Observational Study to Compare Biological Drug Concentration Quantification Techniques and Immunogenicity in Patients with Immune-Mediated Diseases

Author:

Martínez-Pradeda Alejandro1ORCID,Elberdín Laida1,Porta-Sánchez Ángeles1,Outeda María1,Diz-Lois Palomares Mª Teresa2,Vázquez-Rey Teresa2,González-Conde Benito2,Estévez-Prieto Emilio2,Gómez-Besteiro María I.3ORCID,Martín-Herranz Isabel1

Affiliation:

1. Department of Pharmacy, Complexo Hospitalario Universitario de A Coruña (CHUAC), Sergas, Instituto de Investigación Biomédica de A Coruña (INIBIC), Universidade da Coruña (UDC), 15006 A Coruña, Spain

2. Department of Gastroenterology, Complexo Hospitalario Universitario de A Coruña (CHUAC), Sergas, Instituto de Investigación Biomédica de A Coruña (INIBIC), Universidade da Coruña (UDC), 15006 A Coruña, Spain

3. Clinical Epidemiology and Biostatistics Unit, Complexo Hospitalario Universitario de A Coruña (CHUAC), Sergas, Instituto de Investigación Biomédica de A Coruña (INIBIC), Universidade da Coruña (UDC), 15006 A Coruña, Spain

Abstract

Measuring biological drugs’ trough concentrations and the concentrations of anti-drug antibodies is a valuable practice for treatment optimization. ELISA techniques are the gold standard for biological drug concentration quantification, but new techniques such as chemiluminescence immunoassays present some advantages. The aim of this unicentric prospective observational study is to compare the infliximab, adalimumab, vedolizumab and ustekinumab trough levels and anti-adalimumab and anti-infliximab antibodies concentrations obtained when using a chemiluminescent instrument (i-TRACK®, Theradiag, Croissy-Beaubourg, France) and an ELISA instrument (TRITURUS®, Griffols, Barcelona, Spain). Linear regression, Pearson or Spearman tests, Bland–Altman plots and the Cohen kappa test were applied for every sample. The correlation was excellent for both assays in the measurement of all drug concentrations. In general, values were lower when measured using i-TRACK than when using TRITURUS, especially when the values were high. Both techniques proved valuable in clinical practice for monitoring adalimumab and infliximab drug concentration. However, the results were modest for ustekinumab and vedolizumab, so caution is recommended and further research is needed. The limited number of anti-drug antibody-positive samples precluded a comparison between the techniques.

Publisher

MDPI AG

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