000150633 001__ 150633
000150633 005__ 20250214153849.0
000150633 0247_ $$2doi$$a10.1097/FTD.0000000000001295
000150633 0248_ $$2sideral$$a142781
000150633 037__ $$aART-2025-142781
000150633 041__ $$aeng
000150633 100__ $$aLópez Pérez, Juan
000150633 245__ $$aComparative Analysis of 2 Commercially Available Assays for Therapeutic Drug Monitoring of Infliximab and Adalimumab
000150633 260__ $$c2025
000150633 5060_ $$aAccess copy available to the general public$$fUnrestricted
000150633 5203_ $$aBackground: Tumor necrosis factor is a crucial proinflammatory cytokine in immune-mediated diseases. Tumor necrosis factor inhibitors (TNFi), such as infliximab and adalimumab, effectively treat rheumatological and digestive disorders. However, challenges such as primary nonresponse, secondary treatment failure, or adverse reactions limit their efficacy. Monitoring TNFi levels is essential for optimizing treatment and improving outcomes. An enzyme-linked immunosorbent assay (ELISA; Promonitor) was compared with 2 commercially available methods for quantifying infliximab and adalimumab levels: the chemiluminescence assay (i-Track10) and fluorescence assay (Afias-10).
Methods: Serum samples from 166 patients with inflammatory bowel disease were analyzed. Drug levels were measured using i-Track10, Afias-10, and Promonitor. Spearman's correlation analysis, Bland–Altman analysis, analysis of differences, Passing–Bablok regression, and Cohen kappa for agreement assessment were used for statistical analysis.
Results: Strong correlations were observed between Promonitor and Afias-10 for infliximab (rs = 0.982) and adalimumab (rs = 0.972), and with i-Track10 (rs = 0.935 for infliximab, rs = 0.947 for adalimumab). However, significant differences indicated noninterchangeability with ELISA. Passing–Bablok regression showed systematic and proportional biases. Cohen kappa exhibited higher concordance with Afias-10 for therapeutic ranges (κ = 0.962 for infliximab, κ = 0.849 for adalimumab) compared with i-Track10.
Conclusions: Afias-10 and i-Track10 are suitable for TNFi monitoring but are not interchangeable with ELISA. Consistent assay methods should be used for patient monitoring to ensure accuracy and reliability.
000150633 540__ $$9info:eu-repo/semantics/embargoedAccess$$aAll rights reserved$$uhttp://www.europeana.eu/rights/rr-f/
000150633 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/acceptedVersion
000150633 700__ $$aInda-Landaluce, Mercedes
000150633 700__ $$aNocito-Colón, Mercedes
000150633 700__ $$0(orcid)0000-0003-3043-147X$$aMartínez-Lostao, Luis$$uUniversidad de Zaragoza
000150633 7102_ $$11011$$2566$$aUniversidad de Zaragoza$$bDpto. Microb.Ped.Radio.Sal.Pú.$$cÁrea Inmunología
000150633 773__ $$pTher. drug monit.$$tTHERAPEUTIC DRUG MONITORING$$x0163-4356
000150633 8564_ $$s1661148$$uhttps://zaguan.unizar.es/record/150633/files/texto_completo.pdf$$yPostprint$$zinfo:eu-repo/date/embargoEnd/2026-01-24
000150633 8564_ $$s1858921$$uhttps://zaguan.unizar.es/record/150633/files/texto_completo.jpg?subformat=icon$$xicon$$yPostprint$$zinfo:eu-repo/date/embargoEnd/2026-01-24
000150633 909CO $$ooai:zaguan.unizar.es:150633$$particulos$$pdriver
000150633 951__ $$a2025-02-14-14:01:32
000150633 980__ $$aARTICLE