Gut Microbiota Profile Changes in Patients with Inflammatory Bowel Disease and Non-Alcoholic Fatty Liver Disease: A Metagenomic Study.

Gut microbiota imbalances have a significant role in the pathogenesis of Inflammatory Bowel Disease (IBD) and Non-Alcoholic Fatty Liver Disease (NAFLD). Herein, we compared gut microbial composition in patients diagnosed with either IBD or NAFLD or a combination of both. Seventy-four participants were stratified into four groups: IBD-NAFLD, IBD-only, NAFLD-only patients, and healthy controls (CTRLs). The 16S rRNA was sequenced by Next-Generation Sequencing. Bioinformatics and statistical analysis were performed. Bacterial α-diversity showed a significant lower value when the IBD-only group was compared to the other groups and particularly against the IBD-NAFLD group. ß-diversity also showed a significant difference among groups. The higher Bacteroidetes/Firmicutes ratio was found only when comparing IBD groups and CTRLs. Comparing the IBD-only group with the IBD-NAFLD group, a decrease in differential abundance of Subdoligranulum, Parabacteroides, and Fusicatenibacter was found. Comparing the NAFLD-only with the IBD-NAFLD groups, there was a higher abundance of Alistipes, Odoribacter, Sutterella, and Lachnospira. An inverse relationship in the comparison between the IBD-only group and the other groups was shown. For the first time, the singularity of the gut microbial composition in IBD and NAFLD patients has been shown, implying a potential microbial signature mainly influenced by gut inflammation.

Nursing-sensitive outcomes in adult inflammatory bowel disease: A systematic review.

AIMS: To evaluate nursing activity through outcomes that are affected, provided, and/or influenced by nurses and defined as nursing-sensitive outcomes in adult IBD patients. DESIGN: Systematic review without meta-analysis. DATA SOURCES: PubMed, Embase, CINAHL, PsycINFO, and the Cochrane Library databases on August 2019. REVIEW METHODS: Peer-reviewed articles published between 2000-2020 were reviewed. The outcome measures were contextualized and presented by OMERACT Filter 2.0. RESULTS: Twenty-four studies were included. Eighteen nursing-sensitive outcomes were identified. These outcomes defined eight domains for health intervention, fitting into three core areas (resource use/economic impact, life impact, pathophysiological manifestations). Fifty-three measurement instruments were identified. CONCLUSIONS: Through 53 measurement tools, with use of OMERACT framework, 18 nursing-sensitive outcomes in the main 3 core areas were identified, highlighting the multidimensional role of nursing. Further insights are to be carried out to define nursing outcomes included in IBD nursing intervention studies. IMPACT: These results could serve as a cornerstone for further investigations and validation by a panel of experts to standardizing nursing activity in a multidisciplinary context.

Effects of listening to music in digestive endoscopy: A prospective intervention study led by nursing.

AIMS: To explore whether music can reduce anxiety and pain in patients who underwent diagnostic endoscopic examinations in conscious and deep sedation and to assess degree of satisfaction and willingness to repeat the procedure. DESIGN: Prospective study led by nursing. METHODS: Between March 2019-June 2019, consecutive outpatients undergoing endoscopic examinations were simple matched into four groups: Group 1: conscious sedation with music; Group 2: conscious sedation without music; Group 3: deep sedation with music and Group 4: deep sedation without music. Ten minutes before the procedure, two trainee nurses applied music. State-Trait Anxiety Inventory was used to evaluate anxiety. RESULTS: Before and at the end of the procedure, patients who listened to music had a lower level anxiety than those who did not listen and, also, reported lower pain intensity during procedure. Only within Group 1 median anxiety, measured after the procedure, is lower than that measured before. In the bivariate logistic regression model, pain and listening to music were independent factors for satisfaction and willingness to repeat procedure. CONCLUSION: music in digestive endoscopy reduce pain and anxiety in conscious sedation, thus could be used to reduce anxiety in support to conscious sedation leading to lower usage of deep sedation and consequently reduction of costs and adverse events. IMPACT: Anxiety in digestive endoscopy limits patients' satisfaction. Music in digestive endoscopy as a specific nursing intervention could reduce anxiety of patients. This nursing intervention study confirms positive effect of music in digestive endoscopy. As part of nursing management, the addition of music to daily care practice in digestive endoscopy may reduce anxiety and increase the patient's degree of satisfaction. Use of music could limit deep sedation use in digestive endoscopy with consequent reduction of risks for patients, execution times, and costs of procedures.

