Publications by authors named "Fabio Salvatore Macaluso"

Background: The efficacy of tofacitinib (TOFA) in various rheumatic diseases has generated interest in its potential benefits for treating spondyloarthritis (SpA) associated with ulcerative colitis (UC).

Objectives: RETUCAS (Real-world Effectiveness of Tofacitinib on Ulcerative Colitis-Associated Spondyloarthropathy) is the first study designed to evaluate the effectiveness of TOFA in UC-associated SpA.

Design: This was a prospective, multicentre, single-arm, observational study promoted by the Italian Group for the Study of Inflammatory Bowel Disease.

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Background: Janus kinase inhibitors (JAKi), including tofacitinib (TOFA, pan-JAK) and filgotinib (FILGO, selective JAK1), are oral agents approved for moderate-to-severe ulcerative colitis (UC). Head-to-head comparative data in real-world settings are limited.

Aim: To compare effectiveness and safety of TOFA and FILGO in patients with UC.

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Background: Liver diseases are common in patients with inflammatory bowel disease (IBD). Little is known about how specialists perceive and manage liver enzyme abnormalities. This study investigates the current practice and educational needs of IBD specialists in the management of liver enzyme abnormalities.

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Introduction: Inflammatory bowel disease (IBD) poses significant clinical challenges due to its chronic, disabling nature. Despite established guidelines, care standards remain inconsistent globally. In 2020, the European Crohn's Colitis Organisation (ECCO) developed quality-of-care standards.

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The QUASAR clinical development program evaluated the efficacy of guselkumab-an IL-23p19 subunit inhibitor-for the treatment of moderate-to-severe ulcerative colitis. Guselkumab demonstrated rapid control of symptoms, as well as significant rates of objective disease remission. However, real-world evidence will be crucial to confirm these findings in patient subgroups that were not included in the QUASAR program.

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Article Synopsis
  • * A survey involved 47 out of 128 Italian centers, revealing a CIF prevalence of about 1%, with higher rates in academic settings and only a small percentage of centers routinely conducting necessary assessments.
  • * Although 12 centers used the medication teduglutide (TED) with a reported success rate of over 50%, overall management of SBS and CIF was found to be inadequate in the participating centers.
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Spondyloarthritis (SpA) is the most frequent extraintestinal manifestation in patients with inflammatory bowel diseases (IBD). When IBD and spondyloarthritis coexist, musculoskeletal and intestinal disease features should be considered when planning a therapeutic strategy. Treatment options for IBD and SpA have expanded enormously over the last few years, but randomized controlled trials with specific endpoints focused on SpA are not available in the IBD setting.

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Article Synopsis
  • * Recent European guidelines suggest using a mix of clinical, lab, and imaging techniques to track disease progression, emphasizing that traditional symptom-based methods aren't improving long-term outcomes.
  • * The review introduces a comprehensive monitoring algorithm that incorporates both invasive and noninvasive methods, including bedside intestinal ultrasound (IUS) and video-capsule endoscopy, to enhance patient care.
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Background And Aims: Pragmatic studies designed to test interventions in everyday clinical settings can successfully complement the evidence from registration and explanatory clinical trials. The European consensus project PRACTICE-IBD was developed to identify essential criteria and address key methodological issues needed to design valid, comparative, pragmatic studies in inflammatory bowel diseases [BDs].

Methods: Statements were issued by a panel of 11 European experts in IBD management and trial methodology, on four main topics: [I] study design; [II] eligibility, recruitment and organisation, flexibility; [III] outcomes; [IV] analysis.

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The therapeutic armamentarium for gastroenterologists in treating ulcerative colitis (UC) has been rapidly growing since the introduction of monoclonal antibodies directed against anti-TNFs. Ustekinumab is a monoclonal antibody binding the shared p40 subunit of IL-12 and IL-23, and the inhibition of these two cytokines, implicated in host response to microbial pathogens, has demonstrated clinical efficacy in different immune-mediated diseases, including moderate-to-severe UC. This narrative review summarizes the newest clinical evidence regarding the efficacy, effectiveness and safety of ustekinumab in moderate-to-severe UC, including specific situations (pregnancy, breastfeeding, elderly/pediatric populations, extraintestinal manifestations, acute severe UC, pouchitis and dual biological therapy).

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Background: The vaccination status of patients with inflammatory bowel disease (IBD) should be investigated before starting any treatment, and patients should eventually be vaccinated against vaccine-preventable diseases (VPDs). Patients with IBD may have suboptimal vaccination rates. The aim of this study was to evaluate the vaccination coverage, attitude towards vaccinations, and determinants among an Italian cohort of patients with IBD.

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Background: Real-world evidence is needed to determine the value of tofacitinib (TOFA) for the treatment of ulcerative colitis (UC).

Aim: To assess the safety and effectiveness of TOFA in clinical practice.

Methods: TOFA-UC is a multicenter, observational study performed among the Sicilian Network for Inflammatory Bowel Disease (SN-IBD).

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Article Synopsis
  • Patients with inflammatory bowel disease (IBD) in Italy face malnutrition risks, with a study assessing the nutritional care provided at 120 IBD centres through a web-based questionnaire.* -
  • Out of 76 responses (63.3% completion), only 35.5% of centres have a dedicated nutritionist, while 68.4% have a multidisciplinary team, but nutritional evaluations are primarily conducted by gastroenterologists.* -
  • Overall, the nutritional care provided is deemed inadequate, highlighting a need for better education and structural improvements to effectively manage malnutrition among IBD patients.*
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Background And Aim: Postoperative recurrence (POR) following ileocolonic resection is a major concern in patients with Crohn's disease (CD). The role of ustekinumab (UST) in this setting is poorly known.

Methods: All consecutive CD patients with a baseline colonoscopy at 6-12 months from ileocolonic resection showing POR (Rutgeerts score ≥ i2) who were treated with UST after the baseline colonoscopy and with an available post-treatment endoscopy, were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Diseases (SN-IBD).

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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.

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Article Synopsis
  • - The treatment options for Crohn's disease (CD) are growing quickly, especially with the introduction of biologic therapies like infliximab and adalimumab.
  • - There is a lot of variation in how doctors are treating CD, which highlights the need for standardized guidelines.
  • - This review analyzed current research on biologic treatments for adults with CD and aims to create clinical recommendations based on high-quality evidence.
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Background: Sarcopenia has been associated with poor prognosis in chronic diseases.

Aims: To investigate the role of sarcopenia in predicting clinical and endoscopic outcomes in patients with Crohn's disease (CD).

Methods: Consecutive CD patients who started biologics between 2014 and 2020 and underwent abdominal magnetic resonance or computed tomography within 6 months from the beginning of the biological therapy were enroled.

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Background And Aims: Many observational studies on the use of vedolizumab [VDZ] in patients with Crohn's disease [CD] and ulcerative colitis [UC] have been published in the past few years. We aimed to comprehensively summarise its effectiveness and safety by pooling data only from observational studies.

Methods: PubMed/Medline and Embase were systematically searched for observational studies on patients with CD and UC treated with VDZ through December 2021.

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Article Synopsis
  • There is currently no cure for Crohn's disease (CD), so patients require ongoing treatment to manage inflammation.
  • Several biological drugs have been approved for CD, including monoclonal antibodies like infliximab and adalimumab, aimed at different inflammation pathways, as well as darvadstrocel for specific complications.
  • The Italian Group for the Study of Inflammatory Bowel Disease has developed new guidelines using GRADE methodology to improve the management of CD, providing 19 evidence-based recommendations across various clinical situations.
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