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Crohn Disease: HELP
Articles by Alessandro Armuzzi
Based on 49 articles published since 2010
(Why 49 articles?)
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Between 2010 and 2020, A. Armuzzi wrote the following 49 articles about Crohn Disease.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Guideline Use of corticosteroids and immunosuppressive drugs in inflammatory bowel disease: Clinical practice guidelines of the Italian Group for the Study of Inflammatory Bowel Disease. 2017

Gionchetti, Paolo / Rizzello, Fernando / Annese, Vito / Armuzzi, Alessandro / Biancone, Livia / Castiglione, Fabiana / Comberlato, Michele / Cottone, Mario / Danese, Silvio / Daperno, Marco / D'Incà, Renata / Fries, Walter / Kohn, Anna / Orlando, Ambrogio / Papi, Claudio / Vecchi, Maurizio / Ardizzone, Sandro / Anonymous2840898. ·Department of Medical and Surgical Sciences, IBD Unit, University of Bologna, Bologna, Italy. Electronic address: Paolo.gionchetti@unibo.it. · Department of Medical and Surgical Sciences, IBD Unit, University of Bologna, Bologna, Italy. · AOU Gastroenterology, Careggi University Hospital, Florence, Italy. · IBD Unit Complesso Integrato Columbus-Gemelli Hospital Catholic University Foundation, Rome, Italy. · University "Tor Vergata", Department of Systems Medicine, Rome, Italy. · Gastroenterology Unit, Federico II University, Naples, Italy. · Gastrointestinal Unit, Ospedale Central Hospital, Bolzano, Italy. · Department of Medicine, Pneumology and Nutrition Clinic, V. Cervello Hospital, Ospedali Riuniti Villa Sofia-Cervello University of Palermo, Palermo, Italy. · IBD Center, Humanitas Clinical and Research Centre, Milan, Italy. · Gastroenterology Unit, A.O. Ordine Mauriziano Hospital, Turin, Italy. · Department of Surgical and Gastroenterological Sciences, University of Padua, Padua, Italy. · Clinical Unit for Chronic Bowel Disorders, Department of Internal Medicine, IBD Unit Messina, University of Messina, Messina, Italy. · Department of Gastroenterology, San Camillo-Forlanini Hospital, Rome, Italy. · Gastroenterology Unit, San Filippo Neri Hospital, Rome, Italy. · Gastroenterology and Gastrointestinal Endoscopy Unit, IRCCS San Donato Hospital, San Donato Milanese, Italy. · Gastroenterology and Digestive Endoscopy, ASST Fatebenefratelli Sacco, University of Milan, Milan, Italy. ·Dig Liver Dis · Pubmed #28254463.

ABSTRACT: The two main forms of intestinal bowel disease, namely ulcerative colitis and Crohn's disease, are not curable but can be controlled by various medical therapies. The Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) has prepared clinical practice guidelines to help physicians prescribe corticosteroids and immunosuppressive drugs for these patients. The guidelines consider therapies that induce remission in patients with active disease as well as treatment regimens that maintain remission. These guidelines complement already existing guidelines from IG-IBD on the use of biological drugs in patients with inflammatory bowel diseases.

2 Guideline The Italian Society of Gastroenterology (SIGE) and the Italian Group for the study of Inflammatory Bowel Disease (IG-IBD) Clinical Practice Guidelines: The use of tumor necrosis factor-alpha antagonist therapy in inflammatory bowel disease. 2011

Orlando, Ambrogio / Armuzzi, Alessandro / Papi, Claudio / Annese, Vito / Ardizzone, Sandro / Biancone, Livia / Bortoli, Aurora / Castiglione, Fabiana / D'Incà, Renata / Gionchetti, Paolo / Kohn, Anna / Poggioli, Gilberto / Rizzello, Fernando / Vecchi, Maurizio / Cottone, Mario / Anonymous3360672 / Anonymous3370672. ·Department of Medicine, Pneumology and Nutrition Clinic, "V. Cervello" Hospital, Ospedali Riuniti "Villa Sofia-Cervello" University of Palermo, Italy. ambrogiorlando@tiscali.it ·Dig Liver Dis · Pubmed #20843756.

ABSTRACT: Biological therapies are an important step in the management of Inflammatory Bowel Diseases. In consideration of high cost and safety issues there is the need to have clear recommendations for their use. Despite the American Gastroenterological Association and the European Crohn's and Colitis Organisation have published exhaustive Inflammatory Bowel Disease guidelines, national guidelines may be necessary as cultural values, economical and legal issues may differ between countries. For these reasons the Italian Society of Gastroenterology and the Italian Group for the study of Inflammatory Bowel Disease have decided to elaborate the Italian guidelines on the use of biologics in Inflammatory Bowel Disease. The following items have been chosen: definitions of active, inactive, steroid dependent and resistant disease; measures of activity; anti-tumor necrosis factor alpha therapy use in active steroid dependent and refractory luminal Crohn's Disease, in fistulising Crohn's Disease, in steroid dependent and resistant active Ulcerative Colitis; risk of cancer; risk of infections during anti-tumor necrosis factor alpha therapy; special situations. These guidelines are based on evidence from relevant medical literature and clinical experience of a national working group.

3 Editorial Beyond remission and mucosal healing in Crohn's disease. Exploring the deep with cross sectional imaging. 2017

Maconi, Giovanni / Armuzzi, Alessandro. ·Gastroenterology Unit, Department of Biomedical and Clinical Sciences, L. Sacco University Hospital, Milan, Italy. Electronic address: giovanni.maconi@unimi.it. · IBD Unit, Presidio Columbus, Fondazione Policlinico Gemelli Università Cattolica, Rome, Italy. Electronic address: alearmuzzi@yahoo.com. ·Dig Liver Dis · Pubmed #28449813.

ABSTRACT: -- No abstract --

4 Review Management of patients with complex perianal fistulas in Crohn's disease: Optimal patient flow in the Italian clinical reality. 2020

Spinelli, Antonino / Armuzzi, Alessandro / Ciccocioppo, Rachele / Danese, Silvio / Gionchetti, Paolo / Luglio, Gaetano / Orlando, Ambrogio / Rispo, Antonio / Rizzello, Fernando / Sofo, Luigi / Solina, Gaspare / Poggioli, Gilberto. ·Division of Colon and Rectal Surgery, Humanitas Clinical and Research Hospital, Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy. Electronic address: antonino.spinelli@humanitas.it. · IBD Unit, A. Gemelli Hospital, Cattolica University, Rome, Italy. · Gastroenterology Unit, Department of Medicine, G.B. Rossi University Hospital, Verona, Italy. · Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy; IBD Center, Humanitas Clinical and Research Hospital, Rozzano, Milan, Italy. · Emilia-Romagna IBD Regional Referral Center, Department of Medical and Surgical Sciences, S. Orsola-Malpighi University Hospital, Bologna, Italy. · Surgery Unit, Department of Public Health, Federico II University Hospital, Naples, Italy. · IBD Unit, "Villa Sofia-Cervello" Hospital, Palermo, Italy. · Gastroenterology Unit, Federico II University Hospital, Naples, Italy. · Abdominal SUrgery Unit, Department of Gastroenterology, Endocrine-metabolic and Nephrourological Science, A. Gemelli Hospital, Cattolica University, Rome, Italy. · Unit of General and Oncological Surgery, Department of Surgery, "Villa Sofia-Cervello" Hospital, Palermo, Italy. · Digestive Surgery Department, S. Orsola-Malpighi University Hospital, Bologna, Italy. ·Dig Liver Dis · Pubmed #31901310.

