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Background Biological drugs used for IBD are detected in breast milk at a concentration below 10% of the maternal serum concentration and have therefore been considered as permitted drugs. However, warnings have recently been published regarding vaccination with live agents in children whose mothers receive infliximab during breastfeeding. Aim To assess the risk of serious adverse events related to the administration of live vaccines in children exposed to biological drugs in utero or whose mothers were receiving biological agents during breastfeeding. Methods Children born to IBD mothers from DUMBO registry of GETECCU were included. DUMBO is a prospective, observational and multicentre registry, which enrolls pregnant women with IBD over 5 years in 70 centres in Spain. Data on treatment during gestation, type of lactation, breastfeeding, end-date of breastfeeding, maternal treatments during breastfeeding and serious adverse events in children from birth are being prospectively included contacting with the mothers every-3-months. Following the Spanish immunization calendar, rotavirus vaccine is (voluntarily) administered at 2, 4 and 6 (3rd dose only with Rotateq®) months; measles, mumps and rubella (MMR) at 12 months and 3-4 years of age; and varicella at 15 months and 3-4 years of age. Results 526 newborns were included in the registry at the time of data analysis. A total of 205 (39%) had been exposed to biologics during pregnancy or breastfeeding (table 1): 80 (42%) during pregnancy, 7 (2%) during breastfeeding, and 109 (57%) during both. Newborn’s demographics and exposure to drugs during breastfeeding are summarized in table 2. Mean follow-up was 12 months; proportion of children breastfed during follow-up is shown in table 3a. The percentage of children who had been vaccinated according to the recommended schedule was above 95% at all visits (table 3b). Live vaccines administered to children exposed in utero to biologics during the 3rd trimester of gestation are shown in table 4a. From birth, 71% of infants were breastfed (52% exclusively breastfed). Live vaccines administered to children breastfed at least until month 6, until month 12 and until month 15 are summarized in table 4b. No serious adverse event related to live vaccine was reported in our cohort. Conclusion Administration of live virus vaccines from 12 months of age in children born to IBD mothers and exposed to biological drugs in utero or during breastfeeding seems safe and should not be recommended against vaccination or breastfeeding. Rotavirus vaccine (under 6 months of age) appears to be equally safe in these children.

Background Main aim: To assess the durability of tofacitinib treatment in patients with ulcerative colitis (UC). Secondary aims: To assess the short and long-term effectiveness; the tolerability of tofacitinib in clinical practice; and to evaluate the evolution of extraintestinal manifestations (EIMs) and immunomediated inflammatory diseases (IMIDs). Methods Retrospective, multicenter study including UC patients who had received the first tofacitinib dose at least 8 weeks before the inclusion. Patients were followed-up from the first tofacitinib dose to treatment discontinuation or last visit, whichever came first. Only patients with active disease [Partial Mayo Score (PMS)>2] at tofacitinib start were considered in the effectiveness analysis. Clinical effectiveness was based on PMS. In patients who stopped tofacitinib before their last visit, the last observation carried forward method was used to impute missing values at subsequent time points. Results 408 patients were included (figure 1). Incidence rate of tofacitinib discontinuation was 41% per patient-year of follow-up. The probability of maintaining tofacitinib is shown in figure 2a. Main reasons for tofacitinib withdrawal were primary non-response (44%) and loss of response (26%). Age at the start of tofacitinib (older) (HR=0.98, 95%CI=0.97-0.99) and the severity of clinical activity were associated with tofacitinib withdrawal (mild vs. remission: HR=1.5, 95%CI=0.5-4; and moderate-severe vs. remission: HR=3.0, 95%CI=1.2-7.4). Short-term effectiveness is shown in figure 3a. To have moderate-severe vs. mild disease activity at baseline (OR=0.2, 95%CI=0.1-0.4) and age at tofacitinib start (older) (OR=1.01, 95%CI=1.002-1.03) were associated with clinical remission at week 8. The probability of maintaining response in shown in figure 2b. Tofacitinib dose was escalated in 55 patients (66%) of those who had lost response, and 82% of them improved (60% regained remission). The proportion of patients on 10 mg b.i.d was over 40% in all timepoints during follow-up. The proportion of patients in clinical remission during follow-up in shown in figure 3b. Adverse events during tofacitinib treatment are summarized in figure 4. There was not any signal of negative impact of tofacitinib on EIM o IMIDs. Conclusion Tofacitinib is effective in inducing remission even in highly refractory UC patients. A relevant proportion of patients discontinue the treatment, mostly due to primary failure. Dose escalation is effective to regain response after loss of efficacy. The safety profile is similar to that previously reported

