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Long-Term Safety Data Reported for Certolizumab Pegol (Cimzia) in Crohn’s Disease

Seven-year results presented at Digestive Disease Week

Results have been reported from the PRECiSE 3 trial, a 7-year open-label extension study of certolizumab pegol (Cimzia, UCB) — the longest continuous trial of an anti-tumor necrosis factor (TNF) therapy evaluating long-term safety in Crohn’s disease. Remission was also assessed over the trial period.

The new data were presented at Digestive Disease Week, being held May 3–6 in Chicago.

A total of 595 patients with Crohn’s disease were enrolled in the PRECiSE 3 trial after the completion of the PRECiSE 1 and 2 pivotal studies. The patients received certolizumab pegol 400 mg every 4 weeks for up to 7 years. No new safety signals were identified during the study. However, patients treated with certolizumab pegol are at an increased risk of developing serious infections that may lead to hospitalization or death.

In 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 1 to year 7, as defined by a Harvey Bradshaw Index (HBI) score of less than four. The remission rates (analyzed by last observation carried forward and by non-responder imputation methods, respectively) were 58% (347/594) and 45% (266/594) at year 1; 56% (331/594) and 26% (152/594) at year 3; and 55% (325/594) and 13% (78/594) at year 7.

Open-label extension studies can have limitations, including potential enrichment of the study population with responders, the lack of a placebo control, and patient dropout rates due to tolerability problems.

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-naïve patients (n = 475). Results from this analysis suggested that the mean duration of remission was shorter among patients with prior anti-TNF exposure compared with the bio-naïve patients (1.5 years vs. 2.3 years, respectively), as was the mean duration of the treatment response (2.5 years vs. 3.1 years, respectively).

In the U.S., Cimzia (certolizumab pegol) is approved for reducing the signs and symptoms of Crohn’s disease and for maintaining a clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

The PRECiSE (Pegylated Antibody FRagment Evaluation in Crohn’s Disease: Safety and Efficacy) development program is composed of two placebo-controlled studies (PRECiSE 1 and 2) and two open-label safety follow-up studies. In these pivotal trials, the primary efficacy endpoints of clinical response were evaluated using the Crohn’s Disease Activity Index (CDAI) and were defined as a decrease in the CDAI score of more than 100 points.

In 2007, the two former studies were published in the New England Journal of Medicine. These studies demonstrated that patients with moderate-to-severe Crohn’s disease achieved and maintained a clinical response during treatment with certolizumab pegol for up to 6 months compared with placebo. In a follow-up open-label extension study (PRECiSE 3), the patients continued to receive certolizumab pegol every 4 weeks for up to 7 years. The HBI, which only requires scoring from the day before the study visit and involves fewer components, was used to evaluate Crohn’s disease activity in the PRECiSE 3 trial.

Source: PR Newswire; May 5, 2014.

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