Randomised clinical trial: certolizumab pegol for fistulas in Crohn's disease - subgroup results from a placebo-controlled study

Aliment Pharmacol Ther. 2011 Jan;33(2):185-93. doi: 10.1111/j.1365-2036.2010.04509.x. Epub 2010 Nov 17.


Background: Treatment options for fistulizing Crohn's disease (CD) are limited.

Aim: 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.

Conclusion: Continuous treatment with certolizumab pegol improves the likelihood of sustained perianal fistula closure compared with placebo.

Trial registration: ClinicalTrials.gov NCT00152425.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized
  • Certolizumab Pegol
  • Crohn Disease / complications
  • Crohn Disease / drug therapy*
  • Digestive System Fistula / drug therapy*
  • Digestive System Fistula / etiology
  • Double-Blind Method
  • Female
  • Humans
  • Immunoglobulin Fab Fragments / therapeutic use*
  • Male
  • Middle Aged
  • Polyethylene Glycols / therapeutic use*
  • Regression Analysis
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • Young Adult


  • Antibodies, Monoclonal, Humanized
  • Immunoglobulin Fab Fragments
  • Polyethylene Glycols
  • Certolizumab Pegol

Associated data

  • ClinicalTrials.gov/NCT00152425