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PMO-21 Table 1 Oct 19 Nov 19 Dec 19 Jan 20 Feb 20 Mar 20 Apr 20 May 20 Jun 20 Jul 20 No. of tests with complete prescribing data 66 67 70 66 72 71 45 55 71 56 No. on CI % of tests 30 38 36 35 33 33 20 31 35 16 45.5% 56.7% 51.4% 53.0% 45.8% 46.5% 44.4% 56.4% 49.3% 28.6% Thiopurine specifically % of tests 24 24 26 24 22 25 17 22 27 14 36.4% 35.8% 37.1% 36.4% 30.6% 35.2% 37.8% 40.0% 38.0% 25.0% Non standard dosing % of tests 33 30 37 37 34 39 19 32 43 28 50.0% 44.8% 52.9% 56.1% 47.2% 54.9% 42.2% 58.2% 60.6% 50.0% Proactive TDM 42 50 39 42 43 48 31 34 40 31 ConclusionsOur data suggests prescribing practices remain largely static. However July 2020’s drop in CI prescribing may be an early indicator of decreased use. The small rise in non-standard dosing may be due to COVID-19 strategies employed to reduce hospital attendances and requires further review. While the nature of our data will not convey the complete COVID-19 impact, it highlights the need for stringent review of post-COVID-19 clinical practices, patient outcomes, and updated clinical guidance as our understanding of the COVID-19 impact on IBD develops.ReferencesShields S, et al. Frontline Gastroenterology Published Online First: 30 September 2020. doi: 10.1136/flgastro-2020-101563Ungaro RC, et al. Gut Published Online First: 20 October 2020. doi: 10.1136/gutjnl-2020-322539

Introduction 50% of patients with Crohn’s Disease (CD) will have surgery within the first 10 years, with 35% requiring additional surgery. The REMIND cohort linked male gender, smoking and previous resection to recurrence.1 The link between CD and deprivation is debated2, and its influence on recurrence is unknown. We aimed to define our local post-operative CD population, highlighting recurrence rates. Methods CD resections between 2008–2014 were identified from NHS Greater Glasgow & Clyde Pathology Archive. Data including gender, age at diagnosis and resection, Montreal Classification and smoking status was obtained from Electronic Patient Records. Scottish Index of Multiple Deprivation (SIMD) score was determined by postcode and was ranked 1–5 (most to least deprived). A minimum of 5 years of follow up data was collected. Type of recurrence was recorded as: 1) clinical recurrence - symptom flare requiring course of steroids or inpatient admission; 2) biochemical recurrence - faecal calprotectin >250µg/l; 3) endoscopic recurrence; or 4) surgical recurrence – the need for further CD-related surgery. Results 304 patients (59.5% female) were included. Median age at diagnosis was 29 (range 3–82 years) and at resection was 43 (range 17–85 years). 82.9% had terminal ileal, colonic, or ileocolonic involvement. Upper GI and perianal disease occurred in 17.1% and 12.8% respectively. 94% had a stricturing or penetrating phenotype. 52.9% of patients were never-smokers, 16.5% were ex-smokers and 30.6% were current smokers. 33.6% patients had a SIMD score of 1. 47% of patients had clinical recurrence and 48.7% had biochemical recurrence with 49 patients 16.1% requiring further surgery for Crohn’s disease. There were significant associations between younger age at diagnosis/resection, male sex, current smoking and biochemical, surgical and clinical recurrence respectively. There was no significant association between SIMD score and recurrence of any type. Conclusions Our data suggests rates of post-operative recurrence in line with existing published data. Risk factors for this are similar to those identified in the REMIND study1, with younger age at diagnosis/resection, male sex and smoking all associated with higher rate of recurrence. Our data suggests deprivation does not influence recurrence rates. However more work is needed to validate this in larger, prospective cohorts. References Auzolle, et al. Male gender, active smoking and previous intestinal resection are risk factors for post-operative endoscopic recurrence in Crohn’s disease: results from a prospective cohort study. Aliment Pharmacol Ther 2018 Nov;48(9):924–932 Wardle, et al. Literature review: impacts of socioeconomic status on the risk of inflammatory bowel disease and its outcomes. Bottom of Form European Journal of Gastroenterology & Hepatology 29(8):879–884.

