Eli Lilly, Incyte’s rheumatoid arthritis drug studies show positive effect

EliĀ Lilly and Company and Incyte Corporation have announced on Wednesday 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, said the company.

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.

“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.”

At week 4, in patients treated with baricitinib (2 mg and 4 mg doses), the improvement in the physical component score of SF-36 was statistically significant compared to the improvement seen in the placebo group. This improvement was sustained through week 24 for both baricitinib doses.

Both doses of baricitinib (2 mg and 4 mg) also significantly improved fatigue as early as week 4 compared to placebo, and the greater improvement compared to placebo was maintained throughout the study. The study also showed that baricitinib treatment resulted in significant reductions in the duration of morning joint stiffness as early as week 1 (for 4 mg dose) compared to placebo, and the greater improvement compared to placebo was maintained throughout the study. There were also significant improvements in physical functioning and pain in the baricitinib-treated groups at week 12 and week 24, compared with placebo, explained Lilly.

The differences in improvement in Patient’s Global Assessment of Disease Activity and disability were evident as early as week 1 in the baricitinib-treated groups versus placebo. For patient’s assessment of pain, only baricitinib 4 mg was shown to be statistically significantly different from placebo at week 1.

“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.”Ā 

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