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Ustekinumab Trough Concentrations Are Associated with Biochemical Outcomes in Patients with Crohn's Disease.


ABSTRACT:

Objective

It is unknown whether ustekinumab (UST) levels can predict clinical outcomes in Crohn's disease (CD) patients. We assessed the exposure-response relationship of UST trough concentrations with biochemical outcomes at week 24 in a prospective, real-world setting.

Methods

We performed a prospective study in patients with CD starting UST in four academic centres in the Netherlands. All patients received a weight-adjusted intravenous (IV) UST induction dose, followed by one subcutaneous (SC) dose of 90 mg UST at 8 weeks. Maintenance therapy consisted of 90 mg subcutaneous UST every 8 or 12 weeks. Individual UST concentration time course during treatment were estimated using a population pharmacokinetic (PK) model. Quartile analysis and logistic regression were performed to analyse if UST concentrations at week 8 were associated with biochemical remission rates at week 24 (C-reactive protein (CRP) ≤ 5 mg/L and / or faecal calprotectin (FC) ≤ 250 mg/kg).

Results

In total, 124 patients with CD were included. Patients achieving biochemical remission at week 12 and 24 had significantly higher UST levels at week 8 compared to patients without biochemical remission (6.6 µg/mL versus 3.9 µg/mL, P < 0.01 and 6.3 µg/mL versus 3.9 µg/mL, P < 0.01, respectively). In quartile analysis, patients with UST levels in the highest quartile (≥ 6.3 µg/mL at week 8) had higher biochemical remission rates at week 12 and week 24. There was no association between UST levels at and corticosteroid-free clinical remission rates.

Conclusion

In this real-world cohort of patients with CD, UST levels in the highest quartile (≥ 6.3 µg/mL) at week 8 were associated with higher biochemical remission rates at week 24.

SUBMITTER: Straatmijer T 

PROVIDER: S-EPMC10188378 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Ustekinumab Trough Concentrations Are Associated with Biochemical Outcomes in Patients with Crohn's Disease.

Straatmijer Tessa T   Biemans Vince B C VBC   Moes Dirk Jan A R DJAR   Hoentjen Frank F   Ter Heine Rob R   Maljaars P W Jeroen PWJ   Theeuwen Rosaline R   Pierik Marieke M   Duijvestein Marjolijn M   van der Meulen-de Jong Andrea E AE  

Digestive diseases and sciences 20230315 6


<h4>Objective</h4>It is unknown whether ustekinumab (UST) levels can predict clinical outcomes in Crohn's disease (CD) patients. We assessed the exposure-response relationship of UST trough concentrations with biochemical outcomes at week 24 in a prospective, real-world setting.<h4>Methods</h4>We performed a prospective study in patients with CD starting UST in four academic centres in the Netherlands. All patients received a weight-adjusted intravenous (IV) UST induction dose, followed by one s  ...[more]

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