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Tocilizumab study offers new hope for children with arthritis

June 23, 2006

A new study has confirmed significant improvements after treatment with tocilizumab amongst children with systemic juvenile idiopathic arthritis (sJIA), who do not tolerate or have an inadequate response to conventional therapies. Professor Shumpei Yokota presented the encouraging results of the first double-blind, placebo controlled trial for tocilizumab at the Annual European Congress of Rheumatology in Amsterdam today (Thursday 22 June).

Juvenile Idiopathic Arthritis (JIA) is a relatively rare disease, affecting 30 to 150 children per 100,000 per year in Europe.1 "Systemic JIA is a specific type of juvenile idiopathic arthritis and it is one of the most severe types as it affects the whole body and most of the joints. As well as swollen and painful joints, the child has rashes, high fever, is severely lacking in energy and is generally very unwell", said Professor Yokota.

Tocilizumab, previously known as MRA, is currently undergoing phase III trials for moderate to severe adult onset rheumatoid arthritis (RA) as well as sJIA. Tocilizumab blocks the action of a protein, called interleukin 6 (IL-6), which provokes inflammation.

The study presented by Professor Yokota and the research team involved a total of 56 children, 35 of them were female, and the mean age was 8.3 years old. Disease activity was assessed in a number of ways such as number of active joints, number of joints with limitations of motion, physician's/parent's global assessment, two inflammatory disease parameters (ESR and CRP) and through a parental heath assessment questionnaire (CHAQ). 68% of the children had an improvement rate of 70%, while more than 85% had an improvement rate of 50%. Treatment was generally well tolerated, though two patients experienced serious adverse events; one anaphylactoid reaction and one gastrointestinal hemorrhage. Both patients returned to normal after discontinuation of tocilizumab.

"The goals of the treatment for children with arthritis are to relieve pain and inflammation, slow down or prevent the destruction of joints, as well as restore use and function of the joints to promote optimal growth, physical activity, and social and emotional development in the child. This study confirms that tocilizumab is one of the most promising therapies to treat children with sJIA who have not benefited from conventional therapies", said Professor Yokota.

European League Against Rheumatism