ABSTRACT: Perianal fistulizing Crohn's disease (PFCD) is a common, disabling and aggressive phenotype that negatively impacts on the quality of life of affected patients. Its successful treatment is still a struggle for both physicians and patients. Significant advances in the management of this condition have occurred in the last two decades holding promise for a better future. This culminated into the concept of a collaborative multidisciplinary approach using the latest medical therapies combined with modern surgical and endoscopic techniques. Despite this, PFCD management and treatment have not been standardized yet. Thus the gastroenterologist and surgeon have to be familiar with several approaches and/or techniques. The positioning of each therapeutic option will certainly evolve with new data, but for the time being it should be driven by patient's characteristics, physician's preference and/or experience, costs and availability in local practice. Additionally, patient's perception of benefits and risks of treatment may differ from those of physicians and recognition of this difference is a starting point for difficult clinical decision-making. In this paper, a multidisciplinary group of Italian IBD experts explore and discuss current medical and surgical therapeutic options, highlighting areas of unmet needs in PFCD, with particular focus on the optimal patient flow within the Italian clinical reality.

5 Review Use of biosimilars in inflammatory bowel disease: a position update of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD). 2019

Fiorino, Gionata / Caprioli, Flavio / Daperno, Marco / Mocciaro, Filippo / Principi, Mariabeatrice / Viscido, Angelo / Fantini, Massimo Claudio / Orlando, Ambrogio / Papi, Claudio / Annese, Vito / Danese, Silvio / Vecchi, Maurizio / Rizzello, Fernando / Armuzzi, Alessandro / Anonymous6661075 / Anonymous6671075. ·IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Center, Rozzano, Italy; Department of Biomedical Sciences, Humanitas University, Rozzano, Italy. · Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy, and Gastroenterology and Endoscopy Unit, Fondazione IRCCS Cà Granda, Ospedale Policlinico di Milano, Milan, Italy. · Division of Gastroenterology, Ospedale Ordine Mauriziano di Torino, Turin, Italy. · Gastroenterology and Endoscopy Unit, A.R.N.A.S Civico-Di Cristina-Benfratelli Hospital, Palermo, Italy. · Gastroenterology Unit, Department of Organ Transplantation (DETO), Policlinico Universitario, Bari, Italy. · Department of Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy. · Department of Systems Medicine, Tor Vergata University of Rome, Rome, Italy. · IBD Unit, A.O. Osp. Riuniti "Villa Sofia-Cervello", Palermo, Italy. · IBD Unit, San Filippo Neri Hospital, Rome, Italy. · IG-IBD member, Florence, Italy. · IBD Unit, DIMEC, University of Bologna, Bologna, Italy. · IBD Unit, Presidio Columbus, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: alessandro.armuzzi@policlinicogemelli.it. ·Dig Liver Dis · Pubmed #30872085.

ABSTRACT: The first infliximab biosimilar for the treatment of inflammatory bowel disease (IBD) was introduced in 2013, and today eight anti-TNF alpha biosimilars (three for infliximab and five for adalimumab) have been approved and licensed by the European Medicines Agency. Biosimilars present great potential in terms of cost saving and possible consequential reinvestment in the health care system. The increasing knowledge about the process of biosimilar development and use in IBD and the publication of many prospective clinical studies and real-life clinical experiences have progressively changed the point of view of IBD physicians. In the present position paper, the Italian Group for the Study of Inflammatory Bowel Disease present and discuss their updated statements and positions on this topic, with emphasis on the concepts of biosimilarity and extrapolation across indications, safety and immunogenicity, interchangeability and switching, automatic substitution, and, finally, patient education about biosimilars.

6 Review Ustekinumab in the management of Crohn's disease: Expert opinion. 2018

Armuzzi, Alessandro / Ardizzone, Sandro / Biancone, Livia / Castiglione, Fabiana / Danese, Silvio / Gionchetti, Paolo / Orlando, Ambrogio / Rizzello, Fernando / Scribano, Maria Lia / Vecchi, Maurizio / Daperno, Marco. ·IBD Unit Presidio Columbus, Fondazione Policlinico Gemelli Università Cattolica, Rome, Italy. Electronic address: alessandro.armuzzi@unicatt.it. · UOC Gastroenterologia e Endoscopia Digestiva ASST Fatebenefratelli Sacco - DIBIC "L. Sacco" Università degli Studi, Milan, Italy. · Università degli Studi di Roma "Tor Vergata", Rome, Italy. · Gastroenterologia Università "Federico II" di Napoli, Naples, Italy. · Department of Gastroenterology, Istituto Clinico Humanitas, Rozzano, Milan, Italy. · IBD Unit, DIMEC, University of Bologna, S Orsola-Malpighi Hospital Bologna, Italy. · UOSD MICI AO Osp. Riuniti "Villa Sofia-Cervello", Palermo, Italy. · IBD Unit, San Camillo-Forlanini Hospital, Rome, Italy. · Department of Biomedical Sciences for Health, University of Milan, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. · Gastroenterology Unit, Mauriziano Hospital, Turin, Italy. ·Dig Liver Dis · Pubmed #29610019.

ABSTRACT: This expert-opinion paper reviews available evidence for the use of ustekinumab, a human interleukin 12/23 monoclonal antibody, in the treatment of Crohn's disease and discusses its potential role in the current treatment scenario for the condition. Ustekinumab appears to be associated with rapid and sustained clinical effect, as reported from the clinical research program, with additional support for potential mucosal healing. These characteristics are paralleled by a favorable safety profile, lack of immunogenicity and the presence of systemic anti-inflammatory activity. Importantly, ustekinumab requires only one single intravenous administration, while subsequent dosing is administered subcutaneously, with potential advantages for home-based therapy. Lastly, the dosage of ustekinumab is flexible. On the basis of the evidence, ustekinumab has a role in patients with primary failure or secondary loss of response to anti-tumor necrosis factor agents, as well as in those who have adverse events on front-line biologics or are reinitiating therapy after a treatment holiday. Current evidence suggests that ustekinumab may be particularly suitable in patients who present extra-intestinal manifestations of the disease or are at risk of infections. Ustekinumab may also be considered in the first-line setting, especially in frail patients, in young subjects or in those who have concomitant immune-mediated diseases.

7 Review Review article: The pharmacokinetics and pharmacodynamics of drugs used in inflammatory bowel disease treatment. 2015

Quetglas, E G / Armuzzi, A / Wigge, S / Fiorino, G / Barnscheid, L / Froelich, M / Danese, Silvio. ·Project Strategy & Science, Grünenthal GmbH, Aachen, Germany. ·Eur J Clin Pharmacol · Pubmed #26008212.

ABSTRACT: BACKGROUND: The following review is a compilation of the recent advances and knowledge on the behaviour of the most frequently used compounds to treat inflammatory bowel disease in an organism. RESULTS: It considers clinical aspects of each entity and the pharmacokinetic/pharmacodynamic relationship supported by the use of plasma monitoring, tissue concentrations, and certain aspects derived from pharmacogenetics.

