TY - JOUR
T1 - Certolizumab Trough Levels and Antibodies in Crohn Disease
T2 - A Single-Center Experience
AU - Ramos, Guilherme Piovezani
AU - Al-Bawardy, Badr
AU - Braga Neto, Manuel Bonfim
AU - Bledsoe, Adam C.
AU - Quinn, Kevin P.
AU - Heron, Valérie
AU - Willrich, Maria Alice V.
AU - Johnson, Amanda
AU - Chedid, Victor G.
AU - Coelho-Prabhu, Nayantara
AU - Kisiel, John B.
AU - Papadakis, Konstantinos A.
AU - Pardi, Darrell
AU - Kane, Sunanda
AU - Tremaine, William J.
AU - Raffals, Laura
AU - Bruining, David H.
AU - Faubion, William A.
AU - Harmsen, William S.
AU - Loftus, Edward V.
N1 - Publisher Copyright:
© 2021 The Author(s) 2021. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.
PY - 2021/7/1
Y1 - 2021/7/1
N2 - 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.
AB - 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.
KW - Crohn disease
KW - certolizumab pegol
KW - inflammatory bowel disease
KW - therapeutic drug monitoring
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U2 - 10.1093/crocol/otab019
DO - 10.1093/crocol/otab019
M3 - Article
AN - SCOPUS:85111983572
SN - 2631-827X
VL - 3
JO - Crohn's and Colitis 360
JF - Crohn's and Colitis 360
IS - 3
M1 - otab019
ER -