The results of the continuation PRECiSE 3 study showed that at 80 weeks, more than 85% of the patient subgroup who continuously received Cimzia 400mg subcutaneously every four weeks maintained clinical response, with nearly 74% of these patients achieving remission, as measured by the Harvey-Bradshaw Index.
The PRECiSE 3 study is a long-term open label continuation of the phase III program for Cimzia. On the basis of ongoing positive results, UCB filed for the drug’s approval with both the FDA and the European Medicines Agency in 2006.
UCB said that the primary endpoint of the PRECiSE 3 extension was to assess the safety of chronic therapy with Cimzia. The secondary endpoints were to obtain data on plasma concentrations and antibodies to Cimzia and to obtain additional efficacy data with up to 18-months continuous exposure to the drug.
“These study results show robust rates of clinical response and remission during an 18-month period in patients with Crohn’s disease,” said Stephen Hanauer, who was co-author of the Cimzia study.
Cimzia is being hailed as having the potential to generate annual sales of up to $1 billion. However, approval of the drug in the US has been delayed by two years due to the need for additional clinical information that will not be complete until late 2008.