Eli Lilly and Company and Incyte Corporation announced that new data from RA-BEACON - a pivotal phase 3 study of baricitinib in the treatment of moderate-to-severe rheumatoid arthritis (RA) - showed baricitinib demonstrated significant improvement in patient-reported outcomes and health-related quality of life (HRQOL) measures, fatigue and pain compared with placebo. The results of the study were published in Annals of the Rheumatic Diseases. The global trial is part of the ongoing study of baricitinib, a once-daily oral medication currently under regulatory review for the treatment of moderate-to-severe RA.
The RA-BEACON study included patients who had insufficient response or intolerance to previous treatment with biologic disease-modifying antirheumatic drugs (bDMARDs), including tumor necrosis factor (TNF) inhibitors. In these patients, treatment with baricitinib through 24 weeks significantly improved most patient-reported outcomes compared with placebo, and patients receiving baricitinib 4 mg showed the most rapid and greatest change. Previously, baricitinib has also shown significant clinical efficacy in these patients.
HRQOL was assessed using the 36-Item Short Form Health Survey (SF-36), a patient-reported instrument that collects information in multiple domains, including physical function, bodily pain, general health, limitation in role, vitality and social functioning.
"These positive results from the RA-BEACON study, which assessed outcomes that impact health-related quality of life, fatigue and pain, reinforce baricitinib's potential to address an unmet need for patients with rheumatoid arthritis whose previous treatment with biologics failed," said Terence Rooney, M.D., Lilly's senior medical director for baricitinib. "If approved, baricitinib may help address some of the challenges patients with rheumatoid arthritis who are not achieving remission or low disease activity with their current biologic therapy face when performing daily activities."
"In addition to symptoms associated with inflammation, patients with RA commonly suffer from impaired physical function and fatigue, which can significantly impact their quality of life," said Steven Stein, M.D., chief medical officer, Incyte Corporation. "It's encouraging to see that treatment with baricitinib, at both doses studied, improves the debilitating symptoms experienced by patients with RA, especially in those for whom biologic DMARDs have not been effective."
The RA-BEACON study enrolled 527 patients who previously had failed at least one TNF inhibitor, and included 199 patients who also had received prior treatment with one or more non-anti-TNF biologic agents. Patients received baricitinib 4 mg (n=177) or 2 mg (n=174) or placebo (n=176) daily, in addition to their existing background therapies, for 24 weeks. Clinical efficacy and safety results from the RA-BEACON study were published earlier this year in the New England Journal of Medicine.
In RA-BEACON, through 24 weeks, 77 percent of patients on baricitinib 4 mg and 71 percent of patients on baricitinib 2 mg experienced treatment-emergent adverse events (AEs), compared to 64 percent of patients in the placebo group. Discontinuation rates due to AEs were 6 percent, 4 percent and 4 percent, respectively.
The most common AEs reported for baricitinib-treated patients included headache, upper respiratory infections and nasopharyngitis. There were no cases of tuberculosis or gastrointestinal perforations. Rates of serious adverse events (SAEs) were 10 percent for baricitinib 4 mg, 4 percent for baricitinib 2 mg and 7 percent for placebo. One death was reported in the baricitinib 4 mg dose group (stroke). A large majority of patients completing this 6-month trial opted to participate in a long-term extension study.
