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1.
Am J Gastroenterol ; 2024 Mar 19.
Artículo en Inglés | MEDLINE | ID: mdl-38305302

RESUMEN

INTRODUCTION: Patients with ulcerative colitis (UC) receiving immunosuppressive drugs are at substantial risk of colectomy. We aimed to assess the risk of postoperative complications of tofacitinib exposure before colectomy in comparison with biologics. METHODS: A multicenter, retrospective, observational study was conducted in patients with UC who underwent total colectomy for medically refractory disease, exposed to tofacitinib or a biologic before surgery. Primary outcome was the occurrence of any complication within 30 (early) and 90 (late) days after surgery. Secondary outcomes were the occurrence of infections, sepsis, surgical site complications, venous thromboembolic events (VTE), hospital readmissions, and redo surgery within the same timepoints. RESULTS: Three hundred one patients (64 tofacitinib, 162 anti-tumor necrosis factor-α agents, 54 vedolizumab, and 21 ustekinumab) were included. No significant differences were reported in any outcome, except for a higher rate of early VTE with anti-tumor necrosis factor-α agents ( P = 0.047) and of late VTE with vedolizumab ( P = 0.03). In the multivariate analysis, drug class was not associated with a higher risk of any early and late complications. Urgent colectomy increased the risk of any early (odds ratio [OR] 1.92, 95% confidence interval [CI] 1.06-3.48) complications, early hospital readmission (OR 4.79, 95% CI 1.12-20.58), and early redo surgery (OR 7.49, 95% CI 1.17-47.85). A high steroid dose increased the risk of any early complications (OR 1.96, 95% CI 1.08-3.57), early surgical site complications (OR 2.03, 95% CI 1.01-4.09), and early redo surgery (OR 7.52, 95% CI 1.42-39.82). Laparoscopic surgery decreased the risk of any early complications (OR 0.54, 95% CI 0.29-1.00), early infections (OR 0.39, 95% CI 0.18-0.85), and late hospital readmissions (OR 0.34, 95% CI 0.12-1.00). DISCUSSION: Preoperative tofacitinib treatment demonstrated a postoperative safety profile comparable with biologics in patients with UC undergoing colectomy.

2.
Int J Mol Sci ; 25(5)2024 Feb 28.
Artículo en Inglés | MEDLINE | ID: mdl-38474034

RESUMEN

The advent of biologic drugs has revolutionized the treatment of Inflammatory Bowel Disease, increasing rates of response and mucosal healing in comparison to conventional therapies by allowing the treatment of corticosteroid-refractory cases and reducing corticosteroid-related side effects. However, biologic therapies (anti-TNFα inhibitors, anti-α4ß7 integrin and anti-IL12/23) are still burdened by rates of response that hover around 40% (in biologic-naïve patients) or lower (for biologic-experienced patients). Moreover, knowledge of the mechanisms underlying drug resistance or loss of response is still scarce. Several cellular and molecular determinants are implied in therapeutic failure; genetic predispositions, in the form of single nucleotide polymorphisms in the sequence of cytokines or Human Leukocyte Antigen, or an altered expression of cytokines and other molecules involved in the inflammation cascade, play the most important role. Accessory mechanisms include gut microbiota dysregulation. In this narrative review of the current and most recent literature, we shed light on the mentioned determinants of therapeutic failure in order to pave the way for a more personalized approach that could help avoid unnecessary treatments and toxicities.


Asunto(s)
Productos Biológicos , Enfermedades Inflamatorias del Intestino , Humanos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Citocinas/metabolismo , Factor de Necrosis Tumoral alfa/uso terapéutico , Corticoesteroides/uso terapéutico , Productos Biológicos/uso terapéutico
3.
Clin Gastroenterol Hepatol ; 20(6): e1483-e1487, 2022 06.
Artículo en Inglés | MEDLINE | ID: mdl-34478878

RESUMEN

Noninfective drug-related pneumonitis (DRP) is a well-known adverse effect of several drugs: clinical manifestations have mostly an acute/subacute onset and vary from mild to life-threatening. Several DRP cases have been described in patients receiving anti-tumor necrosis factor α, rituximab, and tocilizumab.1,2 To date, only 4 reports of vedolizumab-related pneumonitis have been presented.3-5.


