UCB announced results from its PRECiSE 3 (PEGylated antibody fragment evaluation in Crohn’s disease: safety and efficacy) clinical trial for Cimzia (certolizumab pegol) in patients with moderate to severe Crohn’s disease. The findings were presented at presented at Digestive Disease Week in Chicago, IL.
PRECiSE 3 was a 7-year open label extension clinical trial and the longest continuous trial of an anti-TNF therapy evaluating long-term safety in patients with Crohn’s disease. A total of 595 patients received certolizumab pegol (CZP) 400mg every 4 weeks for up to 7 years. Annual remission rates ranged from 68–76% during the trial, with last observation remission rates and non-responder imputation methods at 58% and 45% at Year 1, 56% and 26% at Year 3, and 55% and 13% at Year 7, respectively.
Mean duration of remission was shorter for patients with prior anti-TNF exposure (1.5 years) vs. bio-naive patients (2.3 years), in addition to the mean duration of treatment response (2.5 years vs. 3.14 years, respectively). In the study, no new safety signals were recognized.
Cimzia is indicated to reduce signs and symptoms of moderately to severely active Crohn’s disease and to maintain clinical response in adult patients with inadequate response to conventional therapy.
For more information call (800) 477-7877 or visit Cimzia.com.