Introduction Treatment with exclusive enteral nutrition (EEN) offers a nutritional therapy paradigm in Crohn’s disease, with the extensive modulation of gut microbiome being its proposed mechanism of action(1). Recent studies propose variable clinical efficacy for 85% EN (Cheat EN/CEN), 50% EN (Partial EN/PEN) and 20% EN (maintenance EN/MEN), and a dose-dependent effect of EN use in CD(2–4). Therefore, this study aims to investigate the dose-dependent effect of 100%, 85%, 50%, and 20% EN on faecal microbial metabolites; and to investigate if this effect can be used as a compliance marker for EEN. Methods Healthy adults followed EEN, CEN, PEN or MEN diet for 7 days. Fresh faecal samples were collected before and after each dietary intervention. Dietary assessment was performed throughout the intervention using estimated weight food diaries. Faecal pH, Bristol Stool Chart Score (BSCS), short chain fatty acids and hydrogen sulphide were measured. Results 122 faecal samples were collected from 61 subjects. The Mean(SEM) EN intake for the 4 groups was EEN:100(0), CEN:86(0.5), PEN:50(0.4), MEN:20(0.2)% of total energy intake. The baseline levels of all faecal sample measures were no different between the 4 groups. Faecal propionate and BSCS significantly decreased only during EEN (all p≤0.03). Faecal pH significantly increased during EEN, CEN and PEN (all p Conclusions EEN and CEN extensively modulate faecal microbial metabolites. PEN induces variable effects and further analysis should investigate if this variation reflects differences in the non-EN food intake of the participants (50%). MEN had no effect on faecal microbial metabolites. Further analysis including high-throughput deep sequencing techniques will provide additional information about the dose-dependent effect of EN regimen on gut microbiome composition. 1) Quince, Am J Gastroenterol 110, 1718–1729; 2) Logan, APT 50, 664–674, 2019; 3) Gupta, IBD 19, 1374–1378, 2013; 4) Lee, IBD 21, 1786–1793, 2015

Introduction Whilst anti-TNF drugs such as adalimumab (ADL) have revolutionised the management of Inflammatory Bowel Disease treatment outcomes are not universally favourable with 30% primary non response (PNR) and 46% secondary loss of response (SLOR) rates reported1,2. Therapeutic drug monitoring (TDM) – measurement of serum drug levels (DL) and anti-drug antibodies - has become popular with clinicians who use it to optimize biologic therapy through serum DL guided dose adjustment. Conventionally TDM is based on the interpretation of trough DL, obtained by drawing a blood sample immediately prior to the next drug dose. Obtaining an ADL trough DL can be challenging as the drug is administered as a subcutaneous injection usually in the patient’s own home. The aim of this project was to determine the current use of non-trough ADL TDM in clinical practice and determine whether timing of ADL TDM in relation to next planned dose is clinically important. Methods All ADL DLs performed in 2018 in the Scottish Biologic TDM service3 were identified. DLs were included for patients in sustained clinical remission (SCR), on 40 mg every other week dosing, and if time from last dose was ≤14 days. TDM performed during induction and for PNR or SLOR were excluded, as were patients on nonstandard dosing or with missing data on dose and interval. Results were analysed by quartile according to time from the last drug dose. Results 338 DLs were included. Median DL is 8µg/ml (range Conclusion It is not necessary to use trough DLs when performing ADL TDM for individuals in SCR. This data should give clinicians the confidence to use opportunistic ADL TDM testing in a clinical setting. Further work should be undertaken on non-trough testing of ADL DLs in other clinical scenarios. Disclosure Biogen GmbH contributed funding for this research. Authors had full editorial control and approval of all content. References Ben-Horin S and Chowers. Aliment Pharmacol Ther 2011; 33: 987–995. Osterman MT, Haynes K, Delzell E, et al. Clin Gastroenterol Hepatol 2014;12:811–817. https://www.nhsggc.org.uk/media/251621/scottish-biologic-tdm-service-gastroenterology-guidance-03122018.pdf

