Findings from the PRECiSE 3 (P3) open label extension study for Cimzia® (certolizumab pegol; CZP), demonstrating the longest continuously running maintenance trial for an anti-TNF in Crohn's disease, will be exhibited at the 2010 Annual Scientific Meeting of the American College of Gastroenterology (ACG), taking place in San Antonio from October 15 – 20. Additionally, long-term efficacy data from the PRECiSE 4 (P4) clinical trial also will be presented at the meeting.
Results of the P3 open-label extension study showed that continuous therapy with Cimzia provided long-term remission for more than 4.5 years in patients who initially responded to Cimzia in the six-month PRECiSE 2 study (P2). In the PRECISE 2 double blind, placebo controlled clinical trial, 48% of patients achieved remission at six months. Sustained long-term remission was observed among patients who had previous anti-TNF exposure (77% remission), as well as anti-TNF naive patients (73% remission).
Similarly, results of the P4 open-label extension study showed long-term remission rates among patients treated with Cimzia (naive – 63%; non-naive – 50%). For some patients, disease remission was achieved in as early as 4 weeks (38% of patient population). Additionally, the data demonstrates that patients who are losing response to Cimzia or experience an interruption in therapy can be recaptured with one additional dose of Cimzia. The data suggests re-induction therapy may have long-term benefits in helping patients who experienced drug interruption or loss of initial response achieve response and maintain remission.
"Collectively, these Cimzia data findings are important for patients living with moderate to severe Crohn's disease and the gastroenterologists treating them, as long-term remission is the ultimate goal of treatment," said Cem Kayhan, MD, Medical Director at UCB. "It also is encouraging that Cimzia data demonstrated a simple recapture strategy to help patients who may have active Crohn's disease and begin to lose response achieve response and maintain remission."
Cimzia is indicated for reducing the 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.