Background/Objectives: Celiac disease (CeD) is a complex autoimmune enteropathy triggered by gluten intake in genetically predisposed individuals. While the bacterial microbiome has been extensively studied in CeD, the role of the gut virome and mycobiome is less well defined. Emerging evidence suggests that viruses and fungi may influence mucosal immunity, intestinal permeability and gluten tolerance, acting as potential environmental cofactors in the onset of this disease. Methods: A narrative review of the literature was conducted to summarize current knowledge of the composition, development and function of the gut virome and mycobiome and to explore their potential involvement in CeD pathogenesis. Results: The gut virome shows high interindividual variability and dynamic maturation early in life. Multiple studies have associated early enterovirus or parechovirus infections with an increased risk of celiac autoimmunity, supporting a virus-gluten "double hit" model. Viral dysbiosis in CeD has been reported to include an enrichment of human polyomavirus 2 (JC polyomavirus) and of specific enterobacterial phages. The mycobiome, although less abundant, also displays disease-associated alterations: cross-sectional mycobiome studies have reported higher relative abundance of Saccharomyces, Candida, and Tricholomataceae and lower relative abundance of Pichia and Pneumocystis taxa in children with CeD. Conclusions: Current evidence, although preliminary, supports associations between selected viral exposures and CeD-related immune alterations, whereas current phageome and mycobiome findings mainly describe cross-sectional compositional differences. These data do not establish temporal direction or causality, and further longitudinal and mechanistic investigations are required before preventive or therapeutic implications can be considered.

Treatment of Crohn's disease (CD) is complex and based on different drugs. The biological treatments act on different stages of immunophysiopathological processes of the disease to change the evolution or natural history. The targets of these therapies, most of which are still experimental, and still off label in pediatrics, are highly selective and include proinflammatory cytokines, the CD4 positive T cells, the Thl and Th2 subgroups and adhesion molecules. At present monoclonal antibodies against TNF-a studied and/or used for Crohn's disease are four: a chimerical one (Infliximab), a 95% humanized one (CDP 571), a humanized and pegylated one (Certolizumab pegol) and finally a fully humanized type (Adalimumab). On the contrary, have been considered TNF-a recombinant receptors (Etanercept and Onercept) that have proven be ineffective for the treatment of active CD. The paediatric Crohn's is an early onset form of disease, that much better takes advantage of biological therapy compared with late onset adulthood forms.

Many organs have been described as involved in long-COVID processes. Concerning the stomach, few cases have been reported and discussed. Particularly, we have very few information about the potential direct damage to the gastric mucosa caused by SARS-CoV-2. We report the case of a 45-year-old Italian woman with no known chronic diseases or food intolerances who developed severe gastrointestinal manifestations as long COVID-19 manifestation following a SARS-CoV-2 infection. During the acute phase of COVID-19, she exhibited, among other symptoms including respiratory ones, an intense vasculitis affecting the superficial veins of the lower limbs and near-total desquamation of the lingual epithelium. Treatment with corticosteroids (betamethasone) led to complete remission in a few days. However, after recovery, she suddenly developed worsening heartburn and esophageal reflux. A year later, she was diagnosed with severe gastritis and mild dysplasia of the gastric body. Anamnesis revealed new-onset food intolerances to gluten-containing food and dairy foods. Histological examination showed Helicobacter pylori (HP) infection. After eradication therapy and dietary modifications, her gastric inflammation regressed, and dysplasia resolved. We hypothesize that SARS-CoV-2 may have triggered disruption of the gastric mucosa homeostasis, in turn leading to both food intolerances and HP proliferation. This case raises the question of whether SARS-CoV-2-induced molecular mimicry mechanisms may have long-term consequences on the gastric muco-microbiotic layer and in turn on the whole gastric homeostasis.