8 Review Management of perianal fistulas in Crohn's disease: an up-to-date review. 2015

Marzo, Manuela / Felice, Carla / Pugliese, Daniela / Andrisani, Gianluca / Mocci, Giammarco / Armuzzi, Alessandro / Guidi, Luisa. ·Manuela Marzo, Carla Felice, Daniela Pugliese, Gianluca Andrisani, Giammarco Mocci, Alessandro Armuzzi, Luisa Guidi, IBD Unit, Complesso Integrato Columbus, Università Cattolica del Sacro Cuore, 00168 Rome, Italy. ·World J Gastroenterol · Pubmed #25663759.

ABSTRACT: Perianal disease is one of the most disabling manifestations of Crohn's disease. A multidisciplinary approach of gastroenterologist, colorectal surgeon and radiologist is necessary for its management. A correct diagnosis, based on endoscopy, magnetic resonance imaging, endoanal ultrasound and examination under anesthesia, is crucial for perianal fistula treatment. Available medical and surgical therapies are discussed in this review, including new local treatment modalities that are under investigation.

9 Review Clinical trials in luminal Crohn's disease: a historical perspective. 2014

Hindryckx, Pieter / Baert, Filip / Hart, Ailsa / Armuzzi, Alessandro / Panès, Julian / Peyrin-Biroulet, Laurent / Anonymous4780794. ·Department of Gastroenterology, Ghent University hospital, Ghent, Belgium. · Department of Gastroenterology, AZ Delta, Roeselare, Belgium. · IBD Unit, St Mark's Hospital, Watford Road, Harrow, Middlesex HA1 3UJ, UK. · IBD Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy. · Department of Gastroenterology, Hospital Clinic, IDIBAPS, CIBER Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain. · Inserm U 954 and Department of Hepato-Gastroenterology, University Hospital of Nancy-Brabois, Université de Lorraine, Vandoeuvre-lès-Nancy, France. ·J Crohns Colitis · Pubmed #24841216.

ABSTRACT: It goes back to 1932 when Dr. Burrill Bernard Crohn and co-workers published their landmark paper, describing regional ileitis as a disease entity. However, clinical trial research has been developing rather slowly in luminal Crohn's disease. It took until the early seventies before the first randomized clinical trial was set up by the National Co-operative Crohn's Disease Study (NCCDS) group. Although the efforts of this group triggered a first wave of clinical trials in Crohn's disease, the lack of guidelines for conducting a clinical trial in this research area resulted in a variety of study designs and much criticism. Besides having a rather small sample size and a short follow-up time, they were often characterized by vague and subjective assessment of disease activity and treatment response. Following the advent of a new and very potent drug class in the late nineties, the anti-TNF agents, investigators started to re-think their study protocols and the first guidelines were set up by the regulatory authorities. Over the last 15years, clinical trials in luminal Crohn's disease have been evolving significantly. Inclusion criteria have been shifting from clinical scores such as Crohn's Disease Activity Index (CDAI) to more objective disease activity parameters such as biomarkers (C-reactive protein and faecal calprotectin) and endoscopic lesions. Primary endpoints have been developing from clinical response to corticosteroid-free remission and more ambitious end-points such as mucosal healing. In this paper, we will give a historical overview on clinical trials in luminal Crohn's disease, before and within the biologic era, and provide insight into how they have shaped our current understanding of trial designs in Crohn's disease.

10 Review Italian Expert Panel on the management of patients with coexisting spondyloarthritis and inflammatory bowel disease. 2014

Olivieri, Ignazio / Cantini, Fabrizio / Castiglione, Fabiana / Felice, Carla / Gionchetti, Paolo / Orlando, Ambrogio / Salvarani, Carlo / Scarpa, Raffaele / Vecchi, Maurizio / Armuzzi, Alessandro. ·Rheumatology Department of Lucania, San Carlo Hospital of Potenza and Madonna delle Grazie Hospital of Matera, Italy. · Division of Rheumatology, Misericordia e Dolce Hospital, Prato, Italy. · Gastroenterology Unit, University Federico II, Naples, Italy. · IBD Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy. · IBD Unit, Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, University of Bologna, Italy. · IBD Unit, Internal Medicine, A.O. Ospedali Riuniti "Villa Sofia-Cervello", Palermo, Italy. · Rheumatology Unit, Department of Internal Medicine, Azienda Ospedaliera ASMN, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy. · Rheumatology Unit, Department of Clinical and Experimental Medicine, University Federico II, Naples, Italy. · Gastroenterology and Gastrointestinal Endoscopy Unit, IRCCS Policlinico San Donato, Department of Biomedical Sciences for the Health, University of Milan, Milan, Italy. · IBD Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy. Electronic address: alearmuzzi@yahoo.com. ·Autoimmun Rev · Pubmed #24726868.

ABSTRACT: Spondyloarthritis (SpA) is a group of diseases with similar clinical, radiologic and serologic features, including SpA associated with inflammatory bowel disease (IBD-associated SpA). Several studies have estimated the occurrence of SpA in IBD patients as ranging from 17% to 39%, confirming that SpA is the most frequent extra-intestinal manifestation in patients with IBD. In this paper, the expert panel presents some red flags to guide clinicians - both rheumatologists and gastroenterologists - to make a correct diagnosis of IBD-associated SpA in clinical practice. IBD-associated SpA classification, clinical presentation and diagnostic work-up are also presented. From the therapeutic point of view, only separate recommendations/guidelines are currently available for the treatment of Crohn's disease, ulcerative colitis and for both axial and peripheral SpA. However, when IBD and SpA coexist, the therapeutic strategy should be modulated to take into account the variable manifestations of IBD in terms of intestinal and extra-intestinal features, and the clinical manifestations of SpA, with particular attention to peripheral enthesitis, dactylitis and anterior uveitis. To our knowledge, this is the first attempt to define therapeutic algorithms for the integrated management of different IBD-associated SpA clinical scenarios.

11 Review Ileal Crohn's disease: CEUS determination of activity. 2012

De Franco, Antonio / Marzo, Manuela / Felice, Carla / Pugliese, Daniela / Veronica, Alessandra Di / Bonomo, Lorenzo / Armuzzi, Alessandro / Guidi, Luisa. ·Dipartimento di Bioimmagini e Scienze Radiologiche, Policlinico Agostino Gemelli, Catholic University, Rome, Italy. antonio.defranco3@tin.it ·Abdom Imaging · Pubmed #22223202.

ABSTRACT: Transabdominal ultrasound is currently accepted as a clinical first-line tool in the assessment of Crohn's disease activity. During recent years, great improvements have been achieved in ultrasound examination with the introduction of high-frequency transducers, ultrasonographic microbubble contrast agents, and dedicated contrast-specific ultrasound software. Therefore, contrast-enhanced ultrasonography (CEUS) is emerging as one of the most important imaging techniques in the diagnosis and follow-up of patients with ileal Crohn's disease. It is non-invasive and non-ionizing, easily repeatable, well-tolerated by patients and has significant diagnostic accuracy. Moreover, the possibility to monitor response to therapies, describing, and quantifying contrast enhancement behavior by specific software, represents an interesting aspect of its utilization, considering the still open questions about the correct use of immunosuppressive and biological agents. The aim of our review is to provide an updated overview of the role of CEUS in the patients who have an ileal localization of Crohn's disease, defining its qualitative and quantitative features.

