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Background The use of ustekinumab (UST) and vedolizumab (VDZ) as first line therapy for inflammatory bowel disease (IBD) is increasing due to safety reasons and contraindications of anti-TNFs. However, there are no studies evaluating their efficacy and safety in clinical practice under these circumstances. Thus, our aims were to describe bionaïve patients’ characteristics starting VDZ or UST and to evaluate treatment persistence of these drugs and their safety profile in this scenario. Methods Descriptive, retrospective and multicenter study based on the ENEIDA registry (a large, prospectively maintained database of the Spanish Working Group in IBD –GETECCU). All IBD patients never exposed to biological agents who started VDZ or UST as first-line biological treatment were identified. Results Out of 29,450 IBD patients ever exposed to biological drugs included in the ENEIDA registry, 924 patients met the inclusion criteria. Of these, 366 (40%) started UST and 558 (60%) VDZ as first line biological therapy. UST group: 48% women, 90% Crohn's disease (43% ileal; 13% colic; 43.5% ileocolic; 31% upper gastrointestinal involvement; 25% stricturing behaviour; 12% penetrating, 18% perianal disease), 10% ulcerative colitis (74% extensive, 17% left-sided, 9% proctitis), 27% had extraintestinal manifestations (EIM). Median age at the beginning of UST was 57 years (IQR 57-70), 17% patients had a past history of malignancy and, 34% had associated comorbidities. UST indication was luminal activity except in 2% for perianal disease and 5% for EIM. At the end of follow-up (median 14 months [IQR 6-30]), 12 patients (3.3%) developed adverse effects (AEs) that led to treatment discontinuation in the majority of them (92%). VDZ group: 44% women, 42% Crohn's disease (44% ileal; 18% colic; 38% ileocolic; 25% upper gastrointestinal involvement; 28% stricturing behaviour; 13% penetrating; 7% perianal disease), 58% ulcerative colitis (50% extensive, 42% left-sided, 8% proctitis), 17% had EIM. The median age at the beginning was 61 years (IQR 48-71), 24% had past history of malignancy and, 34% associated comorbidities. The indication was exclusively luminal activity. At the end of follow-up (median 21 months [IQR 8-36]), 36 patients (6.5%) had AEs, that lead to treatment withdrawal in 67% of them (24 patients). Cumulative treatment persistence rates were 78%, 60% and 50% for VDZ and 85%, 75% and 66% for UST at 12, 24 and 36 months, respectively (P Conclusion In clinical practice, VDZ and UST are used first-line particularly in elderly patients with comorbidities. Both treatments have a good safety profile and a high persistence of treatment, being superior for ustekinumab.

Background An increased risk of lymphoma has been described in patients with Inflammatory Bowel Disease (IBD). The aims of our study were to determine the clinical presentation of lymphoma, previous exposure to immunosuppressive and biologic therapies, and the management and evolution of lymphomas in patients with IBD. Methods IBD patients with diagnosis of lymphoma from October 2006 to June 2021 were identified from the prospectively maintained ENEIDA registry of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU). Investigators at each participating centre provided additional information on lymphomas. Results We identified 52 patients with lymphoma in 18 centres following 21,740 patients with IBD (2.4 cases of lymphoma/1,000 patients with IBD; 95% CI 1.8-3.1). 35 were men (67%) and 27 (52%) had Ulcerative Colitis. Non-Hodgkin lymphoma was the most common lymphoma (65%). The median age at diagnosis of lymphoma was 59 years old (IQR 48-67). 31 patients (60%) received thiopurines, and 20 (38%) an anti-TNF drug (one of them had not received thiopurines) before lymphoma diagnosis. Age at diagnosis of lymphoma was lower in those patients treated with thiopurines (53 ± 17 years old) and anti-TNF drugs (47 ± 17 years old) than in those patients not treated with thiopurines nor anti-TNF drugs before the diagnosis of lymphoma (63 ± 12 years old; p Conclusion Most IBD patients with lymphoma had been treated with thiopurines and/or anti-TNF agents before lymphoma diagnosis, and these patients were younger at diagnosis of lymphoma than those not treated with these drugs. IBD treatment was usually changed after a diagnosis of lymphoma. Relapse and mortality of lymphoma were not related to the use and duration of thiopurines or biologic therapies.