The mucus layer covering the gastrointestinal tract forms a specialised interface where mucins, microbes, and extracellular vesicles create a dynamic, self-regulating ecosystem. Here, we introduce the concept of the muco-microbiotic layer as an integrated eco-physiological system that maintains mucosal homeostasis through coordinated structural, metabolic, and immune functions. The MuMi layer varies regionally in its biochemical composition, microbial inhabitants, and environmental parameters—from the acidic stomach to the anaerobic colon—thereby generating distinct niches for microbial colonisation and metabolite production. We summarise current evidence on how mucin glycans, mucus-associated microbiota, and vesicle-mediated signalling sustain barrier integrity, nutrient flux, and immune tolerance. Perturbations in any of these components lead to barrier failure, microbial encroachment, and inflammation, contributing to a broad spectrum of disorders, including gastritis, inflammatory bowel disease, colorectal cancer, and metabolic syndrome. Methodological advances such as organoid and mucus-on-chip models, spatial multi-omics, and vesiculomics are now enabling site-specific analyses of this complex system. Conceptually, defining the mucus, microbiota, and vesicular compartments as a single MuMi layer provides a new framework for understanding mucosal physiology and pathophysiology, emphasising the interdependence between structure and function. Integrating this perspective into experimental and clinical research may open new avenues for diagnostics and therapies targeting mucosal health.

Background/Objectives: An increasing number of studies have reported liver involvement in both children and adults with celiac disease (CD). This often manifests as isolated hypertransaminasemia or hepatic steatosis (HS). The aim of this study was to define the prevalence of hypertransaminasemia and HS in a pediatric population with CD before starting a gluten-free diet (GFD) and to analyze how the introduction of a GFD could modify this condition. We also conducted a state-of-the-art literature review of the association between hypertransaminasemia, metabolic dysfunction-associated steatotic liver disease (MASLD) and CD. Methods: We retrospectively reviewed the clinical charts of pediatric CD patients diagnosed in three different pediatric units of Sicily, analyzing clinical, laboratory, ultrasound, and histology data before and 12 months after the introduction of a GFD. Results: A total of 160 patients (65.0% females, median age 6.4 (0.8-13.2) years) were included; hypertransaminasemia and HS prevalences at diagnosis were 8.1% and 6.1%, respectively. Subjects with hypertransaminasemia were younger (p = 0.01) than those without and had higher frequencies of HS (p = 0.034) and anti-tissue transglutaminase (tTg) immunoglobulin (Ig)G positivity (p = 0.046). Subjects with HS were younger (p = 0.0001) and had a higher frequency of hypertransaminasemia (p = 0.029) compared to non-steatotic ones. After 12 months of a GFD, hypertransaminasemia and HS persisted in 53.8% and 50.0% of patients, respectively. Conclusions: The prevalences of hypertransaminasemia and HS in Sicilian pediatric CD patients seem to be lower than those reported in other geographical areas. A GFD can reverse the trend of liver involvement, although periods of longer than 12 months may be necessary. However, a GFD has been associated with an increased prevalence of HS, and so regular follow-up involving a nutritionist should be recommended to guide physicians in patient management.

Chronic infection with Helicobacter pylori is the leading environmental cause of gastric carcinogenesis, yet the molecular pathways remain incompletely defined. This review links H. pylori-derived outer membrane vesicles (OMVs) and host epithelial exosomes through their shared cargo of heat shock protein 60 (GroEL/Hsp60). We proposed the concept of the “muco-microbiotic layer” as a fifth, functionally distinct layer of the gastric wall, where bacterial and host extracellular vesicles (EVs) interact within the mucus–microbiota interface. In this compartment, OMVs carrying bacterial GroEL and exosomes containing human Hsp60 engage in bidirectional communication that may promote chronic inflammation and epithelial transformation, with putative participation of molecular mimicry. The high structural homology between microbial and human Hsp60 enables repeated immune exposure to trigger cross-reactive responses—potentially leading to autoimmune-driven tissue damage, immune tolerance, and immune evasion in pre-neoplastic lesions. This vesicular crosstalk aligns with the evolution from non-atrophic gastritis to atrophy, from intestinal metaplasia to dysplasia, and lastly adenocarcinoma. Therapeutically, targeting EV-mediated Hsp60/GroEL signaling might offer promising strategies: EV-based biomarkers for early detection, monoclonal antibodies against extracellular Hsp60/GroEL, modulation of vesicle release, and probiotic-derived nanovesicles to restore mucosal balance. Hence, recognizing the muco-microbiotic layer and its vesicle-mediated signaling provides a new framework for understanding the infection–inflammation–cancer axis and for developing diagnostic and therapeutic approaches in H. pylori-associated gastric cancer.