Background The safety of ustekinumab in pregnant patients with inflammatory bowel disease (IBD) and in their offspring has been barely studied. Aims Primary: To know the risk of serious adverse events (SAEs) in women exposed to ustekinumab during pregnancy and in their offspring. Secondary: To assess the risk of complications of the mothers and their offspring. To describe the patterns of use of ustekinumab during pregnancy in these patients Methods Patients with IBD exposed to ustekinumab during pregnancy from DUMBO registry of GETECCU were included. DUMBO is a prospective, observational and multicentre registry, which enrols pregnant women with IBD over 5 years in 70 centres in Spain. The registry was kicked off in September 2019. SAE definition was based on “Clinical Safety Data Management: Definitions and Standards for Expedited Reporting by European Medicines Agency”. Study protocol is summarized in figure 1. Results 49 pregnant patients have been exposed to ustekinumab during pregnancy so far (table 1). All pregnancies were singleton. Two patients were lost of follow-up (1st and 2nd trimester) but had uneventful pregnancies up-to last visit. There were 2 miscarriages (4%) at 1st trimester of gestation, 34 newborns and 11 pregnancies that were still on-going at the time of this analysis. All patients were on ustekinumab at conception (57% of them 90 mg/8 weeks). A total of 12 patients (24%) withdrawn ustekinumab during pregnancy: 1 (8%) due to disease flare, 1 (8%) underwent surgery due to intestinal obstruction, 2 (17%) due to patient’s choice (at 1st and 2nd trimester), and 8 (67%) due to clinicians’ decision (1 at 1st, 5 at 2nd and 2 at 3rd trimesters). No patient flared up after ustekinumab discontinuation. 10 (20%) patients had SAEs: 2 miscarriages, 1 intestinal infection, 1 subcorionic hematoma, 3 preterm birth, 1 intestinal obstruction and perforation (underwent surgery), 1 preeclapmsia, and 1 stoma obstruction. A total of 34 women gave birth after a median of 39 weeks gestation [interquartile range (IQR)=38–40], 3 (9%) preterm births, 55% by caesarean section (82% obstetric reasons and 18% perianal fistulae). Of the 34 newborns, 53% were female, median birth weight was 3,110 g (IQR=2,820–3,325), 3 (9%) low-birth weight, and 50% were breastfed exclusively. Median babies’ follow-up was 12 months (IQR=7–16). During follow-up, 3 children (9%) had severe infections (2 urinary infections, and 1 bronchiolitis by respiratory syncytial virus). In addition, 4 (13%) children were hospitalized: 1 cardiorespiratory arrest, 1 prematurity, 1 jaundice, and 1 vesicoureteral reflux Conclusion Ustekinumab seems to be safe during pregnancy in patients with IBD and their offspring.

