Detailed results from phase III study RA-BEAM of LY 3009104 (baricitinib) shown superior to Humira (adalimumab) in rheumatoid arthritis- Eli Lilly/Incyte

Eli Lilly and Incyte Corporation announced further detailed data from pivotal phase III study RA-BEAM of LY 3009104 (baricitinib) in rheumatoid arthritis (RA) patients. The findings demonstrated statistical superiority for investigational therapy baricitinib over Humira (adalimumab) after 12 weeks based on several critical measures of rheumatoid arthritis disease activity, including ACR20, ACR50 and ACR70 response rates – composite scores that represent at least a 20%, 50% and 70% improvement in multiple components of RA disease activity.

Improvements in mean number of swollen and tender joints and a reduction in pain were seen as early as one week for baricitinib versus placebo. At 52 weeks, baricitinib significantly improved all seven components of the ACR composite score compared to adalimumab, including reducing the number of tender and swollen joints, reducing patients' pain and improving physical function. Patient-reported outcomes, including degree of tiredness and the severity and duration of morning joint stiffness, assessed daily for the first 12 weeks of the study, were all significantly improved with baricitinib compared to adalimumab. At week 52, structural changes in the joints, as measured by changes in the modified Total Sharp Score, were significantly improved for both baricitinib and adalimumab compared with placebo.

Comment: Lilly and Incyte previously announced that the study met its primary objective of demonstrating superiority for baricitinib versus placebo based on ACR20 response rate after 12 weeks of treatment. Data were presented at the American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting.