Health Boards
UCB announced today that it 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® (certolizumab pegol) in patients with adult onset active psoriatic arthritis (PsA) demonstrated a clinically relevant and statistically significant improvement at week 12 in the signs and symptoms of psoriatic arthritis. 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.
Source: ucb.com
Top-line results from the RAPID-PsA™ phase 3 study evaluating the efficacy and safety of Cimzia® (certolizumab pegol) in patients with adult onset active psoriatic arthritis (PsA) demonstrated a clinically relevant and statistically significant improvement at week 12 in the signs and symptoms of psoriatic arthritis. 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.
Source: ucb.com