UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Cimzia® (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis (PsA).
"The FDA's approval of Cimzia® for the treatment of active PsA provides an additional, effective treatment option for those living with the condition. Psoriatic arthritis 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," said Dr. Philip J. Mease, Director Rheumatology Research, Swedish Medical Center and Clinical Professor, University of Washington School of Medicine, Seattle, WA, U.S. "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-TNF exposure. The ACR20 results showed that Cimzia® rapidly improved the signs and symptoms of PsA for patients with response observed as early as the first week of treatment for some patients."
"UCB has a long heritage in rheumatology, with many years of clinical experience with Cimzia® in moderate-to-severe rheumatoid arthritis. This approval represents the third indication for Cimzia® in the U.S. and reaffirms the value of our commitment to developing medicines that treat serious, chronic diseases, and in turn help those with PsA," said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President, UCB.
PsA is a chronic, inflammatory condition that causes pain, swelling and stiffness in and around the joints and tendons, and usually occurs in combination with psoriasis. In most people with PsA, psoriasis develops before joint problems. When hands and feet are affected in PsA, nail changes can occur, as well as swelling in the fingers and toes (dactylitis). PsA affects approximately 0.24 percent of the population worldwide; up to 30 percent of the estimated 7.5 million psoriasis patients in the U.S. will develop PsA. Research suggests that nearly one in four people with psoriasis in the U.S. may have undiagnosed PsA.
FDA approval of Cimzia® for active PsA is based on data from the RAPIDTM-PsA study, an ongoing, Phase 3, 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® 400 mg at Weeks 0, 2 and 4 or placebo, followed by either Cimzia® 200 mg every other week, Cimzia® 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 (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® 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 modified mTSS Score. Patients treated with Cimzia® 400 mg 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.6
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 U.S., 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.