Efficacy and Safety of Certolizumab Pegol in an Unselected Crohn's Disease Population: 26 Week Data of the FACTS II Survey.
Details
Serval ID
serval:BIB_C368C9BDDB8D
Type
Inproceedings: an article in a conference proceedings.
Publication sub-type
Abstract (Abstract): shot summary in a article that contain essentials elements presented during a scientific conference, lecture or from a poster.
Collection
Publications
Institution
Title
Efficacy and Safety of Certolizumab Pegol in an Unselected Crohn's Disease Population: 26 Week Data of the FACTS II Survey.
Title of the conference
Annual meeting of the Swiss Society of Gastroenterology, Swiss Society for Visceral, Surgery Swiss Association for the Study of the Liver, Swiss Association of Clinical Nutrition
Address
Interlaken, Switzerland, September 23-24, 2010
ISBN
1424-7860
Publication state
Published
Issued date
2010
Peer-reviewed
Oui
Volume
140
Series
Swiss Medical Weekly
Pages
11S
Language
english
Notes
Meeting Abstract
Abstract
BACKGROUND: Certolizumab pegol (Cimzia, CZP) was approved for the treatment of Crohn's disease (CD) patients in 2007 in Switzerland as 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 26 were completed by gastroenterologists in hospitals and private practices.
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 Harvey Bradshaw Index (HBI) was observed under CZP therapy (12.24.9 at week 0 vs 6.34.7 at week 6 and 6.75.3 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 behaviour, 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.
METHODS: Evaluation questionnaires at baseline, week 6 and 26 were completed by gastroenterologists in hospitals and private practices.
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 Harvey Bradshaw Index (HBI) was observed under CZP therapy (12.24.9 at week 0 vs 6.34.7 at week 6 and 6.75.3 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 behaviour, 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.
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Create date
04/11/2010 15:11
Last modification date
20/08/2019 15:38
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