12 Clinical Trial Effect of tight control management on Crohn's disease (CALM): a multicentre, randomised, controlled phase 3 trial. 2018

Colombel, Jean-Frederic / Panaccione, Remo / Bossuyt, Peter / Lukas, Milan / Baert, Filip / Vaňásek, Tomas / Danalioglu, Ahmet / Novacek, Gottfried / Armuzzi, Alessandro / Hébuterne, Xavier / Travis, Simon / Danese, Silvio / Reinisch, Walter / Sandborn, William J / Rutgeerts, Paul / Hommes, Daniel / Schreiber, Stefan / Neimark, Ezequiel / Huang, Bidan / Zhou, Qian / Mendez, Paloma / Petersson, Joel / Wallace, Kori / Robinson, Anne M / Thakkar, Roopal B / D'Haens, Geert. ·Department of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: jean-frederic.colombel@mssm.edu. · Inflammatory Bowel Disease Unit, Department of Medicine, University of Calgary, Calgary, AB, Canada. · Imelda General Hospital, Bonheiden, Belgium. · Clinical and Research Centre for Inflammatory Bowel Disease, ISCARE Clinical Centre, Prague, Czech Republic; First Medical Faculty, Charles University, Prague, Czech Republic. · AZ Delta, Roeselare-Menen, Belgium. · Hepato-Gastroenterologie HK, sro, Hradec Králové, Czech Republic. · Department of Gastroenterology, Bezmialem Vakif University, Istanbul, Turkey. · Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria. · Presidio Columbus, Fondazione Policlinico Gemelli Università Cattolica, Rome, Italy. · Service de Gastro-entérologie et Nutrition Clinique, Nice, France; Université de Nice-Sophia-Antipolis, Nice, France. · Oxford University Hospitals, Oxford, UK. · Department of Biomedical Sciences, Humanitas University, Milan, Italy; Humanitas Clinical and Research Centre, Milan, Italy. · Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, CA, USA. · Department of Gastroenterology, University of Leuven, Leuven, Belgium. · Department of Medicine, University of California, Los Angeles, CA, USA. · Department of Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany. · AbbVie Inc, North Chicago, IL, USA. · AbbVie Spain SLU, Madrid, Spain. · Academic Medical Center, Amsterdam, Netherlands. ·Lancet · Pubmed #29096949.

ABSTRACT: BACKGROUND: Biomarkers of intestinal inflammation, such as faecal calprotectin and C-reactive protein, have been recommended for monitoring patients with Crohn's disease, but whether their use in treatment decisions improves outcomes is unknown. We aimed to compare endoscopic and clinical outcomes in patients with moderate to severe Crohn's disease who were managed with a tight control algorithm, using clinical symptoms and biomarkers, versus patients managed with a clinical management algorithm. METHODS: CALM was an open-label, randomised, controlled phase 3 study, done in 22 countries at 74 hospitals and outpatient centres, which evaluated adult patients (aged 18-75 years) with active endoscopic Crohn's disease (Crohn's Disease Endoscopic Index of Severity [CDEIS] >6; sum of CDEIS subscores of >6 in one or more segments with ulcers), a Crohn's Disease Activity Index (CDAI) of 150-450 depending on dose of prednisone at baseline, and no previous use of immunomodulators or biologics. Patients were randomly assigned at a 1:1 ratio to tight control or clinical management groups, stratified by smoking status (yes or no), weight (<70 kg or ≥70 kg), and disease duration (≤2 years or >2 years) after 8 weeks of prednisone induction therapy, or earlier if they had active disease. In both groups, treatment was escalated in a stepwise manner, from no treatment, to adalimumab induction followed by adalimumab every other week, adalimumab every week, and lastly to both weekly adalimumab and daily azathioprine. This escalation was based on meeting treatment failure criteria, which differed between groups (tight control group before and after random assignment: faecal calprotectin ≥250 μg/g, C-reactive protein ≥5mg/L, CDAI ≥150, or prednisone use in the previous week; clinical management group before random assignment: CDAI decrease of <70 points compared with baseline or CDAI >200; clinical management group after random assignment: CDAI decrease of <100 points compared with baseline or CDAI ≥200, or prednisone use in the previous week). De-escalation was possible for patients receiving weekly adalimumab and azathioprine or weekly adalimumab alone if failure criteria were not met. The primary endpoint was mucosal healing (CDEIS <4) with absence of deep ulcers 48 weeks after randomisation. Primary and safety analyses were done in the intention-to-treat population. This trial has been completed, and is registered with ClinicalTrials.gov, number NCT01235689. FINDINGS: Between Feb 11, 2011, and Nov 3, 2016, 244 patients (mean disease duration: clinical management group, 0·9 years [SD 1·7]; tight control group, 1·0 year [2·3]) were randomly assigned to monitoring groups (n=122 per group). 29 (24%) patients in the clinical management group and 32 (26%) patients in the tight control group discontinued the study, mostly because of adverse events. A significantly higher proportion of patients in the tight control group achieved the primary endpoint at week 48 (56 [46%] of 122 patients) than in the clinical management group (37 [30%] of 122 patients), with a Cochran-Mantel-Haenszel test-adjusted risk difference of 16·1% (95% CI 3·9-28·3; p=0·010). 105 (86%) of 122 patients in the tight control group and 100 (82%) of 122 patients in the clinical management group reported treatment-emergent adverse events; no treatment-related deaths occurred. The most common adverse events were nausea (21 [17%] of 122 patients), nasopharyngitis (18 [15%]), and headache (18 [15%]) in the tight control group, and worsening Crohn's disease (35 [29%] of 122 patients), arthralgia (19 [16%]), and nasopharyngitis (18 [15%]) in the clinical management group. INTERPRETATION: CALM is the first study to show that timely escalation with an anti-tumour necrosis factor therapy on the basis of clinical symptoms combined with biomarkers in patients with early Crohn's disease results in better clinical and endoscopic outcomes than symptom-driven decisions alone. Future studies should assess the effects of such a strategy on long-term outcomes such as bowel damage, surgeries, hospital admissions, and disability. FUNDING: AbbVie.

13 Clinical Trial Mongersen, an oral SMAD7 antisense oligonucleotide, and Crohn's disease. 2015

Monteleone, Giovanni / Neurath, Markus F / Ardizzone, Sandro / Di Sabatino, Antonio / Fantini, Massimo C / Castiglione, Fabiana / Scribano, Maria L / Armuzzi, Alessandro / Caprioli, Flavio / Sturniolo, Giacomo C / Rogai, Francesca / Vecchi, Maurizio / Atreya, Raja / Bossa, Fabrizio / Onali, Sara / Fichera, Maria / Corazza, Gino R / Biancone, Livia / Savarino, Vincenzo / Pica, Roberta / Orlando, Ambrogio / Pallone, Francesco. ·From the Department of Systems Medicine, University of Tor Vergata (G.M., M.C.F., S.O., L.B., F.P.), Gastroenterology Unit-Azienda Ospedaliera San Camillo-Forlanini (M.L.S.), Inflammatory Bowel Disease Unit, Complesso Integrato Columbus, Catholic University (A.A.), and Inflammatory Bowel Disease Unit, Department of Internal Medicine, Division of Gastroenterology, Sandro Pertini Hospital Rome (R.P.), Rome, Department of Surgery, L. Sacco University Hospital (S.A., M.F.), Department of Pathophysiology and Transplantation, University of Milan and Ospedale Policlinico di Milano (F. Caprioli), and Department of Biomedical Sciences for Health, University of Milan, and Gastroenterology Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Policlinico San Donato, San Donato Milanese (M.V.), Milan, First Department of Internal Medicine, St. Matteo Hospital Foundation, University of Pavia, Pavia (A.D.S., G.R.C.), Gastroenterologia, Università Federico II di Napoli, Naples (F. Castiglione), Dipartimento di Scienze Chirurgiche Oncologiche e Gastroenterologiche-Unita' Operativa di Gastroenterologia-Universita' degli Studi di Padova, Padua (G.C.S.), Department of Medical and Surgical Specialties, Gastroenterology SOD2, Azienda Ospedaliero Universitaria Careggi, Florence (F.R.), Division of Gastroenterology, Casa Sollievo Sofferenza Hospital, IRCCS, San Giovanni Rotondo (F.B.), Department of Internal Medicine, Gastroenterology and Hepatology Unit, University of Genoa, Genoa (V.S.), and the Division of Internal Medicine Villa Sofia-Cervello Hospital, University of Palermo, Palermo (A.O.) - all in Italy · and the Department of Medicine, Medical Clinic 1, University of Erlangen-Nürnberg, Erlangen, Germany (M.F.N., R.A.). ·N Engl J Med · Pubmed #25785968.

