Abstract Background Tofacitinib (TOF) is an effective treatment for ulcerative colitis (UC). A relationship between dose and both response and side-effect profile is recognised for JAK inhibitors. Dose reduction from 10mg bd to 5mg bd is therefore associated with improved safety but also with a risk of relapse. The BRITE study aimed to identify clinical predictors and biomarkers of relapse in a cohort of patients with stable UC undergoing TOF dose reduction. Methods Steroid-free patients with stable UC responding to TOF 10mg bd for at least 8 weeks were followed from dose reduction to time of relapse or for one year. Relapse was defined by worsening modified Mayo score, including an increase in the rectal bleeding and endoscopic subscores of ≥ 1 point. Clinical and endoscopic assessment with biopsy was performed prior to dose reduction (baseline) and at end of trial. PBMCs were isolated at baseline and were cryopreserved. Flow cytometry analysis of phospho-STAT levels of STAT1, STAT3, STAT4 and STAT5 was performed in T cells from unstimulated and cytokine-stimulated baseline PBMC. In addition, CD4 T cells were isolated from PBMC and were stimulated with plate-bound anti-CD3 and anti-CD28 (TCR activation) for 5 days; cell supernatants were analysed for 17 CD4 T-helper (Th) cell effector cytokines using a 17-cytokine Luminex assay. Results 50 patients were enrolled across 3 centres; baseline characteristics are displayed in table 1. 23 (46%) patients relapsed after a median duration of 23 weeks (IQR 9-45). Demographics, disease duration, prior advanced therapy exposure (including duration on TOF), and baseline clinical, biochemical (calprotectin/CRP), and histo-endoscopic disease severity were not associated with risk of relapse. In contrast, molecular differences in CD4 T-cell function were identified in relapsers and non-relapsers. pSTAT5 levels were significantly induced by IFNa in relapse patients (p<0.05), but not in remission patients (Fig 1a), while canonical pSTAT5 activation by IL2 showed no significant differences between the two cohorts of patients. Furthermore, TCR activation of baseline CD4 T cells showed significantly higher expression of IL10 (p=0.01) in remission patients compared to relapse (Fig 1b). Higher levels of resting pSTAT1High expression that was refractory to IFNa stimulation in relapse patients but inducible in remission patients was also identified (p=<0.01). Conclusion In this large prospective study of TOF dose reduction, in contrast to previous studies, no baseline clinical or endoscopic predictors of relapse were found. However, potentially clinically useful association with markers of T cell activation were identified and should be investigated further.

Abstract Background Data on outcomes following de-escalation of dose-intensified ustekinumab (UST) in Crohn’s disease (CD) have not been reported. This retrospective cohort study aimed to evaluate the failure rates 6, 12, and 24 months after de-escalation from dose-intensified UST to standard dose UST and identify predictors of failure. Methods Single centre, retrospective study of consecutive CD patients undergoing de-escalation of dose-intensified UST (90mg 4-weekly) to standard dosing (90mg 8-weekly). De-escalation and post de-escalation decisions were informed by protocolised 6-monthly assessment using Harvey-Bradshaw Index, C-reactive protein (CRP), faecal calprotectin (FCP), drug level and intestinal ultrasound. Failure was defined by re-escalation of UST, corticosteroids, switch out of class, or IBD-related hospitalisation or surgery. Success was defined by continued standard UST dosing. Categorical variables were compared using Fisher-exact and continuous variables using Mann-Whitney U tests between groups. Results 14 patients underwent de-escalation from April 2020 to March 2023. The median age was 41 years, disease duration 15 years, and duration on dose-intensified UST 34 months. 43% received IV reinduction at time of escalation, 86% had previous exposure to advanced therapies, of which 43% were dose-intensified. 36% were on an immunomodulator (IMM) at de-escalation. In the 6 months prior to de-escalation, the median CRP was 3.5mg/L, FCP 96mg/g, and 91% were in sonographic remission. 5/14 (36%) failed de-escalation at 6 months and 9/14 (64%) failed by 12 months. Of those with 24 months follow up, 9/12 (75%) failed de-escalation. Median time to failure was 8 months (IQR 4.5-13). All patients who failed underwent re-escalation and 2 required surgery. UST drug levels reduced from 3.6 to 1.9mg/mL 6 months post de-escalation. Re-escalation successfully recaptured response in 7/9 (78%). A greater proportion of patients with successful de-escalation at 12 months received concomitant IMM compared to those that failed (80% vs. 11%, respectively; p = 0.02). There were no other significant differences in clinical or disease characteristics between those with failure vs. success at 6, 12, or 24 months, although numbers were small (Table 1). Conclusion One-third of patients failed de-escalation of dose-intensified UST at 6 months, two-thirds failed at 12 months and three-quarters by 24 months. Patients considered for a trial of de-escalation need close, objective monitoring as most failure occurs early, and re-escalation is successful in the majority. Concomitant IMM may reduce failure rates and should be considered. Further studies are required to confirm these findings and identify additional predictors of de-escalation failure.