Introduction Microscopic colitis (MC) is still perceived to be an ‘uncommon’ condition1. Despite significant impact on quality of life1, many aspects of the patient journey remain unclear. A National MC Disease Registry is being developed with the aim of gathering data on epidemiology, variations in clinical practice and patient journey. The secondary aim is to generate academic and clinical data to help create more stream-lined MC Services, improving patient care and outcomes. Methods Retrospective data was collected across 6 Scottish (2 DGHs/4 University teaching) units. Once identified from Pathology databases, further data was collected from electronic records. Results In total, 527 patients were enrolled on the registry; of whom, 54 were excluded due to incomplete information. Out of 473 patients [Collagenous colitis 328(69%), Lymphocytic colitis 127(27%), 18 unspecified (4%)] included in the analysis, 358(76%) were female, aged 20–96 (median 67) years. Watery diarrhoea (463, 98%) and abdominal pain (111, 23%) were predominant symptoms. Weight loss was noted in 115(24%). Eight (2%) patients developed complications; 2 adverse drug reactions, 1 colorectal malignancy and 3 required surgical intervention for intractable symptoms related to MC. Variations were noted in the following areas: Patient journey: Whilst 230(49%) were referred directly to Gastroenterology, 109(23%) were referred initially to Surgery– with subsequent referral to Gastroenterology following colonoscopy. This led to delay in therapy initiation in a proportion of patients. In one unit, average length of symptoms at diagnosis was 5.7 months, with an average length of 9.1 months to see Gastroenterology. Medications: There was no evidence of medication review in 121(26%) patients. Reducing-dose Budesonide was the first line treatment in 205(43%). Though 174(37%) did not require initial medical therapy; of these 18(10%) required subsequent treatment with Budesonide. There are 4(1%) patients on biologics and 4(1%) patients on immunomodulators specifically for MC– all of which were treated with budesonide first line. Follow-up: A majority, 337(71%) were followed-up in clinic, with 260(77%) later discharged. Relapse was noted in 118(25%) patients. Conclusions Initial findings from the first MC Registry in the UK demonstrate variability in referral pathway, patient journey and management. Data suggests association with alarm features and significant complications. Reference Townsend T, Campbell F, O’Toole P, et al. Microscopic colitis: diagnosis and management. Frontline Gastroenterology 2019;10(4):388–93

Introduction Biosimilar infliximab (BI) has been widely adopted in to clinical practice since launch in 2015. Switching patients with Inflammatory Bowel Disease (IBD) from originator infliximab (OI) to BI was endorsed by the BSG and ECCO despite a lack of data on the long-term implications of this strategy. Infliximab discontinuation (ID) occurs in 20–40% patients per annum. It is unclear whether switching to BI affects ID rates. This study assessed long-term outcomes after a managed BI switch programme. Methods Individuals with Crohn’s disease (CD) and Ulcerative Colitis (UC) who were changed from OI to BI in a switch programme in Dec 2016 were reviewed via electronic patient records. Demographics and pre-switch disease characteristics were recorded. Pre-switch medications and laboratory data were collected. Changes to BI dose/frequency at switch and during follow-up were recorded along with other changes to IBD medications. Post-switch durability of clinical response was evaluated. Rates of IBD related steroid use, hospitalisation and surgery were gathered. Incidence of adverse events was determined. Potential pre-switch indicators of future ID were explored. Results 76 individuals considered to be clinically responding to OI were entered in to the BI switch programme. 2 patients had OI stopped prior to 1st dose BI based on clinical assessment and Therapeutic Drug Monitoring (TDM) results. 74 people were switched from OI to BI. At time of switch 38 (51%) were prescribed an immunomodulator. 52/74 (70%) were on 5 mg/kg 8 weekly treatment, the rest on higher doses. 48/74 had a pre-switch FC, 32 (67%) FC 2 years post switch, 54/74 (73%) remained on BI with sustained clinical response. ID was observed in 20 (27%); 11 (55%) now on another biologic, 8 (40%) biologic free. 33/54 remaining on BI had treatment escalation at time of or subsequent to switch. There was 1 non-treatment/IBD related death. 1 infusion reaction adverse event was observed. There were 6 IBD related surgeries, 4 unplanned hospital admissions and 12 required steroids for IBD flare. Evaluation of data identified no pre-switch factors associated with ID. Conclusions Over 2 years of follow-up clinical response was maintained in the majority of individuals following BI switch. Rates of ID were lower than historically reported in non-switched patient cohorts. BI switching appears to be a safe and effective intervention.

