title: Certolizumab pegol for active Crohn's disease: a placebo-controlled, randomized trial.
abstract: OBJECTIVE
  Certolizumab pegol (CZP) is a pegylated-conjugated Fab' against tumor necrosis factor (TNF). Additional data are needed regarding the efficacy of induction therapy with CZP in active Crohn's disease (CD).
  
  
  METHODS
  A placebo-controlled trial evaluated the efficacy of CZP therapy in 439 adults with moderate to severe CD naive to anti-TNF therapy. Patients were randomized to receive CZP (400 mg subcutaneously) or placebo at weeks 0, 2, and 4. The primary end point was clinical remission at week 6.
  
  
  RESULTS
  Clinical remission rates at week 6 in the CZP and placebo groups were 32% and 25% (P = .174), respectively. Remission rates at weeks 2 and 4 in the CZP and placebo groups were 23% and 16% (P = .033) and 27% and 19% (P = .063), respectively. Clinical response rates at weeks 2, 4, and 6 in the CZP and placebo groups were 33% and 20% (P = .001), 35% and 26% (P = .024), and 41% and 34% (P = .179), respectively. There were significantly greater rates of clinical remission at week 6 for CZP in patients with increased concentrations of C-reactive protein (≥5 mg/L) at entry. Serious adverse events developed in 5% and 4% of patients in the CZP and placebo groups, respectively.
  
  
  CONCLUSIONS
  The primary end point did not reach statistical significance. Significant differences between CZP and placebo were observed in patients who had increased concentrations of C-reactive protein when the study began. Future clinical trials should emphasize the treatment of patients who have objective evidence of inflammation in addition to symptoms of active disease.
authors.affiliation: Division of Gastroenterology, University of California San Diego, La Jolla, 92093-0063, USA. wsandborn@ucsd.edu
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Stefan
authors.initials: S
authors.lastname: Schreiber
authors.forename: Brian G
authors.initials: BG
authors.lastname: Feagan
authors.forename: Paul
authors.initials: P
authors.lastname: Rutgeerts
authors.forename: Ziad H
authors.initials: ZH
authors.lastname: Younes
authors.forename: Ralph
authors.initials: R
authors.lastname: Bloomfield
authors.forename: Geoffroy
authors.initials: G
authors.lastname: Coteur
authors.forename: Juan Pablo
authors.initials: JP
authors.lastname: Guzman
authors.forename: Geert R
authors.initials: GR
authors.lastname: D'Haens
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized; D002097:C-Reactive Protein / Q000032:analysis; D000068582:Certolizumab Pegol; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage*; D007155:Immunologic Factors / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007140:Immunoglobulin Fab Fragments; D007155:Immunologic Factors; D010919:Placebos; D011092:Polyethylene Glycols; D002097:C-Reactive Protein; D000068582:Certolizumab Pegol