Background Female sex has been associated with a worse response to anti-TNF drugs and with discontinuation of these drugs in immune-mediated diseases. Data in Inflammatory Bowel Disease (IBD) are unclear. The aims of study are to assess possible differences in long-term treatment persistence and safety of biological drugs between women and men with IBD. Methods Multicenter observational study carried out with data from the ENEIDA registry. Patients diagnosed with Crohn's disease (CD) or ulcerative colitis (UC) who receive or have received biological drugs, and have had a minimum treatment follow-up of 6 months, were included. We evaluated the first biological treatment used in the patient. Statistic analysis; Regression logistic models were used for safety evaluation. Kaplan-Meier curves, Log-Rank test and COX regression were used to treatment persistance. Results A total of 51,595 patients with IBD were evaluated [ 25,947 with CD (13238 men and 12709 women) and 25,648 with UC (13596 men and 12052 women)]. Mean follow up of 13 years. Biologic use: 28.7% of the evaluated patients had been treated with at least one biologic drug. Biologics use in UC was less common in women than in men (15.5% vs. 17.2%, OR (95%CI): 0.88 (0.81-0.94), p= 0.001) and there were no differences between sexes in CD ( 45.7% in men, 44.7% in women). Infliximab (IFX) and adalimumab (ADA) were the most used drugs (in 8914 and 5269 patients, respectively). Safety evaluation. Women suffered more frequently adverse effects to IFX and ADA than men, being the withdrawal of IFX and ADA due to adverse effects also significantly more frequent in women than in men. Biological treatment persistence in patients with IBD was longer in men than in women [median 3.1 years vs. 2.3 years, p < 0.001]. Female sex was a risk factor of biologic discontinuation [adjusted hazard ratio [aHR] (95%CI): 1.20 (1.14-1.25), p Figure 1. Conclusion 1.The use of biologics in ulcerative colitis seems to be higher in men than in women. 2. Female sex is an independent risk factor for the development of adverse effects to IFX and ADA and for the discontinuation of these drugs. 3. The long-term persistence of IFX and ADA (as first biological treatments) is low, being higher in men compared to women.

Background The coexistence of immune-mediated diseases and non-pharmacological immunosuppression states are rare and might determine the natural history of the disease and therapeutic decisions of the physician. IBD guidelines recommend screening for human immunodeficiency virus (HIV) before starting immunosuppressive treatment, but data on the impact of HIV infection on IBD and its management in the era of biological drugs are scarce. Therefore, our aim was to describe IBD phenotype, immunosuppressive requirements, and prevalence of opportunistic infections (OI) in patients with IBD and coexistent HIV infection. Methods Case-control, retrospective, multicenter study including all IBD patients with available HIV serology on the ENEIDA registry (a large, prospectively maintained database of the Spanish Working Group in IBD –GETECCU). IBD patients with positive HIV serology were selected (HIV+) and compared to HIV seronegative IBD patients (controls), matched 1:3 by year of IBD diagnosis, age, gender and type of IBD). Demographic, clinical IBD characteristics, therapeutic requirements, OI and IBD complications were registered. Results Eighty-eight HIV+ IBD patients and 264 controls were included. In the whole cohort, 81% were men, 56.8% had ulcerative colitis (UC), 36.4% Crohns’ disease (CD) and 6.8% IBD unclassified. Median age at IBD diagnosis was 38 years (IQR 30-47), median age at HIV infection diagnosis was 36 years (IQR 30-42), 46.3% being were firstly diagnosed of IBD. Among UC patients, HIV+ had a lower proportion of extensive disease (24.5% vs 44.8%; P=0.002), and a higher proportion of proctitis (38.8% vs. 16.6%; P=0.002) than controls, without differences on disease proximal progression (7.7% vs 7.9%). Among CD patients, HIV+ presented a higher proportion of colonic involvement than controls (40.6% vs 12,6%, P=0.002) and lower penetrating behavior (10.7% vs 25%; ns). HIV+ had a lower proportion of extraintestinal manifestations (10.7% vs 25.4%; P=0.005). Although it was not statistically significant, a trend towards a lower proportion of hospitalizations (25.6% vs 35.3%) and IBD complications (6.3% vs. 9.2%) in HIV+ was observed. Regarding IBD therapeutic requirements, immunosuppressant (40.5% vs 58.7%; P=0.003) and biological drugs (28.3% vs 42.8%; P=0.020) were used less frequently among HIV+ than among controls. Conversely, HIV+ had a higher rate of OI (38.3% vs 17.8%; P Conclusion The coexistence of IBD and HIV infection seems to be associated with a less aggressive IBD phenotype and a lower use of immunosuppressants and biologicals but with a remarkable rate of OI.

