Introduction

Ustekinumab (UST) is becoming widely used as a therapeutic option for Crohn's disease (CD) as a biologic agent with a novel mechanism of interleukin (IL)-12/23 inhibition, which is expected to have therapeutic effects on pathology involving factors other than tumor necrosis factor (TNF)-α. In this study, we investigated the effect of UST on skin lesions and the rate of subsequent continuous maintenance treatment of CD with skin lesions that appeared as a paradoxical reaction to TNF-α inhibitor (TNFi).

Aims & Methods

Fifty-four patients with CD who were introduced UST as 2nd or 3rd Bio at our hospital from June 2017 to September 2020 were retrospectively enrolled in the study. We defined treatment discontinuation as hospitalization, surgery, or treatment change due to CD exacerbation. The cumulative continuous maintenance dose rate was calculated by the Kaplan-Meier method.

Results

Of the 54 patients, 10 had skin lesions as a paradoxical reaction to the previous TNFi. Eight patients were males, and 2 were females. The median (interquartile range) values for each were: age, 35.4 (32.9–39.2) year-old; disease duration, 13.4 (6.4–18.1) years; Harvey-Bradshaw Index (HBI), 3 (1–5.5); CRP, 0.22 (0.04–0.38) mg/dL, Alb 3.95 (3.6–4.4) g/dL. Infliximab in 4 patients and adalimumab in 6 patients were used as the last TNFi. Of the 10 patients in the group with the paradoxical reaction, 4 (50%; 2 psoriasiform eruptions, 2 folliculitis, and 1 palmoplantar pustulosis) achieved complete response of skin lesions, 5 (50%; 2 psoriasiform eruptions and 2 exacerbations of atopic dermatitis) achieved partial response. After 1 year of UST induction, the cumulative continuous treatment rate was 56.3% in the group with no paradoxical reaction and 70% in the group with paradoxical reaction, and there was no statistical difference between the two groups (Log-rank; P = 0.349). A univariate Cox regression analysis also showed that the clinical history of skin paradoxical response was not associated with UST sustained efficacy (Table).

Conclusion

UST was highly effective in treating skin lesions as a paradoxical reaction to TNFi (90% partial or complete response). The cumulative continuous treatment rate after induction of UST was comparable to that of the group without paradoxical skin reaction, indicating that UST is useful for treating CD with paradoxical skin reaction to TNFi.

Disclosure

The authors declare no conflicts of interest associated with this manuscript.

Introduction

Colon Capsule Endoscopy (CCE) offers a non-invasive alternative to colonoscopy for lower gastrointestinal (GI) investigations. However, its adoption is limited by lengthy reading times, reader fatigue, and variable diagnostic accuracy. These factors are often influenced by bowel preparation quality and completion rates. Artificial intelligence (AI) has shown the potential to improve diagnostic accuracy of polyp detection and reduce reading times in capsule endoscopy.

Aims & Methods

Objective(s): The primary aim is to assess the diagnostic accuracy of Computer-Aided Detection (CADe) system (AiSPEED™) assisted CCE reading using full-video analysis in a real-world clinical setting. Secondary outcome was to assess a) non-inferiority compared to standard clinician reading in detecting polypoid lesions and b) mean reading time.
Methods: CESCAIL study is a multi-centre study of 14 UK centres recruited 720 participants between November 2021 and September 2024. Participants (prospectively and retrospectively enrolled ) included those ≥18 years referred for CCE under the urgent cancer pathway or for post-polypectomy surveillance. CCEs were performed using PillCam™ COLON 2 and analysed using AiSPEED™. CCE videos were evaluated by separate clinicians who provided standard readings, while AI-assisted reading included an AI-assisted pre-reader review and subsequent clinician validation.

Results

720 patients were enrolled, with 673 included in the final analysis. The capsule excretion rate before battery depletion was 77.1%, with adequate bowel preparation achieved at 78.1% (with standard) and 74.0% (with AI-assisted reading) (McNemar p=0.108). In the per-patient analysis, the diagnostic yield for detecting polyps was 63.6% (428/673) for standard reading and 70.6% (475/673) for AI-assisted reading, using the expert panel as the reference standard. These findings confirmed both non-inferiority (p<0.001) and superiority (p<0.001) of the AI-assisted reading. The diagnostic accuracy for detecting polyps requiring follow-up procedure (flexible sigmoidoscopy/colonoscopy) was 0.96 (95% CI: 0.95–0.98) for AI-assisted reading, compared to 0.91 (95% CI: 0.89–0.93) for standard reading (p<0.0001) (see Table 1). The mean reading time per video was 8.7 minutes for AI-assisted reading compared to 47.3 minutes for standard reading, representing a 5.4-fold reduction.

