Certolizumab Trough Levels and Antibodies in Crohn's 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 (+8 others)
2021 Crohn's & Colitis 360  
Background Certolizumab pegol (CZP) has been successfully used for the treatment of Crohn's disease (CD); however, real-world data regarding the utility of CZP trough levels (CTL) are lacking. Aims 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 2016-2019. Outcomes included: median CTL; presence of anti-CZP antibodies; biochemical response (BR); clinical response
more » ... nical response (CR); radiologic response (RR), radiologic healing (RH) and mucosal healing (MH). Results Seventy-seven CD patients were included. Median CTL was 18.9 ug/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 ug/mL, p=0.0015) and RR (29.6 vs 5.8 ug/mL; p=0.006). CZP dosing at least every 2 weeks were associated with higher odds of achieving MH (OR 3.2, 95% CI 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 OR of 5.83 (95% CI 1.57-21.73) of change in management. Receiver operating characteristic curve and quartile analysis suggested that CTL>19 ug/mL are associated with increased rates of CR and RR. Conclusions Higher CTL were significantly associated with CR and RR. The rate of CZP antibodies was 27.3%. Our data suggest maintenance CTL of ≥19 ug/ml should be achieved in order to optimize outcomes in clinical practice.
doi:10.1093/crocol/otab019 fatcat:bbwexzzmjfhufmptxbhudl3b6i