Reason for request

Extension of indication

-


Clinical Benefit

Substantial

the actual benefit of CIMZIA is substantial in the treatment of severe active axial spondyloarthritis, including ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis but with objective signs of inflammation on MRI and/or elevated CRP, in adults who have had an inadequate response to or are intolerant to non-steroidal anti‑inflammatory drugs.


Clinical Added Value

no clinical added value

CIMZIA (certolizumab) does not provide any improvement in actual benefit (level V, non-existent) in comparison with HUMIRA (adalimumab) in the treatment of patients with severe active axial spondyloarthritis (including severe active ankylosing spondylitis and severe active axial spondyloarthritis without radiographic evidence of ankylosing spondylitis but with objective signs of inflammation on MRI and/or elevated CRP) in whom NSAIDs have failed (inadequate response or intolerance).