Introduction Therapeutic drug and antibody monitoring (TDM) of infliximab (IFX) is used with increasing regularity as a tool to optimize outcomes in inflammatory bowel disease (IBD). Trough levels (TL) of 2–8 mcg/ml are recommended during maintenance IFX treatment. The introduction of biosimilar infliximab (BI) in 2015 lead to widespread switching of patients from originator infliximab (OI) to BI. The value of TDM when switching to BI has not been defined. This study aimed to assess the impact of TDM testing before and after a managed switch to BI. Methods Individuals with IBD treated with OI and demonstrating a satisfactory response to treatment, were entered in to BI switch programme in Dec 2016. Pre-switch information was provided to patients, virtual or face to face clinical assessment was undertaken and it was recommended that all patients had pre-switch TDM performed. After switching patients returned to routine clinical care. Further TDM was performed at clinician discretion with recommendation to follow published TDM testing guidance.1 Virtual review of all patients was undertaken 2 years post-switch. Demographics, pre and post switch TDM data, OI and BI dosing regimens and other IBD related medications were recorded along with clinical outcome data. Comparative analysis of pre-switch and most contemporary TDM results was performed. Results 76 individuals considered to be clinically responding to OI were entered in to the BI switch programme. 70/76 (92%) had TDM at Of 69/74 with pre-switch TDM, 32/69 (46%) had subtherapeutic TLs ( 58/74 (78%) had TDM testing in the 2 years after switch (median no. tests 2; range 1 – 5) at which point 54/74 (73%) remained on BI with sustained clinical response. 49 out of 54 still on BI had both pre and post switch TDM with results demonstrating a statistically significant increase in mean TLs (2.1 vs 6.3 mcg/ml; p Conclusions High rates of sustained clinical response were observed to occur following a BI switch supported by the use of pre and post switch TDM. TDM dose escalation resulted in a statistically significant increase in TLs, this may account for the rates of continued clinical response Reference Papamichael K. Frontline Gastroenterol. 2016 Oct;7(4):289–300.