ABSTRACT: BACKGROUND: Crohn's disease-related inflammation is characterized by reduced activity of the immunosuppressive cytokine transforming growth factor β1 (TGF-β1) due to high levels of SMAD7, an inhibitor of TGF-β1 signaling. Preclinical studies and a phase 1 study have shown that an oral SMAD7 antisense oligonucleotide, mongersen, targets ileal and colonic SMAD7. METHODS: In a double-blind, placebo-controlled, phase 2 trial, we evaluated the efficacy of mongersen for the treatment of persons with active Crohn's disease. Patients were randomly assigned to receive 10, 40, or 160 mg of mongersen or placebo per day for 2 weeks. The primary outcomes were clinical remission at day 15, defined as a Crohn's Disease Activity Index (CDAI) score of less than 150, with maintenance of remission for at least 2 weeks, and the safety of mongersen treatment. A secondary outcome was clinical response (defined as a reduction of 100 points or more in the CDAI score) at day 28. RESULTS: The proportions of patients who reached the primary end point were 55% and 65% for the 40-mg and 160-mg mongersen groups, respectively, as compared with 10% for the placebo group (P<0.001). There was no significant difference in the percentage of participants reaching clinical remission between the 10-mg group (12%) and the placebo group. The rate of clinical response was significantly greater among patients receiving 10 mg (37%), 40 mg (58%), or 160 mg (72%) of mongersen than among those receiving placebo (17%) (P=0.04, P<0.001, and P<0.001, respectively). Most adverse events were related to complications and symptoms of Crohn's disease. CONCLUSIONS: We found that study participants with Crohn's disease who received mongersen had significantly higher rates of remission and clinical response than those who received placebo. (Funded by Giuliani; EudraCT number, 2011-002640-27.).

14 Clinical Trial Immune response to influenza A/H1N1 vaccine in inflammatory bowel disease patients treated with anti TNF-α agents: effects of combined therapy with immunosuppressants. 2013

Andrisani, G / Frasca, D / Romero, M / Armuzzi, A / Felice, C / Marzo, M / Pugliese, D / Papa, A / Mocci, G / De Vitis, I / Rapaccini, G L / Blomberg, B B / Guidi, L. ·Operative Unit of Internal Medicine and Gastroenterology, Complesso integrato Columbus, Catholic University Sacro Cuore, Roma, Italy. ·J Crohns Colitis · Pubmed #22673636.

ABSTRACT: BACKGROUND AND AIMS: Our first objective was to evaluate the immune response to the adjuvanted 2009 A/H1N1 pandemic (pH1N1) vaccine in inflammatory bowel disease (IBD) patients treated with anti-TNF-α alone or combined with immunosuppressants (IS). Second and third aims were the safety of pH1N1 vaccine and the effects on IBD clinical activity. METHODS: 36 patients with Crohn's disease (CD) and 26 with ulcerative colitis (UC) and thirty-one healthy control (HC) subjects were enrolled. 47 patients were on anti TNF-α maintenance monotherapy and 15 on anti TNF-α combined with IS. Sera were collected at baseline (T0) and 4 weeks after the vaccination (T1) for antibody determination by hemagglutination inhibition (HAI). Disease activity was monitored at T0 and T1. RESULTS: Seroprotective titers (≥1:40) in patients were comparable to HC. Seroconvertion rate (≥4 fold increase in HAI titer) was lower than HC in IBD patients (p=0.009), either on anti TNF-α monotherapy (p=0.034) or combined with IS (p=0.011). Geometric mean titer (GMT) of antibodies at T1 was significantly lower in patients on combined therapy versus those on monotherapy (p=0.0017) and versus HC (p=0.011). The factor increase of GMT at T1 versus T0 was significantly lower in IBD patients versus HC (p=0.042), and in those on combined immunosuppression, both versus monotherapy (p=0.0048) and HC (p=0.0015). None of the patients experienced a disease flare. CONCLUSION: Our study has shown a suboptimal response to pH1N1 vaccine in IBD patients on therapy with anti TNF-α and IS compared to those on anti-TNF-α monotherapy and HC.

15 Article Association of Biomarker Cutoffs and Endoscopic Outcomes in Crohn's Disease: A Post Hoc Analysis From the CALM Study. 2020

Reinisch, Walter / Panaccione, Remo / Bossuyt, Peter / Baert, Filip / Armuzzi, Alessandro / Hébuterne, Xavier / Travis, Simon / Danese, Silvio / Sandborn, William J / Schreiber, Stefan / Berg, Sofie / Zhou, Qian / Kligys, Kristina / Neimark, Ezequiel / Suleiman, Ahmed A / D'Haens, Geert / Colombel, Jean-Frederic. ·Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria. · Inflammatory Bowel Disease Unit, Department of Medicine, University of Calgary, AB, Canada. · Imelda General Hospital, Bonheiden, Belgium. · AZ Delta, Roeselare-Menen, Belgium. · Presidio Columbus, Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy. · Inflammatory Bowel Disease Center, University of Nice-Sophia Antipolis, CHU of Nice, Nice, France. · Translational Gastroenterology Unit, National Institute for Health Research Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, UK. · Department of Biomedical Sciences, Humanitas University, Milan, Italy. · Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, CA, USA. · Department of Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany. · Global Medical Affairs, AbbVie AB, Solna, Sweden. · AbbVie Inc., North Chicago, IL, USA. · Research and Development, Gastroenterology/Immunology, AbbVie Inc., Worcester, MA, USA. · Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen am Rhein, Germany. · Academic Medical Center, Amsterdam, Netherlands. · Department of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. ·Inflamm Bowel Dis · Pubmed #32105310.

ABSTRACT: BACKGROUND: CALM was a randomized phase 3 trial in patients with Crohn's disease (CD) that demonstrated improved endoscopic outcomes when treatment was escalated based on cutoffs for inflammatory biomarkers, fecal calprotectin (FC), C-reactive protein (CRP), and CD Activity Index (CDAI) remission vs CDAI response alone. The purpose of this post hoc analysis of CALM was to identify drivers of treatment escalation and evaluate the association between biomarker cutoff concentrations and endoscopic end points. METHODS: The proportion of patients achieving CD Endoscopic Index of Severity (CDEIS) <4 and no deep ulcers 48 weeks after randomization was evaluated according to CRP <5 mg/L or ≥5 mg/L and FC <250 μg/g or ≥250 μg/g. Subgroup analyses were performed according to disease location, and sensitivity analyses were conducted in patients with elevated CRP and/or FC at baseline. The association between endoscopic end points and biomarker cutoffs was performed using χ 2 test. RESULTS: The proportion of patients who achieved the primary end point CDEIS <4 and no deep ulcers was significantly greater for those with FC <250 µg/g (74%; P < 0.001), with an additive effect for CRP <5 mg/L. The association of FC <250 µg/g with improved endoscopic outcomes was independent of disease location, although the greatest association was observed for ileocolonic disease. Fecal calprotectin <250 µg/g, CRP <5 mg/L, and CDAI <150 gave a sensitivity/specificity of 72%/63% and positive/negative predictive values of 86%/42% for CDEIS <4 and no deep ulcers 48 weeks after randomization. CONCLUSION: This post hoc analysis of CALM demonstrated that a cutoff of FC <250 µg/g is a useful surrogate marker for mucosal healing in CD.