Background Prospective registries are necessary to evaluate the safety of inflammatory bowel disease (IBD) treatment during pregnancy and in children in the long term. Aims The overall aim of DUMBO registry is to know the risk of serious adverse events (SAEs) during pregnancy and in children up to 4 years of age exposed during pregnancy to drugs for IBD (mainly focused on biologics), compared to unexposed children. In this analysis we aim to evaluate the risk of SAEs during pregnancy and the predictive factors of it (mainly focused on IBD drugs). Methods Prospective, observational and multicentre registry, which enrols pregnant women with IBD (Crohn’s disease, ulcerative colitis, IBD-unclassified) over 5 years in 70 centres in Spain. The registry was kicked off in September 2019. SAE was defined based on “Clinical Safety Data Management: Definitions and Standards for Expedited Reporting by European Medicines Agency”. Study protocol is summarized in figure 1. Results 433 women have been included so far; 241 got pregnant at least 9 months before this interim analysis (table 1). Mean age was 34 years, and 17% of women had active disease at any time during pregnancy. 23% of pregnancies were exposed to immumodulators (thiopurines), 25% to biologics and 10% to combo therapy (biologics and immunomodulators). 85 pregnancies (35%) were exposed to biologics (60 anti-TNF, 17 ustekinumab, and 8 vedolizumab) either in combo or in monotherapy. There were 237 newborns (227 singleton and 5 pair of twins), 9 miscarriages and 1 abortion. 72% of patients had vaginal delivery and 28% C-sections (18% due to perianal CD or active disease). A total of 59 pregnancies (24.5%) reported at least one SAE: 32% in exposed to biologics and 20.5% in non-exposed group (p>0.05) (figure 2). Four out of 17 pregnancies exposed to ustekinumab and 3 out of 8 exposed to vedolizumab had SAEs (non-related with the drug). In the multivariate analysis, adjusted by disease activity, in comparison with no immunosuppressive treatment, neither immunosuppressants [Odds ratio (OR)=1.1, 95% confidence interval (CI)=0.3–4.3] nor biologics in monotherapy or in combo (OR=0.8; 95%CI=0.2–3) were associated with higher risk of SAEs. 40 patients (17%) were hospitalised due to complications during pregnancy or delivery (figure 3). Two patients underwent surgery during pregnancy due to IBD complications Conclusion IBD treatment (either immunomodulators or biologics) does not increase the risk of SAEs during pregnancy. Nevertheless, one-quarter of IBD women suffer SAEs during pregnancy and about 20% need hospitalisation, which should be taken into account when managing IBD during pregnancy.

Background Bile acid diarrhoea (BAD) is common in patients with Crohn’s disease (CD), but its recognition is challenging since symptoms are similar to those of active inflammatory disease. The current clinical gold standard for diagnosing BAD is the Se-HCAT test, however, it is inconvenient to the patient and has limited availability. FGF19 is a hormone produced in the enterocytes of the ileum in response to absorbed BAs. Serum FGF19 levels are a direct marker of BA absorption, and they are reduced in BAD. The aim of this study was to evaluate the performance of FGF19 as a diagnostic tool for BAD in Crohn’s disease. Methods Fasting serum FGF19 levels and Se-HCAT retention were measured before bowel preparation in 63 consecutive Crohn’s disease patients referred for an ileocolonoscopy. Clinical, endoscopic and biologic data were prospectively recorded. BAD was defined as an abdominal retention Results BAD was present in 60% of non-resected CD (NR-CD) patients and in 93% of ileal-resected (IR-CD) patients. FGF19 levels were lower in IR-CD patients (median 23 pg/ml; IQR, 3–44) than in the NR-CD patients (61 pg/ml; IQR, 18–121) (p = 0.02). FGF19 levels were inversely related with ileal resection length in IR-CD patients (rs = -0.52, P = 0.01). FGF19 and Se-HCAT values were positively related (rs = 0.57, P < 0.0001), whereas FGF19 was inversely related with the number of bowel movements (rs = -0.31, P=0.01) and Bristol scale (rs = -0.27, P= 0.04). No significant relation was found between FGF19 and clinical (CDAI) nor endoscopic (SES-CD) scores. Area under the ROC curve for FGF19 to detect SeHCAT at Conclusion Serum FGF19 can be used as a simple blood test to the diagnostic of BAD in CD. FGF19 measurement could be an adjunct in guiding treatments for diarrhoea in CD.

