Routinely utilized in-house assays for infliximab, adalimumab and their anti-drug antibody levels

AbstractBy monitoring serum concentrations of infliximab (IFX) and adalimumab (ADL) and levels of their antibodies in patients with inflammatory diseases, clinicians can adjust dose and increase safety and effectiveness of treatment. The aim was to develop and validatein-house enzyme-linked immunosorbent assays (ELISAs) for IFX and ADL, together with anti-IFX and anti-ADL ELISAs for routine detection and further analysis with acid dissociation of immune complexes. Furthermore, the objectives were to comparein-house assays with commercial ELISAs and reporter gene assays (RGAs) and to determine cross-reactivity between original Remicade ®/Remsima™ and their antibodies.In-house ELISAs were validated (imprecision, accuracy among other criteria) and compared with commercial apDia ELISAs and RGAs. Correlation coefficients, intraclass correlation coefficients, agreement, and bias were calculated. Allin-house ELISAs gave precise and repeatable results. The immune complexes between IFX and anti-IFX were found in 3% of samples, while complexes between ADL and anti-ADL were found in 14% of samples. Significant correlations were found betweenin-house and apDia ELISAs and RGA for IFX, ADL, anti-IFX, and anti-ADL results. Remicade ®, Remsima™, and their antibodies could be accurately measured with either apDia orin-house IFX and anti-IFX ELISAs. Accurate and precisein-house ELISAs, highly comparable with commercial ELISAs and RGAs, were developed and validated for routine analysis of...
Source: Immunologic Research - Category: Allergy & Immunology Source Type: research