Efficacy and safety of certolizumab pegol for Crohn's disease in clinical practice.

Abstract

BACKGROUND:

Certolizumab pegol (CZP) is Food and Drug Administration (FDA)-approved to treat Crohn's disease (CD). However, the efficacy and safety of CZP outside clinical trials are not well established.

AIM:

To report the efficacy, safety and predictors of response to CZP in CD patients treated during a 6-year period since FDA-approval at a tertiary care centre.

METHODS:

All CD patients who received CZP at our institution between 2008 and 2013 were evaluated through retrospective medical record-based review of steroid-free complete response (SCR), loss of response and safety.

RESULTS:

A total of 358 patients were included. One hundred twelve patients (31.3%) and 189 (52.8%) received CZP as their second and third biological agent, respectively. The probability of SCR at 26 week was 19.9% (95% CI, 15.9-24.5). The probability of survival free of loss of response at 2 year was 45.7% (95% CI, 32.5-59.5). A predictor of SCR was age at CD diagnosis of >40 years old (hazard ratio, HR relative to those <17, 4.69; 95% CI, 1.75-12.61). Negative predictors included present perianal fistula (HR, 0.39; 95% CI, 0.16-0.98) and prior primary nonresponse to adalimumab (ADA; HR relative to secondary loss of response, 0.18; 95% CI, 0.04-0.76). Twenty-three patients (6.4%) experienced serious adverse events and 19 patients (5.3%) discontinued CZP due to adverse events.

CONCLUSIONS:

Certolizumab pegol was both effective and well tolerated for the treatment of Crohn's disease in this large tertiary care centre enriched with biologics-exposed patients. It may be more effective in patients without early-aged Crohn's disease diagnosis, prior primary nonresponse to adalimumab and present perianal fistula.

• Authors: W Moon, L Pestana, B Becker, E V Loftus Jr, K A Hanson, D H Bruining, W J Tremaine, S V Kane
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 42 Issue 4 Pg. 428-40 (Aug 2015) ISSN: 1365-2036 [Electronic] England
• PMID: 26081839 (Publication Type: Journal Article)
• Copyright: © 2015 John Wiley & Sons Ltd.

Chemical References

• Biological Products
• Adalimumab
• Certolizumab Pegol

Topics

• Adalimumab (therapeutic use)
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Biological Products (therapeutic use)
• Certolizumab Pegol (adverse effects, therapeutic use)
• Crohn Disease (drug therapy)
• Female
• Humans
• Male
• Middle Aged
• Rectal Fistula (pathology)
• Retrospective Studies
• Tertiary Care Centers
• Treatment Outcome
• United States
• United States Food and Drug Administration
• Young Adult