Malaltia inflamatòria intestinal; Colitis ulcerosa; Malaltia de Crohn; Tractament biològic Enfermedad inflamatoria intestinal; Colitis ulcerosa; Enfermedad de Crohn; Tratamiento biológico Inflammatory bowel disease; Ulcerative colitis; Crohn's disease; Biological treatment La malaltia inflamatòria intestinal engloba la colitis ulcerosa i la malaltia de Crohn. Totes dues condicionen un alt impacte en la qualitat de vida i el seu maneig implica elevats costs directes i indirectes. Les opcions terapèutiques per als pacients amb malaltia inflamatòria intestinal han augmentat considerablement en els darrers vint anys. Actualment, disposem de cinc medicaments biotecnològics que actuen en diferents dianes terapèutiques: tres inhibidors del factor de necrosi tumoral (infliximab, adalimumab i golimumab), una antiintegrina a4β7 (vedolizumab) i un anticòs anti-IL-12/23 (ustekinumab). A més, disposem del primer fàrmac sintètic dirigit enfront de la cinasa Janus (tofacitinib) per a la colitis ulcerosa. La incorporació de medicaments biosimilars (actualment, infliximab i adalimumab) ha permès reduir-ne considerablement el cost. En aquest article es revisaran les principals indicacions d’aquests medicaments i els estudis més importants que han permès la seva incorporació en pràctica clínica, així com els principals efectes secundaris. La enfermedad inflamatoria intestinal engloba la colitis ulcerosa y la enfermedad de Crohn. Todas ellas condicionan un alto impacto en la calidad de vida, y su manejo implica elevados costes directos e indirectos. Las opciones terapéuticas, para los pacientes con enfermedad inflamatoria intestinal, han aumentado considerablemente en los últimos veinte años. Actualmente, disponemos de cinco medicamentos biotecnológicos que actúan en diferentes dianas terapéuticas: 3 inhibidores del factor de necrosis tumoral (infliximab, adalimumab y golimumab), una anti-integrina a4β7 (vedolizumab) y un anticuerpo anti-IL12 / 23 (ustekinumab). Además, disponemos del primer fármaco sintético dirigido frente la Janus quinasa (tofacitinib) para la colitis ulcerosa. La incorporación de medicamentos biosimilares (actualmente, de infliximab y adalimumab) ha permitido reducir considerablemente su coste. En este artículo se revisarán las principales indicaciones de estos medicamentos, los estudios más importantes que han permitido su incorporación en práctica clínica, así como los principales efectos secundarios.

Background Controlled studies show high efficacy of budesonide in inducing short-term clinical remission in collagenous colitis (CC), but relapses are common after its withdrawal. Aim To evaluate the need for high-dose budesonide (≥6 mg/d) to maintain clinical remission in CC. Methods Analysis of a multicentre retrospective cohort of 75 patients with CC (62.3 ± 1.5 years; 85% women) treated with budesonide in a clinical practice setting between 2013 and 2015. Frequency of budesonide (9 mg/d) refractoriness and safety, and the need for high-dose budesonide to maintain clinical remission, were evaluated. Drugs used as budesonide-sparing, including azathioprine and mercaptopurine, were recorded. Logistic regression analysis was performed to evaluate the risk factors associated with the need for high-dose budesonide (≥6 mg/d) to maintain clinical remission. Results Budesonide induced clinical remission in 92% of patients, with good tolerance. Fourteen of 68 patients (21%; 95% CI, 13–32%) needed high-dose budesonide to maintain remission. Only intake of NSAIDs at diagnosis (OR, 8.6; 95% CI, 1.6–44) was associated with the need for high-dose budesonide in the multivariate analysis. Treatment with thiopurines was effective in 5 out of 6 patients (83%; 95% CI, 44–97%), allowing for withdrawal from or a dose decrease of budesonide. Conclusions One fifth of CC patients, especially those with NSAID intake at diagnosis, require high-dose budesonide (≥6 mg/d) to maintain clinical remission. In this setting, thiopurines might be effective as budesonide-sparing drugs.

