Certolizumab Trough Levels and Antibodies in Crohn Disease: A Single-Center Experience

Guilherme Piovezani Ramos, Badr Al-Bawardy, Manuel Bonfim Braga Neto, Adam C. Bledsoe, Kevin P. Quinn, Valérie Heron, Maria Alice V. Willrich, Amanda Johnson, Victor G. Chedid, Nayantara Coelho-Prabhu, John B. Kisiel, Konstantinos A. Papadakis, Darrell Pardi, Sunanda Kane, William J. Tremaine, Laura Raffals, David H. Bruining, William A. Faubion, William S. Harmsen, Edward V. Loftus

Research output: Contribution to journalArticlepeer-review


Background: Certolizumab pegol (CZP) has been successfully used for the treatment of Crohn disease (CD); however, real-world data regarding the utility of CZP trough levels (CTLs) are lacking. We aimed to correlate CTL with CD outcomes and to determine frequency of CZP antibodies. Methods: Retrospective evaluation of all CD patients on maintenance CZP with CTL obtained between 2016 and 2019. Outcomes included: median CTL, presence of anti-CZP antibodies, biochemical response (BR), clinical response (CR), radiologic response (RR), radiologic healing (RH), and mucosal healing (MH). Results: Seventy-seven CD patients were included. Median CTL was 18.9 μg/mL (interquartile range, 7.6-35.4). Twenty-three patients (27.3%) had positive antibody levels, with lower median CTL compared to patients with no antibodies (0.0 vs 29.8; P < 0.0001). Median CTL levels were higher in patients with vs without CR (30.4 vs 10.3 μg/mL; P = 0.0015) and RR (29.6 vs 5.8 μg/mL; P = 0.006). CZP dosing at least every 2 weeks was associated with higher odds of achieving MH (odds ratio, 3.2; 95% confidence interval, 1.03-9.97). CTL resulted in change in clinical management in 62.7% of cases and presence of CMZ antibodies was associated with an odds ratio of 5.83 (95% confidence interval, 1.57-21.73) of change in management. Receiver operating characteristic curve and quartile analysis suggested that CTL >19 μg/mL is associated with increased rates of CR and RR. Conclusions: Higher CTL was significantly associated with CR and RR. The rate of CZP antibodies was 27.3%. Our data suggest maintenance CTL of ≥19 μg/mL should be achieved in order to optimize outcomes in clinical practice.

Original languageEnglish (US)
Article numberotab019
JournalCrohn's and Colitis 360
Issue number3
StatePublished - Jul 1 2021


  • Crohn disease
  • certolizumab pegol
  • inflammatory bowel disease
  • therapeutic drug monitoring

ASJC Scopus subject areas

  • Gastroenterology


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