Daniel Bertin1, Mélanie Serrero2, Jean Charles Grimaud2, Ariadne Desjeux2, Sophie Desplat-Jégo3. 1. Assistance Publique-Hôpitaux de Marseille, Hôpital de la Conception, Pôle de Biologie, Service d'Immunologie, 13005 Marseille, France; Aix-Marseille Univ, CNRS, INP, Inst Neurophysiopathol, Marseille, France. Electronic address: daniel.bertin@ap-hm.fr. 2. Service de Gastroentérologie, Hôpital Nord, Assistance Publique-Hôpitaux de Marseille, France. 3. Assistance Publique-Hôpitaux de Marseille, Hôpital de la Conception, Pôle de Biologie, Service d'Immunologie, 13005 Marseille, France; Aix-Marseille Univ, CNRS, INP, Inst Neurophysiopathol, Marseille, France.
Abstract
BACKGROUND: There are many studies presenting data of biologics and several ELISA kits commercially available for monitoring infliximab serum trough levels (s-IFXt) and anti-drug antibodies (ADAb). We propose to compare technical characteristics and results of three different assays on a cohort of 35 patients under infliximab (IFX) and suffering from inflammatory bowel disease (IBD). PATIENTS AND METHODS: s-IFXt and ADAb were systematically measured with three ELISA kits: Lisa-Tracker® Duo infliximab (Theradiag®), Ridascreen® IFX Monitoring (R-Biopharm AG®) and Promonitor® IFX (Progenika Biopharma SA®). RESULTS: The main technical features that differed between kits for measuring s-IFXt were: (i) TNF coating, (ii) immune complexes revelation strategy and/or (iii) interference with other anti-TNFα agents. For kits measuring ADAb, they were revelation steps and unit of results. There was an excellent mathematical correlation of s-IFXt between assays however Bland-Altman analysis denoted (i) s-IFXt were on average 48 to 69% higher in Ridascreen® than in the other two assays, and (ii) elevated s-IFXt were higher with Promonitor® compared to Lisa-Tracker®. As a consequence, there were some substantial discrepancies between assays for classification of s-IFXt into concentration ranges. Despite unstandardized units, pairwise qualitative comparison showed a perfect agreement between the three pairs of ADAb assays. CONCLUSION: Our data show that the evaluated assays are not quantitatively interchangeable due to substantial variations in some results that could lead, for some patients, to divergent therapeutic decisions. We remind to be cautious when comparing study results issued from different kits and recommend using the same assay for the longitudinal follow-up of IBD patients.
BACKGROUND: There are many studies presenting data of biologics and several ELISA kits commercially available for monitoring infliximab serum trough levels (s-IFXt) and anti-drug antibodies (ADAb). We propose to compare technical characteristics and results of three different assays on a cohort of 35 patients under infliximab (IFX) and suffering from inflammatory bowel disease (IBD). PATIENTS AND METHODS: s-IFXt and ADAb were systematically measured with three ELISA kits: Lisa-Tracker® Duo infliximab (Theradiag®), Ridascreen® IFX Monitoring (R-Biopharm AG®) and Promonitor® IFX (Progenika Biopharma SA®). RESULTS: The main technical features that differed between kits for measuring s-IFXt were: (i) TNF coating, (ii) immune complexes revelation strategy and/or (iii) interference with other anti-TNFα agents. For kits measuring ADAb, they were revelation steps and unit of results. There was an excellent mathematical correlation of s-IFXt between assays however Bland-Altman analysis denoted (i) s-IFXt were on average 48 to 69% higher in Ridascreen® than in the other two assays, and (ii) elevated s-IFXt were higher with Promonitor® compared to Lisa-Tracker®. As a consequence, there were some substantial discrepancies between assays for classification of s-IFXt into concentration ranges. Despite unstandardized units, pairwise qualitative comparison showed a perfect agreement between the three pairs of ADAb assays. CONCLUSION: Our data show that the evaluated assays are not quantitatively interchangeable due to substantial variations in some results that could lead, for some patients, to divergent therapeutic decisions. We remind to be cautious when comparing study results issued from different kits and recommend using the same assay for the longitudinal follow-up of IBDpatients.
Authors: Lívia Moreira Genaro; Luís Eduardo Miani Gomes; Ana Paula Menezes de Freitas Franceschini; Hugo Dugolin Ceccato; Rafael Nascimento de Jesus; Amanda Pereira Lima; Cristiane Kibune Nagasako; João José Fagundes; Maria de Lourdes Setsuko Ayrizono; Raquel Franco Leal Journal: Am J Transl Res Date: 2021-12-15 Impact factor: 4.060
Authors: Konstantinos Papamichael; William T Clarke; Niels Vande Casteele; Katharine A Germansky; Joseph D Feuerstein; Gil Y Melmed; Corey A Siegel; Peter M Irving; Adam S Cheifetz Journal: Clin Gastroenterol Hepatol Date: 2020-03-05 Impact factor: 11.382