Roche's RoACTEMRA approved in Europe for children living with a rare and severe form of arthritis
Roche announced that the European Commission has approved the use of RoACTEMRA (tocilizumab) for the treatment of active Systemic Juvenile Idiopathic Arthritis (sJIA) in patients two years of age and older who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids (medicines used to treat inflammation).
- (1888PressRelease) August 04, 2011 - RoACTEMRA (known as ACTEMRA outside Europe) can be given alone or in combination with methotrexate in patients with sJIA.
“This approval in Europe is an important advance in the treatment of sJIA, a debilitating condition affecting children,” said Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development. “RoACTEMRA is the first and only biological treatment to demonstrate significant efficacy in this patient population and offers physicians a new option for this extremely difficult to treat disease.”
sJIA is the rarest form of Juvenile Idiopathic Arthritis (JIA), also known as Juvenile Rheumatoid Arthritis (JRA).(1) The disease affects about 10 to 20 percent of children with JIA,(2) with the peak age of onset between 18 months and two years,(2,3) although the disease can persist into adulthood. sJIA has a two to four percent overall estimated mortality rate, and accounts for almost two-thirds of all deaths among children with arthritis.(4) The severity of sJIA varies from person to person and can include symptoms ranging from joint inflammation accompanied by intermittent fever, skin rash, anaemia, enlargement of the liver or spleen and inflammation of the lining of the heart and/or lungs.(5) In the most severe cases of sJIA, up to two-thirds of children experience chronic arthritis, and approximately half of children will develop significant joint disabilities.(6,7)
RoACTEMRA is currently used for the treatment of adult rheumatoid arthritis in people who have either responded to, or who were intolerant to, previous therapy with one or more DMARDs or tumour necrosis factor (TNF) inhibitors. It is the only licensed biologic treatment to target the interleukin-6 (IL-6) pathway, which plays a pivotal role in sJIA pathogenesis.
About the TENDER Study
The submission to expand the label was based on positive data from a Phase III study known as TENDER. The study assessed the short term safety and efficacy of RoACTEMRA versus placebo, in reducing signs and symptoms in patients (aged 2 – 17years) with active sJIA. The results showed that 85 percent (64/75) of children with sJIA receiving RoACTEMRA experienced a 30 percent improvement (JIA ACR30) in the signs and symptoms of sJIA and an absence of fever after 12 weeks of therapy, compared with 24 percent (9/37) of children receiving placebo (p
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