Ulcerative Colitis as an Independent Risk Factor for Hepatic Steatosis.

Inflammatory bowel disease (IBD) is an inflammatory condition of the gastrointestinal tract encompassing Crohn disease and ulcerative colitis, often associated with extraintestinal manifestations. Nonalcoholic fatty liver disease represents one of the described inflammatory bowel disease-related liver diseases. To understand the IBD contribution to nonalcoholic fatty liver disease onset, we compared liver fat content and fibrosis between IBD patients and healthy controls integrating medical and nursing expertise (integrated nursing approach). A total of 95 patients and 53 healthy volunteers were recruited. Only nondiabetic and nonobese individuals were included in the study. Liver evaluation was performed by an experienced nurse using transient elastography. We found that IBD patients had higher liver fat content than the control group (p = .003). Bonferroni post hoc analyses revealed that patients with Crohn disease or ulcerative colitis had higher liver fat than the control group. We also found that ulcerative colitis was associated with more than a 4-fold increased risk for mild steatosis and 7-fold increased risk for moderate/severe steatosis independently from other risk factors such as glucose and body mass index. In conclusion, we showed for the first time that ulcerative colitis is an independent risk factor for hepatic steatosis measured by transient elastography.

Gastrointestinal Symptoms of and Psychosocial Changes in Inflammatory Bowel Disease: A Nursing-Led Cross-Sectional Study of Patients in Clinical Remission.

Background and Objectives: Nursing management in Inflammatory Bowel Disease (IBD) is focused on global patient care. Starting from basic knowledge of diagnostic and therapeutic management, nurses can assess the impact of IBD on patients' quality of life not only at the physical level, but also at the psychological, social, and emotional levels. The aim of this study was to evaluate the impact of gastrointestinal symptoms on psychosocial changes in IBD patients in remission through nursing-led Patient-Reported Outcomes. Materials and Methods: We performed a cross-sectional study of 109 IBD patients in clinical and endoscopic remission. Specialist nurses invited patients to complete questionnaires on gastrointestinal symptoms and quality of life through the Patient-Reported Outcomes Measurement Information System (PROMIS). Results: We found that the gastrointestinal symptoms that the patients reported had a significant impact on the analyzed aspects of health. More specifically, belly pain, diarrhea, and bloating were associated with depressive symptoms (p < 0.001), anxiety (p < 0.001), fatigue (p < 0.001), and sleep disturbances (p < 0.001). Moreover, these symptoms also significantly affected patients' social dimension in terms of satisfaction with participation in social roles (p < 0.001, p < 0.05, and p < 0.001 for belly pain, diarrhea, and bloating, respectively) and physical functions (p < 0.001). The results were virtually the same in a multivariable analysis adjusted by age, gender, body mass index (BMI), and disease duration. Conclusions: Even during remission, gastrointestinal symptoms are the main factors that influence quality of life in IBD patients. This exploratory study highlights the need to adopt validated questionnaires in clinical practice, and demonstrates that PROMIS is a valid, objective, and standardized instrument that can help nursing staff to better define the consequences of the disease in a patient's daily life.

COVID-19 and Inflammatory Bowel Disease: Patient Knowledge and Perceptions in a Single Center Survey.

Background and objectives: Spreading of SARS-CoV-2 infection from China to countries with a higher prevalence of inflammatory bowel disease (IBD) has generated concern among gastroenterologists and patients. The aim of this survey is to evaluate knowledge about clinical importance of COVID-19, disease management, prevention measures, and anxiety level during pandemic among patients with IBD. Material and methods: From 15th March to 15th April 2020, a questionnaire survey was administered to 200 patients with IBD by email or phone application. The questionnaire consisted of five sections: (1) anthropometric, demographic and clinical characteristics, (2) knowledge about clinical importance of COVID-19, (3) IBD management, (4) prevention measures, (5) anxiety level during pandemic. Results: One hundred forty two questionnaires were completed. Ninety-seven patients (68.3%) were males with a mean age of 46 years (SD 13; range 17-76). Fifty-four individuals (38%) were affected by Crohn disease and 88 (62%) by Ulcerative Colitis. Most patients reported high knowledge about clinical importance of COVID-19 (80%), IBD management (72%), and prevention measures (97%). Sixty-two percent of them showed moderate-high level of anxiety. High education level was independently associated with high knowledge about clinical importance of COVID-19 (odds ratio [OR] 5, 95% confidence interval [CI] 1.49-16.6, p = 0.009) and older age (OR 1, 95%, CI 1.01-1.1, p = 0.01), while the receipt of e-format educational material with low knowledge about clinical importance of COVID-19 (OR 3, 95%, CI 1.08-9.3, p = 0.03). Displaying an active disease appeared to be independently associated with low knowledge of IBD management (OR 5.8, 95% CI 1.4-22.8, p = 0.01) and no variables other than an older age was independently associated with higher level of anxiety (OR 1.04, 95% CI 1.009-1.09, p = 0.01). Conclusions: High educational level and aging promote knowledge about clinical importance of COVID-19, while e-format educational material does not. Taken together with findings that an active disease status compromises knowledge of IBD management and the high level of anxiety related to increasing age, these data suggest the need of further supporting patient-oriented strategies in IBD during Covid-19 pandemic.

