New data on Cimzia for Crohn’s Disease treatment to be demonstrated at DDW 2010

UCBApr 30 2010

Studies and analyses of the Crohn’s Disease (CD) treatment Cimzia® (certolizumab pegol) demonstrating new data will be exhibited at Digestive Disease Week (DDW) 2010, taking place in New Orleans from May 1-5, 2010.

“Cimzia data at this year’s DDW provide important and positive clinical insights, namely, that Cimzia offers long-term efficacy in multiple patient populations,” said Cem Kayhan, MD, Associate Medical Director at UCB.  “This body of research will help clinicians understand the lasting benefits of Cimzia when treating Crohn’s Disease patients.”

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.

Posters highlighting results from multiple pivotal trials demonstrate long term efficacy and utility of Cimzia (certolizumab pegol) in the treatment of Crohn’s Disease patients:

• Long-Term Remission with Certolizumab Pegol in Crohn’s Disease: Efficacy Over 4 Years in Patients with No Prior TNF-alpha Inhibitor Exposure (PRECiSE 3 Study)
  • Continuous therapy with 400mg of certolizumab pegol (CZP) provided long-term remission over four years in patients who initially responded to CZP induction therapy.  These remission rates were observed in PRECiSE 3 bio-naive patients receiving CZP.  For full study information, please see: http://download.abstractcentral.com/DDW2010/myddw/S1040.html
  • Poster S1040, May 2, 8:00 am – 5:00 pm, ENMCC: Hall F

• Certolizumab Pegol is Effective at Maintaining Response and Remission in Patients with Fistulising Crohn’s Disease: 3-Year Results from the PRECiSE 3 Study:
  • CZP demonstrated sustained efficacy and remission among patients with fistulising CD over 3 years, as measured by Harvey-Bradshaw Index (a symptom severity questionnaire).  For full study information, please see: http://download.abstractcentral.com/DDW2010/myddw/S1035.html
  • Poster S1035, May 2, 8:00 am – 5:00 pm, ENMCC: Hall F

• Certolizumab Pegol demonstrates Efficacy in Maintaining Response and Remission in Patients with active Crohn’s Disease Regardless of their Immunosuppressant Treatment Status at Entry to the PRECiSE 2 Study:
  • This analysis of the placebo-controlled PRECiSE 2 (PEGylated Antibody Fragment Evaluation in Crohn's Disease 2) study demonstrated the sustained efficacy of CZP in maintaining response and remission over 26 weeks in both patients who had been previously exposed or were naïve to oral immunosuppressants (IS).  A tendency toward a larger level of response and remission was seen in IS naïve patients. For full study information, please see: http://download.abstractcentral.com/DDW2010/myddw/S1037.html
  • Poster S1037, May 2, 8:00 am – 5:00 pm, ENMCC: Hall F

• Predictors of Response and Remission to Certolizumab Pegol in Patients with Crohn’s Disease: Data from the WELCOME Study
  • This study measured the accuracy of various predictors of response to CZP among moderate to severe CD patients who had failed on IFX.  Predictors tested included: age, CD duration, symptoms and activity, resection, previous use of corticosteroids or immunosuppressants, reason for IFX failure, smoking status, C-reactive protein or anti-IFX antibodies.  Results demonstrated that none of these factors predicted clinical response; however, localization of CD, resection, number of resections and baseline disease activity did have a significant impact on the probability of achieving remission after 26 weeks of treatment.  In addition, certain combinations of interactions were identified as being conducive to maintaining response and remission.  For full study information, please see: http://download.abstractcentral.com/DDW2010/myddw/S1030.html
  • Poster S1030, May 2, 8:00 am – 5:00 pm, ENMCC: Hall F

Additional data at this year’s DDW also suggest that patients using Cimzia show higher rates of compliance and persistency than usually seen in chronic disease states.

• Administrative claims data analysis of Certolizumab pegol in Crohn’s disease patients demonstrates low rates of dose escalation and high compliance and persistency
  • This analysis demonstrated a low dose escalation rate among CD patients taking CZP 400 mg for up to 9 months.  Less than 2% of patients met the criteria for dose escalation (defined as receiving incremental doses of 400 mg less than 16 days apart).  In addition, rates of compliance and persistency, as measured by Medication Possession Ratio, were high (91% and 66%, respectively).  For full study information, please see: http://download.abstractcentral.com/DDW2010/myddw/T1324.html
  • Poster T1324, May 4, 8:00 am – 5:00 pm, ENMCC: Hall F

Following is a guide to additional Cimzia posters that will be exhibited during DDW:  

• Dosing With Certolizumab Pegol (CZP) 200 Mg Every 2 Weeks (Q2w) Provides Higher Plasma Trough Concentrations than 400 Mg Every 4 Weeks (Q4w)
  • Poster S1029, May 2, 8:00 am – 5:00 pm, ENMCC: Hall F

• No significant transfer of certolizumab pegol compared with IgG in the perfused human placenta in vitro
  • Poster W1208, May 5, 8:00 am – 5:00 pm, ENMCC: Hall F

• Endoscopic Mucosal Improvement in Patients with Active Crohn's Disease Treated with Certolizumab Pegol: Week 10 and 54 Results of the MUSIC Trial
  • Poster S1045, May 2, 8:00 am – 5:00 pm, ENMCC: Hall F