Clinical and demographic characteristics predictive of treatment outcomes for certolizumab pegol in moderate to severe Crohn's disease: analyses from the 7‐year PRECiSE 3 study

Abstract

SUMMARY BackgroundClinical factors were previously identified as predictors of short-term treatment efficacy in Crohn's disease (CD). The PRECiSE 3 (P3) 7-year trial provides an opportunity to study predictors of short-and long-term clinical remission among CD patients treated with certolizumab pegol (CZP).

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“…There was, however, no association with body composition and secondary loss of response. Interestingly, although demonstrated in another observational study, obesity (BMI >30 in this study) did not predict primary or secondary loss of response and was poorly correlated with all of the composite markers of body composition.…”

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“…Smokers also had a shorter duration of response (1.8 months) compared with nonsmokers (4.5 months) . Similarly data from PRECISE‐3 have indicated that smoking status was associated with a greater likelihood of active disease at any time point compared to former smokers or nonsmokers (HR: 1.404; 95% CI: 1.09–1.77; P = 0.007) …”

“…However, its utility as a predictive tool is yet to be validated. Data from PRECISE‐3 have recently demonstrated in 377 patients treated with certolizumab with a follow‐up time of 7 years that older age, haematocrit, prior IBD surgery and entry HBI are all factors that are predictive of primary nonresponse in certolizimub‐treated patients …”

“…However, younger patients are more likely to respond to anti‐TNF drugs than older patients . In certolizumab‐treated patients, a multivariate analysis of the PRECISE‐3 study showed that for every year of age, the probability of achieving primary response reduced [HR 0.989] …”

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“…An elevated CRP can also be associated with better response to anti-TNF therapy and earlier CRP normalization is associated with a better sustained response, whereas higher CRP over time is associated with loss of response ( 18 ). Th ese observations not only highlight the limitations of patient reported outcomes and clinical indices for assessing disease activity but also suggests that elevated CRP along with other blood parameters such as hemoglobin, hematocrit, and eosinophil count can be associated with a poor prognosis and loss of response in CD ( 19 ).…”