Year 2025 / Volume 117 / Number 4
Original
Impact of ustekinumab exposure on clinical outcomes during induction in inflammatory bowel disease

205-212

DOI: 10.17235/reed.2024.10521/2024

Carles Iniesta-Navalón, Manuel Ríos-Saorín, Lorena Rentero-Redondo, Isabel Nicolás-de Prado, Rosa Gómez-Espín, Elena Urbieta-Sanz,

Abstract
Background: understanding the relationship between ustekinumab (UST) exposure and clinical outcomes in inflammatory bowel disease (IBD) induction is crucial. However, evidence remains limited, highlighting the need to comprehend UST’s pharmacokinetic variability for tailored treatments. Aims: this study aimed to investigate the association between UST exposure during the induction phase and clinical outcomes and identifying factors associated with UST exposure during this period. Methods: a retrospective observational study was conducted on a cohort of consecutive IBD patients. The primary endpoint was to assess the association between UST exposure at week 8 and both clinical and biochemical remission at week 26, as well as the absence of disease flare-ups during the initial six months of treatment. The secondary endpoint was to investigate the relationship between baseline characteristics and UST exposure at week 8. Results: a total of 56 IBD patients were included. Variables associated with adequate UST exposure included baseline fecal calprotectin < 500 µg/g (OR: 7.72 [95 % CI: 1.75-34.03]) and female sex (OR: 4.56 [95 % CI: 1.12-18.60]). A cut-off UST trough levels of 8.3 μg/ml yielded an area under the curve (AUC) of 0.74 (95 % CI: 0.58-0.90, p = 0.021) to predict normal fecal calprotectin levels, and 8.6 µg/ml resulted in an AUC of 0.724 (95 % CI: 0.558-0.863) to predict clinical remission. Conclusions: this study demonstrates a significant association between UST concentrations and clinical and biochemical remission in IBD patients. Results suggest that standard induction doses may not be sufficient for all patients, highlighting the importance of treatment individualization to optimize outcomes.
Lay Summary
This research addressed the impact of Ustekinumab exposure on patients with inflammatory bowel disease (IBD) during the first six months of treatment, also exploring pharmacokinetic variability. Significant variability in Ustekinumab levels was observed, linked to differences in clinical and biochemical remission, as well as in flare prevention. Higher Ustekinumab levels at week 8 consistently correlated with better clinical outcomes by week 26, suggesting a potential therapeutic target for optimizing Ustekinumab dosing in IBD patients. This supports the need to consider treatment individualization and monitoring Ustekinumab concentrations, as standard doses may not be suitable for all patients, especially those with higher risk profiles. These findings underline the importance of personalized care to optimize clinical outcomes in IBD.
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Iniesta-Navalón C, Ríos-Saorín M, Rentero-Redondo L, Nicolás-de Prado I, Gómez-Espín R, Urbieta-Sanz E, et all. Impact of ustekinumab exposure on clinical outcomes during induction in inflammatory bowel disease. 10521/2024


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Publication history

Received: 06/05/2024

Accepted: 24/11/2024

Online First: 04/12/2024

Published: 03/04/2025

Article revision time: 197 days

Article Online First time: 212 days

Article editing time: 332 days


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