BACKGROUND: Certolizumab pegol (CZP) is Food and Drug Administration (FDA)-approved to treat @entity30 ( @entity30 ). 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 @entity30 @entity1 treated during a 6-year period since FDA-approval at a tertiary care centre. METHODS: All @entity30 @entity1 who received CZP at our institution between 2008 and 2013 were evaluated through retrospective medical record-based review of @entity479 -free complete response (SCR), loss of response and safety. RESULTS: A total of 358 @entity1 were included. One hundred twelve @entity1 (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 @entity30 diagnosis of >40  years old (hazard ratio, HR relative to those <17, 4.69; 95% CI, 1.75-12.61). Negative predictors included @entity292 (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 @entity1 (6.4%) experienced serious adverse events and 19 @entity1 (5.3%) discontinued CZP due to adverse events. CONCLUSIONS: Certolizumab pegol was both effective and well tolerated for the treatment of @entity30 in this large tertiary care centre enriched with biologics-exposed @entity1 . It may be more effective in @entity1 without early-aged @entity30 diagnosis, prior primary nonresponse to adalimumab and @entity292 .

Efficacy and safety of certolizumab pegol for XXXX in clinical practice.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity292 :: ('MESH:D005402', 'Disease') :: ['present perianal fistula'] @entity30 :: ('MESH:D003424', 'Disease') :: ['CD', "Crohn's disease"] @entity479 :: ('D013256', 'Chemical') :: ['steroid']
@entity30 :: (MESH:D003424,Disease) :: ['Crohn's disease']
