Cimzia® - Axial spondyloarthritis (axSpA)
In Europe, Cimzia® (certolizumab pegol) is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising:
Ankylosing spondylitis (AS) (also known as radiographic axial spondyloarthritis)
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 AS (also known as non-radiographic axial spondyloarthritis)
Adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and /or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to NSAIDs.
Cimzia® - Non-radiographic axial spondyloarthritis (nr-axSpA)
Cimzia® (certolizumab pegol) is a tumor necrosis factor (TNF) blocker indicated in the US for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
Warning: serious infections and malignancy
See full prescribing information for complete boxed warning.
- Increased risk of serious infections leading to hospitalisation or death including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (5.1)
- Cimzia should be discontinued if a patient develops a serious infection or sepsis (5.1)
- Perform test for latent TB; if positive, start treatment for TB prior to starting Cimzia (5.1)
- Monitor all patients for active TB during treatment, even if initial latent TB test is negative (5.1)
- Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which Cimzia is a member (5.2). Cimzia is not indicated for use in pediatric patients (8.4).