Reason for request

Extension of Inclusin

No clinical benefit demonstrated by comparison with other TNF inhibitors in the management of patients with severe non-radiographic axial spondyloarthritis with objective signs of inflammation and who failed NSAIDs.


  • SIMPONI now has Marketing Authorisation in the treatment of severe non-radiographic axial spondyloarthritis in adults with objectives signs of inflammation, taking the form of an elevated level of C-reactive protein (CRP) and/or signs visible in magnetic resonance imaging (MRI), in patients with an inadequate response to non-steroidal antiinflammatories (NSAIDs).
  • Since no comparison is available with other TNF inhibitors indicated in non-radiographic axial spondyloarthritis, it is not possible to rank SIMPONI relative to other TNF inhibitors.

Clinical Benefit



Clinical Added Value

no clinical added value


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