DEPDC5 variants increase fibrosis progression in Europeans with chronic hepatitis C virus infection.

UNLABELLED: Chronic hepatitis C virus (HCV) infection may progress to cirrhosis and hepatocellular carcinoma (HCC). Recently, two genetic variants, DEPDC5 rs1012068 and MICA rs2596542, were associated with the onset of HCC in Asian subjects with chronic HCV infection. The aim of the present study was to analyze whether DEPDC5 and MICA genetic variants were associated with liver disease progression in European subjects with chronic HCV infection. In a Northern Italian discovery cohort (n = 477), neither DEPDC5 rs1012068 nor MICA rs2596542 were associated with HCC (n = 150). However, DEPDC5 rs1012068 was independently associated with cirrhosis (n = 300; P = 0.049). The association of rs1012068 with moderate to severe fibrosis was confirmed in an independent cross-sectional German cohort (n = 415; P = 0.006). Furthermore, DEPDC5 rs1012068 predicted faster fibrosis progression in a prospective cohort (n = 247; P = 0.027). Next, we examined the distribution of nonsynonymous DEPDC5 variants in the overall cross-sectional cohort (n = 912). The presence of at least one variant increased the risk of moderate/severe fibrosis by 54% (P = 0.040). To understand the molecular mechanism underlying the genetic association of DEPDC5 variants with fibrosis progression, we performed in vitro studies on immortalized hepatic stellate cells (LX-2). In these cells, down-regulation of DEPDC5 resulted in increased expression of ß-catenin and production of its target matrix metallopeptidase 2 (MMP2), a secreted enzyme involved in fibrosis progression. CONCLUSION: DEPDC5 variants increase fibrosis progression in European subjects with chronic HCV infection. Our findings suggest that DEPDC5 down-regulation may contribute to HCV-related fibrosis by increasing MMP2 synthesis through the ß-catenin pathway.

Effect of excess body weight on the genetic susceptibility to cancer.

Excess body weight and genetics play important roles in cancer susceptibility. Although several studies have reported on obesity and genetic variants as separate risk factors for cancer, very few studies have investigated the interaction between excess body weight and genetic variants in cancer susceptibility. In this review, we focus on the interplay between these 2 risk factors, which are a major determinant of the individual risk of cancer onset.

Challenging clinical cases in HCV infection.

We present clinical cases, which underline some difficulties in diagnosis and treatment of hepatitis C virus (HCV) infection. Case report #1 shows a patient who avoided clinical follow-up for HCV until the development of hepatocellular carcinoma. In this patient, non-invasive procedures did not allow to make a differential diagnosis between hydatidosis and hepatocellular carcinoma but diagnosis was only made with liver biopsy.

Motivational Interviewing as a Strategy to Improve Adherence in IBD Treatment: An Integrative Review Amidst COVID-19 Disruptions.

Aims and Objectives: This review aims to analyze the effectiveness of motivational interviewing (MI) in enhancing therapeutic adherence and compliance in adult patients with inflammatory bowel disease (IBD), especially considering the disruptions caused by the COVID-19 pandemic. Background: IBD, which includes conditions such as ulcerative colitis and Crohn's disease, affects over 10 million people globally. It significantly impacts both physical and psychological well-being, leading to challenges in therapeutic adherence. Only 25-47% of patients with IBD adequately follow prescribed treatments. Design and Methods: An integrative methodology that combines qualitative and quantitative research was utilized, following a 7-step framework. This framework encompasses identifying the research question, devising a search strategy, performing a critical appraisal, summarizing findings, extracting data, conducting an analysis, and drawing conclusions. Results: Poor adherence to therapy among patients with IBD can exacerbate disease progression and result in complications. MI has been identified as a promising approach to improving both adherence and treatment outcomes. Studies, including those predating the COVID-19 pandemic, have demonstrated MI's effectiveness in enhancing adherence among patients with IBD. Conclusions: MI shows promise in enhancing adherence among adult patients with IBD. Although initial results are promising, additional research is needed to thoroughly understand its effectiveness across various clinical contexts. Relevance to Clinical Practice: The findings underscore the potential of MI as an integral component of IBD treatment strategies, suggesting that its implementation could enhance patient-provider interactions and lead to better overall health outcomes.