Asunto(s)
Colitis Ulcerosa , Enfermedades Inflamatorias del Intestino , Neumonía , Anticuerpos Monoclonales Humanizados , Colitis Ulcerosa/tratamiento farmacológico , Fármacos Gastrointestinales/efectos adversos , Humanos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Neumonía/inducido químicamente , Neumonía/tratamiento farmacológico , Rituximab/uso terapéutico , Factor de Necrosis Tumoral alfa/uso terapéutico
4.
Am J Gastroenterol ; 117(8): 1279-1287, 2022 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-35467558

RESUMEN

INTRODUCTION: The use of ustekinumab and vedolizumab as second-line therapies in patients with Crohn's disease (CD) in which tumour necrosis factor alpha inhibitors (TNFi) failed is still debated. The aim of this study was to compare, in a large multicenter observational retrospective cohort, the effectiveness of ustekinumab and vedolizumab as second-line therapies, as assessed by clinical and objective outcomes including endoscopy and gastrointestinal imaging. METHODS: Clinical response, remission, and steroid-free remission at weeks 26 and 52 were evaluated in a retrospective propensity score-weighted and propensity score-matched cohort of patients in which TNFi failed. Objective response and remission were evaluated by 1 or more techniques among endoscopy, magnetic resonance/computed tomography enteroclysis, and small bowel ultrasound. RESULTS: A total of 470 patients with CD (239 treated with ustekinumab and 231 treated with vedolizumab) were included in the study. At week 26, clinical outcomes were similar between the 2 groups. At week 52, clinical remission (ustekinumab 42.5% vs vedolizumab 55.5%, P = 0.01) and steroid-free remission (ustekinumab 40.6% vs vedolizumab 51.1%, P = 0.038) rates were significantly higher in vedolizumab-treated patients. Three hundred two patients (hundred thirty-five treated with ustekinumab and hundred sixty-seven treated with vedolizumab) had an objective evaluation of disease activity at baseline and week 52. At week 52, objective response and remission rates were similar between the 2 groups. Clinical response at week 26 predicted steroid-free remission at week 52 in both ustekinumab-treated and vedolizumab-treated patients. Safety profiles were similar between the 2 groups. DISCUSSION: In patients with CD in which TNFi failed, both ustekinumab and vedolizumab showed similar clinical effectiveness after 26 weeks of treatment. At 1 year, vedolizumab was associated with a higher rate of clinical remission when compared with ustekinumab. However, no difference was observed between the 2 groups when objective outcomes were investigated at this time point.


Asunto(s)
Anticuerpos Monoclonales Humanizados , Enfermedad de Crohn , Ustekinumab , Anticuerpos Monoclonales Humanizados/uso terapéutico , Enfermedad de Crohn/tratamiento farmacológico , Humanos , Inducción de Remisión , Estudios Retrospectivos , Resultado del Tratamiento , Inhibidores del Factor de Necrosis Tumoral , Ustekinumab/uso terapéutico
5.
Entropy (Basel) ; 22(4)2020 Mar 31.
Artículo en Inglés | MEDLINE | ID: mdl-33286176

