Certolizumab pegol (Cimzia, UCB, Inc.) has received FDA clearance for the treatment of adult patients with active PsA.
“The FDA’s approval of certolizumab pegol for the treatment of active PsA provides an additional, effective treatment option for those living with the condition. PsA brings with it a heavy disease burden that often strikes during the prime years of life, impacting health-related quality of life and physical function,” explains Philip J. Mease, MD, director rheumatology research, Swedish Medical Center and clinical professor, University of Washington School of Medicine, Seattle, WA. “The RAPID-PsA study supporting the US approval is the first randomized, controlled study of an anti-TNF in PsA to include patients with and without prior anti-tumor necrosisi factor (anti-TNF) exposure. The American College of Rheumatology ACR20 results showed that certolizumab pegol rapidly improved the signs and symptoms of PsA for patients with response observed as early as the first week of treatment for some patients.”
The drug’s FDA approval 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 certolizumab pegol 400 mg at weeks 0, 2 and 4 or placebo, followed by either certolizumab pegol 200 mg every other week, Certolizumab pegol 400 mg every 4 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 at week 24.5 ACR20, 50 and 70 response rates at weeks 12 and 24 were higher for each certolizumab pegol dose group relative to placebo. Patients treated with certolizumab pegol 200 mg 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 mTSS. Patients treated with certolizumab pegol 400 mg every 4 weeks did not demonstrate greater inhibition of radiographic progression at week 24, compared with placebo-treated patients. Treatment with certolizumab pegol also resulted in improvement in skin manifestations in patients with PsA.
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.
In the US, certolizumab pegol 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 certolizumab pegol in the treatment of adults with active axial spondyloarthritis, including patients with ankylosing spondylitis.
