Eli Lilly and Company and Incyte Corporation announced that new data from RA-BEACON, a phase 3 study of baricitinib in the treatment of moderate-to-severe rheumatoid arthritis (RA), indicated baricitinib had demonstrated significant improvement in patient-reported outcomes and health-related quality of life (HRQOL) measures, fatigue and pain compared with placebo.
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 trial included patients who had insufficient response or intolerance to earlier treatment with biologic disease-modifying anti-rheumatic drugs (bDMARDs), including tumour necrosis factor (TNF) inhibitors.
In these patients, treatment with baricitinib through to 24 weeks significantly improved most patient-reported outcomes compared with placebo, and patients receiving 4mg of baricitinib indicated the most rapid and greatest change.
Baricitinib has also previously shown significant clinical efficacy in the 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. The SF-36 reports physical and mental component scores.
The study results indicated that at week 12, a clinically important improvement in the physical component score was achieved by 49% of patients taking 2mg of baricitinib, 53% of patients taking 4mg of baricitinib and 32% of patients in the placebo group.
At week 24, a clinically important improvement in the physical component score was achieved by 39% of patients taking 2mg of baricitinib, 45% of patients taking 4mg of baricitinib and 21% of patients in the placebo group.
Lilly's senior medical director for baricitinib Terence Rooney said: "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.
"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."
During week four, patients treated with baricitinib (2mg and 4mg doses) had shown a statisically significant improvement in the physical component score of SF-36 when compared to the improvement seen in the placebo group, and this improvement was sustained through week 24 for both baricitinib doses.