Psoriatic Arthritis - Cimzia reg; Certolizumab Pegol Shows Promise
On Thursday, UCB announced its intention to submit regulatory applications for Cimzia® (certolizumab pegol) by the end of this year. The drug is designed to treat psoriatic arthritis, an inflammation of the joints, or arthritis, which typically occurs in combination with psoriasis, a skin disorder. People with PsA generally suffer from stiff, painful joints, and experience warmth and swelling in their joints and surrounding tissues.
The majority of PsA sufferers develop psoriasis, a common disorder affecting about 2 to 3% of people worldwide, before joint problems occur, however, in some cases the development process can be the other way around. Left untreated PsA, which affects about 24 in 10,000 people, can be a disabling disease. According to most estimates between 5 and 10% of individuals with psoriasis will develop PsA, however some studies estimate the figure to be as high as 30%.
The 48-week, multi-center, double-blind, parallel-group, phase 3 study involved 409 patients, who were randomized to either receive 200 mg every two weeks or 400 mg every four weeks of certolizumab pegol or placebo.
The findings of the RAPID-PsA™ phase 3 study that assessed Cimzia's® (certolizumab pegol) efficacy and safety in patients with adult onset active psoriatic arthritis (PsA), showed a clinically relevant and statistically important improvement of PsA characteristics in patients' at week 12. Following the first analyses, no new safety signals were observed, with adverse events being consistent with those seen in other trials of certolizumab pegol.
Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President at UCB announced:
"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. We shall discuss the study results with the regulatory authorities and present them at upcoming major rheumatology congresses."
Cimzia® is already approved in the E.U., in combination with methotrexate to treat moderate to severe active RA in adult patients who show only limited response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate, whilst in the U.S., the drug has been granted approval for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease, who were inadequately responsive to conventional therapy as well as to treat adults with moderate to severe active RA.
Written by Petra Rattue
View drug information on Cimzia.
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Added: 10 апреля 2012
Added: 10 апреля 2012
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