BACKGROUND:Therapeutic monitoring of infliximab is limited by the time lag between drug-level measurement and dose adjustment, along with the cost of dose escalation. Strategies for dose reduction in stable patients on maintenance infliximab at supratherapeutic levels are uncertain. This study determined the feasibility of a pharmacist-driven strategy for immediate dose adjustment using a sliding scale at the point of care in stable patients with inflammatory bowel disease on maintenance therapy. METHODS:Adult patients with stable disease undergoing maintenance therapy with infliximab infusions, 5 mg/kg every 8 weeks, were prospectively studied. Trough drug levels were assessed by a rapid assay (and later by ELISA) at all infusions for up to 12 months with immediate but quantitatively small dose adjustment according to a sliding scale targeting a therapeutic range of 3-7 mcg/mL. Disease activity was assessed both clinically and biochemically. RESULTS:The rapid assay and ELISA detected similar infliximab levels, and the strategy added approximately 30 minutes to the duration of infusion events. Only 20% of 48 patients (77% with Crohn disease) had baseline trough infliximab concentrations within the therapeutic range. This value increased 3-fold after 24 and 48 weeks of interventions. One in 2 patients had baseline supratherapeutic levels, and most were brought into the therapeutic range without a discernible impact on disease activity by 1 dose adjustment, but 2 or 3 adjustments were generally needed for 29% of patients with subtherapeutic levels. Overall, drug costs were reduced by 4%. CONCLUSIONS:Immediate dose adjustment after infliximab rapid assay performed by a pharmacist using a sliding scale is a feasible strategy. Supratherapeutic infliximab levels can be safely and quickly brought into the therapeutic range using small dose adjustments without affecting disease activity, offsetting (at least partly) costs associated with dose escalation.

Objective:Intestinal ultrasound (IUS) is an inexpensive, non-invasive method of diagnosing and monitoring inflammatory bowel disease (IBD). We aimed to establish the proportion of lower gastrointestinal endoscopies (LGIEs) and magnetic resonance enterographies (MREs) that could have been performed as IUS, the potential pathology miss-rates if IUS was used and the associated cost savings.Methods:All MREs and LGIEs performed for either assessment of IBD activity or investigation of possible IBD, performed at a single UK tertiary centre in January 2018, were retrospectively reviewed against predetermined criteria for IUS suitability. Case outcomes were recorded and cost of investigation if IUS was performed instead was calculated.Results:73 of 260 LGIEs (28.1%) and 58 of 105 MREs (55.2%) met the criteria for IUS suitability. Among potential IUS-suitable endoscopy patients, one case each of a <5 mm adenoma and sessile serrated lesion were found; no other significant pathology that would be expected to be missed with IUS was encountered. Among IUS-suitable MRE patients, no cases of isolated upper gastrointestinal inflammation likely to be missed by IUS were found, and extraintestinal findings not expected to be seen on IUS were of limited clinical significance. The predicted cost saving over 1 month if IUS was used instead was £8642, £25 866 and £5437 for MRE, colonoscopy and flexible sigmoidoscopy patients, respectively.Conclusion:There is a significant role for IUS, with annual projected cost savings of up to almost £500 000 at our centre. Non-inflammatory or non-gastrointestinal pathology predicted to be missed in this cohort was of limited clinical significance.

