FDA OKs Certolizumab (Cimzia) for Nonradiographic Axial Spondyloarthritis

The US Food and Drug Administration (FDA) has approved the tumor necrosis factor inhibitor certolizumab pegol (Cimzia, UCB Pharma) for treatment of adults with nonradiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation.



Nr-axSpA causes inflammation in the spine and other symptoms without visible damage on x-ray.

Certolizumab injection is the first FDA-approved treatment of nr-axSpA and "fulfills an unmet need" for these patients, Nikolay Nikolov, MD, of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research, said in a news release.

Certolizumab was studied in a randomized, placebo-controlled trial involving 317 adults with nr-axSpA who had objective signs of inflammation, as indicated by elevations in C-reactive protein (CRP) and/or sacroiliitis on MRI.

Patients treated with certolizumab showed greater improvement on the Ankylosing Spondylitis Disease Activity Score, a composite scoring system that assesses disease activity, including patient-reported outcomes and CRP levels, relative to those given placebo.

The overall safety profile in this patient population was consistent with the known safety profile of the drug in other patient groups. There is a boxed warning about increased risk for serious infections leading to hospitalization or death; such infections include tuberculosis, bacterial sepsis, and invasive fungal infections, among others.

Certolizumab is not indicated for use in pediatric patients.

Certolizumab is already approved in the United States for the treatment of adults with moderately to severely active Crohn's disease, moderate to severe rheumatoid arthritis, active ankylosing spondylitis, and moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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