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Aliment Pharmacol Ther. 2009 Mar 15;29(6):605-14. doi: 10.1111/j.1365-2036.2009.03929.x.

Meta-analysis: the efficacy and safety of certolizumab pegol in Crohn's disease.

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Department of Gastroenterology, Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou 310009, China.



Certolizumab pegol is the third anti-TNF-alpha agent approved by the Food and Drug Administration of the United States.


To provide a comprehensive up-to-date review of the efficacy and safety of certolizumab in Crohn's disease (CD).


Electronic databases, including PubMed, EMBASE, the Cochrane library and the Science Citation Index, were searched to retrieve relevant trials. In addition, meeting abstracts and the reference lists of retrieved articles were reviewed for further relevant studies.


Three trials, enrolling a total of 1040 patients, are included in the meta-analysis to evaluate the short-term efficacy of certolizumab, which is effective for rapid induction and long-term maintenance of clinical response or remission and can improve quality of life in patients with Crohn's disease. Certolizumab is also effective for patients who have lost response to infliximab. However, its efficacy in infliximab-exposed patients is probably less than in infliximab-naive patients. Re-induction with certolizumab in patients who have flared on maintenance therapy can rescue a significant proportion of patients. There is no significant association between the efficacy of certolizumab and the baseline C-reactive protein level. In comparison with placebo, certolizumab does not increase the risk of serious adverse events.


Certolizumab is effective and safe in treating Crohn's disease. Further studies are still required to assess its full safety profile.

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