title: Randomised clinical trial: certolizumab pegol for fistulas in Crohn's disease - subgroup results from a placebo-controlled study.
abstract: BACKGROUND
  Treatment options for fistulizing Crohn's disease (CD) are limited.
  
  
  OBJECTIVE
  To examine whether fistula closure is maintained at week 26 following treatment with certolizumab pegol.
  
  
  METHODS
  Patients with draining fistulas at baseline from PRECiSE 2 (n = 108) received open-label induction with certolizumab pegol 400 mg at weeks 0 (baseline), 2 and 4. Response was defined as ≥100-point decrease from baseline in the Crohn's Disease Activity Index. Nonresponders (50/108) were excluded. At week 6, responders with draining fistulas (N = 58) were randomised to certolizumab pegol 400 mg (n = 28) or placebo (n = 30) every 4 weeks across weeks 8-24. Fistula closure was evaluated throughout the study, with a final assessment at week 26.
  
  
  RESULTS
  The majority of patients (55/58) had perianal fistula. At week 26, 36% of patients in the certolizumab pegol group had 100% fistula closure compared with 17% of patients receiving placebo (P = 0.038). Protocol-defined fistula closure (≥50% closure at two consecutive post-baseline visits ≥3 weeks apart) was not statistically significant (P = 0.069) with 54% and 43% of patients treated with certolizumab pegol and placebo achieving this end point, respectively.
  
  
  CONCLUSIONS
  Continuous treatment with certolizumab pegol improves the likelihood of sustained perianal fistula closure compared with placebo.
authors.affiliation: Department of Medicine I, Christian Albrechts University, University Hospital Schleswig-Holstein, Kiel, Germany. s.schreiber@mucosa.de
authors.forename: S
authors.initials: S
authors.lastname: Schreiber
authors.forename: I C
authors.initials: IC
authors.lastname: Lawrance
authors.forename: O Ø
authors.initials: OØ
authors.lastname: Thomsen
authors.forename: S B
authors.initials: SB
authors.lastname: Hanauer
authors.forename: R
authors.initials: R
authors.lastname: Bloomfield
authors.forename: W J
authors.initials: WJ
authors.lastname: Sandborn
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized; D000068582:Certolizumab Pegol; D003424:Crohn Disease / Q000150:complications / Q000188:drug therapy*; D016154:Digestive System Fistula / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D012044:Regression Analysis; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007140:Immunoglobulin Fab Fragments; D011092:Polyethylene Glycols; D000068582:Certolizumab Pegol