Cimzia FDA Approved to Treat Active Psoriatic Arthritis in Adults

October 1, 2013

The FDA recently approved UCB's Cimzia(certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis (PsA). The FDA approval of Cimzia for active PsA is based on data from the RAPID-PsA study, an ongoing, Phase III, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of certolizumab pegol in 409 patients with active and progressive adult onset PsA. Patients received a loading dose of Cimzia 400mg at baseline, week two, and week four, or placebo, followed by either Cimzia 200mg every other week, Cimzia 400mg every four weeks, or placebo every other week. Patients were evaluated for signs and symptoms of PsA using the ACR20 response at week 12 and for structural damage using the modified Total Sharp Score (mTSS) at Week 24.

ACR20, 50, and 70 response rates at weeks 12 and 24 were higher for each Cimzia dose group relative to placebo. Patients treated with Cimzia 200mg every other week demonstrated greater reduction in radiographic progression compared with placebo-treated patients at Week 24, as measured by change from baseline in total modified mTSS Score. Patients treated with Cimzia 400mg every four weeks did not demonstrate greater inhibition of radiographic progression at Week 24, compared with placebo-treated patients.Treatment with Cimzia also resulted in improvement in skin manifestations in patients with PsA. However, the safety and efficacy of Cimzia 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 to 68% of patients in the placebo group. Serious adverse events occurred in 7% of patients in the certolizumab pegol group (combined dose) compared to 4% of patients in the placebo group. The safety profile for patients with PsA treated with Cimzia was similar to the safety profile seen in patients with RA and in patients with previous experience with Cimzia.

In the US, Cimzia is also approved for the treatment of adults with moderately to severely active rheumatoid arthritis. In addition, it is approved for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.The FDA is also reviewing a filing for Cimzia in the treatment of adults with active axial spondyloarthritis (axSpA), including patients with ankylosing spondylitis (AS).

In the EU, Cimzia in combination with methotrexate (MTX) is approved for the treatment of moderate to severe active rheumatoid arthritis in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs including MTX. Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.

The European Medicines Agency is currently reviewing a filing for certolizumab pegol in the treatment of adult patients with active PsA. In September 2013, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending extending the European Union marketing authorization for the use of Cimzia in the treatment of adult patients with severe active axSpA. A final decision from the European Commission is expected within two months.

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