Longterm safety and effectiveness of the anti-interleukin 6 receptor monoclonal antibody tocilizumab in patients with systemic juvenile idiopathic arthritis in Japan.

摘要: Objective. To assess the longterm safety and effectiveness of tocilizumab (TCZ) in systemic-onset juvenile idiopathic arthritis (sJIA). Methods. The extension phase 2 pivotal studies (phase II with 11 patients III 56 patients) active sJIA was analyzed. Patients received open-label TCZ (8 mg/kg, every weeks) without concomitant use disease-modifying antirheumatic drugs. Results. In total, 67 were enrolled. All corticosteroid at baseline. Median duration exposure to 3.4 years. Nine withdrew from study [4 because adverse events (AE), 4 development anti-TCZ antibodies, 1 inadequate response]. Rates AE serious 803.7/100 patient-years (PY) 34.7/100 PY, respectively. most common infections (13.2/100 PY). No cases malignancy or death reported. Two infusion reactions reported testing negative for antibodies. One definite macrophage activation syndrome (MAS) case potential MAS identified. American College Rheumatology (ACR) response rates attained early treatment period maintained throughout study: Week 168, JIA ACR 30, 50, 70, 90, 100 80.3%, 75.4%, 60.7%, 18.0%, 22 (32.8%) completely discontinued corticosteroids flare. Conclusion. has demonstrated durability children shown good tolerability a low discontinuation rate associated AE, response. (ClinicalTrials.govNCT00144599 NCT00144612). (First Release March 15 2014; J Rheumatol 2014;41:759-67; doi:10.3899/jrheum.130690)