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Cimzia in patients with severe active axial spondyloarthritis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis

the Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Cimzia ( Certolizumab pegol ).

The CHMP has adopted a new indication as follows:

Axial spondyloarthritis - Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising: ankylosing spondylitis ( AS ); adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs ( NSAIDs );

Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis - Adults with severe active axial spondyloarthritis without radiographic evidence of ankylosing spondylitis but with objective signs of inflammation by elevated CRP andor MRI, who have had an inadequate response to, or are intolerant to NSAIDs.

The full indications for Cimzia will be as follows:

Rheumatoid arthritis

Cimzia, in combination with Methotrexate ( MTX ), is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying antirheumatic drugs ( DMARDs ) including Methotrexate, has been inadequate.
Cimzia can be given as monotherapy in case of intolerance to Methotrexate or when continued treatment with Methotrexate is inappropriate.
Cimzia has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with Methotrexate.

Axial spondyloarthritis

Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising:

Ankylosing spondylitis - Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs ( NSAIDs );

Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis - Adults with severe active axial spondyloarthritis without radiographic evidence of ankylosing spondylitis but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to NSAIDs. ( Xagena )

Source: European Medicines Agency, 2013

XagenaMedicine_2013