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.

Ambulanzzentrum Gastroenterologie am Klinikum Lüneburg Lüneburg Germany

Clinical and Research Center for Inflammatory Bowel Diseases Clinical Center ISCARE Prague Czech Republic

Department of Gastroenterology and Hepatology Amsterdam University Medical Center Amsterdam The Netherlands

Digestive Disease Center Bispebjerg Hospital Copenhagen Denmark; Gastro Unit Section of Medicine Hvidovre Hospital Copenhagen Denmark

Division of Gastroenterology Surgical Department Hospital Beatriz Ângelo Loures Portugal

Gastroenterology Unit Department of Biomedical and Clinical Sciences; Luigi Sacco University Hospital University of Milan Milan Italy

Gastroenterology Unit Mauriziano Hospital Turin Italy

IRCCS Humanitas Research Hospital Rozzano Milan Italy

Janssen Cilag B 5 Breda The Netherlands

Janssen Cilag Polska Sp Z o o Warsaw Poland

Janssen Cilag Russia Moscow Russian Federation

Janssen Cilag S p A Milan Italy

Janssen Cilag SARL Issy les Moulineaux France

Klinik für Allgemeine Innere Medizin und Gastroenterologie Klinikum Lüneburg Lüneburg Germany

The Royal Melbourne Hospital Melbourne Australia

Università Cattolica del Sacro Cuore UOC Reumatologia Fondazione Policlinico Universitario Agostino Gemelli IRCSS Roma Italy

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ClinicalTrials.gov
NCT03107793