Background CT-P13 is the first and only subcutaneous (SC) formulation of infliximab (IFX) which received EMA approval in July 2020 for the treatment of Crohn’s disease (CD) and ulcerative colitis (UC). This study compares efficacy and safety between IFX SC and vedolizumab (VDZ) in moderate-to-severe CD or UC patients using data from the pivotal study of IFX SC, VISIBLE 2 and recently presented systematic literature review and meta-analysis [1]. Methods This comparative study analyses 7 randomised controlled trials. The IFX SC trial (NCT02883452) was compared with the VDZ trials including GEMINI II, GEMINI III, VISIBLE 2 for CD and GEMINI I, VISIBLE 1, and VARSITY for UC. VISIBLE 2 was added in this analysis as it was published after the presented meta-analysis. In all studied VDZ trials, only responders at week 6 continued to receive maintenance treatment except VARSITY trial, which followed a treat-through design. Crohn’s Disease Activity Index (CDAI)-70, CDAI-100 response and clinical remission for CD, and clinical response, clinical remission, and mucosal healing for UC at week 6 (induction) and 1 year (week 50–54, maintenance) were compared between IFX SC and VDZ for evaluating efficacy. Discontinuation due to lack of efficacy and safety profiles over 1 year were also assessed. Results In the patients with CD, IFX yielded significantly better efficacy results in the induction phase compared to VDZ with non-overlapping 95% confidential interval while IFX SC displayed better results, although statistically non-significant during the maintenance phase (Table 1). In UC, similar efficacy was shown between the treatments during both induction and maintenance phase (Table 2). The proportion of patients discontinued due to lack of efficacy was significantly higher in VDZ compared to IFX SC in both CD (IFX SC 5% and VDZ 32%) and UC (IFX SC 3% and VDZ 15%) over 1 year (Tables 1,2). The safety profiles were generally comparable between IFX SC and VDZ. Similar proportion of patients experienced serious adverse event (9% and 14% in CD; 12% and 11% in UC in IFX SC and VDZ). The proportion of patients experiencing serious infection between the treatments was also similar in both CD and UC (Tables 3,4). Conclusion Better efficacy was shown in IFX SC compared to VDZ in CD, while a similar efficacy was shown in UC. A significantly higher proportion of patients were discontinued due to lack of efficacy in VDZ compared to that of IFX SC over 1 year. Safety profiles over 1 year were generally comparable between IFX SC and VDZ in both indications. Reference 1. Peyrin-Biroulet, L. (2021). P0414 Efficacy and safety of infliximab and vedolizumab in patients with inflammatory bowel diseases: a systematic review and meta-analysis. Poster presented at: 2021 UEG Week.

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.