16 Article Histopathology of inflammatory bowel disease - Position statement of the Pathologists of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) and Italian Group of Gastrointestinal Pathologists (GIPAD-SIAPEC). 2020

Villanacci, Vincenzo / Reggiani-Bonetti, Luca / Caprioli, Flavio / Saragoni, Luca / Salviato, Tiziana / Mescoli, Claudia / Canavese, Gabriella / Manenti, Stefania / Spada, Elisabetta / Baron, Luigi / Leoncini, Giuseppe / Cadei, Moris / Battista, Serena / Armuzzi, Alessandro. ·Institute of Pathology, ASST Spedali Civili, Brescia, Italy. Electronic address: villanac@alice.it. · Department of Diagnostic, Clinic and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy. · Gastroenterology and Endoscopy Unit, Fondazione IRCCS Cà Granda, Ospedale Policlinico di Milano, and Department of Pathophysiology, Department of Transplantation, University of Milan, Milan, Italy. · Department of Pathological Anatomy, AUSL Romagna, Morgagni-Pierantoni Hospital, Forlì, Italy. · Surgical Pathology and Cytopathology Unit, Department of Medicine (DIMED), University of Padova, Padua, Italy. · Pathology Department, Azienda Ospedaliera Città della Salute e della Scienza di Torino, Turin, Italy. · Institute of Pathology, ASST Spedali Civili, Brescia, Italy. · Pathology Unit, St. Leonardo Hospital, Castellammare di Stabia, Naples, Italy. · Pathology Unit, ASST del Garda, Desenzano del Garda (BS), Brescia, Italy. · Institute of Pathology Azienda Ospedaliera Universitaria Integrata, Udine, Italy. · IBD Unit, Presidio Columbus Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Rome, Italy. ·Dig Liver Dis · Pubmed #31884010.

ABSTRACT: Diagnosis of the inflammatory bowel diseases ulcerative colitis (UC) and Crohn's disease (CD) relies mainly on the histopathological examination of endoscopic biopsies of the gastrointestinal tract. To facilitate the accurate diagnosis of these two conditions, this paper addresses key issues on the: (A) gastrointestinal biopsy procedure, (B) histomorphological characteristics of UC and CD, and (C) diagnosis of dysplasia. The 13 statements presented here represent the consensus of two groups of Italian pathologists (IG-IBD and GIPAD).

17 Article ECCO Guidelines on Therapeutics in Crohn's Disease: Surgical Treatment. 2020

Adamina, Michel / Bonovas, Stefanos / Raine, Tim / Spinelli, Antonino / Warusavitarne, Janindra / Armuzzi, Alessandro / Bachmann, Oliver / Bager, Palle / Biancone, Livia / Bokemeyer, Bernd / Bossuyt, Peter / Burisch, Johan / Collins, Paul / Doherty, Glen / El-Hussuna, Alaa / Ellul, Pierre / Fiorino, Gionata / Frei-Lanter, Cornelia / Furfaro, Federica / Gingert, Christian / Gionchetti, Paolo / Gisbert, Javier P / Gomollon, Fernando / González Lorenzo, Marien / Gordon, Hannah / Hlavaty, Tibor / Juillerat, Pascal / Katsanos, Konstantinos / Kopylov, Uri / Krustins, Eduards / Kucharzik, Torsten / Lytras, Theodore / Maaser, Christian / Magro, Fernando / Marshall, John Kenneth / Myrelid, Pär / Pellino, Gianluca / Rosa, Isadora / Sabino, Joao / Savarino, Edoardo / Stassen, Laurents / Torres, Joana / Uzzan, Mathieu / Vavricka, Stephan / Verstockt, Bram / Zmora, Oded. ·Department of Surgery, Cantonal Hospital Winterthur, Winterthur, Switzerland. · University of Basel, Basel, Switzerland. · Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy. · IBD Center, Humanitas Clinical and Research Center, Milan, Italy. · Department of Gastroenterology, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK. · Humanitas Clinical and Research Center, Division of Colon and Rectal Surgery, Humanitas University, Department of Biomedical Sciences, Milan, Italy. · Imperial College London, Department of Surgery and Cancer, St Mark's Hospital, Department of Gastroenterology, London, UK. · IBD Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita' Cattolica del Sacro Cuore, Rome, Italy. · Department of Internal Medicine I, Siloah St Trudpert Hospital, Pforzheim, Germany. · Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark. · Department of Systems Medicine, University 'Tor Vergata' of Rome, Rome, Italy. · Gastroenterology Practice Minden, Minden, Germany. · Imelda GI Clinical Research Centre, Imelda General Hospital, Bonheiden, Belgium. · Gastrounit, Medical Division, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark. · Department of Gastroenterology, Royal Liverpool University Hospital, Liverpool, UK. · Department of Gastroenterology and Centre for Colorectal Disease, St Vincent's University Hospital, Dublin, Ireland. · Department of Surgery, Aalborg University Hospital, Aalborg, Denmark. · Department of Medicine, Division of Gastroenterology, Mater Dei Hospital, Msida, Malta. · Department of Surgery, Hospital Zollikerberg, Zollikerberg Zürich, Switzerland. · Visceral Surgery, Cantonal Hospital Winterthur, Winterthur, Switzerland; Department of Human Medicine, Faculty of Health, University of Witten/Herdecke, Witten, Germany. · IBD Unit, DIMEC, University of Bologna, Bologna, Italy. · Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa [IIS-IP], Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas [CIBEREHD], Madrid, Spain. · IBD UNIT, Hospital Clíico Universitario 'Lozano Blesa', IIS Aragón, CIBEREHD, Zaragoza, Spain. · Department of Gastroenterology, Barts Health NHS Trust, Royal London Hospital, London, UK. · Fifth Department of Internal Medicine, Sub-department of Gastroenterology and Hepatology, University Hospital Bratislava and Faculty of Medicine, Comenius University Bratislava, Slovakia. · Clinic for Visceral Surgery and Medicine, Inselspital, University Hospital of Bern, Bern, Switzerland. · Department of Gastroenterology and Hepatology, University and Medical School of Ioannina, Ioannina, Greece. · Department of Gastroenterology, Tel-HaShomer Sheba Medical Center, Ramat Gan, Israel; and Sackler Medical School, Tel Aviv, Israel. · Department of Gastroenterology, Hepatology and Nutrition, Pauls Stradins Clinical University Hospital, Department of Internal Medicine, Riga Stradiņš University, Riga, Latvia. · Department of Internal Medicine and Gastroenterology, Hospital Lüneburg, Lüneburg, Germany. · National Public Health Organization, Athens, Greece. · Outpatients Department of Gastroenterology, Hospital Lüneburg, Lüneburg, Germany. · Department of Pharmacology and Therapeutics; Institute for Molecular and Cell Biology, University of Porto, Faculty of Medicine, Porto, Portugal. · Department of Medicine [Division of Gastroenterology] and Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON, Canada. · Department of Surgery, and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden. · Department of Advanced Medical and Surgical Sciences, Universitá degli Studi della Campania 'Luigi Vanvitelli', Naples, Italy. · Department of Gastroenterology, IPOLFG, Lisbon, Portugal. · Department of Gastroenterology and Hepatology, University Hospitals, KU Leuven, Leuven, Belgium. · Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy. · Department of General Surgery, Maastricht University Medical Centre+, Maastricht, The Netherlands. · Department of Gastroenterology, Hospital Beatriz Ângelo, Loures, Portugal. · Department of Gastroenterology, IBD unit, Beaujon Hospital, APHP, Clichy, France. · Division of Gastroenterology and Hepatology, University Hospital, Zürich, Switzerland. · Department of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium, and Department of Chronic Diseases, Metabolism and Ageing, TARGID - IBD, KU Leuven, Leuven, Belgium. · Department of Surgery, Shamir Medical Center [Assaf Harofe], Tel Aviv, Israel. ·J Crohns Colitis · Pubmed #31742338.