Enacted Stigma in Inflammatory Bowel Disease: An Italian Phenomenological Study.

Inflammatory bowel disease (IBD) is a chronic disease of the gastrointestinal tract that has a profound impact on the quality of life of those afflicted with it. The scientific literature shows how the quality of life of people with IBD influences and is influenced by the clinical manifestations of the disease. Strongly connected with excretory functions, which have always been taboo in society, these clinical manifestations can lead to stigmatizing behaviours. The purpose of this study was to understand the lived experiences of the enacted stigma of people with IBD through Cohen's phenomenological method. Two main themes (stigma in the workplace and stigma in social life) and one subtheme (stigma in love life) emerged from the data analysis. The data analysis revealed that stigma is associated with a multitude of negative health outcomes for the people targeted by it and can add to the already complex physical, psychological and social burdens endured by people with IBD. Having a better understanding of the stigma attached to IBD will facilitate the development of care and training interventions that can improve the quality of life of people suffering from IBD.

Preparing Patients for Cosmetic Surgery and Aesthetic Procedures: Ensuring an Optimal Nutritional Status for Successful Results.

Aesthetic and cosmetic medical practices have attracted considerable consumer attention globally. However, possible complications vary and range from mild, self-resolving ecchymoses or edema to more persistent complications. The aim of this review is to identify the nutritional deficits or excesses associated with the major complications of reconstructive surgery, aesthetic surgery, and mini-invasive aesthetic procedures. An additional goal is to provide a bundle of actions for professionals working in the industry in order to reduce the risks of aesthetic procedures and improve the clinical outcomes. Granulomas, hypertrophic scars and keloids, seromas, infections and xerosis, hyperpigmentation, petechiae, livedo reticularis, slower wound healing, and other poor outcomes are frequently associated with nutritional deficiencies. Nutritional status can markedly affect wound healing and tissue repair following surgical interventions, as well as the outcomes of aesthetic and cosmetic medical practices. Professionals working in this industry, therefore, need to consider the nutritional aspects of their patients to obtain the best results.

Peripheral intravenous catheter insertion and therapy administration: simulator learning.

BACKGROUND AND AIM: Obtaining, positioning and managing intravenous access is complex but common procedure in nursing care practice. Learning the right knowledge and skills during basic nurse education is an essential goal. The use of simulators allows for a better acquisition of skills, guaranteeing safety for patients and nursing students. However, the literature is still lacking on the use of simulation for intravenous cannulation procedures and device management, presenting few conflicting results. The aim of this study was to examine the effect of simulator-based learning on vascular access management in a population of nursing students. METHODS: Using comparative observational study design we evaluated the effect of simulator learning on vascular access management in a nursing student population. RESULTS: The differences between the scores at t1 between the groups of students are significant for obtaining vascular access with relative management of the device and intravenous therapy (t = 3.062, p = 0.001), while at t0, albeit with strong differences in scores means (t = 0.061, p = 0.871) are not statistically significant. Early use of the simulator is also fundamental over time (t = 5.362, p = 0.001). Furthermore, the satisfaction noted by the students during the clinical simulations improves with the increase in the number of the same, as it can influence the single performance. CONCLUSIONS: Nursing training based on the use of simulators favors a better acquisition of skills compared to traditional didactic.

COVID-19 Vaccine Booster Shot Preserves T Cells Immune Response Based on Interferon-Gamma Release Assay in Inflammatory Bowel Disease (IBD) Patients on Anti-TNFα Treatment.