Background A less aggressive phenotype of Crohn’s disease (CD) has been reported in patients with elderly onset CD. Despite this, similar surgical rates among younger and older CD patients have been reported. However, scarce data are available about the risk of postoperative recurrence (POR) regarding the age, and no data are available about the use of immunosuppressants and biological agents for prevention of POR in elderly patients. Our aim was to evaluate the management of CD in the postoperative setting and the rate of surgical POR in CD patients according to the age at surgery. Methods Cohort study including all adult CD patients in the ENEIDA registry (a prospectively-maintained database of the Spanish Working Group in IBD –GETECCU-) who underwent a first intestinal resection with ileo-colonic anastomosis. Patients were grouped regarding their age at the moment of the first surgery: over 60 years (elderly) and between 18 and 60 years of age (controls). Preventive treatment for POR, surgical POR (need for a further intestinal resection) and postoperative morbidity were compared between both groups. Results Out of the 69,740 IBD patients included in the ENEIDA database, 3,982 had a first intestinal resection for Crohn’s disease with an ileo-colonic anastomosis between 2005 and 2020. Of them, 535 were elderly and 3,454 controls. Time from IBD diagnosis to surgery was significantly longer in the elderly (114±128 vs. 93±97 months; p Conclusion The elderly patients show similar rates of surgical POR as compared to younger patients. Given the high risk of thiopurine and anti-TNF-related adverse events, elderly patients with inflammatory pattern would benefit from preventive therapy with safer biologicals.

Background Our aims were: 1.) to compare the characteristics of SARS-CoV-2 infection in IBD patients in the second and third wave with respect to the results published in our site in the first wave (I. Guerra et al. Inflamm Bowel Dis. 2021 Jan 1;27(1):25–33) and 2.) to compare the date of the second and third wave with data of general population from the Autonomous Community of Madrid Methods Cohort, observational study in IBD patients followed in our IBD Unit with SARS-CoV-2 infection between March 2020 and May 2020 (first wave) and between July 2020 to March 2021 (second-third wave). All data were collected by telephone interview and reviewing the electronical medical records Results The demographic characteristics of the patients included are shown in Table 1. Table 1. First Wave(Nº of cases 28/805) Second-Third wave(Nº of cases 51/805) P-Value Mean age 55±14 y 45±13 y 0.004 Gender (female) 13 (46.4%) 29 (56.9%) 0.61 Type of IBD (Crohn’s disease) 11 (39.3%) 29 (56.9%) 0.38 Smoking (Yes) 1 (3.6%) 12 (23.5%) 0.048 Cormobilities (Yes) 17 (60.7%) 15 (29.4%) 0.09 IMM treatment (Yes) 10 (35.7%) 19 (37.3%) 0.92 Anti-TNF treatment (Yes) 5 (17.8%) 15 (29.4%) 0.27 Regarding clinical features of SARS-CoV-2 infection in both group of patients are represented in Table 2. Table 2. First Wave(Nº of cases 28/805) Second-Third wave(Nº of cases 51/805) P-Value Digestive symptoms 14 (50.0%) 22 (43.1%) 0.64 Cough 21 (75.0%) 13 (25.5%) 0.0096 Fever 24 (85.7%) 22 (43.1%) 0.07 Dyspnoea 13 (46.4%) 9 (17.6%) 0.045 Dysosmia/dysgeusia 17 (60.7%) 20 (39.2%) 0.11 Headache 17 (60.7%) 13 (25.5%) 0.04 Myalgia 11(36.3%) 10 (19.6%) 0.15 Severity (moderate-severe) 15 (53.6%) 6 (11.7%) 0.031 IUC admission 1 (3.5%) 0 (0%) 0.18 Mortality 1 (3.5%) 1 (2.0%) 0.61 Any treatment for COVID-19 infection (Yes) 15 (53.6%) 5 (9.8%) 0.0014 Temporary withdrawal of IBD treatment (Yes) 13 (46.4%) 6 (11.7%) 0.009 The severity of disease was not related to immunomodulators and/or biological treatments in both cohorts. The number of COVID-19 cases by date in our IBD Unit in comparison with the cases in the Community of Madrid are shown in the Figure 1. Conclusion The patients diagnosed in the first wave were older and more symptomatic. Although the number of severe cases was higher in the first wave, influenced by the limited availability of tests in that period, no difference was found in mortality or in the percentage of ICU admissions.Severity of SARS-CoV-2 infection was not related to immunosuppression and in the second-third wave the IBD treatment was maintained more frequently.The distribution of cases in our series was in concordance with the data obtained in the general population.