Summary Background Low‐quality evidence suggests that pre‐operative exclusive enteral nutrition (E/EN) can improve postoperative outcomes in patients with Crohn's disease (CD). It is not standard practice in most centres. Aims To test the hypothesis that pre‐operative EN in patients undergoing ileal/ileocolonic surgery for CD is associated with improved postoperative outcome. Methods We performed a single centre retrospective observational study comparing surgical outcomes in patients receiving pre‐operative EN (≥600 kcal/day for ≥2 weeks) with those who received no nutritional optimisation. Consecutive adult patients undergoing ileal/ileocolonic resection from 2008 to 2020 were included. The primary outcome was postoperative complications <30 days. Secondary outcomes included EN tolerance, specific surgical complications, unplanned stoma formation, length of stay, length of bowel resected, readmission and biochemical/anthropometric changes. Results 300 surgeries were included comprising 96 without nutritional optimisation and 204 optimised cases: oral EN n = 173, additional PN n = 31 (4 of whom had received nasogastric/nasojejunal EN). 142/204 (69.6%) tolerated EN. 125/204 (61.3%) initiated EN in clinic. Patients in the optimised cohort were younger at operation and diagnosis, with an increased frequency of penetrating disease and exposure to antibiotics or biologics, and were more likely to undergo laparoscopic surgery. The optimised cohort had favourable outcomes on multivariate analysis: all complications [OR 0.29; 0.15–0.57, p < 0.001], surgical complications [OR 0.41; 95% CI 0.20–0.87, p = 0.02], non‐surgical complications [OR 0.24 95% CI 0.11–0.52, p < 0.001], infective complications [OR 0.32; 95% CI 0.16–0.66, p = 0.001]. Conclusions Oral EN was reasonably well tolerated and associated with a reduction in 30‐day postoperative complications. Randomised controlled trials are required to confirm these findings.

BACKGROUND AND AIMS:Metastatic Crohn's disease is an extraintestinal cutaneous manifestation characterised by non-specific inflammatory lesions anatomically separate from the gut; genital involvement is rare. We conducted a systematic review of anogenital Crohn's disease and granulomatosis, to provide a synthesis of epidemiology, clinical features, and treatment outcomes. METHODS:A systematic search of the literature was conducted via MEDLINE, EMBASE, and the Cochrane database from inception to December 1, 2020. Two investigators extracted and analysed study data. Response and remission were defined as partial improvement or complete resolution of symptoms and examination findings, respectively. RESULTS:Of 9381 screened studies, 185 articles, [410 cases: 273 female, 137 male] were included. The predominant clinical features were oedema, ulcers, fissures, and hypertrophic lesions. Adults and children present similarly. Luminal Crohn's disease was diagnosed in nearly 80% of cases including 45-80% patients without gastrointestinal symptoms (time to inflammatory bowel disease [IBD] from anogenital Crohn's disease diagnosis [range] -43 to 11 years). Antibiotics, corticosteroids, thiopurines, and anti-tumour necrosis factor [TNF] therapy were the most frequently prescribed agents. At final follow-up, non-response, response, and remission rates were 37/304 [12%], 267/304 [88%], and 114/304 [38%], respectively. Oedema was associated with a poor response to topical therapy. Greater response rates to anti-TNF therapy were seen in patients prescribed concomitant immunomodulation [24/25, 96% vs 67/90, 74%, p = 0.02]. CONCLUSIONS:We provide an illustrative summary of the clinical presentation and treatment effectiveness of this rare, under-recognised condition, and a proposed algorithm for approach and management. Prospective studies with longer follow-up are required to define optimal treatment strategies.

