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Cimzia(R) (certolizumab pegol) Provides Long-Term Remission and Response Rates in Infliximab-Refractory Crohn's Patients
Date:6/1/2009

ur weeks, respectively, achieved clinical remission as measured by the CDAI.

No new or unexpected safety signals were observed in this study. Adverse events were previously reported from the WELCOME study: the most common adverse events were headache, nasopharyngitis and nausea. The incidence of serious adverse events (SAEs) was seven percent and the most frequent SAEs involved gastrointestinal disorders (five percent) and infections and infestations (2 percent).

Additional data from the WELCOME study presented at DDW, includes:

  • Health-related Quality of Life: Cimzia(R) (400 mg) administered at every two or four weeks similarly improved patient-reported health-related quality of life as measured by the Inflammatory Bowel Disease Questionnaire (a validated tool assessing bowel symptoms, systematic symptoms, emotional function and social function) by Week 26. (Abstract #S1058)
  • Efficacy Independent of IFX Dosing: Cimzia(R) (400 mg) was efficacious in rapidly inducing a clinical response in the infliximab-refractory patient population regardless of the previous dosages of infliximab. (Abstract #S1064)

"As we continue to study Cimzia(R)'s potential efficacy, we are pleased to be adding to an impressive body of data that supports the use of Cimzia(R) for a variety of moderate to severe Crohn's disease patients," said David Robinson, vice president and general manager of UCB's Immunology Business Unit.

Recently, UCB announced that Cimzia(R) is now available to Crohn's patients in a pre-filled syringe, developed in partnership with OXO Good Grips(R) for subcutaneous self-administration once every four weeks after initial dosing. Cimzia(R), manufactured by UCB, was approved by the U.S. Food and Drug Administration on April 22, 2008.

About WELCOME

The WELCOME study is a 539 pa
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