UCB intends to submit regulatory applications for Cimzia® (certolizumab pegol) in psoriatic arthritis, by end of 2012. Top-line results from the RAPID-PsA™ phase 3 study evaluating the efficacy and safety of Cimzia® in patients with adult onset active psoriatic arthritis (PsA) demonstrated a clinically relevant and statistically significant improvement. Initial analyses suggest that no new safety signals were observed in this study and adverse events were consistent with those seen in other trials of certolizumab pegol.
"We are pleased that Cimzia® has the potential to also benefit patients living with psoriatic arthritis and we are currently preparing for submissions to the regulatory authorities later this year," said Professor Dr Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB. "We shall discuss the study results with the regulatory authorities and present them at upcoming major rheumatology congresses."
In this 48 week, multicenter, double-blind, parallel-group, phase 3 study, 409 patients were randomized to receive certolizumab pegol (200 mg every two weeks or 400 mg every four weeks) or placebo.
In the European Union, Cimzia® in combination with methotrexate is approved for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying antirheumatic drugs (DMARDs) including methotrexate. In the U.S., Cimzia® 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 and for the treatment of adults with moderately to severely active rheumatoid arthritis.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a condition involving joint inflammation (arthritis) that usually occurs in combination with a skin disorder called psoriasis. Signs and symptoms of PsA include stiff, painful joints with warmth and swelling in the joints and surrounding tissues. In most people with PsA, psoriasis appears before joint problems develop. In some cases, psoriatic arthritis develops prior to the skin changes. Left untreated PsA can be a disabling disease. PsA affects an estimated 24 in 10,000 people. Between 5 and 10 per cent of people with psoriasis develop psoriatic arthritis, according to most estimates with some studies suggesting a figure as high as 30 per cent. Psoriasis itself is a common disorder, affecting approximately 2 to 3 percent of the population worldwide.
Cimzia® is the only PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases. The U.S. Food and Drug Administration (FDA) has approved Cimzia® 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 and for the treatment of adults with moderately to severely active rheumatoid arthritis. Cimzia® in combination with MTX, is approved in the EU for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying antirheumatic drugs (DMARDs) including MTX. Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. UCB is also developing Cimzia® in other autoimmune disease indications. Cimzia® is a registered trademark of UCB PHARMA S.A.
UCB, Brussels, Belgium is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8 500 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2010. UCB is listed on Euronext Brussels (symbol: UCB).