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.
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).
  
  
  OBJECTIVE
  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).
authors.affiliation: University of California San Diego School of Medicine, La Jolla, CA, USA.
authors.forename: W J
authors.initials: WJ
authors.lastname: Sandborn
authors.affiliation: The Widjaja Foundation Inflammatory Bowel and Immunology Research Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
authors.forename: G Y
authors.initials: GY
authors.lastname: Melmed
authors.affiliation: The Widjaja Foundation Inflammatory Bowel and Immunology Research Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
authors.forename: D P B
authors.initials: DP
authors.lastname: McGovern
authors.affiliation: Mayo Clinic, Rochester, MN, USA.
authors.forename: E V
authors.initials: EV
authors.lastname: Loftus
authors.affiliation: UCLA Center for Inflammatory Bowel Diseases, Los Angeles, CA, USA.
authors.forename: J M
authors.initials: JM
authors.lastname: Choi
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, NY, USA.
authors.forename: J H
authors.initials: JH
authors.lastname: Cho
authors.affiliation: Houston Methodist, Houston, TX, USA.
authors.forename: B
authors.initials: B
authors.lastname: Abraham
authors.affiliation: Washington University in St. Louis School of Medicine, St. Louis, MO, USA.
authors.forename: A
authors.initials: A
authors.lastname: Gutierrez
authors.affiliation: Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: G
authors.initials: G
authors.lastname: Lichtenstein
authors.affiliation: University of Washington School of Medicine, Seattle, WA, USA.
authors.forename: S D
authors.initials: SD
authors.lastname: Lee
authors.affiliation: Gastroenterology Research of America, San Antonio, TX, USA.
authors.forename: C W
authors.initials: CW
authors.lastname: Randall
authors.affiliation: Vanderbilt University Medical Center, Nashville, TN, USA.
authors.forename: D A
authors.initials: DA
authors.lastname: Schwartz
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
authors.forename: M
authors.initials: M
authors.lastname: Regueiro
authors.affiliation: Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
authors.forename: C A
authors.initials: CA
authors.lastname: Siegel
authors.affiliation: UCB Pharma, Smyrna, GA, USA.
authors.forename: M
authors.initials: M
authors.lastname: Spearman
authors.affiliation: UCB Pharma, Raleigh, NC, USA.
authors.forename: G
authors.initials: G
authors.lastname: Kosutic
authors.affiliation: UCB Pharma, Raleigh, NC, USA.
authors.forename: B
authors.initials: B
authors.lastname: Pierre-Louis
authors.affiliation: UCB Pharma, Raleigh, NC, USA.
authors.forename: J
authors.initials: J
authors.lastname: Coarse
authors.affiliation: Christian-Albrechts University at Kiel, Kiel, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Schreiber
mesh_terms: D000328:Adult; D000068582:Certolizumab Pegol / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000068582:Certolizumab Pegol