Official reprint from UpToDate®
www.uptodate.com ©2016 UpToDate®

Certolizumab pegol for treatment of Crohn disease in adults

Joshua R Korzenik, MD
Section Editor
Paul Rutgeerts, MD, PhD, FRCP
Deputy Editor
Shilpa Grover, MD, MPH


Inhibitors of tumor necrosis factor (TNF)-alpha are important treatment options in patients with Crohn disease. This topic will review the pharmacology, indications, administration, and efficacy of certolizumab pegol for the treatment of Crohn disease in adults. The management of patients with Crohn disease, the role of immunomodulators, and other anti-TNFs in patients with Crohn disease are discussed in detail, separately. (See "Overview of the medical management of mild to moderate Crohn disease in adults" and "Overview of the medical management of severe or refractory Crohn disease in adults" and "Immunomodulator therapy in Crohn disease" and "Infliximab in Crohn disease" and "Adalimumab for treatment of Crohn disease in adults" and "Natalizumab for treatment of Crohn disease in adults".)


Certolizumab pegol is a humanized monoclonal antibody Fab fragment linked to polyethylene glycol that neutralizes TNF. The polyethylene glycol increases its plasma half-life and reduces the requirement for frequent dosing, possibly reducing immunogenicity as well. In vitro studies suggest that certolizumab also has a higher binding affinity for TNF as compared with adalimumab or infliximab [1].

Unlike anti-TNF monoclonal antibodies, certolizumab pegol does not have a Fc region; as a result, it does not activate the complement pathway, result in cell- or antibody-mediated cytotoxicity, or induce apoptosis [1]. However, the clinical significance of these differences is unclear.


Similar to other tumor necrosis factor (TNF)-alpha inhibitors, certolizumab pegol is approved in the United States for the induction and maintenance of response in adults with moderate to severe Crohn disease who have an inadequate response to conventional therapy [2]. We use certolizumab as a second- or third-line anti-TNF agent in patients with Crohn disease who responded to infliximab/adalimumab and then lost response or became intolerant to it. In patients who respond, we continue certolizumab pegol for maintenance therapy. Certolizumab is also available in Canada and European Union countries; however, it is not approved for the management of Crohn disease [3,4].

Contraindications to certolizumab are the same as other TNF-alpha inhibitors and are discussed separately. (See "Tumor necrosis factor-alpha inhibitors: Bacterial, viral, and fungal infections", section on 'Contraindications' and "Tumor necrosis factor-alpha inhibitors: An overview of adverse effects".)


Subscribers log in here

To continue reading this article, you must log in with your personal, hospital, or group practice subscription. For more information or to purchase a personal subscription, click below on the option that best describes you:
Literature review current through: Sep 2016. | This topic last updated: Nov 10, 2015.
The content on the UpToDate website is not intended nor recommended as a substitute for medical advice, diagnosis, or treatment. Always seek the advice of your own physician or other qualified health care professional regarding any medical questions or conditions. The use of this website is governed by the UpToDate Terms of Use ©2016 UpToDate, Inc.
  1. Nesbitt A, Fossati G, Bergin M, et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents. Inflamm Bowel Dis 2007; 13:1323.
  2. Cimzia (certolizumab pegol) United States prescribing information. Revised 10/2013. http://dailymed.nlm.nih.gov/dailymed/about.cfm.
  3. Cimzia (certolizumab pegol) Canada product monograph. January 2014. http://webprod5.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp.
  4. Cimzia (certolizumab pegol) EMA summary of product characteristics. Janaury 3, 2014. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001037/WC500069763.pdf.
  5. Schreiber S, Rutgeerts P, Fedorak RN, et al. A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn's disease. Gastroenterology 2005; 129:807.
  6. Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med 2007; 357:228.
  7. Ford AC, Sandborn WJ, Khan KJ, et al. Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol 2011; 106:644.
  8. Winter TA, Wright J, Ghosh S, et al. Intravenous CDP870, a PEGylated Fab' fragment of a humanized antitumour necrosis factor antibody, in patients with moderate-to-severe Crohn's disease: an exploratory study. Aliment Pharmacol Ther 2004; 20:1337.
  9. Rutgeerts P, Schreiber S, Feagan B, et al. Certolizumab pegol, a monthly subcutaneously administered Fc-free anti-TNFalpha, improves health-related quality of life in patients with moderate to severe Crohn's disease. Int J Colorectal Dis 2008; 23:289.
  10. Feagan BG, Coteur G, Tan S, et al. Clinically meaningful improvement in health-related quality of life in a randomized controlled trial of certolizumab pegol maintenance therapy for Crohn's disease. Am J Gastroenterol 2009; 104:1976.
  11. Feagan BG, Sandborn WJ, Wolf DC, et al. Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab. Aliment Pharmacol Ther 2011; 33:541.
  12. Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al. Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med 2007; 357:239.
  13. Lichtenstein GR, Thomsen OØ, Schreiber S, et al. Continuous therapy with certolizumab pegol maintains remission of patients with Crohn's disease for up to 18 months. Clin Gastroenterol Hepatol 2010; 8:600.
  14. Sandborn WJ, Schreiber S, Hanauer SB, et al. Reinduction with certolizumab pegol in patients with relapsed Crohn's disease: results from the PRECiSE 4 Study. Clin Gastroenterol Hepatol 2010; 8:696.
  15. Sandborn WJ, Abreu MT, D'Haens G, et al. Certolizumab pegol in patients with moderate to severe Crohn's disease and secondary failure to infliximab. Clin Gastroenterol Hepatol 2010; 8:688.
  16. Hanauer SB, Panes J, Colombel JF, et al. Clinical trial: impact of prior infliximab therapy on the clinical response to certolizumab pegol maintenance therapy for Crohn's disease. Aliment Pharmacol Ther 2010; 32:384.
  17. Allez M, Vermeire S, Mozziconacci N, et al. The efficacy and safety of a third anti-TNF monoclonal antibody in Crohn's disease after failure of two other anti-TNF antibodies. Aliment Pharmacol Ther 2010; 31:92.
  18. Moon W, Pestana L, Becker B, et al. Efficacy and safety of certolizumab pegol for Crohn's disease in clinical practice. Aliment Pharmacol Ther 2015; 42:428.
  19. Jones JL, Kaplan GG, Peyrin-Biroulet L, et al. Effects of Concomitant Immunomodulator Therapy on Efficacy and Safety of Anti-Tumor Necrosis Factor Therapy for Crohn's Disease: A Meta-analysis of Placebo-controlled Trials. Clin Gastroenterol Hepatol 2015; 13:2233.
  20. Schreiber S, Lawrance IC, Thomsen OØ, et al. Randomised clinical trial: certolizumab pegol for fistulas in Crohn's disease - subgroup results from a placebo-controlled study. Aliment Pharmacol Ther 2011; 33:185.
  21. Subramanian S, Yajnik V, Sands BE, et al. Characterization of patients with infliximab-induced lupus erythematosus and outcomes after retreatment with a second anti-TNF agent. Inflamm Bowel Dis 2011; 17:99.
  22. Deepak P, Stobaugh DJ. Maternal and foetal adverse events with tumour necrosis factor-alpha inhibitors in inflammatory bowel disease. Aliment Pharmacol Ther 2014; 40:1035.
  23. Mahadevan U, Wolf DC, Dubinsky M, et al. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease. Clin Gastroenterol Hepatol 2013; 11:286.