FRIDAY, March 29, 2019 (HealthDay News) — Cimzia (certolizumab pegol) injection has been approved by the U.S. Food and Drug Administration as the first sanctioned treatment for adults with non-radiographic axial spondyloarthritis (nr-axSpA), a type of arthritis.
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Nr-axSpA causes inflammation in the spine, There is no visible damage seen on x-rays, so it is referred to as non-radiographic, the FDA explained in a news release.
The drug's effectiveness was determined in clinical studies involving 317 adults with nr-axSpA. When assessed for the drug's anti-inflammatory properties, responses were greater for patients treated with Cimzia, compared to those treated with a placebo, the agency said.
The drug's label includes a boxed warning about users' increased risk of serious infections, including tuberculosis, bacterial sepsis (blood infection) and dangerous fungal infections. Cimzia should be discontinued if a user develops a serious infection, the FDA advised.
Doctors should test potential users for TB before starting the drug, the agency said.
The boxed warning also advises that lymphoma (cancer in blood cells) and other types of cancer, some fatal, have been reported in children and adolescents treated with this class of drug, known as tumor necrosis factor (TNF) blockers. Cimzia is not approved for children or teens, the FDA stressed.
Cimzia, first approved in 2008, also is sanctioned for certain adults with Crohn's disease, moderate-to-severe rheumatoid arthritis, active ankylosing spondylitis (AS) and moderate-to-severe plaque psoriasis.
The drug is produced by Belgium-based UCB.
— Scott Roberts
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