FDA Approves Certolizumab for Non-radiographic Axial Spondyloarthritis

The US Food and Drug Administration (FDA) has approved certolizumab pegol injection (Cimzia) for the treatment of adults with non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation. This is the first FDA-approved treatment for the inflammatory arthritis condition.

"Today's approval of Cimzia fulfills an unmet need for patients suffering from non-radiographic axial spondyloarthritis as there [have] been no FDA-approved treatments until now," said Nikolay Nikolov, MD, associate director for rheumatology of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.

The FDA’s decision to approved was supported by efficacy results from a clinical trial of adult patients with non-radiographic axial spondyloarthritis with objective signs of inflammation— elevated C-reactive protein (CRP) levels and/or sacroiliitis on MRI. The trial included 317 adult patients who were randomized to certolizumab or placebo.

Efficacy was gauged using the Ankylosing Spondylitis Disease Activity Score, a composite scoring system that assesses disease activity including patient-reported outcomes and CRP levels. Patients receiving certolizumab had better responses compared to those receiving placebo. The safety profile in the active treatment group was similar to the known safety profile of the drug.

Certolizumab, a tumor necrosis factor (TNF) blocker, was originally approved by the FDA in 2008 and has indications for moderate-to-severe plaque psoriasis, Crohn’s disease, moderate-to-severe rheumatoid arthritis, and active ankylosing spondylitis (AS).

The prescribing information for Cimzia includes a Boxed Warning about the risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections, and infections due to other opportunistic pathogens.