Titre
Efficacy and safety of certolizumab pegol in an unselected crohn's disease population: 26-week data of the FACTS II survey.
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Vavricka, S.R.
Auteure/Auteur
Schoepfer, A.M.
Auteure/Auteur
Bansky, G.
Auteure/Auteur
Binek, J.
Auteure/Auteur
Felley, C.
Auteure/Auteur
Geyer, M.
Auteure/Auteur
Manz, M.
Auteure/Auteur
Rogler, G.
Auteure/Auteur
de Saussure, P.
Auteure/Auteur
Sauter, B.
Auteure/Auteur
Scharl, M.
Auteure/Auteur
Seibold, F.
Auteure/Auteur
Straumann, A.
Auteure/Auteur
Michetti, P.
Auteure/Auteur
Groupes de travail
Swiss IBDnet
Liens vers les personnes
Liens vers les unités
ISSN
1536-4844
Statut éditorial
Publié
Date de publication
2011
Volume
17
Numéro
7
Première page
1530
Dernière page/numéro d’article
1539
Langue
anglais
Notes
Publication types: Clinical Trial, Phase IV ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
Résumé
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.
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.
Sujets
PID Serval
serval:BIB_0D57A5F86107
PMID
Date de création
2011-10-05T10:41:55.691Z
Date de création dans IRIS
2025-05-20T19:12:29Z