Cimzia Provides Sustained Efficacy In Moderate To Severe Crohns Disease Patients: UCB

Cimzia is indicated for reducing the signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

UCB said that P4 is a long-term open label continuation of the Phase III Precise 2 (P2) subpopulation assessing the long-term efficacy, safety and tolerability of CZP patients. P4 was open to patients from the CZP or placebo arm of P2.

In the trial, patients from the treatment arm of P2 received an additional 400mg dose at week 2 and continued 400mg every four weeks thereafter. Patients from the placebo arm received 400mg doses at weeks 0, 2 and 4 and every 4 weeks thereafter.

UCB said that the disease remission was measured using the Harvey-Bradshaw Index at 1, 2, 3 and 4 years among all patients, and, separately, a subset of 84 patients with no previous IFX exposure. These data support the use of Cimzia long term in moderate to severe Crohn’s Disease patients.

Remission rates over four years were comparable among CD patients previously enrolled in the P2 Phase III study in patients previously treated with IFX and IFX-naive patients.

Additionally, these P4 data demonstrate that patients who are losing response to Cimzia can be recaptured with one additional dose of Cimzia at week 2 during their regular four week dosing regimen.

UCB said that the data were presented by William Sandborn, vice-chair, department of gastroenterology and hepatology of Mayo Clinic, as an oral presentation at Digestive Disease Week (DDW) 2010 in New Orleans.

Cem Kayhan, associate medical director of UCB, said: “These data are important to gastroenterologists treating Crohn’s Disease as it can be a complex disease to manage. It is important that there is a simple recapture strategy for patients who may be flaring, regardless of their prior infliximab experience.”