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news.Roche said that RoActemra (known as Actemra outside Europe) is effective in improving the signs and symptoms of systemic Juvenile Idiopathic Arthritis (sJIA). RoActemra is also well tolerated in children with sJIA having a safety profile similar to adults with RA.
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Data from the phase III Tender study showed that, following three months’ treatment with RoActemra, 85% of patients achieved 30% improvement (JIA ACR30) in the signs and symptoms of sJIA and absence of fever, a primary characteristic of sJIA, compared to 24% of patients receiving placebo.
Further data showed 70% achieved JIA ACR70 and 37% achieved ACR90. In addition to the improvement in JIA ACR response nearly two thirds were free of rash after three months.
Roche said that the Tender study findings reflect previous Japanese studies, which demonstrated that RoActemra is well tolerated and effective in children with sJIA who could not tolerate, or showed inadequate response to systemic corticosteroids and immunosuppressants.
Further, RoActemra is already approved in the EU, US and other countries for adult RA, a disease also associated with elevated levels of IL-6 and systemic symptoms such as fatigue, anaemia and fever.
Studies in RA have demonstrated RoActemra’s strong efficacy and safety, with consistently high remission rates across all patient types and inhibition of structural joint damage. In addition it is the only product to have proven superiority to methotrexate in monotherapy in ACR20, ACR50 and ACR70 responses at six months, in adult RA.
Hal Barron, head of global development and chief medical officer for Roche, said: “RoActemra’s striking efficacy confirms a major advance in the treatment of this disease. It promises to have a significant impact in the life of these young children.
“RoActemra inhibits the activity of interleukin-6 (IL-6), a contributor to the major features of sJIA including chronic synovial inflammation, articular cartilage damage, fever, anaemia, growth impairment and osteoporosis. Commenting on IL-6 as a treatment approach.
“RoActemra’s efficacy in treating these symptoms provides further evidence of the pivotal role of IL-6 in mediating joint inflammation and the detrimental systemic effects of chronic inflammatory diseases.”