Details

Autor(en) / Beteiligte

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

Titel

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

Ist Teil von

• Clinical gastroenterology and hepatology, 2023-01, Vol.21 (1), p.153-163.e12

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2023

Quelle

MEDLINE

Beschreibungen/Notizen

• 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. 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. 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%). 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 [Display omitted]