Eli Lilly and Company and Incyte Corporation have reached the primary endpoint at their joint phase 3 study for an investigational medication for the treatment of rheumatoid arthritis, called RA-BEACON. The phase 3 study is analyzing the drug baricitinib, and the first endpoint met is the improvement of ACR20 response compared to placebo after 12 weeks of treatment.
During RA-BEACON investigators are analyzing data from patients who suffered from moderately-to-severely active RA, as well as had previously failed one or more tumor necrosis factor (TNF) inhibitors and were being treated with stable doses of conventional disease-modifying anti-rheumatic drugs (cDMARD). Lilly and Incyte have also announced that they will both announce the preliminary results of the ongoing studies during the next year.
“People with rheumatoid arthritis who have had an inadequate response to TNF inhibitors are generally considered to be the least responsive to subsequent treatments,” said the senior vice president of Lilly and president of Lilly Bio-Medicines, David Ricks. “These results give us further confidence in the potential for baricitinib to be a meaningful treatment option for those suffering from this debilitating condition.”
RA-BEACON has included 527 patients, most of them who had previously been submitted to treatments with either one or more non-anti-TNF biologic agents. During the trial, the participants have been administrated with either one of two doses of once daily baricitinib or placebo, which were added to their conventional disease-modifying anti-rheumatic drug therapy (cDMARDs).
“We are very pleased by these results,” added the chief of drug development and medical officer at Incyte Corporation, Rich Levy, M.D. “Over the next 12 months we look forward to seeing the data from additional Phase 3 studies of baricitinib in rheumatoid arthritis, including patients who have had an inadequate response to conventional DMARDs and in those with earlier stage disease.”
No serious adverse effects were registered with baricitinib, more than with placebo. There were no reports of opportunistic infections or gastrointestinal perforations during the study. On the other hand, the incidence of treatment-emergent adverse events was higher than the one with placebo, being the most common symptoms headaches, upper respiratory tract infections and nasopharyngitis.
Lilly and Incyte will now continue with their ongoing RA-BEACON study, in order to assess the safety and efficacy of baricitinib within a major phase 3 program, which will enroll a total of more than 3,000 rheumatoid arthritis patients. Detailed data will be presented at scientific meetings during the next year.