Resumen Introduccion Infliximab ha demostrado su eficacia en evitar la colectomia a corto y medio plazo en los pacientes con colitis ulcerosa corticorrefractarios (CUCR). No obstante, existen pocos datos acerca del tratamiento de mantenimiento mas adecuado en los pacientes con CUCR que han respondido al tratamiento de induccion a infliximab. El objetivo del estudio es comparar la evolucion a largo plazo de los pacientes corticorrefractarios que han respondido al tratamiento de induccion a infliximab segun hayan seguido tratamiento de mantenimiento con azatioprina en monoterapia o infliximab. Pacientes y metodos Se seleccionaron los pacientes ingresados en 3 centros entre enero de 2005 y diciembre de 2011 por un brote moderado-grave de CUCR que habian respondido a las 3 dosis de induccion de infliximab sin necesidad de colectomia antes de la semana 22 despues de la primera infusion. Resultados Se incluyeron 22 pacientes, 9 (37%) siguieron tratamiento con azatioprina y 15 (63%) con infliximab. Despues de una mediana de 18 meses de seguimiento, los corticoides se pudieron retirar en todos. De los que siguieron tratamiento con azatioprina, infliximab tuvo que ser reintroducido en 4 (44%). No hubo ninguna colectomia. De los 15 pacientes que siguieron tratamiento con infliximab, este requirio ser intensificado en el 53%, aunque en 9 (65%) pudo retirarse por remision clinica. Cuatro pacientes (16%) requirieron colectomia. Conclusiones Segun los resultados del estudio parece recomendable seguir tratamiento con infliximab, incluso en los pacientes no expuestos previamente a tiopurinas, dada la necesidad de reintroduccion de infliximab si se sigue tratamiento con azatioprina en monoterapia.

Chronic diarrhoea is a common presenting symptom in both primary care medicine and in specialized gastroenterology clinics. It is estimated that >5% of the population has chronic diarrhoea and nearly 40% of these patients are older than 60 years. Clinicians often need to select the best diagnostic approach to these patients and choose between the multiple diagnostic tests available. In 2014 the Catalan Society of Gastroenterology formed a working group with the main objective of creating diagnostic algorithms based on clinical practice and to evaluate diagnostic tests and the scientific evidence available for their use. The GRADE system was used to classify scientific evidence and strength of recommendations. The consensus document contains 28 recommendations and 6 diagnostic algorithms. The document also describes criteria for referral from primary to specialized care.

Background AntiTNF therapeutic drug monitoring is currently performed at trough, immediately before drug administration. However, in clinical practice when subcutaneous medications are used, blood extractions often do not coincide with that moment. The aim of this study was to know if adalimumab levels measured between injections are sufficiently similar to trough levels to be used in clinical practice in a similar way. Methods 295 adalimumab level determinations performed at different time points of 99 injection cycles in 55 patients with inflammatory bowel disease (IBD) were included in the study. 51 patients received 40mg every 2 weeks and 4 patients received 80mg every 2 weeks. Results Median adalimumab levels (IQR) at trough, between days 1–4, 5–8 and 9–13 were 10.6 (6–12), 12.3 (7–18), 13 (7–19) and 10.8 (8–12), respectively. The median differences between trough level and days 1–4, 5–8 and 9–13 were 1.7 (IC 95% 1–2.3) (p < 0.001), 2.3 (IC 95% 1.5–3.1) (p < 0.001), 0.6 (IC 95% –0.2–1.3) (p = 0.13), respectively. Conclusion Adalimumab levels between days 9 and 13 from drug injection are very similar to trough level and could be interpreted clinically at the same way. Adalimumab levels between days 1 and 8 are significantly higher, although, differences are small.

