Results of 7-year trial of Cimzia in Crohns-UCB

UCB has announced 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. 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 400 mg every four weeks for up to seven years.

Annual remission rates ranged from 68% to 76% 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% and 45% at year one, 56% and 26% at year three, and 55% and 13% at year seven, respectively. 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). Results were presented at Digestive Disease Week.