Subcutaneous Orencia: Ph III data

An open-label, international Phase III trial in 205 patients with active polyarticular JIA with an inadequate response or intolerance to ≥1 DMARD showed that once-weekly subcutaneous Orencia for 4 months led to a Cmin of 50.1 µg/ml in the cohort of patients ages 2-5 and 42.1 µg/ml in the cohort of patients ages 6-17, achieving the primary endpoint of a target therapeutic Cmin of ≥10 µg/ml at 4 months in the latter cohort. In patients ages 2-5, 86.7% of patients achieved an ACR30 response and 70% of patients achieved an ACR70 response. In patients age 6-17, 80.9% of patients achieved an ACR30 response and 52.6% of patients achieved an ACR70 response. Orencia also led to inactive disease responses, defined as no active joints, physician's global assessment of disease activity of <10 mm and C-reactive protein (CRP) levels of <0.6 mg/dL, in 51.7% of patients ages 2-5 and 29.5% of patients ages 6-17...