Background HLA-DQA1*05 Carriage is associated with development of anti-drug antibodies to infliximab in patients With Crohn’s Disease (Sazonovs et al. Gastroenterology 2019). Our group has shown that the presence of this allele is also an independent predictor of secondary loss of response to infliximab (Guardiola J, ECCO 2019) and adalimumab (Guardiola J ECCO 2020). However, the impact of the HLA-DQA1 * 05 allele on the initial response and persistence of IFX in the first months of treatment is unknown. Methods This is a retrospective cohort study from a prospectively maintained data base at the Hospital Universitari de Bellvitge (third level teaching hospital) Patients with Crohn’s Disease (CD) or Ulcerative Colitis (UC) who initiated IFX to induce remission and who had been followed up for failure or a minimum of 6 months were included. Failure at IFX was defined as the need of escalation or change treatment, surgery, or hospitalization for the first 6 months. Results 99 patients (65 MC, 34 CU) were included. In 63 (63.63%) IFX failed. 39 (39%) were carriers of the HLA-DQA1 * 05 allele. In multivariate analysis, HLA-DQA1*05 carriage (HR 1.9, 95% CI 1.14–3.31 p=0.015), the use of immunomodulators (HR 0.38, 95% CI 0, 23–0.66 p = 0.001) and suffering a CU vs. MC (HR 1.72, 95% CI 1.02–2.89 p = 0.041) were independent predictors of IFX failure. HLA-DQA1 * 05 was also associated with non-persistence of treatment (HR 2,4,95% CI1.45–3.99 p = 0.001). Figure A Conclusion HLA-DQA1*05 carriage is common in patients with IBD and it’s associated with a marked increase in the risk of loss of response to infliximab. Testing for HLA-DQA1*05 would allow treatment to be tailored according to the risk of loss of response.

Background Clinical trials and real-life studies with Ustekinumab in Crohn’s disease show its good efficacy and safety profile. However, there are hardly any data on elderly patients, who are excluded from these clinical trials. Our aim is to evaluate these variables in real-life practice. Methods Retrospective analysis of patients from the prospectively maintained ENEIDA registry treated with Ustekinumab for Crohn’s disease. Elderly patients were selected as those over 60 years old at the start of treatment. They were compared with 2 randomised controls from the same centre, aged less than 60 years, matched for smoking habit. The degree of comorbidity was assessed using the Charlson’s index. Clinical and biochemical activity and effectiveness were defined based on Harvey-Bradshaw index and calprotectin and CRP levels at weeks 16, 32 and 54, when available. Results A total of 648 patients were analysed, 212 elderly (mean age 67 [63.6;72.8] years) and 436 young (mean age 41.6 [32.6;50.0] years). No differences were observed between both groups in baseline variables except for the degree of comorbidity, higher in elderly patients (1.00 [0.00;2.00] vs 0.00 [0.00;0.00], p Clinical response rate was similar in both groups at week 16 (70.5% vs 76.6%, p=0.199), week 32 (67.6% vs 70.2% p=0.104) and week 54 (74% vs 74.9%, p=0.326). Steroid-free remission and biochemical response also showed no differences throughout follow-up. The rate of adverse effects was similar in both groups (14.2% vs 11.2%, p=0.350) except for the occurrence of de novo neoplasms, which was higher in the elderly group (0.69% vs 4.25%, p=0.003). The rate of severe infections (7.08 vs 7.34, p=1.000), the need for surgery (16.5% vs 20.0%, p=0.345) and the need for hospital admission (21.7% vs 19.0%, p=0.489) did not differ. Persistence of UST treatment was similar in both groups (log Rank test p=0.91). Conclusion Ustekinumab achieved clinical response in almost three-quarters of elderly patients, similar to the younger population, with no increase in the rate of infections or other adverse effects, with the exception of de novo neoplasms.

