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Roche today announced that new data being presented at the European League Against Rheumatism (EULAR) congress demonstrates that RoACTEMRA (known as ACTEMRA outside Europe) is highly effective in improving the signs and symptoms of systemic Juvenile Idiopathic Arthritis (sJIA), a severe childhood arthritis, where there are no currently licensed treatments. RoACTEMRA is also well tolerated in children with sJIA having a safety profile similar to adults with RA.
Data from the phase III TENDER studyi showed that, following three months’ treatment with RoACTEMRA, 85 percent of patients achieved 30 percent improvement (JIA ACR30*) in the signs and symptoms of sJIA and absence of fever, a primary characteristic of sJIA, compared to 24 percent of patients receiving placebo.
Further data showed 70 percent achieved JIA ACR70 and 37 percent achieved ACR90. In addition to the significant improvement in JIA ACR response nearly two thirds were free of rash after three months.
“There is a critical need for new therapies for children suffering from the debilitating and life-threatening effects of sJIA, and these data represent an exciting breakthrough”, commented Hal Barron, M.D, Head of Global Development and Chief Medical Officer for Roche. “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.”