RESUMEN

This work participates in the research for potential areas of observational evidence of quantum effects on geometry in a black hole astrophysical context. We consider properties of a family of loop quantum corrected regular black hole (BHs) solutions and their horizons, focusing on the geometry symmetries. We study here a recently developed model, where the geometry is determined by a metric quantum modification outside the horizon. This is a regular static spherical solution of mini-super-space BH metric with Loop Quantum Gravity (LQG) corrections. The solutions are characterized delineating certain polymeric functions on the basis of the properties of the horizons and the emergence of a singularity in the limiting case of the Schwarzschild geometry. We discuss particular metric solutions on the base of the parameters of the polymeric model related to similar properties of structures, the metric Killing bundles (or metric bundles MBs), related to the BH horizons' properties. A comparison with the Reissner-Norström geometry and the Kerr geometry with which analogies exist from the point of their respective MBs properties is done. The analysis provides a way to recognize these geometries and detect their main distinctive phenomenological evidence of LQG origin on the basis of the detection of stationary/static observers and the properties of light-like orbits within the analysis of the (conformal invariant) MBs related to the (local) causal structure. This approach could be applied in other quantum corrected BH solutions, constraining the characteristics of the underlining LQG-graph, as the minimal loop area, through the analysis of the null-like orbits and photons detection. The study of light surfaces associated with a diversified and wide range of BH phenomenology and grounding MBs definition provides a channel to search for possible astrophysical evidence. The main BHs thermodynamic characteristics are studied as luminosity, surface gravity, and temperature. Ultimately, the application of this method to this spherically symmetric approximate solution provides us with a way to clarify some formal aspects of MBs, in the presence of static, spherical symmetric spacetimes.

7.
Dig Liver Dis ; 56(2): 235-241, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-37718225

RESUMEN

The management of inflammatory bowel disease requires continuous medical therapy to achieve and maintain disease control. Thus, women can be exposed to different drugs during conception, pregnancy, and lactation with potentially harmful effects on the mother, foetus, or nursing infant. Conventional drugs and anti-tumour necrosis factor (TNF)-α are considered safe and can be maintained throughout all these phases. Emergent, although limited, data support safety of vedolizumab and ustekinumab, with pregnancy, as well as maternal and neonatal outcomes comparable to women unexposed or treated with anti TNF-α drugs. Placental pharmacokinetics differ between these two biologics, with an inverse infant-to-maternal ratio for vedolizumab, whereas ustekinumab shows a similar profile to anti TNF-α drugs. The clearance of vedolizumab in exposed offspring seems to be faster than anti TNF-α, estimated around 15 and 19 weeks of age, respectively. Currently, the decision to interrupt or maintain these treatments is up to physicians' judgement on a case-by-case basis. In animal studies, Janus kinase (JAK) inhibitors and ozanimod have shown embryotoxicity and teratogenicity. Moreover, tofacitinib and filgotinib seemingly affect female fertility. This review summarizes all existing data on the effects of administration of non-anti-TNF-α biologic agents and small molecules, during conception, pregnancy, and lactation.


Asunto(s)
Enfermedades Inflamatorias del Intestino , Ustekinumab , Recién Nacido , Animales , Femenino , Humanos , Embarazo , Ustekinumab/uso terapéutico , Inhibidores del Factor de Necrosis Tumoral/uso terapéutico , Placenta , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Factor de Necrosis Tumoral alfa , Lactancia
8.
Ann Gastroenterol ; 37(1): 37-45, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38223251

RESUMEN

Background: In the inflammatory bowel disease (IBD) multidisciplinary team, a key figure is the IBD care manager, usually an independent practice nurse, responsible for evidence-based assessment, care planning, treatment evaluation, and provision of practical information, health education, and emotional support to patients. The objective of this study was to evaluate the profile of this figure in Italy. Methods: A team of experienced nurses created a questionnaire based on the Second N-ECCO declaration, which was administered to nurses who worked in an IBD unit for a period of at least 3 years. A definition of IBD care manager was provided to every participant. The questionnaire consisted of 3 sections: behavioral, knowledge and managerial skills that an IBD care manager should exhibit. Results were studied in relation to the benefits for the patient, organizational advantages, clinical advantages and Italian state of the art. Results: Fifty-five nurses participated in the study, from 28 Italian centers. In the evaluation of behavioral skills of IBD care managers, "management and support of the pregnant patient" was the lowest scored item, while "patient privacy" obtained higher scores. In the evaluation of knowledge, "knowledge of intimacy and sexuality" obtained the lowest scores, while "knowledge of psychophysical and social impact of the disease" obtained a higher score. In managerial skills "management of pain" obtained the lowest scores. Conclusion: Our study confirmed that IBD care managers are invaluable nursing figures within the multidisciplinary team that cares for IBD patients, providing benefits to both patients' clinics and management.

