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

Détails

ID Serval
serval:BIB_06FA0455E3EE
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Efficacy and safety of certolizumab pegol induction therapy in an unselected Crohn's disease population: results of the FACTS survey.
Périodique
Inflammatory Bowel Diseases
Auteur⸱e⸱s
Schoepfer A.M., Vavricka S.R., Binek J., Felley C., Geyer M., Manz M., Rogler G., de Saussure P., Sauter B., Seibold F., Straumann A., Michetti P.
Collaborateur⸱rice⸱s
Swiss IBDnet
ISSN
1536-4844 (Electronic)
ISSN-L
1078-0998
Statut éditorial
Publié
Date de publication
2010
Volume
16
Numéro
6
Pages
933-938
Langue
anglais
Notes
Publication types: Clinical Trial, Phase IV ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Résumé
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.
Mots-clé
Adrenal Cortex Hormones/therapeutic use, Adult, Aged, Antibodies, Monoclonal/therapeutic use, Antibodies, Monoclonal, Humanized, Crohn Disease/drug therapy, Female, Humans, Immunoglobulin Fab Fragments/adverse effects, Immunoglobulin Fab Fragments/therapeutic use, Immunologic Factors/therapeutic use, Male, Middle Aged, Polyethylene Glycols/adverse effects, Polyethylene Glycols/therapeutic use, Prospective Studies, Questionnaires, Rectal Fistula/drug therapy, Type="Geographic">Switzerland, Treatment Outcome, Tumor Necrosis Factor-alpha/antagonists &amp, inhibitors, Young Adult
Pubmed
Web of science
Création de la notice
30/06/2010 10:08
Dernière modification de la notice
20/08/2019 12:29
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