Conclusion

AI-assisted reading with AiSPEED™ offers the potential for greater accuracy in polyp detection and significantly reduced clinician reading times during CCE examination compared to standard reading methods.

References

1. Moen S, Vuik FER, Kuipers EJ, Spaander MCW. Artificial Intelligence in Colon Capsule Endoscopy-A Systematic Review. Diagnostics (Basel). 2022;12(8).
2. Mota J, Joao Almeida M, Mendes F, Martins M, Ribeiro T, Afonso J, et al. A Comprehensive Review of Artificial Intelligence and Colon Capsule Endoscopy: Opportunities and Challenges. Diagnostics (Basel). 2024;14(18).
3. Spada C, Piccirelli S, Hassan C, Ferrari C, Toth E, Gonzalez-Suarez B, et al. AI-assisted capsule endoscopy reading in suspected small bowel bleeding: a multicentre prospective study. Lancet Digit Health. 2024;6(5):e345-e53.
4. Spada C, Hassan C, Galmiche JP, Neuhaus H, Dumonceau JM, Adler S, et al. Colon capsule endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2012;44(5):527-36.
5. PillCam COLON 2 for investigation of the colon through direct visualisation [Internet]. NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. August 2024. Available from: https://www.nice.org.uk/guidance/gid-dg10083/documents/final-scope-2.

Disclosure

Hagen Wenzek serves as the CEO, and Elizabeth White is the Project Manager at Corporate Health International which owns the ​intellectual property of AiSPEED^TM

Introduction

Among patients with functional gastrointestinal disorders (FGID), food intake is often identified as a symptom trigger. Common foods known to cause gastrointestinal (GI) symptoms include fatty foods (1) and fermentable carbohydrates (FODMAPs) (2), but the evidence is limited and may vary among different FGID.

Aims & Methods

The aim of this study was to explore if certain foods are considered more tolerable, and which specific foods are identified as triggers of GI symptoms among participants with irritable bowel syndrome (IBS) and functional dyspepsia (FD). An online survey was conducted including n=537 participants from the Swedish general population with symptoms compatible with a functional bowel disorder. The survey included questions on demographics and an adapted food frequency questionnaire that assessed intakes of 38 different food items or aggregated food groups. For each food, participants had to answer whether or not they considered the specific food to be a trigger for GI symptoms.

Results

Among the respondents, a total of 220 participants with IBS and/or FD (mean age 34.7 years, body mass index 26.8 kg/m², women: 78.2%) were included in the analyses, of whom n=128 fulfilled criteria for FD and n=136 for IBS. Foods that were least commonly reported to cause GI symptoms included hard bread, fish and shellfish, berries, nuts, and seeds (Figure). The most frequently reported food triggers included pizza, crisps, confectionery, candy, ice cream, white bread, dairy, french fries, pie, and sausages. White bread, more often than whole grain bread, was reported to cause GI symptoms. Most vegetables and fruits were well tolerated in FD. A few FODMAP-rich vegetables, such as onion, garlic, beans, lentils, cauliflower and cabbage were more often reported as food triggers in IBS compared with FD. Having overlapping IBS and FD increased the prevalence of foods that were considered to cause symptoms.

Conclusion

In individuals with IBS and/or FD, foods traditionally associated with a healthy dietary pattern were less commonly reported to cause GI symptoms, whereas foods associated with western food/junk food were more commonly reported to cause GI symptoms. Promoting healthy food choices seem compatible with dietary treatment of patients with IBS and FD.

References

1, Feinle-Bisset C, Azpiroz F. Dietary and lifestyle factors in functional dyspepsia. Nature reviews Gastroenterology & hepatology. 2013 Mar;10(3):150-7.
2. van Lanen AS, de Bree A, Greyling A. Efficacy of a low-FODMAP diet in adult irritable bowel syndrome: a systematic review and meta-analysis. European journal of nutrition. 2021 Sep;60:3505-22.

Introduction

Many irritable bowel syndrome (IBS) patients report gastrointestinal (GI) symptoms due to various foods, resulting in food avoidance. However, a detailed description of trigger foods and related GI symptoms and avoidance behaviour is lacking. Therefore, we evaluated the extent and nature of food intolerance and avoidance in IBS patients, and its relation to GI symptoms and psychological comorbidities.

