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- Title
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.
- Authors
Sandborn, W. J.; Melmed, G. Y.; McGovern, D. P. B.; Loftus, E. V.; 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.
- 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).
- Subjects
CROHN'S disease; DEMOGRAPHIC characteristics; TREATMENT effectiveness; SURGERY; INFLAMMATORY bowel diseases
- Publication
Alimentary Pharmacology & Therapeutics, 2015, Vol 42, Issue 3, p330
- ISSN
0269-2813
- Publication type
Article
- DOI
10.1111/apt.13251