9.
J Clin Med ; 13(3)2024 Jan 29.
Artículo en Inglés | MEDLINE | ID: mdl-38337460

RESUMEN

Personalised medicine and the identification of predictors of the efficacy of specific drugs represent the ultimate goal for the treatment of ulcerative colitis (UC) in order to break the current therapeutic ceiling. JAK inhibitors are a new class of advanced therapies, orally administered, showing a good profile of efficacy and safety in both randomised controlled trials (RCTs) and real-world studies. Unfortunately, to date, it is not possible to draw the ideal profile of a patient maximally benefiting from this class of drugs to guide clinicians' therapeutic choices. Baseline clinical activities and inflammatory biomarkers, as well as their early variation after treatment initiation, emerged as the main predictors of efficacy from post hoc analyses of RCTs with tofacitinib. Similar findings were also observed in the real-life studies including mainly patients with a history of pluri-refractoriness to biological therapies. At last, a few new biomarkers have been explored, even though they have not been validated in large cohorts. This paper provides a review of the current knowledge on clinical variables and biomarkers predicting response to JAK inhibitors in UC.

10.
Aliment Pharmacol Ther ; 59(12): 1579-1588, 2024 06.
Artículo en Inglés | MEDLINE | ID: mdl-38616417

RESUMEN

BACKGROUND: Few data are available addressing the impact of post-operative management of Crohn's disease (CD) on long-term clinical course. AIM: To assess the evolution of post-operative management strategies over the last 40 years and their impact on the re-operation rate of CD. METHODS: We included 657 patients with CD who had undergone their first radical ileo-caecal resection between 1980 and 2020. Three cohorts were defined according to year of surgery: cohort 1 (1980-1998; n = 198), cohort 2 (1999-2009; n = 218) and cohort 3 (2010-2020; n = 241). We estimated exposure to immunomodulators and anti-TNFα agents after surgery and rates of re-operation using Kaplan-Meier survival analyses. We used Cox proportional hazards regression to assess the association of clinical variables with time to re-operation. RESULTS: Immunosuppressants, (IMMs) and anti-TNFα exposure within 5 years after surgery increased significantly from cohort 1 to cohort 2 and cohort 3 (IMMs: 1.6%, 38.2% and 28.0%, respectively, p < 0.001; anti-TNFα: 0.0%, 20.7% and 52.0%, respectively, p < 0.001). There was no significant difference across cohorts regarding the cumulative probability of re-operation within 5 and 10 years. Multivariate analysis identified IMMs/anti-TNFα exposure before the first surgery (HR 9.15; 95% CI 2.77-30.21) and post-operatively (HR: 0.24; 95% CI 0.07-0.74) as variables associated with the risk of re-operation. However, these associations had a time-varying effect and become non-significant after 5 and 2 years after surgery, respectively. CONCLUSION: Despite increased post-operative use of IMMs and anti-TNFα agents in the last two decades, the impact of these strategies on the risk of long-term re-operation rate has been modest.


