Roche's ACTEMRA Has Met Its Primary Endpoint In A Pediatric Study of Systemic Onset Juvenile Idiopathic Arthritis
Fri, 11/20/2009 - 3:30am
Roche announced today that ACTEMRA (tocilizumab, known as RoACTEMRA within the EU) successfully met its primary endpoint in a paediatric study of systemic onset Juvenile Idiopathic Arthritis (sJIA), by significantly improving disease signs and symptoms, a critical effectiveness measure of a sJIA treatment. The outcome of the so-called TENDER study is good news for children with this particularly aggressive type of juvenile arthritis. At the moment there are no approved therapies for sJIA, a disease which leads to significant illness with high-spiking fevers, arthritis, rashes, infections, and anaemia. SJIA also accounts for almost two-thirds of all deaths among children with arthritis with an overall mortality rate estimated to be between two to four percent. Results from the TENDER study showed that a greater proportion of patients treated with ACTEMRA benefited from a significant reduction in signs and symptoms (JIA ACR30 and the absence of fever) after 12 weeks of therapy, compared to patients treated with placebo. In the TENDER study, ACTEMRA was generally well tolerated and the overall safety profile after 12 weeks of treatment was consistent with previously reported data from other studies. “The TENDER data show the potential of ACTEMRA as a highly effective and well-tolerated treatment for children suffering from sJIA” said William M Burns, CEO of Roche’s Pharmaceuticals Division. “This is a particularly debilitating disease affecting the entire body in which morbidity is high and there is much need for new treatment options in this area. These results are encouraging and should bring hope to those children affected by this difficult to treat disease.” The TENDER study is the first global phase III trial on ACTEMRA, and it confirms earlier data from two Japanese studies.(2,3) Data from this trial will be submitted for presentation at upcoming international scientific meetings and full data and safety follow-up will be used to support future global regulatory filings for a label in a sJIA indication. ACTEMRA is the first of a new class of drug with a novel mechanism of action. It is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody which works by suppressing the activity of IL-6, an important trigger of the inflammatory process. This novel mode of action reduces inflammation of the joints and relieves complications which can affect internal organs in the body (heart, liver, spleen and lymph nodes) know as systemic effects.