title: An engineered human antibody to TNF (CDP571) for active Crohn's disease: a randomized double-blind placebo-controlled trial.
abstract: OBJECTIVE
  We evaluated CDP571, a humanized antibody to tumor necrosis factor, for the treatment of active Crohn's disease.
  
  
  METHODS
  One hundred sixty-nine patients with moderate-to-severe Crohn's disease were enrolled in a 24-week placebo-controlled trial. Patients were initially randomized to a single dose of 10 or 20 mg/kg CDP571 or placebo to assess dose response. Patients were then retreated with 10 mg/kg CDP571 or placebo every 8 or 12 weeks to assess subsequent dosing intervals. The primary endpoint was clinical response at week 2, defined as a decrease in the Crohn's Disease Activity Index score > or = 70 points.
  
  
  RESULTS
  At week 2, clinical response occurred in 45% of CDP571-treated patients compared with 27% of patients in the placebo group (P = 0.023). Patients appeared to benefit from retreatment with CDP571 over 24 weeks, but not all of the results for secondary endpoints were statistically significant. The frequency of severe or serious adverse events was similar among all groups.
  
  
  CONCLUSIONS
  CDP571 at an initial dose of 10 or 20 mg/kg is safe and effective for treatment of patients with moderate-to-severe Crohn's disease. Preliminary evidence suggests that retreatment with 10 mg/kg CDP571 at dose intervals of 8 or 12 weeks may also be beneficial, but additional studies are needed.
authors: Mayo Clinic, Rochester, Minnesota 55905, USA.
authors: W J
authors: WJ
authors: Sandborn
authors: B G
authors: BG
authors: Feagan
authors: S B
authors: SB
authors: Hanauer
authors: D H
authors: DH
authors: Present
authors: L R
authors: LR
authors: Sutherland
authors: M A
authors: MA
authors: Kamm
authors: D C
authors: DC
authors: Wolf
authors: J P
authors: JP
authors: Baker
authors: C
authors: C
authors: Hawkey
authors: A
authors: A
authors: Archambault
authors: C N
authors: CN
authors: Bernstein
authors: C
authors: C
authors: Novak
authors: P K
authors: PK
authors: Heath
authors: S R
authors: SR
authors: Targan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D003424:Crohn Disease / Q000628:therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D014409:Tumor Necrosis Factor-alpha; C402162:CDP 571; D000069285:Infliximab