Ontology highlight
ABSTRACT: 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.
SUBMITTER: Ramos GP
PROVIDER: S-EPMC9802288 | biostudies-literature | 2021 Jul
REPOSITORIES: biostudies-literature
Ramos Guilherme Piovezani GP Al-Bawardy Badr B Braga Neto Manuel Bonfim MB Bledsoe Adam C AC Quinn Kevin P KP Heron Valérie V Willrich Maria Alice V MAV Johnson Amanda A Chedid Victor G VG Coelho-Prabhu Nayantara N Kisiel John B JB Papadakis Konstantinos A KA Pardi Darrell D Kane Sunanda S Tremaine William J WJ Raffals Laura L Bruining David H DH Faubion William A WA Harmsen William S WS Loftus Edward V EV
Crohn's & colitis 360 20210517 3
<h4>Background</h4>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.<h4>Methods</h4>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), c ...[more]