There is limited evidence to guide successful treatment of recurrent Campylobacter infection in patients with common variable immunodeficiency (CVID) already managed on regular immunoglobulin therapy. The role of faecal microbiota transplant (FMT) is uncertain. We report a case of recurrent Campylobacter jejuni infection in a patient with CVID treated with repeated FMT with 18 months of symptom resolution prior to relapse.

A 70-year-old woman with metastatic squamous cell carcinoma of the lung was admitted to hospital in September 2020 with a 3-week history of generalised abdominal pain and postprandial vomiting. She had been diagnosed with squamous cell carcinoma of the lung with a programmed death ligand-1 expression of 90% and only small-volume lung metastases in February 2019. She was soon after commenced on first-line pembrolizumab, a monoclonal antibody targeting programmed cell death protein 1 (PD- 1), which led to a reduction in the size of both primary tumour and metastatic lung nodules. Medical history was significant for dyspepsia diagnosed several years prior and treated with long-term omeprazole 40 mg once a day, chronic obstructive pulmonary disease, ischaemic heart disease and type 2 diabetes. She had no history of non-steroidal …

Abstract Background Gastrointestinal ultrasound (GIUS) is a non-invasive imaging modality capable of detecting intestinal inflammation & associated complications. It has comparable sensitivity & specificity to magnetic resonance enterography (MRE) in detecting ileocolonic disease, however it is less expensive (£24 vs £180) & can be performed at point of care. We aimed to establish the proportion of MREs that could have been performed as GIUS at a tertiary inflammatory bowel disease (IBD) unit, the potential cost savings, & the predicted pathology miss-rates. Methods All MREs performed in January 2018 were retrospectively reviewed. Demographics, scan indication, IBD characteristics, surgical history, & gastrointestinal & non-gastrointestinal findings were collected. Indications deemed suitable for GIUS included: assessment of disease activity of known small bowel (SB) Crohn’s disease; first assessment for presence of SB disease in IBD; & investigation for SB disease in patients without a known diagnosis of IBD. Obesity, complicated surgical history (>1 resection or strictureplasty involving different segments, or stoma), & known proximal SB disease were deemed unsuitable. Results 105 MREs were performed in January 2018. 59 (56%) were deemed suitable for GIUS instead of MRE. Most common reasons for unsuitability included complex surgical history (n=17, 37%), obesity (n=14, 30%), non-appropriate indication (n=12, 26%) & known upper gastrointestinal disease (n=10, 22%). Of suitable cases, 32/59 (54%) had active inflammation detected including 17 (53%) isolated ileal, 8 (25%) ileocolonic, & 6 (19%) isolated colonic. In one case performed as first assessment for SB disease, both ileal & jejunal disease were found, the latter likely to be missed with GIUS. No cases of isolated upper gastrointestinal inflammation were found. Regarding non-gastrointestinal findings in potential GIUS patients, there were two cases of pancreatic cysts necessitating further investigation with serial MRIs & endoscopic ultrasound, yielding a side branch intraductal papillary mucinous neoplasm & a benign serous cyst adenoma. One case of multiple high T2 skeletal lesions was deemed clinically insignificant following further investigations. No other significant extra-intestinal findings not expected to be seen on GIUS were identified. Conclusion Over 50% of MREs could have been performed as GIUS instead, with a potential annual cost saving of over £110,000. No instances of inflammation would have been missed based on distribution, although in one case the full extent of disease may not have been identified on GIUS. Incidental non-gastrointestinal findings resulted in multiple investigations but were of limited clinical significance.

