FDA Approves First Nr-axSpA Drug

The U.S. Food and Drug Administration (FDA) has granted its approval for Cimzia (certolizumab pegol), an injectable drug to treat patients with non-radiographic axial spondyloarthritis (nr-axSpA), an inflammatory type of arthritis.

“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, MD, associate director for rheumatology of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, in a statement.

Nr-axSpA often causes inflammation in the spine, along with other symptoms. However, nr-axSpA is not evidenced through X-ray.

The efficacy of certolizumab pegol in treating nr-axSpA was studied in a randomized, placebo-controlled trial, C‐axSpAnd, the longest placebo-controlled study focused on nr-axSpA, according to the authors.

The multicenter study included 317 patients with active nr-axSpA from Australia, Europe, North America, and Taiwan. Patients were randomized 1:1 to placebo or certolizumab pegol (400 mg at weeks 0, 2, and 4, followed by 200 mg every two weeks) plus non-biologic background medication (NBBM). The study’s primary endpoint was significant 52-week improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS‐MI: ≥ 2.0 point decrease from baseline or lowest possible score [0.6]).

There were 158 patients in the placebo plus NBBM group and 159 in the certolizumab pegol plus NBBM group. After 52 weeks, just under half (47.2%, n = 75/159) of the certolizumab pegol plus NBBM group achieved the primary ASDAS‐MI endpoint, compared to 7% (n = 11/158) of the placebo plus NBBM patients. Patients were permitted to switch to open-label treatment at any point during the study; 60.8% (n = 96/158) of the placebo plus NBBM patients made the switch before the 52-week endpoint, compared to 12.6% (n = 20/159) of the certolizumab pegol plus NBBM patients.

The researchers concluded, “Adding [certolizumab pegol] to background medication is superior to adding placebo in patients with active nr‐axSpA. These results indicate that remission in nr‐axSpA treated without biologics occurs infrequently, demonstrating the need for treatment beyond non‐biologic therapy.”

Certolizumab pegol is sold under the brand name Cimzia, which first received FDA approval in 2008. It is indicated for adults with Crohn’s disease, moderate-to-severe rheumatoid arthritis, active ankylosing spondylitis (AS) and moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

According to the FDA, Cimzia could increase a patient’s risk for serious infections including tuberculosis, bacterial sepsis, and invasive fungal infections. Cimzia is not indicated for pediatric patients.