Exabis Library

Inflammatory bowel disease (IBD) increases colorectal cancer risk. To mitigate this patients undergo endoscopic surveillance to detect dysplasia. However, chronic inflammation alters mucosal and vascular colonic architecture, complicating lesion recognition. Endoscopic advances enhance our ability to accurately characterise these lesions. But training on optical diagnosis of dysplastic lesions in IBD is not widely available. We aim to fill this gap by developing and validating the new OPTIC-IBD online training platform (Figure 1, NCT04924543, funding GutsUK TRN2019-03).

We designed an interactive, self-directed, multi-modality learning module. This includes surveillance principles, optical diagnosis methods, characterisation approach, classifications (SCENIC, Kudo, FACILE¹), examples and self-assessments. We invited participants from Canada, Italy and the UK, including novice (<100 lifetime colonoscopies), intermediate and experienced endoscopists (≥1000). Assessments comprised 24 short endoscopic videos of IBD colonic lesions, divided into 8 non-dysplastic (hyperplastic, inflammatory, sessile serrated lesion [SSL]) and 16 dysplastic lesions (SSL-D, low grade and high grade dysplasia, cancer). Participants classified lesions, predicted histology and rated their confidence. All participants completed online training and feedback. The videos were repeated in a random order after ≥7 days. Participants were then randomised 1:1 to get feedback and extra training. All had a final assessment at 60 days with prior/new videos and similar case mix. We report diagnostic performance for dysplasia, interrater reliability and rater confidence.

We present a planned interim analysis of 77 participants after pre- and post-course assessments (Table 1). Diagnostic accuracy improved (primary endpoint: 44.5 to 54.0%, P<0.0001), particularly for novice and intermediate endoscopists. Sensitivity for dysplasia increased (50.3 to 59.1%) in line with prior experience. Specificity and accuracy were most improved for high confidence diagnoses (44.9 to 70.3% and 55.0 to 64.6%). In multilevel logistic regression, training was associated with correct diagnoses for high confidence (OR 1.40, 1.13-1.77) but not low confidence ratings (OR 1.09, 0.96-1.25). Training improved precision between participants (Table 2) and their confidence (Table 3).

The OPTIC-IBD training module improved participants’ accuracy, precision and confidence in optical diagnosis of dysplasia. Next, we will study the training approaches and classification systems that can best be adopted by non-experts and trainees. Our refined training platform will be made available to improve quality of endoscopic care for people with IBD.

1. Iacucci et al Endoscopy 2019;51(2):133

Vasculitis are a group of rare and potentially life-threatening diseases which are usually classified by the size of the vessels predominantly affected. 
Vasculitis may rarely co-exist with IBD (both UC and CD) as an extra-intestinal manifestation or in association.
There are few small case series and literature reviews in the literature on vasculitis in IBD.

Learning Objectives:
- Definition of vasculitis and how are they classified
- Association between IBD and vasculitis
- Which types are more associated with CD and UC
- Histological features of vasculitis

Pouchitis is a common complication of ileal pouch-anal anastomosis (IPAA) after proctocolectomy in ulcerative colitis (UC). There are currently no approved therapies for chronic pouchitis. Here, we report a multicentre trial of intravenous (IV) vedolizumab (VDZ) for chronic pouchitis after IPAA in patients with UC.

EARNEST was a randomised, double-blind, placebo (PBO)-controlled, phase 4 study of VDZ in patients aged 18-80 years with chronic pouchitis after proctocolectomy with IPAA for UC (NCT02790138). Male and female patients with a history of IPAA for UC and chronic pouchitis were eligible. Patients were randomised (1:1) to receive VDZ IV (300 mg) or PBO on Day 1 and at Weeks (W) 2, 6, 14, 22 and 30, as well as ciprofloxacin for the first 4 weeks. The primary endpoint was modified Pouchitis Disease Activity Index (mPDAI) remission at W14; efficacy was also assessed through other mPDAI/PDAI secondary endpoints and endoscopic exploratory endpoints (assessed by a central reviewer) at W14 and W34. Safety (adverse events [AEs]) was monitored throughout the study.

In total, 102 patients were treated (51 per group). Patients had a mean age of 40.8 years (VDZ) and 42.9 years (PBO). mPDAI remission rates (comprising clinical symptoms and endoscopy domains) were 31.4% (n=16/51) for VDZ vs 9.8% (n=5/51) for PBO at W14 (p=0.013; Figure 1). Significant differences in favour of VDZ over PBO were also seen in mPDAI remission at W34, mPDAI response at W14 and W34, and PDAI remission (comprising clinical symptoms, endoscopy and histology domains) at W14 and W34 (Figure 1). The rate of sustained remission (defined as remission at both W14 and W34) was higher for VDZ vs PBO on both the mPDAI (VDZ 27.5% [n=14/51] vs PBO 5.9% [n=3/51]; difference 21.6 percentage points [95% confidence interval (CI), 6.5-37.0]) and the PDAI (VDZ 31.4% [n=16/51] vs PBO 7.8% [4/51]; difference 23.5 percentage points [95% CI, 8.0-38.8]). Endoscopic ulceration analysis showed greater reductions in number of ulcers from baseline for VDZ over PBO at W14 and W34 (Figure 2). A higher proportion of patients in the VDZ vs PBO group had an improved SES-CD score and achieved SES-CD remission of pouchitis (Figure 2). AE rates were similar between groups and no new safety signals were identified (Table).

This is the first and largest randomised, double-blind PBO-controlled trial of biologic therapy to show significant benefits across multiple treatment outcomes in patients with chronic pouchitis after IPAA for UC. VDZ showed consistent treatment benefits over PBO across clinical, endoscopic and histologic endpoints, together with safety consistent with its established profile.