Immune-modifying treatment in inflammatory bowel disease (IBD) impairs the humoral response. The role of T lymphocytes in this setting is still unclear. This study aims to assess if a booster shot (third dose) of BNT162b2 mRNA COVID-19 vaccine enhanced the humoral response and elicited cellular immunity in IBD patients on different immuno-therapy regimens compared to healthy controls (HCs). Five months after a booster dose, serological and T-cell responses were assessed. The measurements were described using geometric means with 95% confidence intervals. The differences between study groups were assessed by Mann-Whitney tests. Seventy-seven subjects (n = 53 IBD patients and n = 24 HCs), who were fully vaccinated and not previously SARS-CoV-2 infected, were recruited. Regarding the IBD patients, 19 were affected by Crohn's disease and 34 by ulcerative colitis. During the vaccination cycle, half of the patients (53%) were on stable treatment with aminosalicylates, and 32% were on biological therapy. No differences in antibody concentrations between IBD patients and HCs, nor T-cell responses, were found. Stratifying IBD patients based on the type of treatment (anti-TNFα agents vs. other treatment regimens), a decrease only in antibody titer (p = 0.008), but not in cellular response, was observed. Even after the COVID-19 vaccine booster dose, the TNFα inhibitors selectively decreased the humoral immune response compared to patients on other treatment regimens. The T-cell response was preserved in all study groups. These findings highlight the importance of evaluating T-cell immune responses following COVID-19 vaccination in a routine diagnostic setting, particularly for immunocompromised cohorts.

The Impact of an Intensive Care Diary on the Psychological Well-Being of Patients and Their Family Members: Longitudinal Study Protocol.

BACKGROUND: Thanks to medical and technological advancements, an increasing number of individuals survive admission to intensive care units. However, survivors often experience negative outcomes, including physical impairments and alterations in mental health. Anxiety, depression, cognitive impairments, post-traumatic stress disorders, and functional disorders are known collectively as post-intensive care syndrome (PICS). Among the key triggering factors of this syndrome, memory impairment appears to play a significant role. AIMS: This study aims to evaluate the impact of an intensive care diary on the psychological well-being of patients and their relatives after discharge from the ICU. DESIGN: Prospective observational study. EXPECTED RESULTS: The results of this study evaluate the impact of an ICU diary on the quality of life of ICU survivors and their family members.

Safety, hesitancy of coronavirus disease 2019 vaccination and pandemic burden in patients with inflammatory bowel disease: data of a national study (ESCAPE-IBD).

BACKGROUND AND AIMS: The purpose of this study was to present data on the safety of anti- severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination in a cohort of inflammatory bowel disease (IBD) patients of an ongoing multicenter study (ESCAPE-IBD) sponsored by the Italian Group for the study of Inflammatory Bowel Disease (ClinicalTrials.gov Identifier: NCT04769258). METHODS: Anti-SARS-CoV-2 vaccination was administrated to 809 IBD patients. Interviews were conducted to report adverse events related to vaccination. Of these 809, 346 patients were surveyed on the pandemic burden and the main reason for hesitancy in coronavirus disease 2019 vaccination. The chi-square test was used to compare categorical variables. Logistic regression was used to assess the relationship between disease-related characteristics and the onset of adverse events. RESULTS: About 45% of patients had at least one side effect, following the first dose (10%), the second (15%), and both doses (19%). All the adverse events were mild and lasted only a few days. Logistic regression analysis revealed that female sex ( P  < 0.001), younger age ( P  = 0.001), seroconversion ( P  = 0.002), and comorbidity ( P  < 0.001) were significantly associated with adverse events. The survey showed that the main concerns were the possibility of adverse event (33%). Almost all patients (99%) felt safer having been vaccinated at their IBD reference center. CONCLUSION: The vaccine reactions experienced in IBD patients were mostly self-limited. We found high acceptance and good safety of SARS-CoV-2 vaccination in our cohort.

Safety profile of intravenous iron in inflammatory bowel disease: an up-to-date overview.

Up to 30-70% of patients may experience mild and moderate side effects during iron therapy and this is often associated with a poor adherence to therapy. Anemia is frequent in patients with active inflammatory bowel disease (IBD), due to both iron deficiency and chronic inflammation, therefore iron supplementation is frequently needed. Considering that gastrointestinal disorders are the most common side effects with oral iron, in IBD patients intravenous administration must be preferred. Although intravenous iron supplementation remains the most effective therapy of IBD-associated iron deficiency anemia, the perception of risk related to intravenous administration by clinicians could limit this successful strategy. In this narrative review we provided an up to date on the safety of the different iron formulations for intravenous administration, by reporting the most recent studies in IBD patients.

Measuring Mood and Anxiety Disorders by Patient Reported Outcomes in Inflammatory Bowel Disease: A Literature Review Update.

