Roche has unveiled promising late-stage data on Actemra, which shows that the drug significantly improved symptoms of systemic onset juvenile idiopathic arthritis.

Results from the Phase III 108-patient TENDER study showed that a greater proportion of children with sJIA treated with Actemra (tocilizumab), known as RoActemra within the European Union, had fewer disease signs and symptoms after 12 weeks of therapy, compared with those on placebo. The findings confirm earlier data from two Japanese studies and showed that the drug was well tolerated.

Roche noted that 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." The disease accounts for almost two-thirds of all deaths among children with arthritis and the overall mortality rate is estimated to be between 2%-4%.

William Burns, chief executive of Roche’s pharmaceuticals division, said the TENDER data show the potential of Actemra as “a highly effective and well-tolerated treatment for children suffering from sJIA”. He added that 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”.

The data will be used to support future regulatory filings for Actemra in sJIA. The drug, a novel interleukin-6 receptor-inhibiting monoclonal antibody, was first approved in Japan and launched by Roche unit Chugai in June 2005 as a therapy for Castleman's disease and then in April 2008 for rheumatoid arthritis, juvenile idiopathic arthritis and sJIA.

RoActemra was approved in the EU in January this year for the treatment of RA in patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease modifying anti-rheumatic drugs or TNF inhibitors. It is also marketed in several other countries, including India, Brazil, Switzerland and Australia, and was refilled with the US Food and Drug Administration this summer.