Evaluation of the Cross-reactivity of Antidrug Antibodies to CT-P13 and Infliximab Reference Product (Remicade): An Analysis Using Immunoassays Tagged with Both Agents

BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Walter ReinischDae Hyun Yoo

Abstract

During two pivotal clinical trials of the infliximab biosimilar CT-P13 (PLANETAS and PLANETRA), antidrug antibodies (ADAs) and neutralising antibodies (NAbs) were detected in the sera of patients treated with CT-P13 and the reference product (RP; Remicade). The aim was to assess the comparability of Remicade- and CT-P13-tagged immunoassays for the detection of ADAs and NAbs using data from these trials, in order to determine the cross-reactivity of CT-P13 and RP ADAs. Sera from patients with rheumatoid arthritis and ankylosing spondylitis were analysed using an electrochemiluminescence (ECL) bridging assay or Gyros immunoassay, tagged with Remicade or CT-P13 at screening, weeks 14, 30 and 54, and the end of study visit. NAb titre was compared at screening and weeks 14 and 30. The proportion of cross-reactive samples was determined and an inter-rater agreement analysis performed to assess the concordance of results between assays. In PLANETAS, 93.1% (94/101) of RP ADA-positive samples and 93.0% (93/100) of RP NAb-positive samples cross-reacted with CT-P13; 99.0% (103/104) of CT-P13 ADA-positive and 98.0% (98/100) of CT-P13 NAb-positive samples cross-reacted with the RP. In PLANETRA, 94.7% (426/450) of RP ADA-positive samples and...Continue Reading

References

May 2, 2007·FEBS Letters·Masato WatanabeKoh Nakata
Nov 11, 2008·Journal of Pharmaceutical and Biomedical Analysis·Gopi ShankarEugen Koren
Mar 17, 2011·The American Journal of Gastroenterology·Alexander C FordPaul Moayyedi
Apr 15, 2014·Rheumatology International·Lívia Lovato Pires LemosFrancisco Assis Acurcio
Aug 19, 2015·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Sarah S ThomasDaniel E Furst
Sep 24, 2015·Expert Review of Clinical Immunology·Ji Soo KimSeungSuh Hong
Mar 12, 2016·Annals of the Rheumatic Diseases·M Begoña Ruiz-ArgüelloDaniel Nagore
Apr 22, 2016·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Carlos PinedaClaudio Carini

❮ Previous
Next ❯

Citations

Nov 28, 2017·Journal of Comparative Effectiveness Research·Dae Hyun Yoo
Jun 20, 2018·Expert Review of Clinical Immunology·Dae Hyun YooChang-Hee Suh
Sep 1, 2018·Journal of Pediatric Gastroenterology and Nutrition·Lissy de RidderUNKNOWN Paediatric IBD Porto group of ESPGHAN
Mar 2, 2018·Current Treatment Options in Gastroenterology·Frank I Scott, Gary R Lichtenstein
Apr 25, 2019·Current Gastroenterology Reports·Thomas X Lu, Russell D Cohen
Dec 7, 2019·Expert Opinion on Drug Discovery·Ido Veisman, Shomron Ben-Horin
Aug 18, 2020·Expert Opinion on Biological Therapy·Tommaso Lorenzo ParigiSilvio Danese
Dec 1, 2018·Future Oncology·Hope S RugoGeraint Morgan
Sep 6, 2019·British Journal of Clinical Pharmacology·Fernando de MoraRafael Martínez
Nov 14, 2019·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Vibeke StrandJohn D Isaacs
Oct 28, 2019·Annals of Laboratory Medicine·Maurizio BenucciRoberto Verna
Sep 10, 2020·Journal of Clinical Pharmacology·Alexander EserDiane R Mould
May 6, 2019·Reumatología clinica·Miguel Ángel Abad HernándezJuan J Gómez-Reino
May 11, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Md Golam KibriaYutaka Kuroda

❮ Previous
Next ❯

Methods Mentioned

BETA
Assay
enzyme-linked immunosorbent assays
ELISA
ELISAs
glycosylation

Software Mentioned

PLANETAS
PLANETRA

Related Concepts

Related Feeds

Autoimmune Diseases

Autoimmune diseases occur as a result of an attack by the immune system on the body’s own tissues resulting in damage and dysfunction. There are different types of autoimmune diseases, in which there is a complex and unknown interaction between genetics and the environment. Discover the latest research on autoimmune diseases here.