Summary Background Biologics account for a significant cost in inflammatory bowel disease (IBD) management; however, switching from infliximab originator to its biosimilars has enabled cost saving without compromising disease control. The effects on IBD activity and infliximab trough levels of a second switch to another biosimilar are, however, uncertain. Aims To assess the effects on disease activity and infliximab trough levels associated with switching from infliximab biosimilar CT‐P13 to another biosimilar SB2 and compare outcomes in those switching for the first and second time. Methods IBD patients on CT‐P13, including some previously switched from originator, were prospectively followed during a switch to SB2. C‐reactive protein (CRP), trough infliximab level and clinical disease activity indices were collected at baseline, Infusion 3 or 4 (‘early’ after switch), and 1 year. Results One hundred eighty‐six patients (n = 99 second switch) on stable infliximab dosing underwent switching. Compared with baseline, there was no significant change in CRP, clinical disease activity scores or median trough infliximab level at the early time point among first‐switch (baseline vs early: 5.7 vs 6.6 µg/mL, P = 0.05) and second‐switch (4.3 vs 4.9 µg/mL, P = 0.07) patients nor at 1 year (median infliximab trough levels, baseline vs 1 year, in first‐switch [5.7 vs 5.7 µg/mL, P = 0.37] and second‐switch [4.3 vs 4.7 µg/mL, P = 0.06] patients). The proportion of patients in clinical remission did not significantly change at the early (92% vs 91% at baseline, P = 0.75) or 1 year (95% vs 91% at baseline, P = 0.16) time points. There was no significant difference in time to loss of response between patients switching for the first or second time ( P = 0.69). Conclusions Switching from one infliximab biosimilar to another had no adverse impact on infliximab trough levels, and clinical and biochemical disease activity, regardless of whether switching for the first or second time.

Introduction Limited data exist on the safety of fundoplication surgery in patients with oesophageal aperistalsis, with some considering it a contraindication due to risk of dysphagia. We aimed to assess rates & predictors of dysphagia in such patients who underwent fundoplication. Methods Patients with oesophageal aperistalsis based on the Chicago classification v3.0 who underwent fundoplication for confirmed symptomatic reflux were identified at a single centre. Pre-operative high-resolution manometries (HRM) were reviewed, with standard parameters as well as presence of contractile reserve (peristalsis with distal contractile integral (DCI) >100) following multiple water swallows (MWS), solids, or saliva recorded. Patients were excluded if they had an alternate manometric diagnosis, incomplete HRM, or anti-reflux surgery pre-HRM. The hospital odynophagia & dysphagia questionnaire (HODQ) was performed post-operatively. HODQ>6 was considered abnormal. Results 17 patients (7 male, median [IQR] age at surgery 53y [38.5-66.5]) with a median time to post-operative scoring of 34 (18-52) months were included; 13 (76%) had a normal post-operative HODQ. Complete fundoplication was performed in 12 patients, of which 2 (17%) had an abnormal HODQ. There was no significant difference in demographics, type of surgery, or pre-operative HRM parameters between those with a normal vs. abnormal post-operative HODQ (Table 1). Of those with an abnormal post-operative HODQ, 50% had pre-operative dysphagia & all were managed conservatively. There was no correlation between HODQ & maximum DCI achieved with solid or saliva swallows, nor overall number of swallows with DCI >100. Conclusion The majority (76%) of patients with oesophageal aperistalsis did not have dysphagia post-operatively. There were no clinical or HRM predictors of dysphagia, however this was limited by the small numbers who had post-operative dysphagia.

