Value of IUS in Predicting Vedolizumab Efficacy and Assessing Transmural Healing in Early Crohn's Disease: A Multicenter, Prospective Study

Condition(s) studied

Study summary

Crohn's disease(CD) is a chronic nonspecific inflammatory disease of the intestinal tract whose etiology is not yet fully understood,characterized by transmural inflammation , can present with serious complications such as intestinal obstruction, perforation, abdominal abscesses, and fistulae. In recent years, the incidence of CD has increased rapidly, causing a heavy social and economic burden. Currently, the main therapeutic drugs for CD include aminosalicylic acid preparations, glucocorticoids, immunosuppressants, and biological agents. With the development of medical technology, small molecule preparations have begun to be applied to moderate-to-severe Crohn's disease, providing new treatment options for patients with Crohn's disease.

Vedolizumab, a humanized monoclonal antibody.the GEMINI study demonstrated its superior efficacy over placebo in inducing and maintaining clinical remission. And the VERSIFY study confirmed its advantage in achieving mucosal healing, with a transmural healing rate of 29.1% at week 52.

Intestinal ultrasound is a noninvasive, reproducible, convenient, and inexpensive test that can greatly increase the frequency of assessing treatment response and speed up the clinical decision-making process.The 2019 ECCO-ESGAR guidelines recommend intestinal ultrasound for disease monitoring in patients with CD. Multiple studies have shown that most ultrasound markers normalize within 12 weeks of treatment initiation, and in particular, normalization of bowel wall thickness is highly correlated with clinical response at 12 weeks. There are no validated indicators to predict the efficacy of upadacitinib treatment in patients with moderate-to-severe CD in the currently available studies.

Currently, there are no national or international studies in which intestinal ultrasound predicts the efficacy and assesses the transmural healing of vedolizumab therapy. Therefore, we propose for the first time that intestinal ultrasound be used as a method to predict the response to vedolizumab in early CD patients, with the aim of providing evidence to guide the development of individualized treatment plans.

Eligibility

Primary outcome measure(s)

• Bowel wall thickess(BWT) — follow-up time of about 52 weeks
  BWT is measured by intestinal ultrasound. BWT≤3mm means that CD is in quiescent, \>3mm means CD is active

Trial sites (1)

More The Third Xiangya Hospital of Central South University trials in China

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