The FDA has approved Actemra (tocilizumab; Genentech), given alone or in combination with methotrexate, for the treatment of active systemic juvenile idiopathic arthritis (SJIA), or Still’s disease, in children ≥2 years. This approval was based on data from an international, multicenter, controlled trial in which 112 patients aged 2–17 years old with SJIA, who demonstrated inadequate response to or were unable to take NSAIDs and corticosteroids, received either Actemra infusions or placebo infusions every two weeks. Response was defined as at least 30% improvement in the American College of Rheumatology’s JIA efficacy variables, along with absence of fever in the preceding seven days. Study results showed that 85%percent of those receiving Actemra responded to treatment compared with 24% of patients receiving placebo.
Actemra, an interleukin-6 receptor blocker, is already approved for the treatment of adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to other approved therapies.
For more information call (800) 821-8590 or visit www.actemra.com.