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Comparison of Assays for Therapeutic Monitoring of Infliximab and Adalimumab in Patients With Inflammatory Bowel Diseases

Research output: Contribution to journalShort surveypeer-review

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

Original languageEnglish
Pages (from-to)839-841.e2
JournalClinical Gastroenterology and Hepatology
Volume19
Issue number4
DOIs
Accepted/In press2021
PublishedApr 2021

Bibliographical note

Funding Information: Conflicts of interest These authors disclose the following: Niels Vande Casteele reports personal fees from Janssen, Pfizer, Progenity, and Prometheus; grants and personal fees from Takeda and UCB Pharma; and grants from R-Biopharm; Adam S. Cheifetz has received consultancy fees from AbbVie, Janssen, Takeda, Ferring, Miraca, AMAG, Arena, Samsung, Prometheus, and Pfizer; and research support from Miraca. Gil Y. Melmed has received research funding from Pfizer and is a consultant for AbbVie, Boehringer-Ingelheim, Celgene, Janssen, Medtronic, Pfizer, Samsung Bioepis, and Takeda. Peter M. Irving is on the advisory board and speakers bureau for AbbVie, MSD, and Takeda. Corey A. Siegel has served as a consultant or on the advisory board for AbbVie, Amgen, BMS, Celgene, Lilly, Janssen, Sandoz, Pfizer, Prometheus, Sebela, and Takeda; has served as a speaker for CME activities for AbbVie, Celgene, Janssen, Pfizer, and Takeda; has received grant support from the Crohn’s and Colitis Foundation, Agency for Healthcare Research and Quality (1R01HS021747-01), Broad Medical Research Program, AbbVie, Janssen, Pfizer, and Takeda; and owns intellectual property in MiTest Health, LLC, for a patent pending for a “System and Method of Communicating Predicted Medical Outcomes” (filed 3/34/10) (he and Lori Siegel are inventors); in ColonaryConcepts, LLC, for U.S. patents on “Dietary Purgatives” and “Foods, Systems, Methods, and Kits for Providing Electrolyte Replacement” (he is an inventor); he owns equity interest in and is a co-founder of MiTest Health, LLC, and ColonaryConcepts, LLC. Konstantinos Papamichail received a lecture fee from Mitsubishi Tanabe Pharma. The remaining authors disclose no conflicts. Funding Information: Funding This work was funded by Inform Diagnostics , a Research Scholar Award from the American Gastroenterological Association (to Niels Vande Casteele), and Ruth L. Kirschstein National Research Service Award Institutional Research Training Grant 5T32DK007760-18 (to Konstantinos Papamichail). Publisher Copyright: © 2021 AGA Institute Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

King's Authors

Abstract

Comparison data regarding anti–tumor necrosis factor drug concentrations in inflammatory bowel disease (IBD) between the enzyme-linked immunosorbent assay (ELISA) and the homogenous mobility shift assay (HMSA) are scarce.1–3 As decisions in clinical practice depend on the thresholds that define a therapeutic drug concentration, it is important to determine if this varies based on the type of assay used for therapeutic drug monitoring.4 We recently showed a discrepancy between a commercially available ELISA and the HMSA for both infliximab and adalimumab concentrations in patients with IBD.5 Based on the results of the study, Prometheus Laboratories (San Diego, CA) initiated a comprehensive review of their HMSA assays and found that there was an upward drift for both infliximab (from December 2017 to May 2019) and adalimumab (from August 2017 to May 2019), including when our study was performed. Prometheus Laboratories corrected the errant values and reported the revised drug concentrations to physicians (Supplementary Methods). We aimed to compare the corrected infliximab and adalimumab concentrations with the original ELISA values.

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