Asunto(s)
Enfermedad de Crohn , Reoperación , Humanos , Enfermedad de Crohn/cirugía , Enfermedad de Crohn/tratamiento farmacológico , Femenino , Masculino , Reoperación/estadística & datos numéricos , Adulto , Estudios Retrospectivos , Persona de Mediana Edad , Inmunosupresores/uso terapéutico , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Cuidados Posoperatorios/métodos , Adulto Joven , Estimación de Kaplan-Meier , Factores de Tiempo , Modelos de Riesgos Proporcionales
11.
Indian J Gastroenterol ; 43(1): 215-225, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38244138

RESUMEN

BACKGROUND: The transition from in-hospital intravenous administration to subcutaneous therapies to treat inflammatory bowel disease (IBD) can raise some concerns among patients due to the self-administration concerns, the management of potential side effects and the overall worries related to a change of treatment. This study aimed at evaluating patients' opinion about the switch from intravenous to subcutaneous formulations and their knowledge on new available therapeutic options. METHODS: We conducted a survey using a questionnaire prepared by a team of gastroenterologists and nurses working at the IBD unit. It consists of 31 items and has been divided into four sections: descriptive, commitment, knowledge and passage mode opinion. The questions were formulated in Italian and conceived according to daily consultations with patients in everyday practice, without any previous piloting or specific medical literature reference. The survey was administered to consecutive IBD patients in intravenous biological treatment; patients currently or previously treated with subcutaneous therapy were excluded. RESULTS: Four hundred questionnaires were distributed to participants. As many as 311 patients (77.7%) completed the survey, while the remaining were excluded from the analysis; 155 (49.8%) patients were favorable to switch from intravenous to subcutaneous therapy, while only 78 (25.1%) disagreed. In univariate and multi-variate analysis, the approval rate for home therapy was significantly associated with the distance from the IBD center and work/family/personal commitments. Surprisingly, only a quarter of the IBD patients knew that almost all available therapeutic agents have a subcutaneous administration route. Regarding patients' opinion on the efficacy of subcutaneous administration of biological agents compared to intravenous drugs, 194 (63%) had no definite idea, while 44 (14%) believed that the effectiveness could be reduced. CONCLUSION: The transition from in-hospital to subcutaneous therapeutic management of biological therapy at home was generally viewed favorably by patients, especially if they have commitments or were residents far from the IBD center.


Asunto(s)
Colitis Ulcerosa , Enfermedad de Crohn , Enfermedades Inflamatorias del Intestino , Humanos , Enfermedad de Crohn/tratamiento farmacológico , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Encuestas y Cuestionarios , Administración Intravenosa , Terapia Biológica , Colitis Ulcerosa/tratamiento farmacológico
12.
J Clin Med ; 13(7)2024 Mar 23.
Artículo en Inglés | MEDLINE | ID: mdl-38610623

RESUMEN

(1) Background: Inflammatory bowel disease (IBD) is frequently associated to other immune-mediated inflammatory diseases (IMIDs). This study aims at assessing physicians' awareness of the issue and the current status of IMID management. (2) Methods: A web-based survey was distributed to all 567 physicians affiliated to IG-IBD. (3) Results: A total of 249 (43.9%) physicians completed the survey. Over 90% of the responding physicians were gastroenterology specialists, primarily working in public hospitals. About 51.0% of the physicians had access to an integrated outpatient clinic, where gastroenterologists collaborated with rheumatologists and 28.5% with dermatologists. However, for 36.5% of physicians, integrated ambulatory care was not feasible. Designated appointment slots for rheumatologists and dermatologists were accessible to 72.2% and 58.2% of physicians, respectively, while 20.1% had no access to designated slots. About 5.2% of physicians report investigating signs or symptoms of IMIDs only during the initial patient assessment. However, 87.9% inquired about the presence of concomitant IMIDs at the initial assessment and actively investigated any signs or symptoms during subsequent clinical examination. (4) Conclusions: While Italian physicians recognize the importance of IMIDs associated with IBD, organizational challenges impede the attainment of optimal multidisciplinary collaboration. Efforts should be directed toward enhancing practical frameworks to improve the overall management of these complex conditions.