ABSTRACT: This article is the second in a series of two publications relating to the European Crohn's and Colitis Organisation [ECCO] evidence-based consensus on the management of Crohn's disease. The first article covers medical management; the present article addresses surgical management, including preoperative aspects and drug management before surgery. It also provides technical advice for a variety of common clinical situations. Both articles together represent the evidence-based recommendations of the ECCO for Crohn's disease and an update of previous guidelines.

18 Article Are we choosing wisely for inflammatory bowel disease care? The IG-IBD choosing wisely campaign. 2020

Lenti, Marco Vincenzo / Armuzzi, Alessandro / Castiglione, Fabiana / Fantini, Massimo Claudio / Fiorino, Gionata / Orlando, Ambrogio / Pugliese, Daniela / Rizzello, Fernando / Vecchi, Maurizio / Di Sabatino, Antonio / Anonymous4101081. ·First Department of Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Italy. Electronic address: marco.lenti@unipv.it. · IBD Unit, Presidio Columbus, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy. · Gastroenterology, Department of Clinical Medicine and Surgery, University Federico II of Naples, Naples, Italy. · Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy. · IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Center, Humanitas University, Rozzano, Italy. · United Hospitals "Villa Sofia-Cervello", Palermo, Italy. · Department of Internal Medicine and Gastroenterology, University of Bologna, Bologna, Italy. · Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy. · First Department of Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Italy. ·Dig Liver Dis · Pubmed #31648921.

ABSTRACT: BACKGROUND: The "Choosing Wisely" campaigns have the aim of promoting a better clinician-patient relationship. AIMS: The Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) conducted a choosing wisely campaign for IBD. METHODS: Ten IG-IBD panellists conducted the campaign through a modified Delphi process. All IG-IBD members were asked to submit five statements starting with "Do not…" addressing any IBD-related procedure or treatment the necessity of which should be questioned. All recommendations were evaluated by the panellists who prioritised each item. The top ten recommendations were prioritised again by IG-IBD members, and the top five recommendations were identified. RESULTS: 110 members (mean age 42 ± 12; 62 males) participated in the campaign. The top five recommendations were as follow: 1. Do not use corticosteroids for maintenance therapy, or without a clear indication; 2. Do not forget venous thromboembolism prophylaxis in hospitalised patients with active disease; 3. Do not treat perianal Crohn's disease with biologics without prior surgical evaluation; 4. Do not discontinue IBD-related medications during pregnancy unless specifically indicated; 5. Do not delay surgery. CONCLUSION: The IG-IBD promoted a campaign with a bottom-up approach, identifying five recommendations that could be useful for providing a better IBD care, especially among non-IBD experts.

19 Article Tight control for Crohn's disease with adalimumab-based treatment is cost-effective: an economic assessment of the CALM trial. 2020

Panaccione, Remo / Colombel, Jean-Frederic / Travis, Simon P L / Bossuyt, Peter / Baert, Filip / Vaňásek, Tomáš / Danalıoğlu, Ahmet / Novacek, Gottfried / Armuzzi, Alessandro / Reinisch, Walter / Johnson, Scott / Buessing, Marric / Neimark, Ezequiel / Petersson, Joel / Lee, Wan-Ju / D'Haens, Geert R. ·Inflammatory Bowel Disease Unit, University of Calgary, Calgary, Alberta, Canada. · Division of Gastroenterology, Icahn School of Medicine Vanasek, Division of Gastroenterology and Hepatology, New York, New York, USA. · Gastroenterology, John Radcliffe Hospital, Oxford, UK. · Gastroenterology, Imelda General Hospital, Bonheiden, Belgium. · Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium. · Division of Gastroenterology and Hepatology, Hepato-Gastroenterologie HK, sro, Hradec Králové, Czech Republic. · Gastroenterology Department, Bezmialem Vakıf University, Istanbul, Turkey. · Department of Internal Medicine IV, Medical University of Vienna, Vienna, Austria. · Internal Medicine and Gastroenterology, Catholic University, Rome, Italy. · Department of Medicine IV, Medical University Vienna, Vienna, Austria. · Medicus Economics LCC., Milton, Maine, USA. · Medicus Economics, Boston, Massachusetts, USA. · AbbVie Inc., North Chicago, Illinois, USA. · Gastroenterology, AMC, Amsterdam, The Netherlands. ·Gut · Pubmed #31285357.

ABSTRACT: OBJECTIVE: To evaluate the cost-effectiveness of an inflammatory biomarker and clinical symptom directed tight control strategy (TC) compared with symptom-based clinical management (CM) in patients with Crohn's disease (CD) naïve to immunosuppressants and biologics using a UK public payer perspective. DESIGN: A regression model estimated weekly CD Activity Index (CDAI)-based transition matrices (remission: CDAI <150, moderate: CDAI ≥150 to <300, severe: CDAI ≥300 to <450, very severe: CDAI ≥450) based on the Effect of Tight Control Management on Crohn's Disease (CALM) trial. A regression predicted hospitalisations. Health utilities and costs were applied to health states. Work productivity was monetised and included in sensitivity analyses. Remission rate, CD-related hospitalisations, adalimumab injections, other direct medical costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio (ICER) were calculated. RESULTS: Over 48 weeks, TC was associated with a higher clinical remission (CDAI <150) rate (58.2% vs 46.8%), fewer CD-related hospitalisations (0.124 vs 0.297 events per patient) and more injections of adalimumab (40 mg sc) (mean 31.0 vs 24.7) than CM. TC was associated with 0.032 higher QALYs and £593 higher total medical costs. The ICER was £18 656 per QALY. The ICER was cost-effective in 57.9% of simulations. TC became dominant, meaning less costly but more effective, when work productivity was included. CONCLUSION: A TC strategy as used in the CALM trial is cost-effective compared with CM. Incorporating costs related to work productivity increases the economic value of TC. Cross-national inferences from this analysis should be made with caution given differences in healthcare systems. TRIAL REGISTRATION NUMBER: NCT01235689; Results.

