Introduction
Transmural response (TR) and healing (TH) assessed by intestinal ultrasound (IUS) are gaining increasing relevance as treatment targets in Crohn’s disease (CD) [1]. Even though less established in ulcerative colitis [UC], in which the inflammation mainly affects mucosa and submucosa, there is clear evidence that applying IUS in UC is beneficial to monitor short-term response to therapy [2]. However, the long-term IUS outcome, its association to clinical and lab parameters as well as the predictive value of early TR remain elusive.
Aims & Methods
The TRUST BEYOND study is an ongoing, prospective, non-interventional, multi-centre study in patients with active CD or UC who receive a biologic- or Januskinase-inhibitor (JAKi)-therapy at baseline. The study aims to assess the predictive value of TR or TH, evaluated at week 12 for the disease outcome after 52 weeks (TR: reduction of bowel wall thickness (BWT) of at least 25% and/or normalization; TH: normalization of BWT and Colour Doppler signal). For this interim analysis, we report IUS and clinical results as well as fecal calprotectin levels of 77 UC patients on the same therapy after 12 (W12) and 52 weeks (W52) and assessed the predictive value of TR at W12 for clinical remission at W52.
Results
Seventy-seven UC patients (63.6% were male, median age was 38.6 years (30.6 – 55.7) median disease duration of 5.85 years (2.49–12.77)) with clinically active disease (SCCAI 8.5 ± 2.2) with increased BWT at baseline had a documented visit after 52 weeks until February 2023. For the vast majority, the most affected bowel wall segment was the sigmoid colon with a mean BWT of 5.22 ± 1.28 mm at baseline.
At W12 after induction of therapy, the proportion of UC patients with TR and TH was 67.5% (n = 52) and 31.2% (n = 24). At W52, the rates of UC patients increased to 77.9% (n = 60) for TR and 41.6% (n = 32) for TH. Over the study course, patients with TR at W12 and W52 had a numerically lower SCCAI score and reduced fecal calprotectin levels than patients without TR.
Of note, 72.2% (n = 39) of patients with TR at W12 were in clinical remission at W52 compared to 27.8% (n = 15) of patients without early transmural response (p = 0.178).
Conclusion
In this interim analysis of the TRUST BEYOND study, UC patients demonstrated substantial rates of transmural improvements on IUS after 12 and 52 weeks. Patients with early transmural response were more likely to be in remission after one year. This suggests that in UC, IUS has to some degree a predictive value as observed for CD.
References
1. Kucharzik T, Wittig BM, Helwig U, et al. Use of Intestinal Ultrasound to Monitor Crohn's Disease Activity. Clin Gastroenterol Hepatol. 2017; 15:4, 535-42 e2.
2. Maaser C, Petersen F, Helwig U On behalf of the German IBD Study Group and the TRUST&UC study group, et alIntestinal ultrasound for monitoring therapeutic response in patients with ulcerative colitis: results from the TRUST&UC studyGut 2020;69:1629-1636.
Disclosure
T. Kucharzik, U. Helwig, F. Seibold, L. Biedermann, C. Högenauer and C. Maaser have received lecture and consulting fees from AbbVie.
I. Fischer has received consulting fees from AbbVie. L. Hammer and S. Rath are AbbVie employees and may own AbbVie stock or options.
AbbVie sponsored the study; contributed to the design; participated in the collection, analysis, and interpretation of data; in writing, reviewing, and approval of the final version. No honoraria or payments were made for authorship.