Background It has been reported that familial aggregation occurs in 10–20% of inflammatory bowel disease (IBD) patients1. Familial IBD has been associated with disease anticipation2 and with an increased need for immunosuppressants3 and surgery4. However, most studies were performed before the widespread use of biological agents and this may impact on the need for surgery. We aimed to compare the clinical outcomes of IBD (by means of the need for biological therapy and abdominal surgery) between familial and sporadic forms of IBD in the era of biological therapies. Methods Data were extracted from the ENEIDA registry by GETECCU, a Spanish, prospectively-maintained, IBD database in which more than 80 centers are participating. Only adult patients diagnosed with IBD since 2005 and prospectively followed in the registry since diagnosis were included. Familial IBD was defined as those cases with at least one first-degree relative diagnosed with IBD. Sporadic IBD was defined as those cases with no familial relative (of any degree) with IBD. Kaplan-Meier survival curves were performed to evaluate the cumulative probabilities of remaining biologic-free and surgery-free. Log-rank test was performed to compare them between familial and sporadic IBD forms. Chi-square test was performed for the rest of variables. Results A total of 5,263 patients (2,627 Crohn’s disease [CD]; 2,636 ulcerative colitis [UC]) were included. Of them, 507 (10%) were familial cases (274 CD, 233 UC; P=0.05). The median follow-up was 38,4 and 35.5 months, respectively (P=0.086). Familial cases were younger (P=0.022) and had a higher proportion of females among UC cases (P=0.048). No differences were observed in the need for biological therapy in both CD and UC between familial and sporadic IBD. Regarding surgery, no differences were observed in the cumulative probabilities of a first intestinal resection for CD and colectomy for UC. Similar results were obtained when all the analyses were restricted to those subgroups at high-risk for surgery (i.e. CD with ileal involvement and extensive UC). Conclusion In patients diagnosed with IBD in the era of biological therapies, familial forms have the same requirements for biological agents and resectional surgery as sporadic forms. Therefore, familial aggregation does not seem to be a factor for a more aggressive disease.

[Background and Aims] Steroid-dependency occurs in up to 30% of patients with ulcerative colitis [UC]. In this setting, few drugs have demonstrated efficacy in inducing steroid-free remission. The aim of this study was to evaluate the efficacy and safety of adding granulocyte/monocyte apheresis [GMA] to oral prednisone in patients with steroid-dependent UC., [Methods] This was a randomized, multicentre, open trial comparing 7 weekly sessions of GMA plus oral prednisone [40 mg/day and tapering] with prednisone alone, in patients with active, steroid-dependent UC [Mayo score 4–10 and inability to withdraw corticosteroids in 3 months or relapse within the first 3 months after discontinuation]. Patients were stratified by concomitant use of thiopurines at inclusion. A 9-week tapering schedule of prednisone was pre-established in both study groups. The primary endpoint was steroid-free remission [defined as a total Mayo score ≤2, with no subscore >1] at Week 24, with no re-introduction of corticosteroids. [Results] In all 123 patients were included [63 GMA group, 62 prednisone alone]. In the intention-to-treat analysis, steroid-free remission at Week 24 was achieved in 13% (95% confidence interval [CI] 6–24) in the GMA group and 7% [95% CI 2–16] in the control group [p = 0.11]. In the GMA group, time to relapse was significantly longer (hazard ratio [HR] 1.7 [1.16–2.48], P = 0.005) and steroid-related adverse events were significantly lower [6% vs 20%, P < 0.05]. [Conclusions] In a randomized trial, the addition of 7 weekly sessions of GMA to a conventional course of oral prednisone did not increase the proportion of steroid-free remissions in patients with active steroid-dependent UC, though it delayed clinical relapse., This work was supported by an unrestricted research grant from Otsuka Pharmaceuticals.

