First Treatment for Non-Radiographic Axial Spondyloarthritis Granted FDA Approval

This article originally appeared at SpecialtyPharmacyTimes.com.

Officials with the FDA have approved certolizumab pegol (Cimzia, UCB) injection for the treatment of adults with non-radiographic axial spondyloarthritis (nr-axSpA), according to a press release.

With this approval, certolizumab pegol becomes the first FDA-approved therapy for this type of axSpA, filling an unmet clinical need for treatment options, according to the release.

Nr-axSpA, a type of chronic inflammatory disease that affects the axial skeleton, is in the same spectrum of disease as ankylosing spondylitis. However, nr-axSpA may occur as early disease or as separate entity that never progresses to radiographic disease. In nr-axSpA, there is no visible damage seen on x-rays.

In a Specialty Pharmacy Times video series on axSpA, Hillary Norton, MD, discussed non-radiographic disease and ankylosing spondylitis.

“There is some common misunderstanding in the medical community about the distinction between non-radiographic disease and ankylosing spondylitis,” Dr Norton explained in the video. “Our understanding has really evolved in the last few years, and now we understand that these are both in the same spectrum of disease. The symptoms are the same, and the response to treatment is the same, but we don’t know yet who will progress to radiographic disease, and everybody may not progress, particularly women.”

Patients with axSpA also face a high burden of disease involving decreased quality of life, disability, missed time at work, and increased health care costs.

“We have data that show that when patients are treated appropriately with biologics, that this does decrease work absenteeism and thus can help quality of life,” Dr Norton noted.

Certolizumab pegol was originally approved in 2008 and is also indicated for adult patients with Crohn disease, moderate-to-severe rheumatoid arthritis, active ankylosing spondylitis, and moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The approval is based on efficacy data from a clinical trial that evaluated certolizumab pegol for the treatment of nr-axSpA. The study included 317 adult patients with nr-axSpA with objective signs of inflammation, indicated by elevated C-reactive protein (CRP) levels and/or sacroiliitis on MRI. Improvement response was measured on the Ankylosing Spondylitis Disease Activity Score, a composite scoring system that assesses disease activity, including patient-reported outcomes and CRP levels.

The overall safety profile observed in the trial was consistent with the known safety profile of certolizumab pegol.

Certolizumab pegol comes with a Boxed Warning due to increased risks of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections, and other infections.

Visit SpecialtyPharmacyTimes.com to view the full video on non-radiographic versus radiographic axial spondyloarthritis.