SIMPONI

Reason for request

Clinical Benefit

Substantial

Substantial

Clinical Added Value

no clinical added value

" In view of : - the efficacy and safety data versus placebo, - the absence of direct comparative data versus other anti-ANF agents, particularly infliximab, the Transparency Committee considers that SIMPONI (golimumab) does not provide any improvement in actual benefit (IAB V, non-existent) in the treatment of moderately to severely active UC which is resistant to conventional therapies."