1. Ustekinumab Trough Concentrations Are Associated with Biochemical Outcomes in Patients with Crohn’s Disease
- Author
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Straatmijer, T., Biemans, V.B.C., Moes, D.J.A.R., Hoentjen, F., ter Heine, R., Maljaars, P.W.J., Theeuwen, R., Pierik, M., Duijvestein, M., van der Meulen-de Jong, A.E.E., Interne Geneeskunde, MUMC+: MA Maag Darm Lever (9), and RS: NUTRIM - R2 - Liver and digestive health
- Subjects
Crohn's disease ,All institutes and research themes of the Radboud University Medical Center ,lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4] ,Physiology ,Gastroenterology ,Other Research Radboud Institute for Molecular Life Sciences [Radboudumc 0] ,Ustekinumab ,Pharmacokinetics ,SUBCUTANEOUS USTEKINUMAB ,THERAPY ,Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5] ,Inflammatory bowel disease ,SERUM - Abstract
Contains fulltext : 293034.pdf (Publisher’s version ) (Open Access) 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
- Published
- 2023