Epstein-Barr virus (EBV) infection is a common disease both in children and adults, but can lead to several complications; involvement of the blood system is often described, particularly neutropenia and thrombocytopenia, but autoimmune hemolytic anemia is rarely seen. A 12-year-old female was admitted to the “G. Di Cristina” Children’s Hospital of Palermo for jaundice and dark urine. Laboratory investigations revealed anemia, increased levels of total and undirect bilirubin, and elevated transaminases, serum lactate dehydrogenase, and reticulocyte count; a peripheral blood smear showed anisocytosis, and the direct antiglobulin test (DAT) for cold agglutinins was positive. The laboratory evaluation of infectious disease showed the presence of EBV VCA IgM and IgG. A diagnosis of acute autoimmune hemolytic anemia EBV related was made: the patient was initially treated with intravenous methylprednisolone and then with intravenous immunoglobulin, which led to a progressive clinical improvement until complete remission. Autoimmune hemolytic anemia is rarely associated with EBV infection; a review of the English literature revealed only 16 cases. Patients with autoimmune hemolytic anemia should always be evaluated for EBV serology, even in the absence of the typical clinical and hematological features of infectious mononucleosis. For these patients, good prognosis is generally expected.

Background: Dysbiosis, influenced by poor diet or stress, is associated with various systemic diseases. Probiotic supplements are recognized for stabilizing gut microbiota and alleviating gastrointestinal issues, like irritable bowel syndrome (IBS). This study focused on the tryptophan pathways, which are important for the regulation of serotonin levels, and on host physiology and behavior regulation. Methods: Nanovesicles were isolated from the plasma of subjects with chronic diarrhea, both before and after 60 days of consuming a probiotic mix (Acronelle®, Bromatech S.r.l., Milan, Italy). These nanovesicles were assessed for the presence of Tryptophan 2,3-dioxygenase 2 (TDO 2). Furthermore, the probiotics mix, in combination with H2O2, was used to treat HT29 cells to explore its cytoprotective and anti-stress effect. Results: In vivo, levels of TDO 2 in nanovesicles were enhanced in the blood after probiotic treatment, suggesting a role in the gut–brain axis. In the in vitro model, a typical H2O2-induced stress effect occurred, which the probiotics mix was able to recover, showing a cytoprotective effect. The probiotics mix treatment significantly reduced the heat shock protein 60 kDa levels and was able to preserve intestinal integrity and barrier function by restoring the expression and redistribution of tight junction proteins. Moreover, the probiotics mix increased the expression of TDO 2 and serotonin receptors. Conclusions: This study provides evidence for the gut–brain axis mediation by nanovesicles, influencing central nervous system function.

Background: The utilization of anti-tumor necrosis factor-α (anti-TNF-α) biosimilars in inflammatory bowel disease (IBD) is constantly increasing. However, pediatric data are limited. This study aimed to assess the effectiveness and safety of adalimumab biosimilar (ADL-BioS) in pediatric IBD patients. Methods: All consecutive pediatric IBD patients from the Sicilian Network for Inflammatory Bowel Disease cohort treated with ADL-BioS from 2019 to 2021 were recruited. Remission at weeks 14 and 52, treatment persistence, and adverse events were the endpoints of this study. Factors associated with clinical remission and treatment persistence were examined. Results: There were 41 patients in total. Nine (22%) patients were switched from the reference product to ADL-BioS. Two patients had multiple switches. Eleven months was the median follow-up period. Clinical remission was attained by 70.7% and 72.0% of patients on weeks 14 and 52, respectively. Four (9.8%) adverse events occurred (10.1/100 person-year). Treatment persistence was 85.4% at 1 and 2 years. Patients with a longer duration of disease had a higher probability of stopping their treatment (p = 0.036). Conclusions: This is the first real-world study that particularly addresses the use of ADL-BioS in pediatric IBD. With high rates of treatment persistence and a low frequency of non-serious side effects, ADL-BioS seems to be effective.

