Certolizumab pegol for treatment of Crohn disease in adults
- Joshua R Korzenik, MD
Joshua R Korzenik, MD
- AGA Peer Reviewer
- Assistant Professor of Medicine
- Harvard Medical School
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 .
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 . However, the clinical significance of these differences is unclear.
INDICATIONS AND CONTRAINDICATIONS
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 . 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".)
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- INDICATIONS AND CONTRAINDICATIONS
- DOSING AND ADMINISTRATION
- Induction of remission
- Maintenance of remission
- - Patients with relapsed Crohn disease
- - Patients with prior anti-TNF or immunomodulator failure
- - Patients with fistulizing Crohn disease
- ADVERSE EFFECTS
- ADALIMUMAB VERSUS INFLIXIMAB VERSUS CERTOLIZUMAB
- SPECIAL POPULATIONS
- INFORMATION FOR PATIENTS
- SUMMARY AND RECOMMENDATIONS