BackgroundSequential drug treatment with biological agents in ulcerative colitis (UC) is becoming increasingly complex. There are few studies comparing head-to-head outcomes in second-line treatments. The study assesses whether using anti-tumour necrosis factor (anti-TNF)-α therapy following the α4β7 integrin blocker vedolizumab (VDZ) or VDZ after an anti-TNF has more favourable clinical outcomes in UC in a real-world outpatient setting.MethodsPatients with UC who were exposed to first-line anti-TNF (adalimumab or infliximab) or VDZ who subsequently switched to the alternate class between May 2013 and August 2020 were identified by reviewing patient databases at 10 hospitals. Data were collected retrospectively using patient records. Baseline demographics, disease activity indices, biochemical markers, endoscopic Mayo score, colectomy rates, treatment persistence and urgent hospital utilisation composite endpoint (UHUC) rates were examined over a 52-week period.ResultsSecond-line week 52 treatment persistence was higher in the VDZ group (71/81, 89%) versus the anti-TNF group (15/34, 44%; p=0.0001), as were week 52 colectomy-free survival (VDZ: 77/80, 96%, vs anti-TNF: 26/32, 81%; p=0.009), week 52 UHUC survival (VDZ: 68/84, 81%, vs anti-TNF: 20/34, 59%; p=0.002) and week 52 corticosteroid-free clinical remission (CFCR) rates (VDZ: 22/34, 65%, vs anti-TNF: 4/20, 20%; p=0.001).ConclusionCompared with second-line anti TNF usage, the VDZ second-line cohort had significantly higher 52-week treatment persistence, UHUC survival, higher colectomy-free survival rates and higher week 52 CFCR. These data suggest that VDZ is an effective biologic in UC as a second-line therapy after anti-TNF exposure. It highlights the effect of biological order on clinically important outcomes.

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BackgroundCOVID-19 has severely affected UK endoscopy services with an estimate 86% loss of activity during the first wave. Subsequent delays in diagnostic and surveillance procedures highlight the need for novel solutions to tackle the resultant backlog. Transnasal endoscopy (TNE) provides an attractive option compared with conventional upper gastrointestinal endoscopy given its limited use of space, no sedation and reduced nursing resources.Our experienceWe describe piloting and then establishing an outpatient model TNE service in the pandemic era and the implications on resource allocation, training and workforce. We also discuss our experiences and outline ways in which services can evolve to undertake more complex endoscopic diagnostic and therapeutic work. Over 90% of patients describe no discomfort and those who have previously experienced conventional transoral endoscopy preferred the transnasal approach. We describe a low complication rate (0.8%) comprising two episodes of mild epistaxis. The average procedure duration was reasonable (9.9±5.0 min) with full adherence to Joint Advisory Group quality standards. All biopsies assessed were deemed sufficient for diagnosis including those for surveillance procedures.DiscussionTNE can offer a safe, tolerable, high-quality service outside of a conventional endoscopy setting. Expanding procedural capacity without impacting on the current endoscopy footprint has great potential in recovering endoscopy services following the COVID-19 pandemic. Looking forward, TNE has potential to be used both within the endoscopy suite as part of therapeutic procedures, or outside of the endoscopy unit in outpatient clinics, community hospitals, or mobile units and to achieve this in a more sustainable and environmentally friendly way.

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Background Vedolizumab, a gut-selective monoclonal antibody targeting α4β7-integrin, was recently licenced as a subcutaneous (SC) preparation after demonstrating efficacy compared to placebo at maintaining remission in IBD patients who had a clinical response to intravenous (IV) induction therapy. We aimed to assess real-world experience of switching patients to SC administration. Methods Patients across 10 UK centres who had completed induction with IV vedolizumab were offered SC therapy. Demographic data and baseline disease characteristics (disease type and behaviour, medication history) were collected, alongside biochemical markers (C-reactive protein, faecal calprotectin), disease activity scores (SCCAI, partial Mayo or modified Harvey Bradshaw Index) and quality of life scores (IBD-Control-8) at baseline (defined as the first dose of SC medication), 8 and 24. Data was also collected on drug persistence, hospital admissions, steroid use and reported adverse events. Results 351 patients were switched to SC dosing. All had data collected for weeks 0 and 8 and 164 had data at week 24. There were no statistically significant differences in biochemical markers, disease activity scores or quality of life at weeks 0, 8 or 24, nor were there statistically significant differences in rates of biochemical remission or clinical remission. Subcutaneous vedolizumab persistence at week 24 was 86% (141/164), with discontinuation due to disease activity (n=9), adverse events (n=11), non-compliance (n=2) and pregnancy (n=1). Of the 23 who discontinued SC, 12 switched back to IV (4 of whom at an escalated dose), 4 changed to another biologic and 7 stopped/paused biologic therapy. Within the 24-week study period, 7.9% (n=13) required steroids, 2.4% (n=4) had an IBD-related hospital admission and 8.5% (n=14) experienced an adverse reaction of which 7 were injection site-related. One patient experienced an anaphylactoid reaction upon restarting IV vedolizumab. There were no statistically significant associations between baseline characteristics (including clinical or biochemical markers, duration of vedolizumab use or prior ant-TNF exposure) and week 32 outcomes. Conclusion Switching from IV to SC vedolizumab appears to maintain rates of remission with no significant changes in biochemical markers, clinical scores or quality of life, with SC administration persistence of 86% at week 24. Further long-term data on safety is required.