Background and Aims Intestinal ultrasound (IUS) is a useful modality to monitor patients with inflammatory bowel diseases (IBD). Little is known about the use of IUS and appropriate definitions for transmural response (TR) and healing (TH). We aimed to establish the use of IUS in monitoring TH as a potential target in routine medical practice. Methods Based on the prospective, non-interventional, multicentre studies TRUST and TRUST&UC, we conducted a post-hoc analysis of 351 IBD patients with increased bowel wall thickness (BWT). We analysed the rates of patients achieving TR and TH, comparing three definitions of TH. In 137 Crohn’s disease (CD) patients, the predictive value of TR and TH was investigated for the clinical and sonographic outcome at week 52. Results Within 12 weeks of treatment intensification, 65.6% (n = 118) of CD patients and 76.6% (n = 131) of ulcerative colitis (UC) patients showed a TR. Depending on the definition, 23.9%–37.2% (n=58/67/43) of CD patients and 45.0%–61.4% (n=90/105/77) of UC patients had TH at week 12. CD patients with TH were more likely to reach clinical remission at week 12 (OR 3.33 [1.09–10.2]; p = 0.044) and a favourable sonographic outcome (OR 5.59 [1.97–15.8]; p = 0.001) at week 52 compared with patients without TH. Conclusions IUS response and TH in a relevant proportion of patients suggests that IUS is a useful method to assess transmural inflammatory activity in daily clinical practice. TR and TH are predictive for the sonographic outcome at week 52.

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Background In the treat-to-target era, frequent and objective monitoring of disease activity in IBD patients is emphasized [1]. Over the past years, intestinal ultrasound (IUS) has become a useful modality to monitor and assess disease activity and response to therapy. (Trans)mural response and healing examined by IUS have emerged as outcome measures of growing interest and potential therapeutic goals in the IBD community [2–4]. However, the predictive value of a composite clinical/IUS improvement for the long-term outcome remains elusive. Methods TRUST BEYOND is an ongoing, prospective, observational, multi-centre study in patients with active CD or UC initiating a biologic- or Januskinase-inhibitor (JAKi)-therapy at baseline. The aim of this study is to assess the predictive value of IUS parameters evaluated at week 12 for the long-term outcome after 52 weeks (assessed by clinical+ sonographic endpoints). For this interim analysis, 89 IBD patients (39 CD, 50 UC) with a documented visit at week 52 until September were included. The predictive value of (trans)mural response (TR; reduction of ≥ 25% in bowel wall thickness, BWT) and clinical remission at W12 was evaluated for the outcome at W52. Results Eighty-nine IBD patients in clinical flare with increased BWT were included into this analysis. Patients were predominantly female (53.9%,n=48) with a median age of 34.3 years (29.0–51.5) and a median disease duration of 7.18 years (2.31–13.47). Following the induction of advanced therapy, the rate of IBD patients with a (trans)mural response increased from 67.4% (n=60) at W12 to 73.0% (n=65) at W52. Likewise, the proportion of IBD patients demonstrating a (trans)mural healing rose from 32.6% (n=29) at W12 to 41.6% (n=37) at W52. Of note, 53.5% (n=38) of IBD patients who achieved the composite endpoint “clinical remission and (trans)mural response” at W12 were in clinical remission at W52 while only 23.9% of patients who were only in clinical remission at W12 sustained clinical remission until W52 (p=0.007). Moreover, patients achieving both early clinical remission and (trans)mural response had better sonographic outcomes at W52. Fig 1: W52 outcomes of patients with either clinical remission and (trans)mural response or only clinical remission at W12. Conclusion IBD patients who reached the composite endpoint clinical remission and (trans)mural response at week 12 had better outcomes after 1 year compared to patients in early clinical remission only. Our results strongly suggest that it is worth treating patients to composite clinical and sonographic endpoints. Reference 1. Turner D et al. Gastroenterol. 2021; 2 Kucharzik T et al. Clin Gastroenterol Hepatol. 2017; 3 Maaser C et al. Gut 2020; 4 Wilkens R et al. Therap Adv Gastroenterol 2021

Background Patient-reported Outcomes (PRO) are gaining increasing acceptance as new tools to evaluate clinical activity, especially in the context of clinical trials and evaluation of drug efficacy. However, data to support the relevance of these endpoints and their correlation to objective markers of inflammation is still lacking.1 Recently published data demonstrated the feasibility of intestinal ultrasound (IUS) as a routine monitoring technique in clinical practice for Crohn’s disease (CD) and ulcerative colitis (UC) patients.2 Thus, the importance and significance of IUS, as a patient-centric and non-invasive technique has emerged over the last years and will become more relevant in the future.With this sub-analysis of the TRUST&UC study, we aimed to investigate the correlation between improvement in ultrasound parameters and PRO-2 in UC patients. Methods TRUST&UC is a prospective, observational study including 244 patients with an increased bowel wall thickness (BWT) at baseline and active UC (SCCAI ≥ 5). These patients were analysed for the Simple Clinical Colitis Activity Index (SCCAI) subscores stool frequency, urgency and rectal bleeding. These parameters were documented for up to 4 visits (baseline, an optional visit at week 2, week 6 and week 12). Pathological stool frequency was defined as a stool frequency of ≥1 point (≥ 4 stools/day) and pathological rectal bleeding was defined as ≥1 point (traces of blood in stool); the combination of both subscores was defined as PRO-2. Results We found a positive moderate correlation between BWT and the investigated SCCAI-subscores (rectal bleeding and BWT at W12 r = 0.417; stool frequency and BWT at W12, r = 0.483; PRO-2 and BWT at W12, r = 0.518) and even W6, which is in accordance with previously reported correlations of various PROs and endoscopy in UC-patients.3 We demonstrate that patients with normalisation of BWT (sigmoid colon < 4.0 mm) had a significantly higher chance of a non-pathological PRO-2 (pathological PRO-2 yes/no: 4.25 mm and 3.20 mm for week 6 (p < 0.001) and 4.45 mm and 3.00 mm (p < 0.001) for week 12). Conclusion With this sub-analysis of the TRUST&UC study we demonstrated that bowel wall thickness, assessed by intestinal ultrasound, had a moderate correlation with normalisation of patient-reported outcomes as early as week 6 and 12. Furthermore, patients with non-pathological PRO-2 had significantly decreased bowel wall thickness. This again supports the value of intestinal ultrasound in routine medical practice. References

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