Comparative study of a point-of-care test and an enzyme-linked immunosorbent assay (ELISA) for infliximab levels

References

• Roda G, Jharap B, Neeraj N, et al. Loss of response to anti-TNFs: definition, epidemiology, and management. Clin Transl Gastroenterol. 2016;7(1):e135. doi: 10.1038/ctg.2015.63.
   PubMed Web of Science ®Google Scholar
• Savelkoul EHJ, Thomas PWA, Derikx LAAP, et al. Systematic review and meta-analysis: loss of response and need for dose escalation of infliximab and adalimumab in ulcerative colitis. Inflamm Bowel Dis. 2023;29(10):1633–1647. doi: 10.1093/ibd/izac200.
   PubMed Web of Science ®Google Scholar
• Kennedy NA, Heap GA, Green HD, et al. Predictors of anti-TNF treatment failure in anti-TNF-naive patients with active luminal Crohn’s disease: a prospective, multicentre, cohort study. Lancet Gastroenterol Hepatol. 2019;4(5):341–353. doi: 10.1016/S2468-1253(19)30012-3.
   PubMed Web of Science ®Google Scholar
• Papamichael K, Afif W, Drobne D, et al. Therapeutic drug monitoring of biologics in inflammatory bowel disease: unmet needs and future perspectives. Lancet Gastroenterol Hepatol. 2022;7(2):171–185. doi: 10.1016/S2468-1253(21)00223-5.
   PubMed Web of Science ®Google Scholar
• Bjørlykke KH, Jahnsen J, Brynskov J, et al. Therapeutic drug monitoring in inflammatory bowel disease: implementation, utilization, and barriers in clinical practice in Scandinavia. Scand J Gastroenterol. 2023;58(1):25–33. doi: 10.1080/00365521.2022.2108684.
   PubMed Web of Science ®Google Scholar
• Syversen SW, Jørgensen KK, Goll GL, et al. Effect of therapeutic drug monitoring vs standard therapy during maintenance infliximab therapy on disease control in patients with immune-mediated inflammatory diseases. JAMA. 2021;326(23):2375–2384. doi: 10.1001/jama.2021.21316.
   PubMed Web of Science ®Google Scholar
• Pfeiffer-Jensen M, Liao D, Tarp U, et al. Reduced prescription of TNF-inhibitors in chronic arthritis based on therapeutic drug monitoring: a randomized controlled trial. Scand J Rheumatol. 2023;52(5):468–480. doi: 10.1080/03009742.2022.2121081.
   PubMed Web of Science ®Google Scholar
• Marits P, Landucci L, Sundin U, et al. Trough s-infliximab and antibodies towards infliximab in a cohort of 79 IBD patients with maintenance infliximab treatment. J Crohns Colitis. 2014;8(8):881–889. doi: 10.1016/j.crohns.2014.01.009.
   PubMed Web of Science ®Google Scholar
• Maaser C, Sturm A, Vavricka SR, et al. ECCO-ESGAR guideline for diagnostic assessment in IBD part 1: initial diagnosis, monitoring of known IBD, detection of complications. J Crohns Colitis. 2019;13(2):144–164. doi: 10.1093/ecco-jcc/jjy113.
   PubMed Web of Science ®Google Scholar
• Silverberg MS, Satsangi J, Ahmad T, et al. Toward an integrated clinical, molecular and serological classification of inflammatory bowel disease: report of a Working Party of the 2005 Montreal World Congress of Gastroenterology. Can J Gastroenterol. 2005;19(Suppl. A):5A–36A. doi: 10.1155/2005/269076.
   PubMed Web of Science ®Google Scholar
• Khanna R, Zou G, D’Haens G, et al. A retrospective analysis: the development of patient reported outcome measures for the assessment of Crohn’s disease activity. Aliment Pharmacol Ther. 2015;41(1):77–86. doi: 10.1111/apt.13001.
   PubMed Web of Science ®Google Scholar
• Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. N Engl J Med. 1987;317(26):1625–1629. doi: 10.1056/NEJM198712243172603.
   PubMed Web of Science ®Google Scholar
• Walmsley RS, Ayres RCS, Pounder RE, et al. A Simple Clinical Colitis Activity Index. Gut. 1998;43(1):29–32. doi: 10.1136/gut.43.1.29.
