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Yokota S et al. - Tocilizumab is effective in children with systemic-onset juvenile idiopathic arthritis. It might therefore be a suitable treatment in the control of this disorder, which has so far been difficult to manage. Methods- Efficacy and safety of tocilizumab, an anti-IL-6-receptor monoclonal antibody was investigated in children with JIA
- 56 children (aged 2–19 y) with disease refractory to conventional treatment were given 3 doses of tocilizumab 8 mg/kg/2 wks during 6-wks
- Pts achieving an ACR Pedi 30 response and a CRP concn. of <5 mg/L were randomly assigned to receive placebo or to continue tocilizumab treatment for 12 wks
- The primary endpoint of the double-blind phase was an ACR Pedi 30 response and CRP concn. of <15 mg/L
- Pts responding to tocilizumab and needing further treatment were enrolled in an open-label extension phase for at least 48 wks
- The analysis was done by intention to treat
Results- ACR Pedi 30, 50, and 70 responses were achieved by 91%, 86%, and 68% pts, respectively
- 43 pts continued to the double-blind phase and were included in the efficacy analysis
- 17% pts in the placebo group maintained an ACR Pedi 30 response and a CRP concn. of <15 mg/L vs. 80% in the tocilizumab group
- By wk 48 of the open-label extension phase, ACR Pedi 30, 50, and 70 responses were achieved by 98%, 94%, and 90% of 48 pts, respectively
- Serious adverse events were anaphylactoid reaction, gastrointestinal haemorrhage, bronchitis, and gastroenteritis
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