Background Loss of response (LOR) to tumour necrosis factor antagonists (anti-TNF) occurs in up to 50% of patients with inflammatory bowel disease (IBD). The ability to predict which patients are likely to lose response would allow therapies to be tailored to the patient’s characteristics. Immunogenicity is a common cause of LOR. Recently, a GWAS performed using the PANTS cohort demonstrated that carriage of one or more HLA-DQA1*05 alleles confers an increased risk of immunogenicity to anti-TNF therapy (Sazonovs et al. Gastroenterology 2019). We found that HLA-DQA1*05 carriage also identified patients at increased risk of clinical LOR to infliximab (Guardiola et al. ECCO 2019). The aim of our study was to know if carriage of a HLA-DQA1*05 allele is also associated with secondary LOR to adalimumab (ADA) in patients with Crohn’s disease (CD). Methods This is a retrospective cohort study from a prospectively maintained data base. Patients were included if they had achieved response to ADA. LOR was defined as recurrence or worsening of IBD-related symptoms that required a change or intensification in treatment, hospitalisation or surgery. Independent predictors of LOR were identified using univariate and multivariable Cox proportional hazard regression. Results We included 53 patients with Crohn’s disease, followed up to LOR (n = 31, 58%) or a median of 51 months (IQR 35–74). Forty-five per cent were carriers of an HLA-QA1*05 allele. HLA-DQA1*05 carriage was associated with LOR both, upon univariate analysis (HR 2.1 (95% CI 1.1–4.3), p = 0.04) and upon multivariate analysis, after adjusting for immunomodulators use, smoking status and BMI (HR 2.74 (95% CI 1.2–6.2), p = 0.02) (Figure 1). The cumulative persistence rates of ADA after adjusting for immunomodulators use was significantly lower in HLA-DQA1*05 carriers compared with non-carriers (HR 4 (95% CI 1.2–15.5), p = 0.02) (Figure 2). Conclusion HLA-DQA1*05 carriage is frequent and it is associated with a marked increase in the risk of LOR to ADA. HLA-DQA1*05 may become a clinically meaningful genetic marker that could allow for treatment to be tailored according to the risk of LOR, which is a step towards personalised medicine.

Background Colonic cytomegalovirus [CMV] reactivation has been involved in steroid refractoriness in patients with active ulcerative colitis [UC]. The benefits of antiviral therapy in this clinical setting are still under debate, but the burden of viral reactivation has been associated with a poorer outcome in some studies. Our aim was to assess whether the burden of CMV reactivation measured by the number of viral inclusions by immunohistochemistry [IHC-CMV] is associated with a risk of colectomy. Methods Biopsy sets of UC patients with positive IHC-CMV were identified from the Pathology departments of three university hospitals. All biopsies were reviewed by expert pathologists, and the maximum number of IHC-CMV-positive cells in each biopsy set was re-assessed. Epidemiological and clinical features and clinical outcomes were recorded. Results Forty-six positive IHC-CMV cases with UC were included. At the time of CMV reactivation, 70% were receiving corticosteroids, 33% azathioprine, and 24% anti-tumour necrosis factor [TNF] agents. Thirty-two patients [70%] were treated with antiviral therapy. The median number of IHC-CMV-positive cells was 2 cells/biopsy [IQR 1-4]. Fourteen patients [30%] underwent colectomy, and 4 of them [29%] showed persistence of CMV in the surgical specimen. In the multivariate analysis, colectomy was only associated with >2 positive cells/biopsy [p = 0.048] and younger age [p = 0.023]. Conclusions The burden of CMV colonic reactivation in patients with active UC, as measured by IHC, seems to be related to the risk of colectomy, and more data is needed to understand whether antiviral therapy guided by CMV burden will alter the clinical outcome.