Background Crohn’s disease (CD) and ulcerative colitis (UC) evolve with alternate outbreaks and remissions of variable duration. Tumour necrosis factor α antagonists (anti-TNFα) have enhanced the treatment of patients with inflammatory bowel disease (IBD), improving the patient’s quality of life by reducing the number of surgeries and hospitalizations. Despite these advances, about 10–30% of patients do not respond to the treatment after the induction period. Recent studies have pointed, on one hand, gut microbiota can play a role in the anti-TNFα treatment response as gram-positive bacteria can modulate the response of NOD proteins and, on the other hand, gram-negative bacteria can stimulate TLR4 receptors causing activation of NFkß. This study aimed to define a microbial signature that could be used to predict the response of patients with CD and UC to anti-TNFα treatment. Methods This observational study consisted of obtaining a stool sample from 38 IBD patients before starting an anti-TNFα treatment. Patients were recruited at Hospital Universitari Dr. Josep Trueta (Girona) and Hospital Universitari de Bellvitge (l’Hospitalet de Llobregat). During the one-year follow-up period, disease activity levels, faecal calprotectin evolution, and anti-TNFα antibody levels were analysed to assess response to treatment, differentiating 2 groups: responders and non-responders. From each sample, DNA was purified and used in a qPCR for the quantification of the following markers: F. prausnitzii (Fpra) and its phylogroups (PHG-I and PHG-II), E. coli (Eco), A. muciniphila (Akk), Ruminococcus sp. (Rum), Bacteroidetes (Bac), M. smithii (Msm), and the total bacterial load (Eub). Results In this proof of concept, the predictive ability to identify anti-TNFα treatment responders was analysed. Individually, none of biomarkers demonstrated the ability to differentiate between groups with high sensitivity and specificity. However, an algorithm consisting of the combination of 5 microbial markers (Msm, Fpra, PHGII, Rum, and Eub) showed a high capacity to discriminate between responders and non-responders. The algorithm proved high sensitivity and specificity reporting values ​​of 93.33% and 100%, respectively, with a positive predictive value of 100% and a negative predictive value of 75% for predicting response to biologic treatment. Conclusion A specific microbial signature could beneficiate patients with IBD by predicting the therapeutic effectiveness of an anti-TNFα treatment, which could lead to a personalized therapy, improving the patients’ quality of life, saving costs, and gaining time in patient recovery.A larger prospective study will be needed to validate these results.

Background Data about the SARS-CoV-2 infection in inflammatory bowel disease patients (IBD) are scarce. Our aim was to analyse the incidence, clinical presentation, and severity of SARS-CoV-2 infection in IBD patients in the second and the third wave of infection. Methods Cross-sectional, observational study in IBD patients with confirmed SARS-CoV-2 infection by RCP and/or antigen tests from 01 July 2020 to 01 March 2021. All data were collected by telephone interview and reviewing the electronical medical records. Results Fifty-one of 805 IBD patients followed in our Unit were diagnosed of SARS-CoV-2 infection in this period (6.3%; 95% CI 4.6–8.0). Mean age: 45±13 years old; 56.9% female, 23.5% smokers, 56.9% Crohn’s disease, 29.4% comorbidities and 17.6% asymptomatic. Digestive symptoms were reported in 22 patients (43.1%), with diarrhoea as the most common (39.2%, median duration: 4 days; IQR 1–7). The most frequent symptoms other than diarrhoea were low-grade fever/fever in 43.1% (median duration: 3 days; IQR 1–6.5) and dysosmia/dysgeusia in 39.2% (median duration: 15 days; IQR 7–30). Only one patient (2%) was diagnosed with IBD flare-up during infection. Six patients (11.8%) temporarily withdrew their IBD treatment because of COVID-19. Most of the patients had a mild disease (88.2%), no patient had to be admitted in the intensive care unit. Only one patient died (2%) due to SARS-CoV-2 infection and multiple previous comorbidities, 52 years old male with ulcerative colitis in treatment with Mesalazine and dendritic cell sarcoma, common variable inmunodefiency, and primary sclerosing cholangitis progressing to cirrhosis. In the multivariate analysis, the presence of dyspnoea was associated with more severe infection (p=0.007; OR:25.7; 95% CI 2.4–277.8). Patients on immunomodulators and/or biological therapy did not have more severe disease compared to non-immunosuppressed patients (p>0.05). Conclusion SARS-CoV-2 infection was relatively frequent is our series. Dyspnoea was associated with a more severe infection. Severity of SARS-CoV-2 infection was not related to immunosuppression or development of IBD flare-ups and only a small percentage of patients needed to modify IBD medication during infection