13.
J Pers Med ; 14(5)2024 May 10.
Artículo en Inglés | MEDLINE | ID: mdl-38793087

RESUMEN

Mucosal healing (MH) is the main target in ulcerative colitis (UC) treatment. Even if MH lowers the risk of disease reactivation, some patients still relapse. Histologic activity (HA) beyond MH could explain these cases. This study aims to assess how many patients with MH have HA and which lesions are associated with relapse. We retrospectively enrolled UC patients showing MH, expressed as a Mayo Endoscopic Subscore (MES) of 0 and 1 upon colonoscopy. We reviewed the histological reports of biopsies evaluating the presence of typical lesions of UC and assessed the number of clinical relapses after 12 months. Among 100 enrolled patients, 2 showed no histological lesions. According to univariate analysis, patients with a higher number of histological lesions at the baseline had a higher risk of relapse (OR 1.25, p = 0.012), as well as patients with basal plasmacytosis (OR 4.33, p = 0.005), lamina propria eosinophils (OR 2.99, p = 0.047), and surface irregularity (OR 4.70, p = 0.010). However, in the multivariate analysis, only basal plasmacytosis (OR 2.98, p = 0.050) and surface irregularity (OR 4.50, p = 0.024) were confirmed as risk factors for disease reactivation. HA persists in a significant percentage of patients with MH. Despite the presence of MH, patients with basal plasmacytosis and surface irregularity have a higher risk of relapse.

14.
Autoimmun Rev ; 23(5): 103533, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38521214

RESUMEN

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. To address this important clinical topic, the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) and the Italian Society of Rheumatology (SIR) jointly planned to draw updated therapeutic recommendations for IBD-associated SpA using a pseudo-Delphi method. This document presents the official recommendations of IG-IBD and SIR on the management of IBD-associated SpA in the form of 34 statements and 4 therapeutic algorithms. It is intended to be a reference guide for gastroenterologists and rheumatologists dealing with IBD-associated SpA.


Asunto(s)
Enfermedades Inflamatorias del Intestino , Espondiloartritis , Humanos , Enfermedades Inflamatorias del Intestino/terapia , Enfermedades Inflamatorias del Intestino/complicaciones , Italia , Espondiloartritis/diagnóstico , Espondiloartritis/terapia , Espondiloartritis/complicaciones , Consenso , Sociedades Médicas/normas , Reumatología/normas , Manejo de la Enfermedad , Técnica Delphi
15.
Dig Liver Dis ; 56(1): 77-82, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-37474412

RESUMEN

BACKGROUND: The administration of biological drugs in inflammatory bowel diseases (IBD) is increasingly moving from intravenous to subcutaneous formulations. AIMS: To evaluate the efficacy and safety of vedolizumab subcutaneous administration after switching from intravenous administration in ulcerative colitis (UC) patients in corticosteroid-free clinical remission. METHODS: An observational, multicentre, prospective study was conducted by the Italian Group for the study of IBD (IG-IBD). UC patients in clinical remission (pMAYO < 2) not receiving steroids for > 8 months before the switch, and with at least 6 months of follow-up were included. Switch from intravenous to subcutaneous vedolizumab was defined as successful in patients not experiencing a disease flare (pMAYO ≥ 2) or needing oral steroids or stopping subcutaneous vedolizumab during the 6 months of follow-up after the switch. RESULTS: Overall, 168 patients were included. The switch was a success in 134 patients (79.8%). Vedolizumab retention rate was 88.7% at month six. C-reactive protein and faecal calprotectin values did not change after the switch (p = 0.07 and p = 0.28, respectively). Ten of the 19 patients who stopped subcutaneous formulation switched back to intravenous formulation recapturing clinical remission in 80%. Side effects were observed in 22 patients (13.1%). CONCLUSION: Effectiveness of switching from intravenous to subcutaneous vedolizumab formulation in UC patients in steroid-free clinical remission is confirmed in a real-world setting.


