Lilly’s RA drug baricitinib meets Phase III goals
pharmafile | March 31, 2016 | News story | Research and Development | Eli Lilly, Incyte, rheumatoid arthritis
Eli Lilly and Incyte have announced the publication of detailed Phase III trial results from a study of their biologic rheumatoid arthritis drug baricitinib.
As revealed by the data published in the New England Journal of Medicine, the study met its primary endpoint of improved ACR 20 response for baricitinib compared with placebo at week 12. ACR 20 represents at least a 20 percent improvement across selected measures of disease activity.
The RA-BEACON study enrolled 527 patients who previously had failed at least one tumour necrosis factor (TNF) inhibitor, and included 199 patients who also had received prior treatment with one or more non-anti-TNF biologic agents.
55% of patients receiving a 4mg dose of baricitinib achieved an ACR 20 response, as did 49% of those receiving a 2mg dose. 27% of patients receiving a placebo achieved ARC 20. ACR 50 and ACR 70 response rates were also significantly higher for baricitinib compared with placebo at week 12.
“The findings from the RA-BEACON study suggest treatment with baricitinib is associated with meaningful improvements in RA symptoms,” says Terence Rooney, Lilly’s senior medical director for baricitinib. “The baricitinib clinical development program includes a wide range of patients across the RA treatment spectrum. If approved, baricitinib may be a valuable option for rheumatologists and patients who are looking for new alternatives to treat this debilitating disease.”
“The RA patient community is diverse and there continues to be a need for more therapeutic options that address individual treatment needs, including in patients whose disease has not responded to TNF inhibitor therapy,” said Rich Levy, Incyte’s chief drug development officer.
Lilly is currently awaiting a decision on baricitinib’s approval from the US FDA. Lilly licensed the drug from Incyte in 2009.
Joel Levy
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