FDA approves Cimzia for psoriatic arthritis

October 8, 2013

Cimzia (certolizumab pegol, UCB) has been approved by the Food and Drug Administration for the treatment of psoriatic arthritis in adult patients.

 

Cimzia (certolizumab pegol, UCB) has been approved by the Food and Drug Administration for the treatment of psoriatic arthritis in adult patients.

The biologic drug demonstrated improvement in signs and symptoms of psoriatic arthritis in studies of patients with and without prior anti-tumor necrosis factor-alpha exposure, according to a news release.

Cimzia was approved following results of an ongoing, phase 3, multicenter, double-blind, placebo-controlled study of 409 patients with active and progressive adult-onset psoriatic arthritis. Patients were given 400 mg of Cimzia or placebo at zero, two and four weeks, followed by the biologic at 200 mg or 400 mg every four weeks, or placebo every other week.

Patients taking the 200 mg dose every other week had greater reduction in radiographic progression compared to patients taking placebo at 24 weeks. Patients taking 400 mg every four weeks did not demonstrate a greater inhibition of radiologic progression at 24 weeks, however, compared to patients on placebo. Patients treated with certolizumab pegol demonstrated improvement in skin manifestations, but safety and efficacy of the drug in patients with plaque psoriasis has not been established.

Adverse events occurred in 62 percent of patients taking certolizumab pegol, compared to 68 percent in the placebo group.

The approval comes the same week as the FDA’s approval of Stelara (ustekinumab, Janssen Biotech) for the treatment of psoriatic arthritis.