Roche’s RoActemra Eases Symptoms of Systemic Juvenile Idiopathic Arthritis in Phase III Study
Trial finds 85% of sJIA patients achieve 30% symptom reduction, and 37% achieve ACR90.
Treatment of systemic juvenile idiopathic arthritis (sJIA) using Roche and Chugai’s RoActemra led to 85% of patients achieving a 30% improvement in the signs and symptoms of their disease (JIA ACR30) and absence of fever, according to new Phase III trial data. The Tender study also found that 70% of children treated using RoActemra for three months achieved JIA ACR70, and 37% achieved ACR 90. Nearly two-third of treated patients were also free from rash after three months.
In comparison, 24% of patients receiving placebo achieved only JIA ACR30. The adverse effect profile of RoActemra therapy was similar to that recorded for adult RA studies, Roche reports. The placebo-controlled Tender trial included 112 patients with active sJIA and spanned 20 countries. The trial data were presented at the recent European League Against Rheumatism (EULAR) Annual Congress in Rome.
There is currently no licensed treatment for children suffering from sJIA, and the Tender study results represent an “exciting breakthrough, ” claims Hal Barron, M.D., Roche’s CMO and head of global development. “It has the worst long-term prognosis of all childhood arthritis subtypes, accounting for almost two-third of all deaths among children with arthritis, with an overall mortality rate estimated to be between two to four percent,” Dr. Barron adds. “Current treatment consists of high-dose corticosteroids to control systemic symptoms. However, these do not improve the long-term prognosis, and their use is accompanied by severe side effects. RoActemra’s striking efficacy confirms a major advance in the treatment of this disease.”
Roche reports that the Tender trial results mirror previous Japanese studies demonstrating that RoActemra is also well tolerated and effective in children with sJIA who could not tolerate or showed inadequate response to systemic corticosteroids and immunosupressants. The drug is approved in the EU, U.S., and other countries for the treatment of adult RA.