Cimzia (certolizumab pegol) injection is approved for the treatment of adults with non-radiographic axial spondyloarthritis.
Non-radiographic axial spondyloarthritis (nr-axSpA) is a type of inflammatory arthritis that causes inflammation in the spine. It is referred to as non-radiographic, because no damage can be detected on X-rays. Until recently, there was no treatment approved by the U.S. Food and Drug Administration (FDA), but the agency has granted approval to UCB’s Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation.
Cimzia already has FDA approval for the treatment of adult patients with Crohn's disease, moderate-to-severe rheumatoid arthritis, active ankylosing spondylitis (AS) and moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The approval for treatment of nr-axSpA was based on the results of a randomized clinical trial in 317 adult patients with nr-axSpA with objective signs of inflammation as indicated by elevated C-reactive protein levels and/or sacroiliitis (inflammation of the sacroiliac joints) detected using magnetic resonance imaging. Responses were greater for treated patients than those receiving placebo according to the Ankylosing Spondylitis Disease Activity Score.