BACKGROUND:The aim of this study is to compare two groups of celiac patients: the first one, in which diagnosis was based on a "biopsy sparing" approach according to the 2012 ESPGHAN criteria, and the second one, based on the biopsy approach like the one of the 1991 Revised Criteria, in order to find relevant difference for sex, M/F ratio, age at diagnosis, clinical features at the onset, presence and prevalence of concomitant autoimmune disorders.METHODS:Our study involves 61 patients having the Celiac Disease (CD) onset from February 2013 to February 2020. The 32 patients who received diagnosis according "biopsy sparing" criteria were enrolled in group (1) The 29 patients who received diagnosis by duodenal biopsy were enrolled in group (2) Prevalence of comorbidities was analysed through chi-square test.RESULTS:In group 1 the prevalence of comorbidities such as Insulin-Dependent Diabetes Mellitus (IDDM) and thyroiditis was of 53%, while in group 2 it was only of 24%. Analysing the IDDM prevalence between the two groups we found a relevant difference. At the same time, the prevalence of thyroiditis was also significantly different. In group 1, male patients, in particular, would seem to have a higher incidence of CD related autoimmune disorders.CONCLUSIONS:An increased prevalence of IDDM, thyroiditis and juvenile idiopathic arthritis (JIA) in the first group would show that the "biopsy sparing" approach could expose patients to a greater length of disease activity that might be responsible for the onset of such comorbidities. Further studies should be carried out on more numerous samples of patients in order to confirm or not these data.

The current carbapenem-resistant gram-negative bacteria (CR-GN) treatment guidelines lack strong evidence about cefiderocol (CFD) efficacy against CR-GN, especially CRAB. The study's purpose is to evaluate the effectiveness of CFD in a real-life setting. We made a single-center retrospective study of 41 patients who received CFD in our hospital for several CR-GN infections. Bloodstream infections (BSI) affected 43.9% (18/41) of patients, while CRAB affected 75.6% (31/41) of isolated CR-GN patients. Thirty-days (30-D) all-causes mortality affected 36.6% (15/41) of patients, while end-of-treatment (EOT) clinical cure affected 56.1% (23/41). Finally, microbiological eradication at EOT affected 56.1% (23/41) of patients. Univariate and multivariate analysis showed that septic shock is an independent factor associated with mortality. Subgroup analyses showed no difference in CFD effectiveness between monotherapy and combination therapy.

Background: Allergic disease, including food allergies (FA)s, has been identified as a major global disease. The first 1000 days of life can be a “window of opportunity” or a “window of susceptibility”, during which several factors can predispose children to FA development. Changes in the composition of the gut microbiota from pregnancy to infancy may play a pivotal role in this regard: some bacterial genera, such as Lactobacillus and Bifidobacterium, seem to be protective against FA development. On the contrary, Clostridium and Staphylococcus appear to be unprotective. Methods: We conducted research on the most recent literature (2013–2023) using the PubMed and Scopus databases. We included original papers, clinical trials, meta-analyses, and reviews in English. Case reports, series, and letters were excluded. Results: During pregnancy, the maternal diet can play a fundamental role in influencing the gut microbiota composition of newborns. After birth, human milk can promote the development of protective microbial species via human milk oligosaccharides (HMOs), which play a prebiotic role. Moreover, complementary feeding can modify the gut microbiota’s composition. Conclusions: The first two years of life are a critical period, during which several factors can increase the risk of FA development in genetically predisposed children.

Abstract Background The aim of our study is to compare two groups of celiac patients: the first one in which diagnosis was based on the New 2012 ESPGHAN criteria, and the second one based on the 1991 Revised Criteria in order to find relevant difference for sex, M/F ratio, age at diagnosis, clinical features at the onset, presence and prevalence of concomitant autoimmune disorders. Methods Our study involves 61 patients having the CD onset from February 2013 to February 2020. The patients who received diagnosis according to the New 2012 ESPGHAN Criteria were enrolled in group 1. The patients who received diagnosis according to the Revised 1991 Espghan Criteria were enrolled in group 2. Prevalence of comorbidities was analysed through chi-square test. Results In group 1 the prevalence of comorbidities such as IDDM and thyroiditis was of 53%, while in group 2 was only of 24%. Analysing the difference of the IDDM prevalence between the two groups we found a relevant difference. In the same way also the prevalence of thyroiditis was significantly different. In group 1, male patients, in particular, seem to have a higher incidence of CD related autoimmune disorders. Conclusions An increased prevalence of IDDM, thyroiditis and JIA in the first group shows that the new diagnostic criteria could expose patients to a greater lengthy of disease activity responsible for the onset of such comorbidities. Further studies should be carried out on more numerous samples of patient in order to confirm this data.

