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

• Published in: Digestive diseases (Basel) Vol. 35; no. 5; p. 423
• Main Authors: Vavricka, Stephan R, Spasojevic, Milos, Rogler, Gerhard, Schoepfer, Alain M, Seibold, Frank, Borovicka, Jan, Frei, Pascal, Zeitz, Jonas, Greuter, Thomas, Manser, Christine, Scharl, Michael, Misselwitz, Benjamin, Straumann, Alex, Michetti, Pierre, Biedermann, Luc
• Format: Journal Article
• Language: English
• Published: Switzerland 01.01.2017
• Subjects: Adult; Certolizumab Pegol - adverse effects; Certolizumab Pegol - therapeutic use; Cohort Studies; Crohn Disease - drug therapy; Disease Progression; Female; Follow-Up Studies; Humans; Male; Middle Aged; Registries; Surveys and Questionnaires; Time Factors; Treatment Outcome; Tumor Necrosis Factor-alpha - antagonists & inhibitors; Anti-tumor necrosis factor; Real-life cohort; Long-term efficacy; Certolizumab; Crohn’s disease
• DOI: 10.1159/000475494

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. 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. 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). 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.