@article{47185baf6426456ea3ce706d0a9eec18,
title = "Appropriate Therapeutic Drug Monitoring of Biologic Agents for Patients With Inflammatory Bowel Diseases",
abstract = "Background & Aims: Therapeutic drug monitoring (TDM) is widely available for biologic therapies in patients with inflammatory bowel disease (IBD). We reviewed current data and provided expert opinion regarding the clinical utility of TDM for biologic therapies in IBD. Methods: We used a modified Delphi method to establish consensus. A comprehensive literature review was performed regarding the use of TDM of biologic therapy in IBD and presented to international IBD specialists. Subsequently, 28 statements on the application of TDM in clinical practice were rated on a scale of 1 to 10 (1 = strongly disagree and 10 = strongly agree) by each of the panellists. Statements were accepted if 80% or more of the participants agreed with a score ≥7. The remaining statements were discussed and revised based on the available evidence followed by a second round of voting. Results: The panel agreed on 24 (86%) statements. For anti-tumor necrosis factor (anti-TNF) therapies, proactive TDM was found to be appropriate after induction and at least once during maintenance therapy, but this was not the case for the other biologics. Reactive TDM was appropriate for all agents both for primary non-response and secondary loss of response. The panellists also agreed on several statements regarding TDM and appropriate drug and anti-drug antibody (ADA) concentration thresholds for biologics in specific clinical scenarios. Conclusion: Consensus was achieved towards the utility of TDM of biologics in IBD, particularly anti-TNF therapies. More data are needed especially on non-anti-TNF biologics to further define optimal drug concentration and ADA thresholds as these can vary depending on the therapeutic outcomes assessed.",
keywords = "Anti-TNF, Consensus Statement, Crohn's Disease, Immunogenicity, Ulcerative Colitis, Ustekinumab, Vedolizumab",
author = "Konstantinos Papamichael and Cheifetz, {Adam S.} and Melmed, {G. Y.} and Irving, {Peter M.} and {Vande Casteele}, N. and Kozuch, {Patricia L.} and Raffals, {Laura E.} and Leonard Baidoo and B. Bressler and Devlin, {Shane M.} and Jennifer Jones and Kaplan, {Gilaad G.} and Sparrow, {Miles P.} and Velayos, {Fernando S.} and Thomas Ullman and Siegel, {Corey A.}",
note = "Funding Information: Funding Supported by unrestricted educational grants from Takeda, Pfizer, and AbbVie. Funders had no role in the study design, analysis or interpretation of data, review of the manuscript, or decision to publish. Funders were not present at the moderated panel discussions. K.P. is supported by Ruth L. Kirschstein NRSA Institutional Research Training Grant 5T32DK007760-18. The content of this project is solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health (NIH). Conflicts of interest These authors disclose the following: G.Y.M. has received research funding from Pfizer, Prometheus, and Shire and is a consultant for AbbVie, Given Imaging, Luitpold Pharmaceuticals, Janssen, UCB, Celgene, Takeda, Genentech, and Pfizer. P.M.I. is on the Advisory Board and Speaker's Bureau for AbbVie, MSD, and Takeda. L.E.R. has served on the Advisory Board for Ferring Pharmaceuticals with all honoraria paid to Mayo Clinic and is a consultant for Alivio Therapeutics. L.B. has served as a consultant for Pfizer, Janssen, Shire, and Takeda and served as speaker for Janssen, Shire, and Takeda. J.J. has served as a speaker for Jansen, Merck, Schering-Plough, Abbot, and AbbVie and has participated in advisory boards for Janssen, Abbott, and Takeda. G.G.K. has served as a speaker for Pfizer, Janssen, Merck, Schering-Plough, and AbbVie; has participated in advisory board meetings for Jansen and AbbVie; and has received research support from GlaxoSmithKline, Merck, and AbbVie. M.P.S. has received educational grants and research support from Ferring Pharmaceuticals and Orphan Pharmaceuticals; speaker's fees from Janssen, AbbVie, Ferring, Takeda, Pfizer, and Shire; and is on the Advisory Boards of Janssen, Takeda, Pfizer, Celgene, AbbVie, and MSD. B.B. is on the Advisory Board of AbbVie, Janssen, Takeda, Shire, Genentech, Ferring, and Warner Chillcott; the Speaker's Bureau of AbbVie, Janssen, Takeda, and Forrest Laboratory; is a consultant for Celltrion and Pendopharm; and has received research support from AbbVie, Amgen, BMS, Genentech, Janssen, BI, and GlaxoSmithKline. A.S.C. has served on advisory boards for AbbVie, Janssen Takeda, Pfizer, Arena, Samsung, and Bacainn and has received research support from Miraca. S.M.D. has served on Speaker's Bureau and as a consultant for Takeda, Janssen, and AbbVie. N.V.C. has received consultancy fees from Pfizer, Progenity, and Takeda and has received research support from Takeda. C.A.S. has received research funding from AbbVie, Janssen, Takeda, and UCB; delivered CME lectures for AbbVie, Janssen, Merck, and Takeda; and served as an advisor/consultant for AbbVie, Amgen, Janssen, Lilly, Pfizer, Takeda, and Theradiag. The remaining authors disclose no conflicts. Funding Supported by unrestricted educational grants from Takeda, Pfizer, and AbbVie. Funders had no role in the study design, analysis or interpretation of data, review of the manuscript, or decision to publish. Funders were not present at the moderated panel discussions. K.P. is supported by Ruth L. Kirschstein NRSA Institutional Research Training Grant 5T32DK007760-18. The content of this project is solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health (NIH). Publisher Copyright: {\textcopyright} 2019 AGA Institute",
year = "2019",
month = aug,
doi = "10.1016/j.cgh.2019.03.037",
language = "English (US)",
volume = "17",
pages = "1655--1668.e3",
journal = "Clinical Gastroenterology and Hepatology",
issn = "1542-3565",
publisher = "W.B. Saunders Ltd",
number = "9",
}