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
W J Sandborn, G Y Melmed, D P B McGovern, E V Loftus Jr, J M Choi, J H Cho, B Abraham, A Gutierrez, G Lichtenstein, S D Lee, C W Randall, D A Schwartz, M Regueiro, C A Siegel, M Spearman, G Kosutic, B Pierre-Louis, J Coarse, S Schreiber, W J Sandborn, G Y Melmed, D P B McGovern, E V Loftus Jr, J M Choi, J H Cho, B Abraham, A Gutierrez, G Lichtenstein, S D Lee, C W Randall, D A Schwartz, M Regueiro, C A Siegel, M Spearman, G Kosutic, B Pierre-Louis, J Coarse, S Schreiber
Abstract
Background: 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 predictors of short- and long-term clinical remission among CD patients treated with certolizumab pegol (CZP).
Aim: To identify factors that influence long-term remission of CD with CZP treatment.
Methods: Patients who had completed placebo-controlled studies (PRECiSE 1/PRECiSE 2, P1/P2) enrolled in P3 and received open-label CZP 400 mg every 4 weeks up to 7 years. 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.
Results: Predictors 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.
Conclusions: These 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).
© 2015 John Wiley & Sons Ltd.
Source: PubMed