Abstract Background and Aim Patients with chronic diseases are believed to be at increased risk of mental health conditions during the COVID‐19 pandemic. We aimed to assess the incidence of psychological morbidity in inflammatory bowel disease (IBD) patients during the COVID‐19 pandemic, explore for association with risk of severe COVID‐19 and other factors, and establish patients' interest in psychological support. Methods A survey including the Patient Health Questionnaire‐9, General Anxiety Disorder‐7, and Perceived Stress Scale tools for depression, anxiety, and stress was administered to IBD patients from a tertiary center in London, United Kingdom, in June 2020. Results Two hundred seventy‐four patients responded to the survey (57% response rate), with 271 (99%) completing it. Moderate–severe depression was observed in 61 (22.5%), while 49 (18%) had moderate–severe anxiety; 39 (14%) had both diagnoses. Mean (SD) stress score was 16.2 (7.4). There was no association between degree of severe COVID‐19 risk and psychological morbidity. Flare symptoms and fatigue were associated with worse psychological morbidity, while accessibility of information regarding COVID‐19 risk and reducing that risk was protective for depression (odds ratio [OR] 0.56 [0.33–0.94], P = 0.03), anxiety (OR 0.62 [0.4–0.96], P = 0.03), and stress (standardized β‐coefficient −0.15 [−0.28 to −0.03], P = 0.02). Seventy‐nine (30%) respondents were interested in receiving psychological support during the pandemic, while 200 (76%) expressed interest beyond the pandemic. Conclusions Although depression, anxiety, and stress among IBD patients during the pandemic were common, their frequency was similar to pre‐pandemic rates and recent general population levels. Ensuring easy access to personalized risk information with targeted psychological support may mitigate psychological burden as patients reintegrate into society and deal with future COVID‐19 waves.

It was predicted that the biological era might alter the natural history of Crohn’s disease, preventing the well-documented inflammation–fibrosis–fistulisation sequence. However, despite the development of novel biological therapies, average efficacy at 1 year remains at 30–50%, with this number decreasing as second-line therapies are regularly required. Currently, new advanced therapies are under investigation to provide alternatives to available treatments. In addition, novel, nonpharmacological strategies are also being explored. Surgical intervention, currently inevitable in a significant proportion of patients, necessitates that prevention of postoperative recurrence is an important research focus and recent studies have shed light on the long-term efficacy of early operative interventions and emerging surgical techniques. Cellular therapies, including stem cell therapy for perianal disease, stem cell transplantation, and harnessing the therapeutic potential of regulatory T cells, are in various stages of development. These could conceivably change the landscape of Crohn’s disease management. Dietetic interventions offer a lower risk alternative that may be used as an adjunct to other therapies or where immunosuppression is unfavourable. Choosing between these therapeutic options depends on multiple factors, including the associated risk–benefit profile, available alternatives, as well as patient preference. In practice, optimal management is guided by a multidisciplinary team where pharmacological, nonpharmacological, and surgical strategies can be simultaneously explored. This narrative review aims to provide an update on advanced therapies under investigation in clinical trials and offer insights into novel, nonpharmacological approaches with a focus on interventions entering late-phase trials that will be relevant to clinical practice in the near future.

