P885 Pharmacokinetics, pharmacodynamics, and immunogenicity of biosimilar infliximab in pediatric patients with inflammatory bowel disease

生物仿制药 英夫利昔单抗 医学 炎症性肠病 免疫原性 药代动力学 药效学 药理学 疾病 内科学 免疫学 抗体
作者
Valeria Dipasquale,Angela Alibrandi,Salvatore Pellegrino,Vincenzo Ramistella,Claudio Romano
出处
期刊:Journal of Crohn's and Colitis [Oxford University Press]
卷期号:18 (Supplement_1): i1628-i1628
标识
DOI:10.1093/ecco-jcc/jjad212.1015
摘要

Abstract Background The pharmacokinetics and pharmacodynamics of biosimilar infliximab (IFX-BioS) in pediatric inflammatory bowel disease (IBD) are poorly understood. We examined some factors predicting IFX-BioS trough levels (TLs) in children. Methods Children with Crohn's disease (CD) and ulcerative colitis (UC) with an indication to start IFX-BioS in our center were prospectively included (January 2021-June 2022). TLs were measured with an in vitro lateral flow immunoassay (therapeutic range:3-7 microg/mL) at the 4th and 6th infusions and correlated with several covariates. Results A total of 110 TLs in 55 children (34 UC and 21 CD) were included. The mean TLs were 8.8±7.6 microg/mL and 9.8±6.7 microg/mL at the 4th and 6th infusions, respectively. The multivariate linear regression model at the 4th infusion found a positive correlation between TLs and age at diagnosis (B: 1.950, 95% CI: [0.019, 3.882], p=0.048) and IFX-BioS dose/kg (B: 1.962, 95% CI: [0.238, 3.687], p=0.029), and a negative correlation with clinical scores (B: -0.401, 95% CI: [-0.738, -0.064], p=0.023). At the 6th infusion, female gender (B: 6.887, 95 CI: [0.861, 12.913], p=0.029), hemoglobin (B: 1.853, 95% CI: [0.501, 3.204], p=0.011), and IFX-BioS dose/kg (B: 1.792, 95% CI: [0.979, 2.605], p<0.001) were found to be positively correlated to TLs. Clinical remission was achieved in 71% (4th infusion) and 67.2% (6th infusion) of patients. Logistic regression analysis revealed no significant association between combined clinical and biochemical remission and TLs at the 4th (OR: 0.010, 95% CI: [0.928; 11.099], p=0.819) or 6th (OR: 0.017, 95% CI: [0.924; 1.119], p=0.732) infusion, corrected for IFX-BioS dose/kg and interval between infusions. Conclusion We discovered some predictors IFX-BioS TLs in IBD children. Understanding the IFX-BioS pharmacokinetics and pharmacodynamics could allow physicians to identify which patients are at higher risk of poor outcomes and adjust treatment accordingly.

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