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

Sandborn WJ1, Melmed GY2, McGovern DP2, Loftus EV Jr3, Choi JM4, Cho JH5, Abraham B6, Gutierrez A7, Lichtenstein G8, Lee SD9, Randall CW10, Schwartz DA11, Regueiro M12, Siegel CA13, Spearman M14, Kosutic G15, Pierre-Louis B15, Coarse J15, Schreiber S16. Aliment Pharmacol Ther. 2015 Jun 1. doi: 10.1111/apt.13251. [Epub ahead of print]
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1University of California San Diego School of Medicine, La Jolla, CA, USA. 2The Widjaja Foundation Inflammatory Bowel and Immunology Research Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA. 3Mayo Clinic, Rochester, MN, USA. 4UCLA Center for Inflammatory Bowel Diseases, Los Angeles, CA, USA. 5Icahn School of Medicine at Mount Sinai, New York, NY, USA. 6Houston Methodist, Houston, TX, USA. 7Washington University in St. Louis School of Medicine, St. Louis, MO, USA. 8Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA, USA. 9University of Washington School of Medicine, Seattle, WA, USA. 10Gastroenterology Research of America, San Antonio, TX, USA. 11Vanderbilt University Medical Center, Nashville, TN, USA. 12University of Pittsburgh Medical Center, Pittsburgh, PA, USA. 13Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA. 14UCB Pharma, Smyrna, GA, USA. 15UCB Pharma, Raleigh, NC, USA. 16Christian-Albrechts University at Kiel, Kiel, Germany.


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: 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).

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