Clinical relevance of innovative immunoassays for serum ustekinumab and anti-ustekinumab antibody levels in Crohn's disease

Yasuhiro Morita, Takayuki Imai, Shigeki Bamba, Kenichiro Takahashi, Osamu Inatomi, Takako Miyazaki, Kenji Watanabe, Shiro Nakamura, Atsushi Yoshida, Yutaka Endo, Naoki Ohmiya, Tomoyuki Tsujikawa, Akira Andoh

Research output: Contribution to journalArticle

Abstract

Background and Aim: Ustekinumab is a human monoclonal antibody to the p40 subunit of human IL-12/IL-23. The purpose of this report is to verify the newly developed immunoassays for serum ustekinumab and anti-ustekinumab antibody (AUA) concentrations and assess their clinical utility. Methods: Serum ustekinumab trough levels and AUA levels were measured using new immunoassays in 38 patients with Crohn's disease under ustekinumab maintenance injection. Results: Mean ustekinumab trough levels were 2.54 ± 2.1 μg/mL, and 3 of 38 patients (7.9%) were positive for AUAs. There was no association between ustekinumab trough levels and AUA levels. The optimal trough level of ustekinumab to maintain negative C-reactive protein levels (≤ 0.3 mg/dL) was 1.67 μg/mL determined by receiver operating characteristic curve analysis. Ustekinumab trough level negatively but significantly correlated with C-reactive protein, erythrocyte sedimentation rate, and Crohn's disease activity index and positively and significantly correlated with serum albumin levels. Ustekinumab trough levels were significantly higher in biologics-naïve patients than in biologics-experienced patients, although there was no difference in AUA levels. Conclusions: We developed new assays for serum ustekinumab trough and AUA levels. These assays might provide new insights into therapeutic drug monitoring-based management of Crohn's disease patients under ustekinumab therapy.

Original languageEnglish
Pages (from-to)1163-1170
Number of pages8
JournalJournal of Gastroenterology and Hepatology (Australia)
Volume35
Issue number7
DOIs
Publication statusPublished - 01-07-2020

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

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    Morita, Y., Imai, T., Bamba, S., Takahashi, K., Inatomi, O., Miyazaki, T., Watanabe, K., Nakamura, S., Yoshida, A., Endo, Y., Ohmiya, N., Tsujikawa, T., & Andoh, A. (2020). Clinical relevance of innovative immunoassays for serum ustekinumab and anti-ustekinumab antibody levels in Crohn's disease. Journal of Gastroenterology and Hepatology (Australia), 35(7), 1163-1170. https://doi.org/10.1111/jgh.14962