The FDA has approved Cimzia (certolizumab pegol), an injection for the treatment of adults with non-radiographic axial spondyloarthritis (nr-axSpA). This is the first time that the FDA has approved a treatment for this condition.
“Today’s approval of Cimzia fulfills an unmet need for patients suffering from non-radiographic axial spondyloarthritis as there has been no FDA-approved treatments until now,” said Nikolay Nikolov, M.D., associate director for rheumatology of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
According to the FDA, “Non-radiographic axial spondyloarthritis is a type of inflammatory arthritis that causes inflammation in the spine and other symptoms. There is no visible damage seen on x-rays, so it is referred to as non-radiographic.”
“The efficacy of Cimzia for the treatment of non-radiographic axial spondyloarthritis was studied in a randomized clinical trial in 317 adult patients with non-radiographic axial spondyloarthritis with objective signs of inflammation, indicated by elevated C-reactive protein (CRP) levels and/or sacroiliitis (inflammation of the sacroiliac joints) on MRI.”
“The trial measured the improvement response on the Ankylosing Spondylitis Disease Activity Score, a composite scoring system that assesses disease activity including patient-reported outcomes and CRP levels. Responses were greater for patients treated with Cimzia compared to patients treated with placebo. The overall safety profile observed in the Cimzia treatment group was consistent with the known safety profile of Cimzia.”
Kristofer Baumgartner, FDA spokesperson, told OTW, “With regard to your question about how many patients could be helped, based on a paper published in 2013, there are nearly half a million patients with non-radiographic axial spondyloarthritis in the U.S. [Strand V, Rao S, Shillington A, et al. Prevalence of axial spondyloarthritis in United States rheumatology practices: Assessment of SpondyloArthritis international Society criteria versus rheumatology expert clinical diagnosis. Arthritis Care Res. 2013; 65: 1299-306.] Cimzia is intended for those patients with non-radiographic axial spondyloarthritis and signs of inflammation.”