Asunto(s)
Colitis Ulcerosa , Enfermedades Inflamatorias del Intestino , Humanos , Administración Intravenosa , Colitis Ulcerosa/tratamiento farmacológico , Fármacos Gastrointestinales , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Estudios Prospectivos , Esteroides/uso terapéutico , Resultado del Tratamiento
16.
Expert Opin Biol Ther ; 24(1-2): 101-109, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38250818

RESUMEN

BACKGROUND: Ustekinumab (UST) is an interleukin-12/interleukin-23 receptor antagonist recently approved for treating ulcerative colitis (UC) but with limited real-world data. Therefore, we evaluated the effectiveness and safety of UST in patients with UC in a real-world setting. RESEARCH DESIGN AND METHODS: This is a multicenter, retrospective, observational cohort study. The primary endpoints were the clinical remission rate (partial Mayo score, PMS, ≤1) and the safety of UST. Other endpoints were corticosteroid-free remission (CSFR) rate, clinical response rate (PMS reduction of at least 2 points), and fecal calprotectin (FC) reduction at week 24. RESULTS: We included 256 consecutive patients with UC (M/F 139/117, median age 52). The clinical remission and clinical response rates at eight weeks were 18.7% (44/235) and 53.2% (125/235), respectively, and 27.6% (42/152) and 61.8% (94/152) at 24 weeks, respectively. At 24 weeks, CSFR was 20.3% (31/152), and FC significantly dropped at week 12 (p = 0.0004) and 24 (p = 0.038). At eight weeks, patients naïve or with one previous biologic treatment showed higher remission (p = 0.002) and clinical >response rates (p = 0.018) than patients previously treated with ≥ 2. Adverse events occurred in six patients (2.3%), whereas four patients (1.6%) underwent colectomy. CONCLUSION: This real-world study shows that UST effectively and safely treats patients with UC.


Asunto(s)
Colitis Ulcerosa , Humanos , Persona de Mediana Edad , Colitis Ulcerosa/diagnóstico , Colitis Ulcerosa/tratamiento farmacológico , Ustekinumab/efectos adversos , Estudios Retrospectivos , Inducción de Remisión , Estudios de Cohortes , Corticoesteroides/uso terapéutico , Complejo de Antígeno L1 de Leucocito/uso terapéutico , Resultado del Tratamiento
17.
Dig Liver Dis ; 55(6): 695-703, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-36964060

RESUMEN

The therapeutic armamentarium for the management of Crohn's disease (CD) is rapidly expanding. Several biologic therapies (e.g. infliximab, adalimumab, vedolizumab, and ustekinumab) have been regulatory approved, and there is considerable practice variability in the treatment of patients with CD. This technical review systematically searched and identified the current evidence, synthesized it using meta-analytic methodology, appraised its quality, and concisely presented it, thus forming the basis for developing clinical practice recommendations on the use of biologic treatments in adult patients with CD.


Asunto(s)
Productos Biológicos , Enfermedad de Crohn , Adulto , Humanos , Enfermedad de Crohn/tratamiento farmacológico , Infliximab/uso terapéutico , Adalimumab/uso terapéutico , Ustekinumab/uso terapéutico , Productos Biológicos/uso terapéutico
18.
Dig Liver Dis ; 55(4): 442-453, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36792429

RESUMEN

A cure for Crohn's disease (CD), a chronic inflammatory disease of the gastrointestinal tract of unknown etiology, is not available, so patients require lifelong management to keep inflammation under control. The therapeutic armamentarium has expanded with approval of several biological drugs, including infliximab, adalimumab, vedolizumab and ustekinumab - monoclonal antibodies that target different inflammatory pathways - and darvadstrocel, a suspension of expanded human allogeneic, adipose-derived, mesenchymal stromal cells for the treatment of refractory complex perianal fistula. Notwithstanding existing practice guidelines on medical therapy for CD, the Italian Group for the Study of Inflammatory Bowel Disease felt the need to issue new guidelines focused on the use of biologics for managing the intestinal manifestations of CD and based on the GRADE methodology. This document presents recommendations regarding six clinical settings, from the induction to the maintenance of clinical remission, and from optimization and de-escalation of treatments to dealing with perianal CD and post-operative recurrence. The 19 evidence-based statements are supported by information on the quality of the evidence, agreement rate among panel members, and panel comments mainly based on evidence from real world studies.


