrexate, respectively, achieved a DAS28 score calculated using C-reactive protein (DAS28-CRP) of <=3.2 points at week 24 vs. 38% of patients receiving methotrexate alone (p<=0.01 and p<=0.001, respectively). Furthermore, 40% and 41% of patients receiving baricitinib alone and with methotrexate, respectively, achieved a DAS28-CRP score of <2.6 points at week 24 vs. 24% of patients receiving methotrexate alone (p<=0.01 and p<=0.001, respectively). At week 24, baricitinib alone and with methotrexate led to Clinical Disease Activity Index (CDAI) scores of <=10 points in 60% and 59% of patients, respectively, vs. 39% of patients receiving methotrexate alone (p<=0.001 for both) and CDAI scores <=2.8 points in 21% and 22% of patients, respectively, vs. 11% of patients receiving methotrexate alone (p<=0.05 and p<=0.01, respectively). Data were presented at the American College of Rheumatology and the Association of Rheumatology Health Professionals meeting in San Francisco. ...