Background Anxiety and depression are the most common psychological disorders found in Inflammatory Bowel Disease (IBD) patients. Accurate measuring of these disorders should be proposed for a prompt management. Patient-reported outcome measurements (PROMs) allow patients to self-report their psychological symptoms. Objective To highlight the presence of PROMs measuring anxiety and depression in IBD setting evaluating the most used psychometric tools. Methods We reviewed the literature from 2010 up to September 2021. Articles on adult IBD patients assessing depression and anxiety by PROMs in English language were included. Results Thirty-six studies, including 11 psychometric tools were found. Hospital Anxiety and Depression Scale (21 studies), Beck Depression Inventory II (5 studies), Spielberg State-Trait Anxiety Inventory (3 studies), Patient-Reported Outcomes Measurement Information System (3 studies), Symptom Checklist-90 (2 studies), Euro Quality of Life (2 studies) mostly used psychometric tools for anxiety and depression in IBD settings. Conclusion Our review analyzed psychometric tools used for PROMs evaluating anxiety and depression in IBD setting. No chronological differences have emerged, all have been used in the last ten years, highlighting a lack of specificity. The strong association between IBD and mood disorders suggests that clinicians should consider the evaluation of depression and anxiety as integral parts of IBD clinical care. It is essential to identify tools enabling these items to be detected better. A global view of IBD patients, accounting not only for physical but also for psychical symptoms with an early and feasible assessment of unrecognized psychiatric disorders, can have a strong impact on their management strategy.

Fatigue and Associated Factors in an Immune-Mediated Inflammatory Disease Population: A Cross-Sectional Study.

Fatigue is a main symptom of chronic diseases, including immune-mediated inflammatory diseases (IMIDs), such as inflammatory bowel disease (IBD) and inflammatory arthritis (IA); however, the pathophysiological mechanisms are not completely understood. The aim of this study was to assess the prevalence of fatigue and the associated factors in an IMIDs population. A control group, IBD, and IA patients, were enrolled. The PROMIS® fatigue questionnaire was used to evaluate the symptoms. Information on demographics, anthropometrics, disease characteristics, and medications was collected for each participant. A total of 471 subjects (137 with IBD, 103 with IA, and 206 controls) were enrolled. IBD and IA patients reported greater fatigue than controls (p < 0.001, each). In univariate regression, patients with anxiety and depression were more likely to report fatigue (p = 1.40 × 10−9 and p = 3.80 × 10−11, respectively). Males, holding a high school diploma, and being employed were inversely correlated to the domain (p = 1.3 × 10−5; p = 0.003 and p = 0.005, respectively). The use of steroids and disease activity determined increased fatigue (p = 0.014 and p = 0.019; respectively). In the multivariate analysis, anxiety and depression remained associated (p = 0.002 and p = 1.3 × 10−5, respectively). IMIDs patients present increased fatigue compared with healthy subjects. Anxiety and depression are the main associated factors, suggesting a psychological component of the symptom; thus, a holistic management should be established.

Biologics for Inflammatory Bowel Disease in Clinical Practice: A Calabria (Southern Italy) Prospective Pharmacovigilance Study.

BACKGROUND: The use of immune-modifying biological agents has markedly changed the clinical course and the management of Inflammatory bowel diseases (IBDs). Active post-marketing surveillance programs are fundamental to early recognize expected and unexpected adverse events (AEs), representing a powerful tool to better determine the safety profiles of biologics in a real-world setting. METHODS: This study aimed to identify the occurrence of AEs and therapeutic failures linked to biological drugs used in gastroenterology units during a prospective pharmacovigilance program in Southern Italy. Patients affected by IBDs and treated with a biologic agent, from 1 January 2019, to 31 December 2021 (study period) in three gastroenterology units were enrolled. RESULTS: Overall, 358 patients with a diagnosis of active Crohn's disease or ulcerative colitis satisfying inclusion criteria have been enrolled. Infliximab (IFX) was the most administered drug at the index date (214; 59.8%), followed by Adalimumab (ADA; 89; 24.9%), Golimumab (GOL; 37; 10.3%), Vedolizumab (VDZ; 17; 4.7%) and Ustekimumab (UST; 1; 0.3%). Seventy-three patients (20.4%) experienced at least one AE, while 62 patients (17.3%) had therapeutic ineffectiveness. No serious AEs were reported in the follow-up period in the enrolled patients. AEs have been described with IFX (50/214; p = 0.47), GOL (7/37; p = 0.78), ADA (13/89; p = 0.18), and VDZ (3/17; p = 0.52), no AEs have been noticed with UST (0/1). CONCLUSIONS: Based on the low rate of AEs observed and withdrawal from treatment, our data seem to corroborate the favorable beneficial/risk profile of biologics for IBDs.