Eli Lilly and partners announced positive top-line Incyte data rheumatoid arthritis (RA) drug RA-BEACON key Phase III studies. The previous study in 527 cases by at least one anti-tumor necrosis factor (TNF) agents (including the blockbuster drug Humira adalimumab and etanercept Enbrel) treatment failures are taking a stable dose of conventional disease-modifying antirheumatic drugs (cDMARD) moderate to severe rheumatoid arthritis (RA) patients conducted.
Study, in addition to receiving cDMARDs background therapy, the patient also received once daily baricitinib or placebo. The results showed that after 12 weeks of treatment, compared with placebo, baricitinib met its primary endpoint of improving ACR20 response.
Safety, baricitinib side effects similar to placebo, common adverse reactions include headache, upper respiratory tract infection and nasopharyngitis. RA-BEACON study is the first critical study of baricitinib III of the project. Lilly will be announced several key phase III trial data at scientific meetings in 2015.
Anti-tumor necrosis factor (TNF) therapies such as Humira Humira (adalimumab), Remicade Remicade (infliximab) MabThera Rituxan / MabThera (rituximab), Enbrel (etanercept) is the world’s best-selling drug, the four were ranked “2013’s 25 best-selling drugs” list. The success of RA-BEACON study indicates baricitinib expected to open up a world in the already crowded market.
Currently, Lilly and Incyte is conducting a large-scale Phase III projects, including four studies conducted in the United States and a study conducted in China, involving 3000 cases of rheumatoid arthritis (RA) patients, to assess the efficacy and baricitinib Security. Lilly is expected to be four phase III US study completed by the end of 2015, and submit a listing application baricitinib based on the results to FDA.
With conventional injectable TNF blockers different, Lilly baricitinib is an oral designed to block the inflammatory signals and treat immunological diseases (including rheumatoid arthritis) of the underlying cause.