Background Acute pancreatitis is a disorder of reversible inflammation of the pancreas. Only a few cases are related to infections and the most common pathogens are the viruses responsible for mumps, parotitis, and influenza. Epstein-Barr virus (EBV)-associated acute pancreatitis is a rare condition and it may occur in children and adults. Case presentation A 3-year-old female was admitted to the “G. Di Cristina” Children's Hospital in Palermo for vomiting and abdominal pain. Laboratory investigations revealed elevated amylase and lipase, with normal liver function tests. Abdominal ultrasound demonstrated an enlarged pancreas, with hypoechogenic areas; no biliary lithiasis was observed. Infectious disease serology was positive for the presence of EBV VCA IgM and IgG. A diagnosis of EBV-associated acute pancreatitis was made. The patient was treated conservatively and recovered. Conclusions Acute pancreatitis is rarely associated with EBV infection; a review of the English literature revealed only 10 pediatric and 6 adult cases. Patients with pancreatitis should always be evaluated for EBV serology, even in the absence of the typical clinical and hematological features of infectious mononucleosis. For these patients, good prognosis is generally expected.

Objective To provide data on the use of infliximab biosimilars (IFX-BioS) in children with inflammatory bowel disease (IBD). Methods A multicenter, observational, retrospective study was performed among the cohort of the Sicilian Network for IBD. All consecutive IBD children who had at least completed the induction with IFX-BioS from its introduction in Sicily to January 2021 were enrolled. Clinical remission at weeks 14 and 52, treatment persistence, and adverse events were the study outcomes. Results Eighty-seven patients [Crohn’s disease (CD): 57.5% and ulcerative colitis (UC): 42.5%] were included: 75 (86.2%) were antitumor necrosis factor-α (anti-TNF-α) agent naïve, while three (3.45%) were switched from the originator to IFX-BioS. Twenty (23%) patients were multiply switched from the biosimilar CT-P13 to SB2 or GP1111 or vice versa. The median follow-up time was 15 months. Clinical remission was achieved by 55.2 and 65.5% of patients at weeks 14 and 52, respectively, with no differences between CD and UC. Dose escalation was needed in 8.0 and 35.7% of patients during induction and maintenance, respectively. Nine adverse events occurred (incidence rate: 6.13/100 person-year). Treatment persistence was 90.8% at 1 year and 75.7% at 2 years (patients on IFX-BioS at 2 years, n = 28). The risk of treatment discontinuation was higher in patients with extraintestinal manifestations (P = 0.018) and in those who were nonnaïve to anti-TNF-α (P = 0.027). Conclusion This is the largest cohort of pediatric IBD patients treated with IFX-BioS. Real-life data show that IFX-BioS is efficacious in IBD children, with high percentages of treatment persistence and a low incidence of nonserious adverse events.

