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FDA approves Cimzia for treating adult psoriatic arthritis
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The FDA has approved certolizumab pegol for treating adults with active psoriatic arthritis, UCB has announced.
The approval of certolizumab pegol (Cimzia) was based on data from an ongoing, phase 3, double blind study of 409 patients with active and progressive adult-onset psoriatic arthritis (PsA), according to a press release. At weeks 0, 2 and 4, patients received a loading dose of 400 mg certolizumab pegol or placebo, followed by either 200 mg certolizumab pegol every other week, 400 mg certolizumab pegol every 4 weeks or placebo every other week. ACR20 response at week 12 was used to evaluate patients for symptoms of PsA; modified Total Sharp Score (mTSS) at week 24 was used to measure structural damage.
Patients in each certolizumab pegol group had higher ACR 20, 50 and 70 at weeks 12 and 24 compared with placebo recipients. Those receiving 200 mg demonstrated greater reduction in radiographic progression compared with placebo-treated patients at week 24.
While patients with PsA also experienced improved skin manifestations when treated with certolizumab pegol, its safety and efficacy has not been confirmed, the release stated.
Sixty-two percent of patients in the certolizumab pegol groups experienced adverse events, compared with 68% of placebo-treated patients. Serious adverse events were experienced by 7% of certolizumab pegol patients compared with 4% of the placebo cohort.
Reported infections with certolizumab pegol included active tuberculosis, invasive fungal infections, and bacterial, viral and other infections.
Certolizumab pegol currently is approved in the US for treating adults with moderately to severely active rheumatoid arthritis, as well as reducing symptoms of Crohn’s disease.
“The FDA’s approval for Cimzia for the treatment of active PsA provides an additional, effective treatment option for those living with the condition,” Philip J. Mease, MD, director of rheumatology research, Swedish Medical Center, and clinical professor, University of Washington School of Medicine, Seattle, said in the release. “The study supporting the US approval is the first randomized, controlled study of an [anti-tumor necrosis factor] in PsA to include patients with or without prior anti-TNF exposure.”