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.

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

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Background Pain is a debilitating symptom in many patients with Crohn’s disease (CD) both in flare and in remission [1]. However, pain is insufficiently understood and therefore often underrepresented in disease management [2]. Thus, it is of paramount importance to raise awareness for this common but insufficiently managed IBD symptom. With this analysis, we aimed to investigate (1) the prevalence of abdominal pain (AP) and (2) the correlation of AP with further parameters including inflammatory activity assessed by intestinal ultrasound (IUS), lab parameters and patient-well-being in CD patients of the TRUST study cohort. Methods We evaluated the prevalence of pain in 230 of 234 CD patients of the prospective, non-interventional, multi-centre TRUST study. At baseline, all patients were in clinical flare (Harvey-Bradshaw index (HBI) of≥7) and received treatment intensification. IUS parameters such as bowel wall thickness (BWT) and clinical data were assessed at baseline and after 3, 6, and 12 months. AP was analysed using the HBI subscore 2. To investigate the connection between AP and inflammation, AP was correlated with BWT and C-reactive protein (CRP). Results Based on the TRUST study, we found that 95.2% of patients in clinical flare experienced AP. AP was significantly reduced within 12 weeks after treatment intensification (p < 0.001) but 30% (n=69) to 48.3% (n=111) of patients still experienced AP at the subsequent visits (p(T1-T2) = 0.668; p(T2-T3) = 1.000) (figure 1). Of note, 35.6%-42.5% of patients with clinical response had a lasting pain experience (figure 2). AP positively correlated with poor well-being which is in line with previously published results [3]. We found a weak positive correlation between AP and inflammatory activity, represented by BWT (not shown), and between AP and CRP (table 1). Figure 1: Percentage of patients with mild, moderate or severe abdominal pain during the study. *Friedman test with post-hoc Wilcoxon tests. Figure 2: Percentage of patients with abdominal pain and clinical response (reduction of total HBI≥3 points) at the indicated visit Table 1: Spearmann rank correlations for abdominal pain vs. poor general well-being (as measured by the HBI subscore 1) and vs. CRP at baseline Conclusion Our results clearly demonstrate that more than 1/3 of CD patients suffers from AP despite treatment intensification and clinical improvement. We found a weak correlation between AP and markers of inflammatory activity suggesting the existence of a subgroup of patients with persistent pain experience even with IBD treatment. Our data emphasize the importance of adjuvant pain management in IBD. References

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