ACG meeting to exhibit Cimzia data for Crohn's disease treatment

UCBOct 18 2010

Studies and analyses of the Crohn's disease (CD) treatment Cimzia® (certolizumab pegol) will be exhibited at the 2010 Annual Scientific Meeting of the American College of Gastroenterology, taking place in San Antonio from October 15 – 20.  

"Cimzia data at this year's ACG meeting continue to demonstrate real-life significance to those with moderate to severe Crohn's disease who have tried other therapies with no response or have never been treated with an anti-TNF," said Cem Kayhan, MD, Medical Director at UCB.  "These data indicate Cimzia may be beneficial to these patient populations in many aspects, including rapid relief of symptoms, long-term remission maintenance and quality of life improvements."

Individuals with moderate to severe Crohn's disease can experience painful symptoms that could interfere with daily life such as joint pain, abdominal cramps and high fevers.  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 trials demonstrate the utility of Cimzia in the treatment of Crohn's disease patients:

• Endoscopic Improvement in Patients with Active Crohn's Disease Treated with Certolizumab Pegol of Blinded Central Reading of Recorded Endoscopies from the MUSIC Study
  • Central reading of recorded endoscopies confirmed significant improvement in mucosal healing based on CD Endoscopic Index of Severity (CDEIS) scores at Week 10 in patients with active CD who were treated with certolizumab pegol (CZP).  
  • Poster 285, October 17, 3:30 – 7:00 pm, Exhibit Hall CD
• Health-Related Quality of Life Improvements in Patients with Active Crohn's Disease Following Treatment with Certolizumab Pegol in the MUSIC Study
  • In patients with active CD, treatment with CZP resulted in substantial improvement in health-related quality of life, including systemic and bowel symptoms and emotional and social function as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ).  Higher rates of IBDQ remission were associated with endoscopic remission compared with nonremission.
  • Poster 286, October 17, 3:30 – 7:00 pm, Exhibit Hall CD
• Long-Term Maintenance of Remission with No Dose Escalation After Re-induction with Certolizumab Pegol in Patients with Crohn's Disease Exacerbation Who were Naive to Anti-TNF Treatment:  4-Year Results from the PRECiSE 4 Study
  • Demonstrates an additional 400mg dose of CZP successfully recaptured and maintained remission rates in patients with disease exacerbation who were naive to anti-TNF treatment.  Results suggest that re-induction therapy may have long-term benefits in treating patients who experienced drug interruption or loss of initial response.
  • Poster 724, October 18, 10:30 am – 4:00 pm, Exhibit Hall CD
• Long-Term Remission with Certolizumab Pegol in Crohn's Disease: Efficacy Over 4.5 Years in Patients with No Prior TNF Inhibitor Exposure (PRECiSE 3 Study)
  • Continuous therapy with 400mg of CZP provided long-term remission of more than 4.5 years in patients who initially responded to CZP induction therapy.  These remission rates were observed in all PRECiSE 3 patients receiving CZP regardless of previous exposure to infliximab.
  • Poster 1121, October 19, 10:30 am – 4:00 pm, Exhibit Hall CD
• Effect of the PEG Component of Certolizumab Pegol on Calcium Flux in Cellular Systems
  • The PEG component of CZP inhibits calcium flux that may explain the low levels of injection site pain typically seen in patients who are treated with CZP.  
  • Poster 1137, October 19, 10:30 am – 4:00 pm, Exhibit Hall CD
• Compassionate Use of Certolizumab Pegol in Patients with Crohn's Disease Who Have Failed Previous TNF Inhibitor Therapies
• Compassionate use program (COMPAS) showed CZP is effective in patients with difficult to treat CD and those who had previously failed other TNF inhibitor treatments.  The study only included patients with severe and resistant CD.  Yet, the clinical efficacy and safety profiles of CZP were similar to those of the controlled Phase III trials.
• Poster 1120, October 19, 10:30 am – 4:00 pm, Exhibit Hall CD

Following is a guide to additional Cimzia presentations at ACG:

• Certolizumab Pegol 400mg Rapidly Reduced the Signs and Symptoms of Crohn's Disease in Greek Patients Who Previously Failed Infliximab Therapy
  • Poster 1128, October 19, 10:30 am – 4:00 pm, Exhibit Hall CD
• Patient Self-Assessed HBI Correlates Highly with Physician-Assessed HBI in the SECURE Registry
  • Poster 1106, October 19, 10:30 am – 4:00 pm, Exhibit Hall CD
• Patient Response to Anti-TNF Dose Escalation in Crohn's Disease Using Health Claims Data
  • Plenary Session 2: Colon/IBD (#52), October 19
• Induction Therapy With Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease: A Placebo-Controlled Trial
  • Plenary Session 1: Functional/IBD (#59), October 20

To view a full schedule of presentations and poster sessions, please click here http://www.acg.gi.org/acgmeetings/pdfs/2010ACGPrelimProgram.pdf.  To schedule an interview with Cem Kayhan, MD, Medical Director at UCB or Cimzia investigator, William Sandborn, MD (Professor of Medicine, Mayo Clinic, Rochester, MN) please contact Bert Kelly at 404.784.6303 or [email protected].