BACKGROUND: Histological remission has been proposed as a new treatment goal in patients with ulcerative colitis (UC) although no universal definition for microscopic activity exists. AIM: We evaluated the accuracy of histological activity to predict clinical relapse in UC patients with both clinical and endoscopic remission. METHODS: Asymptomatic UC patients in endoscopic remission (Mayo endoscopic sub-score 0 or 1) undergoing surveillance colonoscopy in two referral hospitals were prospectively recruited. All colonic biopsies were analyzed according to the Geboes' score (GS) and the presence of basal plasmacytosis (BP). RESULTS: Ninety-six patients were included (38% women, median (interquartile range) age 50.0 (39.0-58.5) years, median disease duration 12.0 (6.5-19.5) years). Histological activity defined as GS ≥ 2B.1, GS ≥ 3.1, or BP was present in, respectively, 26%, 23% and 12%. Within 12 months from index endoscopy, 23% of the patients presented with clinical relapse. In multivariate analysis, active histological disease was the only risk factor predicting clinical relapse (odds ratio (95% confidence interval) 4.29 (1.55-11.87); p = 0.005 for GS ≥ 2B.1 and 4.31 (1.52-12.21); p = 0.006 for GS ≥ 3.1). CONCLUSIONS: In patients with UC in clinical and endoscopic remission, histological activity is an independent risk factor for clinical relapse. Further prospective studies need to clarify whether treatment optimization is justified in this context. ispartof: UNITED EUROPEAN GASTROENTEROLOGY JOURNAL vol:6 issue:5 pages:765-772 ispartof: location:England status: published

European health systems have developed referral guidelines for the selection of patients for the urgent investigation of suspected colorectal cancer.To evaluate whether quantitative faecal immunochemical testing performs better than commonly used high-risk symptoms based strategies for fast-tracking cancer referrals.We prospectively studied 1054 symptomatic patients referred for a colonoscopy who provided a sample for faecal immunochemical testing. The usefulness of faecal immunochemical testing and two current guidelines for urgent referral were compared for their efficacy in the detection of colorectal cancer and advanced neoplasia.The guidelines detected 46.7% and 43.3% of cases of colorectal cancer while faecal haemoglobin concentration ≥15μg Hb/g detected 96.7% of cases. The diagnostic accuracy of both the guidelines and faecal haemoglobin concentration ≥15μg Hb/g for the detection of advanced neoplasia was: sensitivity 38.3%, 36.1%, 57.1% and specificity 71.8%, 69.5%, 86.6%, respectively. Male gender (OR 2.35; p0.001), age (1.34; p=0.002), and faecal haemoglobin concentration ≥10μg Hb/g (7.81; p0.001) were independent predictive factors of advanced neoplasia.A faecal immunochemical test based-strategy performs better than current high-risk symptoms based strategies for fast-tracking cancer referrals. A score that combines gender, age and a faecal immunochemical test could accurately estimate the risk of advanced neoplasia.

The aim of our work was to test the usability of fecal calprotectin (FC) home-based test in inflammatory bowel disease (IBD) patients. Methods IBD patients were prospectively recruited. They had to measure FC with a dedicated tool and smartphone application, 5 times at two weeks intervals over an 8 weeks period. They had to fill in a usability questionnaire at the first and the last FC measurement. A System Usability Scale (SUS: 0–100) and the Global Score of Usability (GSU: 0–85) were calculated. FC was also centrally measured by ELISA. Results Fifty-eight patients were recruited. Forty-two performed at least one FC measurement and 27 performed all the FC requested measurements. The median (IQR) SUS (0–100) at the first and last use were 85 (78–90) and 81 (70–88), respectively; the median (IQR) GSU (0–85) at the first and last use were 74 (69–80) and 77 (68–83), respectively. Adherence to the planned measurements and usability of the tool were higher in females and in less severe disease. The intra-class correlation coefficient between home-based and centrally measured FC was 0.88. Conclusion The adherence to home-based measurement of FC was fair. Usability scores for the home-based test were high. There was a good correlation with the centrally measured FC by ELISA.