Reason for request

Extension of indication

Insufficient clinical benefit to justify reimbursement for polyarticular juvenile idiopathic arthritis


  • SIMPONI has now been granted a marketing authorisation, in combination with methotrexate (MTX) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in children with a body weight of at least 40 kg, who failed to respond adequately to previous MTX treatment.

  • When combined with MTX, its efficacy was not superior to that of the placebo.

  • Therapeutic alternatives are available, other biotherapies whose efficacy has been established in this indication.



Clinical Benefit



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