RA-BEAM study of baricitinib, a treatment for moderate-to-severe rheumatoid arthritis is published in NEJM.- Eli Lilly + Incyte

Eli Lilly and Company and Incyte Corporation announced additional detailed results from RA-BEAM - a pivotal phase III study of baricitinib in the treatment of moderate-to-severe rheumatoid arthritis (RA) - were published in the New England Journal of Medicine. The New England Journal of Medicine publication includes supplementary data, which show that starting as early as week 8, and sustained through week 52, a higher proportion of patients taking baricitinib achieved ACR50 and ACR70 response - composite scores that represent at least 50 percent and 70 percent improvement, respectively, in multiple components of RA disease activity - compared to adalimumab (Humira). These improvements were statistically significant compared to adalimumab at weeks 12, 20, 28, 32 and 40. At week 52, both ACR50 and ACR70 rates were higher in the baricitinib group compared to adalimumab, although only ACR 50 was statistically significant.A significantly higher proportion of patients taking baricitinib had low disease activity, assessed by the 28-joint Disease Activity Score (using high-sensitivity C reactive protein [DAS28-CRP]), Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) scores, compared to adalimumab at weeks 12 and 52.

Lilly and Incyte previously announced positive topline results of RA-BEAM, stating that the study met its primary objective of demonstrating superiority compared to placebo after 12 weeks of treatment based on ACR20 response - a standard clinical measure that represents at least a 20 percent improvement in RA disease activity.

See-"Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis"- Peter C. Taylor, M.D., Ph.D., Edward C. Keystone, M.D., D�sir�e van der Heijde, M.D., Ph.D., Michael E. Weinblatt, M.D., nie de Bono, M.D., Ph.D., and Yoshiya Tanaka, M.D., Ph.D. et.al.-N Engl J Med 2017; 376:652-662February 16, 2017DOI: 10.1056/NEJMoa1608345.