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Efficacy and safety of certolizumab pegol induction therapy in an unselected Crohn's disease population: Results of the FACTS survey†

Schoepfer, Alain M. MD1,2,‡; Vavricka, Stephan R. MD3,‡; Binek, Janek MD4; Felley, Christian MD5; Geyer, Martin MD6; Manz, Michael MD7; Rogler, Gerhard MD3; de Saussure, Philippe MD8; Sauter, Bernhard MD9; Seibold, Frank MD1; Straumann, Alex MD10; Michetti, Pierre,*

doi: 10.1002/ibd.21127
Original Clinical Articles

Background:: Switzerland was the first country to approve certolizumab pegol (Cimzia, CZP) for the treatment of patients with moderate to severe Crohn's disease (CD) in September 2007. This phase IV study aimed to evaluate the efficacy and safety of CZP in a Swiss multicenter cohort of practice‐based patients.

Methods:: Baseline and Week 6 evaluation questionnaires were sent to all Swiss gastroenterologists in hospitals and private practices. Disease activity was assessed with the Harvey–Bradshaw Index (HBI) and adverse events were evaluated according to WHO guidelines.

Results:: Fifty patients (31 women, 19 men) were included; 56% had complicated disease (stricture or fistula) and 52% had undergone prior CD‐related surgery. All patients had prior exposure to systemic steroids, 96% to immunomodulators, 78% to infliximab, and 50% to adalimumab. A significant decrease in HBI was observed at Week 6 (versus Week 0) following induction therapy with CZP 400 mg subcutaneously at Weeks 0, 2, and 4 (12.6 ± 4.7 Week 0 versus 6.2 ± 4.4 Week 6, P < 0.001). Response and remission rates at Week 6 were 54% and 40%, respectively. We identified 8/11 CD patients undergoing a 50% fistula response (P = 0.021). The frequency of adverse drug reactions attributed to CZP was 6%. CZP was continued in 80% of patients beyond Week 6.

Conclusions:: In a population of CD patients with complicated disease behavior, CZP induced a response and remission in 54% and 40% of patients, respectively. This series provides the first evidence of the effectiveness of CZP in perianal fistulizing CD. Inflamm Bowel Dis 2010

1Department of Visceral Surgery and Medicine, Gastroenterology, University of Bern/Inselspital, Switzerland

2Farncombe Family Institute of Digestive Health Research, McMaster University, Hamilton, ON, Canada

3Division of Gastroenterology, University Hospital of Zurich, Switzerland

4Department of Gastroenterology, Kantonsspital St. Gallen, Switzerland

5Division of Gastroenterology and Hepatology, Lausanne University Medical Center, Lausanne, Switzerland

6Private practice, Wettingen, Switzerland

7Division of Gastroenterology, University Hospital Basel, Switzerland

8Private practice, Geneva, Switzerland

9Department of Gastroenterology, Hirslanden Clinic, Zurich, Switzerland

10Private practice, Olten, Switzerland

*Reprints: Division of Gastroenterology and Hepatology, BH10N, Centre Hospitalier Universitaire Vaudois, CH‐1011 Lausanne, Switzerland

Email: pmichetti@gesb.ch

Received for publication 3 September 2009; Accepted 7 September 2009.

Published online 10 December 2009 in Wiley InterScience (www.interscience.wiley.com).

Grant sponsor: Swiss National Science Foundation; Grant Numbers: 320000‐114009/1, 3347CO‐108792 Swiss IBD Cohort; Grant sponsor: Zurich Centre of Integrative Human Physiology.

Supported by research grants from the Swiss National Science Foundation (320000‐114009/1 to S.R.V., 3347CO‐108792 Swiss IBD Cohort) and a grant of the Zurich Centre of Integrative Human Physiology. This survey is an investigator‐initiated study. UCB had no role in study design, data collection, analysis, interpretation, or writing of the report.

The first 2 authors contributed equally.

© Crohn's & Colitis Foundation of America, Inc.
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