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.

摘要: SUMMARYBackground Clinical 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 short- and long-term clinical remission among CD patients treated with certolizumab pegol (CZP). Aim To identify that influence CZP treatment. Methods Patients who had completed placebo-controlled studies (PRECiSE 1/PRECiSE 2, P1/P2) enrolled P3 received open-label 400 mg every 4 weeks up 7 years. Baseline included, but not limited to, smoking status, duration, prior inflammatory bowel (IBD) surgery, Harvey–Bradshaw Index (HBI), albumin, haematocrit exposure; association time initial (HBI ≤4) was tested for P1/P2; loss remission/frequency maintenance also tested. Univariate analyses multivariate Cox or logistic regression models used. Results Predictors (N = 377) included age, haematocrit, IBD surgery entry HBI (P < 0.05 all). Predictors (N = 437) HBI, serum albumin concentration, status exposure. concentration Significant confirmed stepwise models. Conclusions These several influential parameters short-and treatment. data yield valuable hypotheses regarding More investigation is needed. (ClinicalTrials.gov identifier NCT00552058).