   PubMed Web of Science ®Google Scholar
• Ong E, Huang R, Kirkland R, et al. Therapeutic drug monitoring: performance of a FRET-based point-of-care immunoassay for the quantitation of infliximab and adalimumab in blood; 2020. Available from: doi: 10.26434/chemrxiv.13277321.v2.
   Google Scholar
• Koo TK, Li MY. A guideline of selecting and reporting intraclass correlation coefficients for reliability research. J Chiropr Med. 2016;15(2):155–163. doi: 10.1016/j.jcm.2016.02.012.
   PubMed Web of Science ®Google Scholar
• Hornung RW, Reed LD. Estimation of average concentration in the presence of nondetectable values. Appl Occup Environ Hyg. 1990;5(1):46–51. doi: 10.1080/1047322X.1990.10389587.
   Google Scholar
• Vande Casteele N, Ferrante M, Van Assche G, et al. Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease. Gastroenterology. 2015;148(7):1320–1329.e3. doi: 10.1053/j.gastro.2015.02.031.
   PubMed Web of Science ®Google Scholar
• Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33(1):159–174. doi: 10.2307/2529310.
   PubMed Web of Science ®Google Scholar
• Remicade ema.europa.eu: European Medicines Agency; 2022 [updated 2022 Sep 26; cited 2022 Nov 27]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/remicade
   Google Scholar
• Kornbluth A. Infliximab approved for use in Crohn’s disease: a report on the FDA GI Advisory Committee Conference. Inflamm Bowel Dis. 1998;4(4):328–329. doi: 10.1097/00054725-199811000-00014.
   PubMedGoogle Scholar
• Hemperly A, Vande Casteele N. Clinical pharmacokinetics and pharmacodynamics of infliximab in the treatment of inflammatory bowel disease. Clin Pharmacokinet. 2018;57(8):929–942. doi: 10.1007/s40262-017-0627-0.
   PubMed Web of Science ®Google Scholar
• Fasanmade AA, Adedokun OJ, Ford J, et al. Population pharmacokinetic analysis of infliximab in patients with ulcerative colitis. Eur J Clin Pharmacol. 2009;65(12):1211–1228. doi: 10.1007/s00228-009-0718-4.
   PubMed Web of Science ®Google Scholar
• Papamichael K, Cheifetz AS, Melmed GY, et al. Appropriate therapeutic drug monitoring of biologic agents for patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2019;17(9):1655–1668.e3. doi: 10.1016/j.cgh.2019.03.037.
   PubMed Web of Science ®Google Scholar
• Vande Casteele N. Assays for measurement of TNF antagonists in practice. Frontline Gastroenterol. 2017;8(4):236–242. doi: 10.1136/flgastro-2016-100692.
   PubMed Web of Science ®Google Scholar
• Volkers A, Löwenberg M, Braad M, et al. Validation study of novel point-of-care tests for infliximab, adalimumab and C-reactive protein in capillary blood and calprotectin in faeces in an ambulatory inflammatory bowel disease care setting. Diagnostics. 2023;13(10):1712. doi: 10.3390/diagnostics13101712.
   Google Scholar
• Afonso J, De Sousa HT, Rosa I, et al. Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassays. Therap Adv Gastroenterol. 2017;10(9):661–671. doi: 10.1177/1756283X17722915.
   PubMed Web of Science ®Google Scholar
• WHO International Standard 1st International Standard for Infliximab. World Health Organization; 2019 [cited 2023 May 16]. Available from: https://www.nibsc.org/products/brm_product_catalogue/detail_page.aspx?catid=16/170
   Google Scholar
• Nasser Y, Labetoulle R, Harzallah I, et al. Comparison of point-of-care and classical immunoassays for the monitoring infliximab and antibodies against infliximab in IBD. Dig Dis Sci. 2018;63(10):2714–2721. doi: 10.1007/s10620-018-5144-y.
   PubMed Web of Science ®Google Scholar
• Yarur AJ, Kanagala V, Stein DJ, et al. Higher infliximab trough levels are associated with perianal fistula healing in patients with Crohn’s disease. Aliment Pharmacol Ther. 2017;45(7):933–940. doi: 10.1111/apt.13970.
   PubMed Web of Science ®Google Scholar