Introduction Transabdominal intestinal ultrasound (IUS), best capable of detecting intestinal inflammation & associated complications proximal to the rectum, can potentially obviate the need for endoscopy in certain clinical scenarios. It is non-invasive, able to assess disease extent, can be performed at point-of-care enabling immediate therapeutic decisions, and, costing £24 at our centre, is also less expensive than both colonoscopy (£528) & flexible sigmoidoscopy (£395). We aimed to establish the proportion of lower gastrointestinal endoscopy cases in which IUS could have been used instead, the potential cost savings, & the predicted pathology miss-rates. Methods All colonoscopies & sigmoidoscopies performed at a single UK tertiary centre in January 2018 for either assessment of inflammatory bowel disease (IBD) activity or investigation of gastrointestinal symptoms (specifically diarrhoea, alternating diarrhoea or constipation, or abdominal pain) were retrospectively reviewed. Among patients being investigated for symptoms, only those aged <40 without: calprotectin >250µg/mg; CRP >5mg/L; anaemia; per rectal bleeding; or documented family history of colorectal cancer, were deemed IUS appropriate. Among IBD patients, need for dysplasia surveillance or stricture dilatation, consideration of treatment withdrawal, acute severe ulcerative colitis, isolated proctitis, or performance as part of a trial were features deemed inappropriate for IUS. In either indication, obesity (BMI>30) or complex surgical history were considered unsuitable for IUS. Results 260 endoscopies were performed for the specified indications, of which 73 (28.1%) met criteria to be performed as IUS instead (55 of 220 colonoscopies [25%] & 18 of 40 flexible sigmoidoscopies [45%]). By indication, 46 of 108 [42.6%] cases performed for IBD assessment & 27 of 152 [17.8%] for symptoms met criteria. Among potential IUS patients, one case each of adenoma (<5mm) & sessile serrated lesion (<5mm) were found; no other significant pathology that would be expected to be missed with IUS was encountered. Further, there were no cases of isolated proctitis found among IBD patients deemed suitable for IUS. In contrast, among IUS unsuitable patients, 4 malignancies, 19 cases of adenomatous polyps (6 cases of 5-10mm & 1 case of >10mm), & 8 new cases of IBD were diagnosed, supporting the proposed criteria. Conclusion Using conservative criteria, almost 30% of endoscopies for IBD assessment or symptoms could have been performed as IUS instead, with a potential annual cost saving of >£400,000. No cases of significant non-inflammatory pathology would have been missed with IUS using the proposed criteria.

Abstract Background Biological medicines are well established in the treatment of inflammatory bowel disease (IBD). The aim of this study was to review the natural history of biologic use in a large cohort of patients from a tertiary centre. Methods We performed a retrospective review of prospectively collected records of patients with Ulcerative colitis (UC) and Crohn’s disease (CD) from a single centre. All patients who received ustekinumab, golimumab and vedolizumab between April 2014 and May 2019 were included as were a similar sized cohort of patients who received adalimumab and infliximab. Demographic data, use of concomitant immunomodulation, length of time on drug and reason for stopping treatment were recorded. Results The patient cohort is described in Table 1. Median (range) follow-up was 32 (3–61) months. Infliximab and golimumab were used first line in 92 (94%) patients and 83 (87%) patients, respectively. Ustekinumab and vedolizumab were used later on in treatment with 38 patients receiving ustekinumab third line (47%) and vedolizumab being used second line in 52 patients (44%) and third line in 43 (37%) patients. Table 2 describes the reasons for biologic cessation. Other reasons for discontinuation included adverse drug reaction, pregnancy and patient choice. Concomitant immunomodulation at initiation of biologic was seen in 228 (79%) patients on TNF antagonists, 58 (50%) patients on vedolizumab and 44 (54%) patients on ustekinumab. Conclusion In CD, adalimumab and infliximab display a longer drug survival compared with ustekinumab and vedolizumab possibly due to treatment positioning. In UC, vedolizumab is associated with more treatment persistence than golimumab. Across all biologics, documented cessation due to remission was low, especially in those biologics that are used second or third line.

To quantify the effects of COVID‐19 on our inflammatory bowel disease (IBD) unit, including service provision, prescribing practices and use of therapeutic drug monitoring (TDM).

Background: Early or first-line treatment with biologics, as opposed to conventional immunomodulators, is not always necessary to achieve remission in Crohn's disease [CD] and may not be cost-effective. This study aimed to develop a simple model to predict the need for early biologic therapy, in order to risk-stratify CD patients and guide initial treatment selection. Methods: A model-building study using supervised statistical learning methods was conducted using a retrospective cohort across two tertiary centres. All biologic-naive CD patients who commenced an immunomodulator between January 1, 2004 and December 31, 2016, were included. A predictive score was derived using Cox regression modelling of immunomodulator failure, and was internally validated using bootstrap resampling. Results: Of 410 patients [median age 37 years, 47% male, median disease duration 4.7 years], 229 [56%] experienced immunomodulator failure [39 required surgery, 24 experienced a new stricture, 44 experienced a new fistula/abscess, 122 required biologic escalation] with a median time to failure of 16 months. Independent predictors of treatment failure included raised C-reactive protein [CRP], low albumin, complex disease behaviour, younger age, and baseline steroids. Highest CRP and lowest albumin measured within the 3 months preceding immunomodulator initiation outperformed baseline measurements. After model selection, only highest CRP and lowest albumin remained and the resultant Crohn's Immunomodulator CRP-Albumin [CICA] index demonstrated robust optimism-corrected discriminative performance at 12, 24, and 36 months (area under the curve [AUC] 0.84, 0.83, 0.81, respectively). Conclusions: The derived CICA index based on simple, widely available markers is feasible, internally valid, and has a high utility in predicting immunomodulator failure. This requires external, prospective validation.

