skip to main content
Language:
Search Limited to: Search Limited to: Resource type Show Results with: Show Results with: Search type Index

Biosimilar infiximab CPT-13 for infammatory bowel disease in a real clinical setting: pharmacokinetic outcomes, immunogenicity, and drug survival

Revista española de enfermedades digestivas, 2021-11, Vol.113 (11), p.770 [Peer Reviewed Journal]

COPYRIGHT 2021 Sociedad Espanola de Patologia Digestivas ;ISSN: 1130-0108 ;DOI: 10.17235/reed.2021.7638/2020

Full text available

Citations Cited by
  • Title:
    Biosimilar infiximab CPT-13 for infammatory bowel disease in a real clinical setting: pharmacokinetic outcomes, immunogenicity, and drug survival
  • Author: Iniesta Navalon, Carles ; Gil Candel, Mayte ; Salar Valverde, Ignacio ; Prado, Isabel Nicolas de ; Gomez Espin, Rosa ; Rentero Redondo, Lorena
  • Subjects: Biological products ; Gastrointestinal diseases ; Medical research ; Medicine, Experimental
  • Is Part Of: Revista española de enfermedades digestivas, 2021-11, Vol.113 (11), p.770
  • Description: Background: efficacy and safety were evaluated after switching to a biosimilar infiximab (CPT-13) in patients with infammatory bowel disease (IBD). However, few cohort studies compare the pharmacokinetic profles, immunogenicity, and safety of the reference infiximab (IFX) and CPT-13 in a real clinical setting. Objective: to compare the pharmacokinetic profles and drug survival on the long term of reference IFX and CPT-13 at weeks 54 and 104. A secondary objective was to determine the long-term immunogenicity and safety profle of CPT-13 in patients with IBD in a real clinical setting. Methods: a retrospective, observational cohort analysis was performed in a single center, including patients with IBD under treatment with reference IFX or CPT-13. Serum drug concentrations were compared to determine if there were any signifcant differences in pharmacokinetic outcomes between reference IFX and CPT-13 at 26, 54, 78, and 104 weeks. The drug survival of reference IFX and CPT-13 was determined at weeks 54 and 104. Results: one hundred and six patients were included during the study period. Forty-five (42.5 %) patients received CPT-13 and 61 (57.5 %) received reference IFX. A total of 347 serum samples were analyzed and no signifcant differences were observed between reference IFX and CPT-13. The percentage of patients who achieved serum concentrations within the target therapeutic range was similar in both groups (74.1 % for reference IFX and 72.5 % for CPT-13, p = 0.741). At week 54, withdrawal rates for reference IFX and CPT-13 were 11.5 % and 20.0 %, respectively (p = 0.226), whereas at week 104 they were 26.2 % and 28.9 %, respectively (p = 0.761). Conclusion: the pharmacokinetic characteristics and incidence of immunogenicity of CPT-13 in a real clinical setting are comparable to those of the infiximab originator. The two products also have similar long-term drug survival and the same safety profle. Keywords: Infiximab. Infammatory bowel disease. Biosimilar. Anti-drug antibody. Pharmacokinetics. Drug survival.
  • Publisher: Sociedad Espanola de Patologia Digestivas
  • Language: Spanish
  • Identifier: ISSN: 1130-0108
    DOI: 10.17235/reed.2021.7638/2020
  • Source: DOAJ Directory of Open Access Journals
Back to results list
INSPIRE LIBRARY - TON DUC THANG UNIVERSITY (84-028) 37 755 057 Feedback
19 Nguyen Huu Tho St. Dist.7, HCM thuvien@tdtu.edu.vn

Copyright © 2017 INSPIRE LIBRARY - TON DUC THANG UNIVERSITY

Searching Remote Databases, Please Wait