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E-pub ahead of print

Early ultrasound response and progressive transmural remission after treatment with ustekinumab in Crohn's disease

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  • Torsten Kucharzik
  • Rune Wilkens
  • Maria-Antonietta D'Agostino
  • Giovanni Maconi
  • Manuela Le Bars
  • Marjolein Lahaye
  • Ivana Bravatà
  • Maciej Nazar
  • Lioudmila Ni
  • Elena Ercole
  • Mariangela Allocca
  • Naděžda Machková
  • Floris Ae de Voogd
  • Palmela Carolina
  • Rose Vaughan
  • Christian Maaser
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BACKGROUND & AIMS: In this STARDUST substudy, the effect of ustekinumab on transmural bowel inflammation was assessed in adults with moderate-to-severe Crohn's disease (CD) by using intestinal ultrasound (IUS), a noninvasive imaging procedure.

METHODS: STARDUST was an international, multicenter, phase 3b, interventional, randomized controlled trial specifically designed to compare treat-to-target and standard-of-care treatment strategies in ustekinumab-treated CD patients. In this substudy, the most affected bowel segment at baseline by IUS was used for all analyses. Key IUS endpoints (centrally read, parameter-blinded) were IUS response, transmural remission, bowel wall thickness (BWT), blood flow, bowel wall stratification, and inflammatory fat.

RESULTS: Seventy-seven patients were evaluated. IUS response could be determined 4 weeks after treatment initiation, with progressive improvement through week 48. IUS response and transmural remission rates at week 48 were 46.3% and 24.1%, respectively. IUS response, transmural remission, BWT, and blood flow normalization rates were more pronounced in the colon and biologic-naive patients. Fair/moderate reliability (κ = 0.21-0.51) was observed between week 4 IUS response and week 48 overall endoscopic response and fecal calprotectin/complete biomarker outcomes. Endoscopy and IUS baseline agreement was >90% in determining the terminal ileum as the most affected bowel segment. IUS response absence at week 4 was associated with no endoscopic response (based on the simplified endoscopic score for Crohn's disease terminal ileum subscore) at week 48 (negative predictive value = 73%).

CONCLUSIONS: In this first international, multicenter, interventional study, IUS showed that ustekinumab-treated CD patients achieved progressive IUS response (46.3%) and transmural remission (24.1%) through week 48, with a more robust response in the colon and biologic-naive patients.

CLINICALTRIALS: gov number: NCT03107793.

Original languageEnglish
JournalClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
Pages (from-to)1-52
Number of pages52
Publication statusE-pub ahead of print - 14 Jul 2022

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Copyright © 2022 AGA Institute. Published by Elsevier Inc. All rights reserved.

ID: 79683244