LINKED CONTENT This article is linked to Varkas paper. To view this article, visit https://doi.org/10.1111/apt.15519 .

Introduction: There are limited data on the effect of COVID19 on inflammatory bowel disease (IBD) service provision and prescribing practices Aims \u0026 Methods: We aimed to quantify the effects of COVID19 on our IBD service This included evaluation of service provision, prescribing practices and use of therapeutic drug monitoring (TDM) This is a single centre retrospective observational cohort study We extracted data from our local IBD databases, electronic patient records and radiology and endoscopy reporting systems between 16/3/20-17/4/20 and the corresponding period in 2019 To evaluate differences in prescribing practices we compared treatment decisions, made for patients with active disease in our biologic and immunosuppressant multidisciplinary meeting We then reviewed the characteristics of patients who had been commenced on, or had switched, biologic therapy To compare these cohorts we used Fisher\u0027s exact test for categorical data and Mann-Whitney test for continuous variables Descriptive statistics were used for prescribing practices and service provision Results: Amongst patients initiating IBD therapy, a higher proportion were commenced on biological therapy during COVID19 compared with prepandemic (29/45, 64% vs 19/50, 38%) We compared characteristics of patients commencing on or switching biologic therapy pre-COVID19 (n=37) and during COVID19 (n=36) The cohorts had similar IBD phenotypes, age of onset as well as disease extent/distribution In the pre-COVID19 cohort the median age was higher (36 vs 29 years, p=0 02) and median disease duration was longer (9 3 vs 5 2 years respectively, p=0 009) During COVID19 there was an increase in the proportion of patients receiving vedolizumab (22% vs 39%), adalimumab (19% vs 25%) and ustekinumab (24% vs 28%), while infliximab and tofacitinib prescribing fell (14% vs 3% and 8/37 vs 2/36 respectively) Across all biologic classes there was a reduction in concomitant immunomodulator prescribing and a tendency towards prescribing biologics in immunomodulator-naive patients New prescriptions of thiopurines for any indication fell by 96% (28 vs 1) During COVID19 there was a preference for vedolizumab or ustekinumab compared to the preceding year (24/36, 67% vs 17/37, 46%) and this cohort was more likely to be TNF-naive 18/24 (75%) vs 3/17 (18%) pre-pandemic Use of TDM fell by 75% during the pandemic (240 vs 59 tests pre- and during pandemic respectively) Values for thiopurine metabolites and anti- TNF levels pre- and during COVID19 were 143 vs 44 samples and 97 vs 15 samples respectively The number of patients seen in outpatient clinics was reduced by 68% Similarly, the number of MRI scans, lower gastrointestinal endoscopies or abdominal operations fell by 87%, 85% and 100% respectively Conversely, clinical nurse specialist and pharmacy helpline contacts increased by 76% and 300% respectively Conclusion: We observed prescribing differences during COVID19, bypassing the initiation of immunomodulators and/or anti-TNF therapy for active disease in favour of newer biologic agents, predominantly as monotherapy Judging by the difference in disease duration between the two cohorts, there appeared to be a shift to earlier prescription of biologics We also observed a rapid reorganisation of service provision that included a shift towards telemedicine and online solutions