Abstract Background Few data regarding the use of biosimilars of anti-tumour necrosis factor-a (TNF-a) in children with Inflammatory Bowel Disease (IBD) have been reported. We aimed to assess the efficacy and the safety of biosimilars of infliximab (IFX) and adalimumab (ADA) in paediatric-onset IBD. Methods This was a multicentre, observational, retrospective study performed among the cohort of the Sicilian Network for the Inflammatory Bowel Disease (SN-IBD) and including all patients with paediatric-onset IBD treated with the biosimilars of IFX or ADA. Demographic and clinical data were collected from medical records. PUCAI and PCDAI scores at the time of IFX start, after, 14 and, 54 weeks were recorded. The primary outcome was the rate of clinical remission at weeks, 14 and, 54. Secondary outcomes included treatment duration and incidence of adverse events. Results They were included, 128 patients, of whom, 87 on IFX biosimilar (group, 1) and, 41 on ADA biosimilar (group, 2) (Table 1). Table, 1.Baseline characteristics of patients At week, 14, UC patients on IFX biosimilar had a median PUCAI score of, 10 (IQR, 5.0–22.5), while CD patients a median PCDAI score of, 5 (IQR, 5.00–10.8). Overall, the remission rate on IFX biosimilar at week, 14 was, 61.5%, and it was significantly associated with positive family history [OR, 13.18 (2.44–245.65, p=0.015)], older age at starting biosimilar [OR, 1.19 (1.02–1.41, p=0.038)], and diagnosis of CD (in comparison to UC) [OR, 3.45 (1.35–9.23, p=0.011)]. At week, 54, both UC and CD patients on IFX biosimilar had a median clinical score of, 5. The remission rate was, 69.1%, and no significant association with any variable was found. Patients on ADA showed a remission rate of, 75% at, 14 weeks, and of, 70% at, 54 weeks, both associated with shorter disease duration [OR, 0.67 (0.45–0.93, p=0.025) and OR, 0.55 (0.28–0.86, p=0.026), respectively]. At, 54 weeks, patients on IFX showed a >90% failure-free survival (Figure, 1), which was inversely associated with the presence of extraintestinal manifestations (HR, 5.12, p=0.014) and non-naive patients (HR, 3.81, p=0.025). Patients on ADA biosimilar had >83% failure-free survival at, 12 months (Figure, 2), associated with shorter disease duration (HR, 1.41, p=0.043). About safety, a total of, 13 adverse events were registered, 9 in group, 1 (incidence of, 6.13/100 PY) and, 4 in group, 2 (incidence of, 12.23/100 PY). Most (n=7) were acute infusion reactions. Figure, 1.Failure-free survival on IFX biosimilar Figure, 2.Failure-free survival on ADA biosimilars Conclusion This is one of the largest cohorts of paediatric-onset IBD on biosimilars, and confirmed these drugs are effective and safe in this group of patients, with high percentage of failure-free survival at, 1 year and low incidence of mild adverse events.

Malnutrition is a multifactorial pathology in which genetic, epigenetic, cultural, environmental, socio-economic factors interact with each other. The impact that this disease has on the health of children worldwide is dramatic. Severe acute malnutrition in particular is a disease affecting nearly 20 million preschool children worldwide, most of them in Africa and South East Asia. This work aims to investigate potential prognostic factors in the clinical evolution of acute malnutrition and potential risk factors for the development of the disease. Our study was carried out at the “Hospital da Missão Catolica do Chiulo”, in Angola, where the NGO Doctors with Africa CUAMM has been operating since 2000. In the first part of the study we analyzed the characteristics and clinical evolution of 163 patients hospitalized for acute malnutrition at the UEN (Unidade Especial de Nutrição) of the Chiulo Hospital over a period of 6 months, in order to identify potential prognostic factors of the disease. The second part of our study was carried out by administering a questionnaire to a group of caregivers of malnourished children and to a group of caregivers of non-malnourished children admitted to Pediatrics for other causes, with the aim of identifying potential risk factors for the development of malnutrition. The analysis of prognostic factors revealed that the most relevant are the WHZ (weight for height z-score) at the time of admission, the presence of Stunting and the presence of other pathologies or clinical conditions associated with severe acute malnutrition. The analysis of risk factors has shown that not only food shortages, but also errors in the timing of the suspension of breastfeeding and the timing of the introduction of complementary foods play an important role. Equally important were some family risk factors, including the size of the family unit and the presence of deceased children. It also emerged that the lack of knowledge of what a child needs to grow up healthy often affects the development of malnutrition. It follows that a useful and low-cost tool for preventing child malnutrition would be large-scale nutrition education campaigns.

OBJECTIVE:The aim was to assess the awareness and real-life use of biosimilars in inflammatory bowel disease (IBD) among the members of the Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition (SIGENP).METHODS:An anonymous web survey involving all SIGENP IBD units which can prescribe biosimilars was conducted between July 1st and December 1st, 2020. The questionnaire included 18 questions addressing the most relevant aspects of biosimilars in pediatric IBD, i.e., advantages, disadvantages, costs, traceability, general knowledge, and real-life use. A descriptive analysis of responses was performed.RESULTS:Responses came from 26 pediatric IBD units in Italy, with representation of the North, the Center, and the South of Italy. The majority of participants (n = 20) had spent > 10 years caring for pediatric IBD patients, and worked in a center which had between 100 and 500 registered pediatric IBD patients (n = 14). Most participants (n = 18) reported they were aware that biosimilars have similar efficacy and safety to those of the originator, and all regarded cost-sparing as the main advantage of biosimilars. Most respondents (n = 20) reported they switch from originator to biosimilar in their everyday clinical practice, mostly during the maintenance phase. Most respondents (n = 20) registered no acute adverse events. Nearly all participants felt totally or very confident in using biosimilars.CONCLUSIONS:A few years after the introduction of the first biosimilar into the market, real-life data coming from the major IBD units in Italy confirm a favorable and confident position on the use of biosimilars in pediatric IBD.

