Eli Lilly and Company and Incyte Corporation announced that the RA-BEACON Phase 3 study of baricitinib, an investigational drug for RA, improved the ACR20 response (the response that indicates how much a person’s rheumatoid arthritis improved) in comparison to placebo after twelve weeks of treatment.
The study enrolled 527 patients with moderate and severe active rheumatoid arthritis (RA) that previously failed on one or more tumor necrosis factor (TNF) inhibitors and also patients that were on stable doses of conventional disease-modifying anti-rheumatic drug (cDMARD) therapy. Patients took one or two doses of baricitinib (a once daily drug) or placebo while continuing to take their conventional drugs as well. Other results regarding ongoing Phase 3 projects will be shared in 2015.
RA is an autoimmune condition that is characterized by inflammation and consequent destruction of joints. It affects more than 23 million people in the world, and women are 3 times more likely to have the disease.
Lilly and Lilly Bio-Medicines president David Ricks said in a press release: “People with rheumatoid arthritis who have had an inadequate response to TNF inhibitors are generally considered to be the least responsive to subsequent treatments. These results give us further confidence in the potential for baricitinib to be a meaningful treatment option for those suffering from this debilitating condition.”
Rich Levy, M.D., from Incyte Corporation added: “We are very pleased by these results. 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.”
Serious and adverse events caused by the baricitinib treatment were reported to have had the same incidence as with the placebo. No gastrointestinal perforations or opportunistic infections were observed. However, a higher incidence of adverse events was assessed in baricitinib treatments compared to placebo; the adverse events registered were nasopharyngitis, upper respiratory tract infection and headache. Furthermore, discontinuation rates caused by adverse events were the same in each group, and the majority of the patients decided to undergo a long term program of the drug after the six-month trial was over.
The companies are conducting 4 Phase 3 clinical trials of baricitinib to support its submission to drug authorities in most countries, and the current trials include patients that have not responded to other therapies.