UCB announced today results from the PRECiSE 3 7-year open label extension clinical trial of Cimzia® (certolizumab pegol), the longest continuous trial of an anti-TNF therapy evaluating long-term safety in Crohn's disease. Remission was also assessed over the trial period. Results were presented at Digestive Disease Week (DDW), taking place in Chicago from May 3-6.
"The breadth of the PRECiSE 3 study offers opportunities to examine baseline factors that provide insights into the likelihood of long-term remission in moderate to severe Crohn's disease patients," said William Sandborn, MD, investigator and Chief, Division of Gastroenterology, University of California San Diego. "These data provide insight to the impact of prior anti-TNF use on long-term outcomes among adult patients receiving Cimzia® and its use as a first-line biologic treatment option for Crohn's disease after conventional therapy."
In total, 595 patients enrolled in PRECiSE 3 following the completion of the PRECiSE 1 and 2 pivotal studies (354 enrolled from PRECiSE 1 and 241 enrolled from PRECiSE 2) and received certolizumab pegol (CZP) 400 mg every four weeks for up to seven years. No new safety signals were identified during the study. However, patients treated with Cimzia® are at an increased risk for developing serious infections that may lead to hospitalization or death.
In the observed case analysis of the study, annual remission rates ranged from 68% (269 out of 394 patients still in the study) to 76% (78 out of 103 patients still in the study) from year one to year seven, as defined by a Harvey Bradshaw Index score of less than four. The remission rates analyzed by last observation carried forward and non-responder imputation methods were 58% (347 out of 594 patients) and 45% (266 out of 594 patients) at year one, 56% (331 out of 594 patients) and 26% (152 out of 594 patients) at year three, and 55% (325 out of 594 patients) and 13% (78 out of 594 patients) at year seven, respectively.
Open-label extension studies may have limitations, including potential enrichment of the study population with responders, lack of placebo control, and patient dropout rates due to tolerability issues.
A separate post-hoc analysis of the PRECiSE 3 data evaluated long-term outcomes in Crohn's disease, stratified by patients with prior anti-TNF exposure (N=119) versus bio-naive patients (N=475). Results from the analysis suggested that the mean duration of remission was shorter among patients with prior anti-TNF exposure compared to bio-naive patients (1.5 years vs. 2.3 years, respectively), as was the mean duration of treatment response (2.5 years vs. 3.14 years, respectively).
"Long-term assessments of safety and efficacy are critically important for managing Crohn's disease patients, who suffer a tremendous disease burden," said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB. "UCB is committed to conducting research that aids clinicians in making the most informed treatment decisions for their patients living with Crohn's disease."
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. Please see the important safety information at the end of this press release.