Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn’s Disease - Université de Versailles Saint-Quentin-en-Yvelines Access content directly
Journal Articles Clinical Gastroenterology and Hepatology Year : 2023

Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn’s Disease

Torsten Kucharzik
Rune Wilkens
  • Function : Author
Giovanni Maconi
  • Function : Author
Manuela Le Bars
  • Function : Author
Marjolein Lahaye
  • Function : Author
Ivana Bravatà
  • Function : Author
Maciej Nazar
  • Function : Author
Lioudmila Ni
  • Function : Author
Elena Ercole
  • Function : Author
Mariangela Allocca
  • Function : Author
Naděžda Machková
  • Function : Author
Floris A.E. de Voogd
  • Function : Author
Carolina Palmela
  • Function : Author
Rose Vaughan
  • Function : Author
Christian Maaser
  • Function : Author
Tomas Grega
  • Function : Author
Ivana Niangova
  • Function : Author
Rudolf Repak
  • Function : Author
Petra Matejkova
  • Function : Author
Radka Vanickova
  • Function : Author
Juel Mie Agerbæk
  • Function : Author
Annett Cannon
  • Function : Author
Vittorio Giuliano
  • Function : Author
Christoph Antoni
  • Function : Author
Jürgen Büning
  • Function : Author
Michael Gebel
  • Function : Author
Martin Grewe
  • Function : Author
Sebastian Küpper
  • Function : Author
Nikolas Ryschka
  • Function : Author
Andrej Potthoff
  • Function : Author
Wolfgang Reindl
  • Function : Author
Karolin Schliwa
  • Function : Author
Martin Schulz
  • Function : Author
Hermann Schulze
  • Function : Author
Markus Krankenhaus
  • Function : Author
Marco Affronti
  • Function : Author
Maria Laura
  • Function : Author
Christina Bezzio
  • Function : Author
Flaminia Cavallaro
  • Function : Author
Marina Coletta
  • Function : Author
Andrea Costantino
  • Function : Author
Federico Furfaro
  • Function : Author
Fabrizio Pizzolante
  • Function : Author
Steven Bots
  • Function : Author
Robert de Knegt
  • Function : Author
Ivan Bunganic
  • Function : Author
Zdenek Opravil
  • Function : Author
Joaquin Poza
  • Function : Author
Jordi Rimola
  • Function : Author
Cristina Suarez Ferrer
  • Function : Author

Abstract

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

Domains

Health
Fichier principal
Vignette du fichier
1-s2.0-S1542356522006498-main.pdf (3.13 Mo) Télécharger le fichier
Origin : Publisher files allowed on an open archive
Licence : CC BY - Attribution

Dates and versions

hal-04552336 , version 1 (19-04-2024)

Licence

Attribution

Identifiers

Cite

Torsten Kucharzik, Rune Wilkens, Maria-Antonietta D’agostino, Giovanni Maconi, Manuela Le Bars, et al.. Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn’s Disease. Clinical Gastroenterology and Hepatology, 2023, 21 (1), pp.153-163.e12. ⟨10.1016/j.cgh.2022.05.055⟩. ⟨hal-04552336⟩
2 View
1 Download

Altmetric

Share

Gmail Facebook X LinkedIn More