Phase III RA-BEACON trial of LY 3009104 (baricitinib) in rheumatoid arthritis met endpoint and is published in NEJM- li Lilly/Incyte

Eli Lilly and Incyte Corporation announced that detailed results of RA-BEACON — a pivotal phase III global study of LY 3009104 (baricitinib) for the treatment of moderate-to-severe rheumatoid arthritis (RA) met its primary endpoint of improved ACR 20 response for baricitinib compared with placebo at week 12. ACR 20 represents at least a 20 percent improvement across selected measures of disease activity. ACR 20 response rates were as follows: 55 percent for baricitinib 4 mg, 49 percent for baricitinib 2 mg and 27 percent for placebo.

A statistically significant improvement in ACR 20 response rate with baricitinib versus placebo was observed as early as one week. ACR 50 and ACR 70 response rates were also significantly higher for baricitinib compared with placebo at week 12.A significantly greater proportion of patients treated with baricitinib also achieved a DAS28-CRP score—a measure of RA disease activity—below 2.6 (indicating disease remission) at week 12 compared with patients receiving placebo. Additionally, a greater proportion of patients treated with baricitinib versus placebo achieved score improvements of at least 0.3 on the Health Assessment Questionnaire Disability Index (HAQ-DI)—a patient-reported assessment of physical function— at week 12.Significant improvements in ACR response rates, DAS28-CRP and HAQ-DI that were noted with baricitinib versus placebo at week 12 were maintained through week 24.

Through 24 weeks, the rate of treatment-emergent adverse events (AEs) was higher for baricitinib 4 mg (77 percent) and baricitinib 2 mg (71 percent) than for placebo (64 percent). Discontinuation rates due to AEs were 6 percent, 4 percent and 4 percent, respectively. Data were published in the New England Journal of Medicine.