By 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 validate in-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 compare in-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. All in-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 between in-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 or in-house IFX and anti-IFX ELISAs. Accurate and precise in-house ELISAs, highly comparable with commercial ELISAs and RGAs, were developed and validated for routine analysis of samples of patients treated with IFX (Remicade® or Remsima™) or ADL providing substantial cost benefit. Complex dissociation identified samples with anti-IFX-IFX (3%) and anti-ADL-ADL (14%) complexes indicating the benefit of adding acid dissociation to therapeutic drug monitoring of IFX and ADL.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1007/s12026-018-9050-3 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Comparison between monotest and traditional batch-based ELISA assays for therapeutic drug monitoring of infliximab and adalimumab levels and anti-drug antibodies.
Clin Chem Lab Med
January 2025
Product Development and Support, Progenika Biopharma, SA, Derio, Spain.
Objectives: To compare a new ready-to-use monotest immunoassay, CHORUS Promonitor, for the quantification of serum biological drug levels and anti-drug antibodies of anti-TNF agents, against the reference batch-based ELISA test, Promonitor.
Methods: Blood samples were collected from patients treated with anti-TNF agents, infliximab (IFX) or adalimumab (ADL). IFX and ADL levels, as well as anti-IFX and anti-ADL antibodies were quantified and compared between the standard ELISA reference test, Promonitor, and the automated monotest ELISA assay, CHORUS Promonitor.
Transition to Subcutaneous Infliximab vs Vedolizumab in Inflammatory Bowel Disease: A Prospective Multicenter Study.
Dig Dis Sci
December 2024
Gastroenterology Unit, DiMePreJ, "Aldo Moro" University, Bari, Italy.
Background And Aims: Transition from intravenous (IV) to subcutaneous (SC) administration is an option in inflammatory bowel disease (IBD) with Infliximab (IFX) or Vedolizumab (VDZ). The aim was to compare the adherence, the persistence in therapy, and quality of life (QoL) at baseline, at 6, at 12 months of SC IFX versus SC VDZ.
Methods: This was a prospective, observational, multicenter study on patients with IBD in treatment with IV IFX or VDZ who switched to SC.
Influence of rheumatoid factor levels and TNF inhibitor structure on secondary nonresponse in rheumatoid arthritis patients.
Front Med (Lausanne)
September 2024
Rheumatology Department, La Paz University Hospital, Madrid, Spain.
Article Synopsis
- The EXXELERATE study found that patients with rheumatoid arthritis (RA) and high rheumatoid factor (RF) levels (>203 IU/mL) had worse clinical outcomes when treated with adalimumab (ADL).
- This new study aimed to investigate how RF levels affect the serum levels of TNF inhibitors and the risk of secondary nonresponse in RA patients.
- Results showed that high RF levels were linked to lower drug levels and a significantly higher risk of treatment discontinuation in patients using infliximab (IFX) or ADL, but not in those treated with certolizumab pegol (CZP).
Detection of infliximab, adalimumab, and anti-drug antibodies: Development and validation of new monotest, automated assays on multiparametric instrument.
Pract Lab Med
March 2024
DIESSE Diagnostica Senese S.p.A. Società Benefit: Strada dei Laghi 35-39, Monteriggioni, Siena, Italy.
Article Synopsis
- The study aimed to automate immunoassays for measuring serum levels of infliximab and adalimumab along with anti-drug antibodies using the CHORUS Promonitor kits.
- By comparing the automated kits against the manual versions, researchers analyzed sensitivity and specificity while running tests using human serum samples and drug additions on the CHORUS TRIO instrument.
- Results showed that the automated kits were highly accurate and consistent, demonstrating strong agreement with manual kits and confirming their potential for use in clinical settings for monitoring patients treated with these drugs.
Influence of rheumatoid factor on serum drug levels of TNF inhibitors with different structures in rheumatoid arthritis.
Clin Exp Rheumatol
May 2024
Immuno-Rheumatology Research Group, Institute for Health Research (IdiPAZ), Madrid, and Rheumatology Department, La Paz University Hospital, Madrid, Spain.
Article Synopsis
- Certolizumab pegol (CZP) maintains stable serum levels in rheumatoid arthritis (RA) patients, regardless of baseline rheumatoid factor (RF) status, while treatment with infliximab (IFX) and adalimumab (ADL) shows varying serum drug levels based on RF levels.
- A study of 170 RA patients found that high baseline RF levels were associated with lower serum drug levels for IFX and ADL, but not CZP, after six months.
- Patients with high RF levels experienced higher rates of treatment discontinuation due to non-response with IFX and ADL compared to those receiving CZP, highlighting potential treatment differences based on RF levels.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!