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

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

Author information

1
Department of Medicine I, Christian Albrechts University, University Hospital Schleswig-Holstein, Kiel, Germany. s.schreiber@mucosa.de

Abstract

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.

[Indexed for MEDLINE]
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