Aims & Methods

Food intolerance and avoidance behaviour were evaluated in 124 IBS patients and 113 healthy controls (HC) using a questionnaire with 257 food products of 13 food groups. Per product, participants were asked if they experience symptoms (i.e. nausea, constipation, diarrhoea, bloating, abdominal pain) after consumption, and if they consumed this product despite these symptoms. Furthermore, IBS symptom severity and psychological factors were assessed.

Results

IBS patients reported a higher number of food products with perceived intolerance than HC (median of 18.0 (25^th-75^th percentile 10.0-33.5) vs 1.0 (0.0-8.0), p<0.001). A wide variety of trigger foods was reported, with gas-producing foods and fatty/cream-based dairy products most frequently reported by both groups. Predominant symptoms were abdominal pain and bloating. The number of avoided foods was higher in IBS (15.0 (8.0-27.0) vs 1.0 (0.0-7.0), p<0.001). Food avoidance was not significantly related to symptom type, but was associated with an IBS diagnosis, female sex, and higher screening scores for somatisation and Avoidant/Restrictive Food Intake Disorder.

Conclusion

Self-reported food intolerance and avoidance is higher in IBS than HC, with a wide variety of trigger foods. Food avoidance was significantly related to psychological factors, but not to symptom type. This warrants individual dietary guidance, as well as attention for psychological factors.

Disclosure

D Keszthelyi: DK reports receiving research funding from ZonMw, MLDS, UEG, Rome Foundation, Horizon Europe, Horizon 2020, Grunenthal, Allergan and speaker’s fee from Dr Falk (paid to host institute).
DMAE Jonkers: DMAEJ reports receiving a public–private partnership grant of TKI Well on Wheat? and TKI grants from Agri & Food and Health Holland, the Carbokinetics programme as part of the Netherlands Organisation for Scientific Research–Carbohydrate Competence Center partnership, Organic A2BV/Mothersfinest, and Horizon 2020.

Introduction

Biologic therapies are associated with an increased risk for adverse events such as infections and malignancies. This is of particular importance in elderly patients with inflammatory bowel disease (IBD).

Aims & Methods

The aim of this study was to compare the efficacy and safety of different biologic therapies between IBD patients aged over 60 years and younger patients.All adult patients with IBD treated with biologic agents from 2010 to 2022 in the sole tertiary referral center for inflammatory bowel disease in central Greece were screened for eligibility and their electronic medical records were retrospectively reviewed. Data collected included the socio-demographic and clinical characteristics of the study population, endoscopy reports as well as information regarding treatment compliance and drug sustainability. Adverse events (AEs) and serious AEs were also recorded. Patients with incomplete information were excluded from the analysis.

Results

267 IBD patients were screened for eligibility and 187 were included. The majority (65%) of the patients had Crohn's disease. Of all patients, 47.8% received infliximab, 18% adalimumab, 18% vedolizumab, and 16% ustekinumab. The median duration of biologic treatments was 10 years. Parallel steroid therapy was required in 70% at baseline, 35% at 3 months, 18 % at 6 months, and 5% at 12 months from treatment onset. The efficacy of biologic therapies did not differ significantly between patients aged > 60 years and younger patients. Kaplan-Meyer analysis did not show statistical differences or trends in drug sustainability (P > 0.05), time to an adverse event (P >0.05), and infection rates (P >0.05) among the different classes of biologic agents compared. The most common AEs leading to drug discontinuation were loss of response and local injection site reactions. After adjusting for differences in baseline characteristics between the two age groups, no significant differences in drug sustainability and the need for treatment optimization were found between elderly and younger patients (p >0.05).

Conclusion

Available biologic therapies were characterized by comparable efficacy, sustainability, and safety among elder and younger patients, hardening the preferential selection among the available biologic agents for the elderly. More real-world evidence is required to make treatment recommendations.

References

1. de Silva S, Devlin S, Panaccione R. Optimizing the safety of biologic therapy for IBD. Nat Rev Gastroenterol Hepatol. 2010 Feb;7(2):93-101. doi: 10.1038/nrgastro.2009.221. PMID: 20134491.
2. Lasa JS, Olivera PA, Danese S, Peyrin-Biroulet L. Efficacy and safety of biologics and small molecule drugs for patients with moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):161-170. doi: 10.1016/S2468-1253(21)00377-0. Epub 2021 Nov 29. PMID: 34856198.