Intestinal Ultrasound Is a Non-Invasive Tool for Evaluating Transmural Disease Activity in Crohn’s Disease: Presented at ECCO-IBD

By Eric Ramos

VIENNA, Austria -- February 15, 2020 -- Intestinal ultrasound could be a valuable tool to detect early response to ustekinumab treatment in patients with Crohn’s disease, according to a study presented here at the 15th Congress of the European Crohn’s and Colitis Organisation - Inflammatory Bowel Diseases (ECCO-IBD).

“This was the first international, interventional, multicentre study using intestinal ultrasounds in Crohn’s disease,” reported Torsten Kucharzik, MD, Klinik für Allgemeine Innere Medizin und Gastroenterologie, Klinikum Lüneburg, Lüneburg, Germany.

Dr. Kucharzik and colleagues conducted an analysis of patients enrolled in the intestinal ultrasound substudy of the STARDUST trial. In STARDUST, patients with moderate to severe Crohn’s disease received weight-based intravenous ustekinumab 6 mg/kg at week 0, then subcutaneous ustekinumab 90 mg at week 8. At week 16, patients with a Crohn’s Disease Activity Index score reduction ≥70 points were randomised to treat-to-target maintenance or standard care. All patients in the study had failed conventional therapy and/or 1 biologic.

The aim of the substudy was to assess changes in intestinal ultrasound parameters, including transmural response to ustekinumab induction therapy.

The overall rate of intestinal ultrasound response -- defined as a reduction of ≥25% from baseline in bowel wall thickness (BWT) -- at week 16 was 33.8% (24 of 71 patients). The rate of intestinal ultrasound remission (transmural healing) -- defined as normalisation of BWT, echo stratification, and inflammatory mesenteric fat -- was 11.3% (8 of 71 patients). The most affected segments were ileum in 66% and colon in 34% of patients, with better outcomes found in the colon.

BWT and Doppler’s signal started to normalise at week 8, but mean BWT improvement from baseline was statistically significant as early as week 4 (P = .0002;).

“Intestinal ultrasound response to ustekinumab was detected as early as week 4, and a clinically meaningful percentage of patients achieved transmural healing, primarily in the colon, at week 16,” stated Dr. Kucharzik. “Future studies need to confirm whether early intestinal ultrasound response is predictive of long-term outcomes for patients with Crohn’s disease.”

[Presentation title: Intestinal Ultrasound Response and Transmural Healing After Ustekinumab Induction in Crohn’s Disease: Week 16 Interim Analysis of the STARDUST Trial Substudy. Abstract DOP10]

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