Background: Biological therapies have modified the disease course of pediatric inflammatory bowel disease (IBD) and are routinely used in clinical practice. Our observational study aims to evaluate effectiveness and safety of biologics in IBD. Method: Clinical benefit and safety data of 93 children with IBD, receiving biologics (Infliximab - IFX, Adalimumab - ADA, Golimumab - GOL) from January 2013 to December 2017, were extracted from the cohort of the Sicilian Network of IBD. Results: Among 87 children aged 7-17 years (63 Crohn's disease [CD], 24 Ulcerative colitis [UC]), 101 out of 108 biologic treatments were considered. Evaluation of 74 biologic treatments in CD patients at 26, 52, 104 weeks showed clinical benefit rates of 84.2%, 93.3%, 66.7% with IFX (n= 38) and 88.9%, 84.4%, 65.2% with ADA (n= 36). Biologic treatments (n=27) evaluated in the UC group at 26, 52, 104 weeks, led to clinical benefit rates of 85.7%, 83.3%, 50% in IFX subgroup (n=21) and 40%, 50%, 33% in the ADA subgroup (n=5), respectively. One patient treated with GOL showed 100% clinical benefit at 26 and 52 weeks. Overall adverse events (AEs) rate was 9.25%. Six younger children, < 6 years, receiving 8 treatments (4 ADA, 4 IFX) presented a clinical remission rate of 75% at 12 weeks and 25% at 52 weeks. AEs rate was 25% in this group. Conclusion: Our data show that biologic therapy in children, even at a younger age, is effective in allowing long-term remission with a good safety profile. (C) 2019 Elsevier Masson SAS. All rights reserved.

Background CD is an immune-mediated systemic disease elicited by gluten and related prolamines, it affects genetically susceptible individuals and it is characterized by the presence of gluten-dependent clinical manifestations, CD-specific antibodies, HLA-DQ2 or HLA-DQ8 haplotypes and enteropathy. According to the guidelines published by ESPGHAN in 2012, it is possible to diagnose celiac disease without intestinal biopsy, in symptomatic children and adolescents with very high levels of transglutaminases type-2 antibodies and positive HLA DQ2/DQ8. Aims The aim of our study is to analyse two groups of patients: one in which diagnosis was based on the new ESPGHAN criteria, and another based on the 1991 Revised Criteria. Both are tested for average age of diagnosis, sex, presenting symptoms and comorbidities. The objective is to find relevant differences between the two groups. Patients and methods Our study involves 25 patients having the CD onset from February 2013 to February 2019 with the following features: presence of anti-TTG IgA antibodies with a titer higher than at least 10 times the threshold value, presence of EMA IgA serology, compatible genetic profile (HLA-DQ2 and/or DQ8), clinical features. Patient recruitment was performed using data collected at our Pediatric Gastroenterology Center. The values obtained were compared with those of 25 children (control group) with CD diagnosis performed through the 1991 Revised Criteria. Results In group 1 a prevalence of comorbidities such as IDDM and thyroiditis equal to 48% was found (12 patients out of 25, of which 8 males and 4 females). Out of these: 7 patients have IDDM exclusively, 4 IDDM and thyroiditis together, 1 patient with thyroiditis only. In group 2 there was a prevalence of comorbidities such as IDMM and thyroiditis equal to 20% (5 patients out of 25, of which 2 males and 3 females). Out of these: 4 patients present exclusively IDDM, 1 IDDM and thyroiditis. A statistically significant difference emerged between the two groups of patients when we analyzed the incidence of autoimmuny comorbidities. The P value of χ2 test was indeed <0.05. The IDDM and Thyroiditis variables taken individually are not significant. Conclusion An increased prevalence of overall comorbidities (IDDM and thyroiditis) in the first group shows that the new diagnostic criteria could expose patients to a greater diagnostic delay responsible for the onset of such comorbidities. Further studies should be carried out on more numerous samples to highlight possible statistically significant differences between the two groups.