UCB Presents Long-Term CIMZIA Data in Crohn's Disease

CIMZIA maintained long-term response at stable doses

30-May-2007

UCB announced that new data presented at Digestive Disease Week 2007 (DDW) demonstrated long-term response and remission in Crohn's disease patients treated with CIMZIA(TM) (certolizumab pegol), the only Fc-free PEGylated, Fab' fragment anti-TNF.

The study, called PRECiSE 3 (P3), is a long-term open label continuation of the Phase III PRECiSE Program for CIMZIA(TM). Some of the study results presented at DDW are an interim analysis of a patient subgroup who responded continuously to CIMZIA(TM) during an 18-month period. These patients completed the PRECiSE 1 (P1) or PRECiSE 2 (P2) trials, enrolling in P3 at week 52. At week 80, the study showed that more than 85 percent of the patient subgroup who continuously received CIMZIA(TM) 400 mg subcutaneously every four weeks maintained clinical response, with nearly 74 percent of these patients achieving remission. The extension study used the Harvey-Bradshaw Index (HBI) to assess clinical response (defined as a reduction in HBI score of at least three points) and remission (HBI score less than or equal to four points).

Importantly, results reported from P3 indicated that CIMZIA(TM) was well-tolerated throughout the study. The percentage of patients experiencing injection-site reactions and injection-site pain was low (<2%, <1% respectively).

CIMZIATM is an investigational drug product. According to the company, CIMZIA(TM) is the only Fc-free PEGylated Fab' fragment anti-TNF (Tumour Necrosis Factor). CIMZIA(TM) is Fc-free and thus avoids potential cellular cytotoxicity. CIMZIA(TM) has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.

https://www.bionity.com/en/news/64924/ucb-presents-long-term-cimzia-data-in-crohn-s-disease.html