WASHINGTON — The tumor necrosis factor (TNF) blocker certolizumab pegol (Cimzia) gained an indication for non-radiographic axial spondyloarthritis (nr-axSpA), marking the first treatment to be FDA approved for this inflammatory type of arthritis.
The injection is approved only for adults with objective signs of inflammation and carries a black box warning for serious infection risk. The boxed warning also highlights the risk of lymphoma and other cancers with use of TNF blockers in children and adolescents, although certolizumab was not approved for pediatric nr-axSpA.
“Today’s approval of Cimzia fulfills an unmet need for patients suffering from non-radiographic axial spondyloarthritis as there has been no FDA-approved treatment until now,” according to a statement from Nikolay Nikolov, MD, of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
The new indication was based on a 317-patient placebo-controlled trial that showed major improvement with the addition of certolizumab to background medication, as assessed by patients’ Ankylosing Spondylitis Disease Activity Score (ASDAS). Eligible patients had objective signs of inflammation — elevated C-reactive protein levels, sacroiliitis, or both on MRI. At 1 year, 47.2% of patients on certolizumab had an ASDAS decrease of 2 points or greater compared with 7.0% of placebo patients (P<0.0001).
Certolizumab was initially approved in 2008 and has other indication in adults with 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.