FDA Approves Certolizumab for Psoriatic Arthritis

Megan Brooks

Disclosures

September 30, 2013

The US Food and Drug Administration (FDA) has approved the tumor necrosis factor (TNF) inhibitor certolizumab pegol (Cimzia, UCB Pharma) for the treatment of adults with active psoriatic arthritis (PsA), the company said.

Certolizumab is already approved in the United States for treatment of adults with moderately to severely active rheumatoid arthritis and for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adults with moderately to severely active disease who have had an inadequate response to conventional therapy.

The RAPID-PsA Study

PsA is a chronic, inflammatory condition that causes pain, swelling, and stiffness in and around the joints and tendons. It usually occurs in combination with psoriasis. UCB Pharma says up to 30% of the estimated 7.5 million patients with psoriasis in the United States will develop PsA and nearly 1 in 4 people with psoriasis in the United States may have undiagnosed PsA.

The FDA approval of certolizumab for active PsA is based on data from the RAPID-PsA study, an ongoing, phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving 409 patients with active and progressive adult-onset PsA.

After a loading dose of 400 mg every 2 weeks for the first 4 weeks, patients received either 200 mg once every 2 weeks or 400 mg once a month.

As reported previously by Medscape Medical News, by week 12 patients in the 200-mg and 400-mg groups were significantly more likely to have met the American College of Rheumatology 20% response criteria (ACR20) compared with those in the placebo group. Similarly, ACR50 response rates were better in the 200-mg and 400-mg groups than in the placebo group, as were ACR70 responses rates.

Patients treated with certolizumab, 200 mg every other week, also had greater reduction in radiographic progression compared with placebo-treated patients at week 24.

Certolizumab therapy also led to improvement in skin manifestations in patients with PsA. The company notes, however, that "the safety and efficacy of certolizumab in the treatment of patients with plaque psoriasis has not been established."

Adverse events occurred in 62% of patients in the certolizumab pegol group (combined dose) compared with 68% of patients in the placebo group. Serious adverse events occurred in 7% of patients in the certolizumab pegol group (combined dose) and 4% of patients in the placebo group. 

Overall, the safety profile for patients with PsA treated with certolizumab is similar to that in patients with rheumatoid arthritis and in patients with previous experience with the drug, the company said.

The FDA is reviewing certolizumab for treatment of adults with active axial spondyloarthritis, including patients with ankylosing spondylitis. In July, the FDA's Arthritis Advisory Committee voted narrowly for approval of certolizumab for axial spondyloarthritis.

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