Research Article
Volume 8 Issue 3 - 2021
Method Comparison Study of Two Commercially Available Tests for the Measurement of Ustekinumab Levels
Torres N1*, Atreya R2, Klenske E2, Apraiz I1, Landeta M1, Neurath MF2, Catarino S1, Ruiz del Agua A1, Apraiz I1, Nagore D1 and López M1
1Progenika Biopharma, S.A, A Grifols Company, Derio, Spain
2Department of Medicine 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany
*Corresponding Author: Torres N, Progenika Biopharma, S.A, A Grifols Company, Derio, Spain.
Received:January 16, 2021; Published: February 09, 2021




Abstract

A prospective, observational cohort study was conducted in Crohn´s disease (CD) patients treated with ustekinumab (UTK). Trough UTK and anti-UTK antibody levels were measured with Promonitor®-UTK and Promonitor® Anti-UTK tests (Progenika, Spain), respectively and compared to the corresponding results using LISA TRACKER Ustekinumab DUO (LTU) (Theradiag, France) in 100 serum samples collected at baseline and during the course of UTK treatment. Qualitative and quantitative analysis comparison of the two tests was done using descriptive statistics, Pearson Correlation, Passing-Bablok regression and Bland-Altman analysis. Both assays correlated and can be used for monitoring of UTK levels, however the measurement range and the sample dilution recommended by Promonitor-UTK covers more accurately the UTK concentrations found in CD patients, whereas use of the LTU forces the user to repeat the testing or perform two sample dilutions by default because the recommended sample dilution is not appropriate for the population. In the absence of a gold standard method to unequivocally assess tests accuracy, UTK concentration results measured with different tests should be taken into account with caution and it is advised that monitoring drug concentrations in patients over time would be best done using the same test system.

Keywords: Ustekinumab; Therapeutic Drug Monitoring; Inflammatory Bowel Disease

References

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Citation: Torres N., et al. “Method Comparison Study of Two Commercially Available Tests for the Measurement of Ustekinumab Levels”. EC Gastroenterology and Digestive System 8.3 (2021): 38-41.

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