Asunto(s)
Productos Biológicos , Enfermedad de Crohn , Enfermedades Inflamatorias del Intestino , Humanos , Productos Biológicos/uso terapéutico , Enfermedad de Crohn/terapia , Enfermedades Inflamatorias del Intestino/terapia
19.
Dig Liver Dis ; 55(8): 1042-1048, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-36435716

RESUMEN

BACKGROUND: Predicting clinical outcomes represents a major challenge in Crohn's disease (CD). Radiomics provides a method to extract quantitative features from medical images and may successfully predict clinical course. AIMS: The aim of this pilot study is to evaluate the use of radiomics to predict 10-year surgery for CD patients. METHODS: We selected a cohort of CD patients with CT scan enterographies and a 10-year follow up. The R library Moddicom was used to extract radiomic features from each lesion of CD, segmented in the CT scans. A logistic regression model based on selected radiomic features was developed to predict 10-year surgery. The model was evaluated by computing the area under the curve (AUC) of the receiver operating characteristic curve, sensitivity, specificity, positive and negative predictive values (PPV, NPV). RESULTS: We enroled 30 patients, with 44 CT scans and 93 lesions. We extracted 217 radiomic features from each lesion. The developed model was based on two radiomic features and presented an AUC (95% CI) of 0.83 (0.73-0.91) in predicting 10-year surgery. Sensitivity, specificity, PPV, NPV of the radiomic model were equal to 0.72, 0.90, 0.79, 0.86, respectively. CONCLUSION: Radiomics could be a helpful tool to identify patients with high risk for surgery and needing a stricter monitoring.


Asunto(s)
Enfermedad de Crohn , Humanos , Enfermedad de Crohn/diagnóstico por imagen , Enfermedad de Crohn/cirugía , Proyectos Piloto , Área Bajo la Curva , Modelos Logísticos , Curva ROC , Estudios Retrospectivos
20.
Dig Liver Dis ; 55(8): 1028-1033, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37355395

RESUMEN

BACKGROUND: Patients with inflammatory bowel disease (IBD) are at risk of malnutrition, but little is known about how IBD centres provide nutritional care. AIM: To assess how nutritional care is delivered at IBD centres across Italy. METHODS: 120 IBD centres were invited to answer a web-based questionnaire. RESULTS: 76 questionnaires (63.3%) were completed. An IBD-dedicated nutritionist is present in 27 centres (35.5%). Fifty-two centres (68.4%) have an IBD multidisciplinary team, and 22 of these include a nutritionist. In the outpatient setting, malnutrition risk is evaluated at each visit in 23 centres (30.3%), while nutritional status is assessed at each visit in 21 centres (27.6%). These assessments are performed by a gastroenterologist in almost all centres (93.4% and 88.2%, respectively) and more rarely by a nutritionist (32.9% and 36.9%), dietician (7.9% and 2.6%) or nurse (3.9% and 9.2%). The decision to offer oral nutritional support is made by a gastroenterologist alone (35.5%), a nutritionist alone (23.7%), or a team of the two (38.2%). CONCLUSIONS: Nutritional care for IBD patients appears quite far from satisfactory in the Italian reality. Educational and structural interventions are urgently needed to improve assessment and treatment of malnutrition in everyday clinical practice.


Asunto(s)
Enfermedades Inflamatorias del Intestino , Desnutrición , Humanos , Enfermedades Inflamatorias del Intestino/terapia , Apoyo Nutricional , Encuestas y Cuestionarios , Desnutrición/etiología , Desnutrición/terapia , Italia , Estado Nutricional
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