Introduction The GEMINI trials and an increasing body of real-world data have demonstrated the effectiveness and safety of vedolizumab (VDZ) in IBD. However, there is limited available data about its effect on hospitalisations and steroid use. Our aim was to address this in a large real-world cohort of IBD patients from across Scotland. Methods A multicenter retrospective cohort analysis of medical records was performed across 7 Scottish healthcare trusts. Primary outcomes were hospitalisation rates and overall steroid use in patients remaining on VDZ. Secondary outcomes were safety and intention to treat steroid free remission rates in patients with active disease. All data were prospectively collected as part of routine clinical care. Baseline demographics, clinical scores (HBI or Partial Mayo), faecal calprotectin (FC), endoscopy and radiology at 3, 6 and 12 months was recorded where available. Active disease was defined as endoscopic or radiographic evidence of disease or FC >200 mcg/g. Clinical remission was defined as HBI Results 340 (137 UC and 203 CD) patients were included in the primary analysis with a median follow-up of 9.4 months. Hospitalisation rates per patient-year were 0.60, 0.67, 0.36 and 0.16 at baseline, 3, 6 and 12 months of treatment respectively. Total number of hospitalisations reduced by 52.5% from 204 (12 months prior to VDZ) to 97 (12 months after VDZ). Proportion of patients on concomitant steroids reduced from 39.7% to 16.7% (n=332), 8.1% (n=270), 9.3% (n=194) at 3, 6 and 12 months respectively. In patients with active CD (n=153, 75.4%) steroid free clinical and steroid free biochemical remission rates were; 54.4% and 30.2% at 3 months; 47.7% and 32.1% at 6 months; 28.6% and 33.9% at 12 months. In patients with active UC (n=112, 81.8%) steroid free clinical and steroid free biochemical remission rates were; 57.4% and 40.9% at 3 months; 51.6% and 39.1% at 6 months; 37.5% and 41.2% at 12 months. Our cohort received >2066 VDZ infusions, 2 (0.6%) patients developed infusion reactions, 9 (2.6%) patients developed serious infections and 17 (5.0%) serious adverse events. Conclusions VDZ is associated with reduced hospitalisation and steroid use over 1 year. Steroid free remission rates and safety profile is in keeping with the published literature.

Introduction There is evidence that biosimilar infliximab (BSI) has comparable efficacy and safety to originator infliximab (OI) and is significantly cheaper. ECCO guidelines suggest therapeutic drug monitoring (TDM) can help determine whether infliximab (IFX) should be continued or dose-adjusted during maintenance treatment of inflammatory bowel disease (IBD). Method Our unit developed a switch programme in order to take advantage of the cost savings associated with BSI. We identified patients established on OI as IBD maintenance therapy (n=76). Our IBD nurses counselled patients, gained their consent to switch from OI to BSI, and obtained IFX TDM samples. We audited the usefulness of IFX TDM and whether concomitant immunomodulation (IM) or pretreatment with hydrocortisone were associated with lower rates of antibodies to infliximab (ATI). Results 3 patients were excluded as their trough levels of IFX (TLI) were felt inaccurate due to the timing of the test. 73 were included: 16 (21.9%) had therapeutic TLI (3–7 µg/mL), 3 (4.12%) had high TLI (>7 µg/mL), 37 (50.68%) had low TLI (0.8–2.9 µg/ml) and 17 (23.3%) had TLI IFX TDM changed management in 46 (63%) patients: IFX was dose-optimised in 24 (32.9%) patients and discontinued in 14 (19.2%) others (7 were started on adalimumab or vedolizumab, and 7 stopped biological therapy altogether). 8 (10.9%) patients were re-staged with a view to stopping IFX. No changes were made in 27 (37%) patients: 16 (21.9%) had optimal TLI, 4 (5.5%) were in remission with only marginally suboptimal TLI and no ATI, and 7 (9.6%) had not yet had their IFX TDM reviewed by the MDT. Only one patient did not consent to switching from OI to BSI. 93.5% of patients continuing on IFX were switched from OI to BSI. All patients received some form of co-treatment in an attempt to reduce the development of ATI (table 1). Despite this, 41 (53.9%) patients had ATI. The mean duration of IFX therapy was 34.3 months overall, 33 months in those with ATI, and 35.8 months in those without ATI. Conclusion A switch programme facilitates cost savings, and is acceptable to patients if the rationale is properly explained. IFX TDM altered management in 63% of our patients and therefore should be incorporated in switch programmes. More than half of patients had ATI. This may be explained by the fact that patients had been on IFX for a prolonged time. In our cohort it appears that concomitant IM was better at preventing ATI than pretreatment with hydrocortisone. Disclosure of Interest None Declared