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Background Post-marketing data are required to confirm the durability and the long-term benefit and safety of UST in CD in clinical practice. Our aims were: (1) to evaluate the retention rate of UST in CD patients and to identify predictive factors of UST discontinuation; (2) to assess UST short-term effectiveness; (3) to analyse the durability of the response to UST in the long-term; and (4) to evaluate the safety of UST in clinical practice. Methods Retrospective, multicentre study (>60 centres). Patients with active CD [(Harvey–Bradshaw (HBI) >4)] that received at least one dose of UST intravenously before July 2018 were included. Clinical activity plus biochemical parameters were assessed at every UST administration. Clinical remission was defined as HBI score ≤4, and clinical response as a decrease in HBI ≥3 points. Loss of efficacy was defined as reappearance of symptoms that led to intensify the treatment dose, add another medication to control CD, switching or surgery in patients with short-term remission. The retention rate of UST treatment and the cumulative incidence of loss of efficacy were evaluated by survival curves, and predictive factors were assessed by Cox-regression. The short-term response was evaluated at week 8 and after the induction (week 16). Factors associated with short-term remission were assessed by multivariate analysis. Adverse events were recorded. Data quality was assured by remote monitoring. Results 331 CD patients have been included up to date (Table 1). The incidence rate of UST discontinuation was 15% per patient-year of follow-up: 8%, 13% and 20% at 6, 12 and 18 months (Figure 1). Previous surgery was the only factor associated with a higher risk of UST discontinuation [Hazard ratio (HR) = 2.03, 95% confidence interval (CI) = 1.1–3.6]. Short-term efficacy is shown in Figure 2. Previous surgery (OR = 0.3, 95% CI = 0.2–0.6) and higher HBI score at baseline (OR = 0.8, 95% CI=0.8–0.9) were associated with an impaired response to UST at week 16. The cumulative incidence of loss of response was 32% per-patient-year of follow-up (Figure 3); A higher HBI score at baseline was associated with a higher risk of losing response (HR = 1.2, 95% CI = 1.1–1.3). Neither the concomitant treatment with immunosuppressants nor the number of previous biologics were associated with UST short- and long-term benefit. Thirty adverse events were reported in 25 (7%) patients (Table 2). Conclusion Sustain is the largest real clinical practice study of UST to treat CD patients with the longest follow-up reported to date. UST was demonstrated to be effective in real-world use in the short and long run. Safety was consistent with the known profile of UST.

Aim To assess the likelihood of detecting latent tuberculosis infection [LTBI] by the positive conversion of a serial tuberculin skin test [TST] at 1 year in inflammatory bowel disease [IBD] patients with negative baseline two-step TST. Methods In this multicentre prospective cohort study, we evaluated rate and predictors of conversion of TST at 1 year in patients with negative baseline TST. We also evaluated management of patients who had a positive TST at baseline or a conversion at 1 year. In all patients we assessed TB cases occurring during follow-up. Results Of the 192 IBD patients receiving anti-tumour necrosis factor [TNF] and 220 IBD controls not receiving anti-TNF, 35 [8.5%, 95% CI 5.7-11.3] had positive conversion (median TST induration 13 mm, interquartile range [IQR] 9-16). Ten anti-TNF cohort patients [5.2%, 95% CI 2.5-9.5] versus 25 controls [11.4%, 95% CI 7.5-16.3] had TST conversion [p = 0.029]. In multivariate analysis, conversion was associated with smoking habit (odds ratio [OR] 2.19, 95% CI 1.08-3.97; p = 0.028). Anti-TNF-treated patients had a lower conversion rate [OR 0.41, 95% CI 0.20-0.83; p = 0.013]. The likelihood of conversion correlates with fewer immunosuppressive therapies between baseline TST and TST at 1 year [p = 0.042]. One case of active TB [isoniazid-resistant strain] occurred in a patient with positive baseline TST receiving anti-TNF [0.05 events/100 patient-years]. Conclusions Serial TST at 1 year can detect LTBI in IBD patients receiving anti-TNF therapy with negative baseline TST. Serial TST seems to be advisable to reduce the risk of TB cases associated with inability to detect LTBI in pre-treatment screening.

Background Inflammatory bowel disease (IBD) is considered a chronic inflammatory state that has been associated with nonalcoholic fatty liver disease (NAFLD). Insulin resistance (IR) has been linked to NAFLD and inflammation. Whether if IR is prevalent in IBD and increases the risk of NAFLD in these patients is unknown. We aimed to study if IR is prevalent in a cohort of patients with IBD and associated risk factors. Methods This multicentric cross-sectional study compared 151 IBD patients with 174 age matched non-diabetic controls. Insulin and C-peptide serum levels and IR and beta cell function (%B) indices by homoeostatic model assessment (HOMA2) were evaluated. In the IBD patients fatty liver disease (FLD) was assessed by ultrasound (Grade I-IV) and Transition elastography (Fibroscan ®, values were correlated to liver fibrosis as: 14KPa =F4). .Anthropometric, IBD characteristics, biochemical parameters and concomitant diseases were registered as predictive factors for having IR among IBD patients and assessed by multivariable regression analysis. Results IBD patients (57% female, mean age 48 years(SD 10)), compared to matched controls (68% female, mean age 50 years(SD 16)) exhibited similar HOMA2-IR (0.97 ± 0.64 vs 1.31 ± 0.80, p=0.19) and HOMA2-%B indexes (126 ± 49 vs 134 ± 47, p=0.31) after adjusting by confounders. Obesity, abdominal circumference and triglycerides were associated with the presence of IR in IBD patients, whereas IBD disease patterns, disease activity and inflammatory markers were not related to IR. Mild and moderate FLD was present in 26% and 13 % of IBD patients, respectively. FLD grades correlated with a higher insulin and C-peptide and IR indices as observed in the univariable analysis for HOM2-IR (0.06 (0.01–0.11)) and for HOM2-%B 6(3–10) indices. Patients with severe fat infiltration had higher serum levels of insulin and C-peptide and a superior HOM2-IR (2.4 ± 1.6, p=0.01) and HOMA2-%B (251 ± 40, p Conclusion IBD patients show a similar prevalence of IR compared to controls. However, likewise in the general population, metabolic syndrome factors are associated with IR and FLD, so metabolic syndrome assessment is mandatory among IBD patients.