SIMPONI (golimumab), anti-TNF
RHEUMATOLOGY - PAEDIATRICS - New indication
Opinions on drugs -
Posted on
Feb 06 2019
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
Insufficient |
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