Comparison of Serum Concentrations of Ustekinumab Obtained by Three Commercial Assays in Patients with Crohn's Disease.

Background: Data on the association of ustekinumab (UST) drug concentrations and clinical outcomes are conflicting. We assessed serum UST drug and anti-UST antibody concentrations using three commercially available assays.

Methods: Sixty-one blood samples were analyzed for serum UST drug and anti-UST antibody concentrations using three assays: one homogeneous mobility shift assay (HMSA, Prometheus, Assay A), and two enzyme-linked immunosorbent assays (ELISA; Progenika, Dynacare, Assay B and Theradiag, Assay C).

Results: The median (IQR) serum UST concentrations for the three assays were: Assay A 7.50 (5.35 to 12.88) µg/mL, Assay B 4.02 (2.46 to 6.95) µg/mL and Assay C 4.35 (2.62 to 7.50) µg/mL. A Kruskal-Wallis test confirmed a statistically significant difference between the different assays, X(2) = 30.606, < 0.001. Linear regression showed near twofold increased difference in the absolute drug concentrations between the HMSA and either ELISA. Linear quantitative correlation was observed for all three assays ( = 0.836 for A versus B, = 0.792 for A versus C, = 0.936 for B versus C; < 0.01). The intraclass correlation coefficient (ICC) between assay A and B was 0.649 (95% confidence interval [CI] -0.208 to 0.874); assay A and C was 0.671 (95% CI -0.165 to 0.878); and assay B and C was 0.958 (95% CI 0.928 to 0.975); < 0.001. No anti-UST antibodies were detected.

Conclusion: A good correlation was observed for serum UST drug concentrations and a good agreement was observed between the ELISA tests. However, agreement was poor between the HMSA and each ELISA tests. Clinical recommendations regarding drug concentrations should be based on assay type used.