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Efficacy and safety of certolizumab pegol in an unselected crohn's disease population: 26-week data of the FACTS II survey

Vavricka, Stephan R. MD1,2; Schoepfer, Alain M. MD3,4; Bansky, Georg MD6; Binek, Janek MD5; Felley, Christian MD7; Geyer, Martin MD8; Manz, Michael MD9; Rogler, Gerhard MD, PhD1; de Saussure, Philippe MD10; Sauter, Bernhard MD12; Scharl, Michael MD1; Seibold, Frank MD4; Straumann, Alex MD11; Michetti, Pierre MD7*for the Swiss IBDnet

doi: 10.1002/ibd.21521
Original Clinical Articles

Background: Certolizumab pegol (Cimzia, CZP) was approved for the treatment of Crohn's disease (CD) patients in 2007 in Switzerland as the first country worldwide. This prospective phase IV study aimed to evaluate the efficacy and safety of CZP over 26 weeks in a multicenter cohort of practice-based patients.

Methods: Evaluation questionnaires at baseline, week 6, and week 26 were completed by gastroenterologists in hospitals and private practices. Adverse events were evaluated according to World Health Organization (WHO) guidelines.

Results: Sixty patients (38F/22M) were included; 53% had complicated disease (stricturing or penetrating), 45% had undergone prior CD-related surgery. All patients had prior exposure to systemic steroids, 96% to immunomodulators, 73% to infliximab, and 43% to adalimumab. A significant decrease of the Harvey-Bradshaw Index (HBI) was observed under CZP therapy (12.2 ± 4.9 at week 0 versus 6.3 ± 4.7 at week 6 and 6.7 ± 5.3 at week 26, both P < 0.001). Response and remission rates were 70% and 40% (week 6) and 67% and 36%, respectively (week 26). The complete perianal fistula closure rate was 36% at week 6 and 55% at week 26. The frequency of adverse drug reactions attributed to CZP was 5%. CZP was continued in 88% of patients beyond week 6 and in 67% beyond week 26.

Conclusions: In a population of CD patients with predominantly complicated disease behavior, CZP proved to be effective in induction and maintenance of response and remission. This series provides the first evidence of CZP's effectiveness in perianal fistulizing CD in clinical practice. (Inflamm Bowel Dis 2011;)

1 From the Division of Gastroenterology, University Hospital of Zurich, Switzerland

2 Division of Gastroenterology, Triemlispital, Zurich, Switzerland

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

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

5 Private practice, Zurich, Switzerland

6 Department of Gastroenterology, Kantonsspital St. Gallen, Switzerland

7 Gastroentérologie La Source-Beaulieu and Division of Gastroenterology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

8 Private practice, Wettingen, Switzerland

9 Division of Gastroenterology, University Hospital Basel, Switzerland

10 Private practice, Geneva, Switzerland

11 Department of Gastroenterology, Hirslanden Clinic, Zurich, Switzerland

12 Private practice, Olten, Switzerland

* Gastroentérologie La Source-Beaulieu, Avenue Jomini 8, CH -1004 Lausanne, Switzerland

Email: pmichetti@gesb.ch

Received 22 August 2010; Accepted 10 September 2010

Published online 22 December 2010 in Wiley Online Library (wileyonlinelibrary.com).

This study was 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 two authors contributed equally.

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