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

作者：Sandborn W J^*; Melmed G Y; McGovern D P B; Loftus E V Jr; Choi J M; Cho J H; Abraham B; Gutierrez A; Lichtenstein G; Lee S D; Randall C W; Schwartz D A; Regueiro M; Siegel C A; Spearman M; Kosutic G; Pierre Louis B; Coarse J; Schreiber S

来源：Alimentary Pharmacology and Therapeutics, 2015, 42(3): 330-342.

DOI：10.1111/apt.13251

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).
AimTo identify factors that influence long-term remission of CD with CZP treatment.
MethodsPatients who had completed placebo-controlled studies (PRECiSE 1/PRECiSE 2, P1/P2) enrolled in P3 and received open-label CZP 400mg every 4weeks up to 7years. Baseline predictors included, but were not limited to, smoking status, disease duration, prior inflammatory bowel disease (IBD) surgery, Harvey-Bradshaw Index (HBI), albumin, haematocrit and CZP exposure; association with time to initial remission (HBI 4) was tested for patients who received CZP in P1/P2; time to loss of remission/frequency of maintenance of remission was also tested. Univariate analyses and multivariate Cox or logistic regression models were used.
ResultsPredictors for initial remission (N=377) included age, haematocrit, prior IBD surgery and entry HBI (P<0.05 for all). Predictors for loss of remission (N=437) included HBI, serum albumin concentration, haematocrit, smoking status and exposure. Predictors of maintenance of remission (N=437) included haematocrit, IBD surgery, HBI, disease duration, serum albumin concentration and exposure. Significant predictors were confirmed with stepwise multivariate regression models.
ConclusionsThese analyses identified several influential parameters for short-and long-term remission of Crohn's disease with certolizumab pegol treatment. The data yield valuable hypotheses regarding factors that influence certolizumab pegol treatment. More investigation is needed. (ClinicalTrials.gov identifier NCT00552058).

• 出版日期2015-8