Publication

Long-Term Efficacy and Safety of Certolizumab Pegol in an Unselected Crohn's Disease Population: The FACTS III Survey

Journal Paper/Review - Jun 9, 2017

Units
PubMed
Doi

Citation
Vavricka S, Biedermann L, Michetti P, Straumann A, Misselwitz B, Scharl M, Manser C, Greuter T, Zeitz J, Frei P, Borovicka J, Seibold F, Schoepfer A, Rogler G, Spasojevic M. Long-Term Efficacy and Safety of Certolizumab Pegol in an Unselected Crohn's Disease Population: The FACTS III Survey. Dig Dis 2017; 35:423-432.
Type
Journal Paper/Review (English)
Journal
Dig Dis 2017; 35
Publication Date
Jun 9, 2017
Issn Electronic
1421-9875
Pages
423-432
Brief description/objective

BACKGROUND
Long-term data of certolizumab pegol (CZP) in Crohn's disease (CD) from pivotal registry trials are limited. We therefore aimed to evaluate the long-term efficacy of CZP in clinical practice in Switzerland.

METHODS
In the First Approved Certolizumab Therapeutic Experience in Switzerland-III phase IV multicenter cohort, patients receiving CZP were prospectively included all over Switzerland in (non-) academic hospitals and private practice.

RESULTS
We included 104 CD patients (52 male; only 22.1% anti-tumor necrosis factor (TNF) naïve, CZP as third anti-TNF agent in 46.2%) with follow-up time between 6 weeks up to 5 years. During treatment with CZP, we observed a significant decrease of the Harvey Bradshaw Index from a median of 7 at baseline (interquartile range 4-11) to 4, 5, 4, 3, 3, and 2 at weeks 6, 26, 52, 78, 104, and 156, respectively. While anti-TNF naïve patients showed a significantly better response at the end of induction, during CZP maintenance therapy response was similar as compared to anti-TNF experienced patients as well as between patients with a short (0-5 years) vs. long duration of disease (>5 years).

CONCLUSIONS
CZP is an effective long-term treatment option, including CD patients with long disease duration and prior treatment with 1 or 2 anti-TNF agents.