20 Article Early vedolizumab trough levels predict treatment persistence over the first year in inflammatory bowel disease. 2019

Guidi, Luisa / Pugliese, Daniela / Tonucci, Tommaso Panici / Bertani, Lorenzo / Costa, Francesco / Privitera, Giuseppe / Tolusso, Barbara / Di Mario, Clara / Albano, Eleonora / Tapete, Gherardo / Gremese, Elisa / Papa, Alfredo / Gasbarrini, Antonio / Rapaccini, Gian Ludovico / Armuzzi, Alessandro. ·UOC Medicina Interna e Gastroenterologia Columbus, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. · Università Cattolica del Sacro Cuore, Rome, Italy. · Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy. · Department of General Surgery and Gastroenterology, IBD UNIT-AOUP, Pisa, Italy. · UOC Reumatologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. · UOC Medicina Interna e Gastroenterologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. ·United European Gastroenterol J · Pubmed #31700632.

ABSTRACT: Background: Data from trials of vedolizumab for inflammatory bowel disease and from real-world studies suggest an exposure-response relationship, such that vedolizumab trough levels may predict clinical and endoscopic outcomes. Objective: The purpose of this study was to evaluate in a prospective observational study the utility of an early vedolizumab trough level assay for predicting the first-year vedolizumab therapy outcome. Methods: This prospective observational study included consecutive inflammatory bowel disease patients. We measured vedolizumab trough levels and anti-vedolizumab antibodies at weeks 6 and 14. Clinical outcome was assessed at weeks 6, 14, 22 and 54. The primary endpoint was the correlation between early vedolizumab trough levels and vedolizumab persistence over the first year of treatment, defined as the maintenance of vedolizumab therapy due to sustained clinical benefit. Results: We included 101 patients initiating vedolizumab. A cut-off vedolizumab trough level of 16.55 µg/ml at week 14 predicted vedolizumab persistence within the first year of therapy, with 73.3% sensitivity and 59.4% specificity ( Conclusion: High vedolizumab trough level at week 14 was associated with a higher probability of maintaining vedolizumab therapy over the first year due to sustained clinical benefit.

21 Article Physicians' Knowledge and Application of Immunization Strategies in Patients with Inflammatory Bowel Disease: A Survey of the Italian Group for the Study of Inflammatory Bowel Disease. 2019

Macaluso, Fabio Salvatore / Mazzola, Giovanni / Ventimiglia, Marco / Alvisi, Patrizia / Renna, Sara / Adamoli, Lucia / Galli, Massimo / Armuzzi, Alessandro / Ardizzone, Sandro / Cascio, Antonio / Cottone, Mario / Orlando, Ambrogio / Anonymous7490992. ·IBD Unit, "Villa Sofia-Cervello" Hospital, Palermo, Italy, fsmacaluso@gmail.com. · Department of Sciences for Health Promotion " G. D'Alessandro", University of Palermo, Palermo, Italy. · IBD Unit, "Villa Sofia-Cervello" Hospital, Palermo, Italy. · Gastroenterology of Pediatric Unit, Maggiore Hospital, Bologna, Italy. · Infectious Disease Unit, Department of Biomedical and Clinical Sciences, "Luigi Sacco" University Hospital, Milan, Italy. · IBD Unit, Presidio Columbus Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy. · Department of Biochemical and Clinical Science "L. Sacco", University of Milan, ASST Fatebenefratelli Sacco, Milan, Italy. ·Digestion · Pubmed #31167191.

ABSTRACT: BACKGROUND: No data on European countries about knowledge and application of immunization strategies in patients with inflammatory bowel disease (IBD) are available. OBJECTIVES: We designed a questionnaire aimed at exploring these issues among Italian gastroenterologists dealing with adult and paediatric IBD. METHODS: An anonymous, 24-item, questionnaire was sent via e-mail to all members of the Italian Group for the study of Inflammatory Bowel Disease. Three sets of questions were formulated: (1) Characteristics of respondents; (2) General opinions on the role of vaccines in IBD patients; (3) Immunizations of IBD patients in clinical practice. RESULTS: Of the 455 total surveys sent, there were 198 respondents (response rate: 43.5%). The great majority of respondents (82.9%) reputed as "very important" to perform the vaccinations recommended by the guidelines in patients with IBD. The indication to immunization is given at the diagnosis of the disease by 55.6% of the respondents. The most frequently recommended vaccine in IBD patients is the annual flu vaccine, while the recommendation rate for the other vaccines is variable depending on the different pathogens. CONCLUSIONS: Efforts carried out by the scientific societies are required to increase the awareness of this relevant topic among physicians.

22 Article Real-life effectiveness of ustekinumab in inflammatory bowel disease patients with concomitant psoriasis or psoriatic arthritis: An IG-IBD study. 2019

Pugliese, Daniela / Daperno, Marco / Fiorino, Gionata / Savarino, Edoardo / Mosso, Elena / Biancone, Livia / Testa, Anna / Sarpi, Lucio / Cappello, Maria / Bodini, Giorgia / Caprioli, Flavio / Festa, Stefano / Laino, Gabriella / Maconi, Giovanni / Mazzuoli, Silvia / Mocci, Giammarco / Sartini, Alessandro / D'Amore, Alessandra / Alivernini, Stefano / Gremese, Elisa / Armuzzi, Alessandro. ·IBD Unit, Presidio Columbus, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy. · Gastroenterology Unit, A.O. Ordine Mauriziano, Turin, Italy. · IBD Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Italy. · Gastroenterology Unit, Department Surgery, Oncology and Gastroenterology, University of Padua, Italy. · General and Specialistic Medicine/Gastroenterology, Città della Salute e della Scienza di Torino, Italy. · University of Rome Tor Vergata, Department of Systems Medicine, Gastroenterology, Rome, Italy. · Federico II University, Gastroenterology, Naples, Italy. · Gastroenterologia ed Endoscopia Digestiva Aziendale USL Umbria1, Perugia, Italy. · Gastroenterology and Hepatology Section, DiBiMis, University of Palermo, Palermo, Italy. · Gastrointestinal Unit, Department of Internal Medicine, University of Genoa, Genoa, Italy. · Department of Pathophysiology and Transplantation, University of Milan and Gastroenterology and Endoscopy Unit, IRCCS Cà Granda, IRCCS Policlinico Hospital, Milan, Italy. · IBD Unit, San Filippo Neri Hospital, Rome, Italy. · Department of New Technologies and Translational Research in Medicine and Surgery, University of Pisa, Pisa, Italy. · Luigi Sacco University Hospital, Gastroenterology and IBD Unit, Milan, Italy. · Gastroenterology Unit, San Nicola Pellegrino Hospital, Trani, Italy. · Division of Gastroenterology, "Brotzu" Hospital, Cagliari, Italy. · Department of Internal Medicine, Gastroenterology Unit, University of Modena and Reggio Emilia, Modena, Italy. · Department of Dermatology, Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore, Rome, Italy. · Division of Rheumatology, Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore, Rome, Italy. · IBD Unit, Presidio Columbus, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: alearmuzzi@yahoo.com. ·Dig Liver Dis · Pubmed #30992173.

ABSTRACT: BACKGROUND: Few data exist regarding the effectiveness of ustekinumab in inflammatory bowel disease (IBD) patients treated for concomitant psoriasis or psoriatic arthritis. AIMS: to describe the outcomes of IBD patients who received subcutaneous ustekinumab through a dermatological or rheumatological prescription. METHODS: This multicenter, retrospective study included all IBD patients who were started on ustekinumab for concomitant active psoriasis/ psoriatic arthritis, irrespective of IBD activity. The primary endpoint was overall ustekinumab persistence, defined as the maintenance of therapy because of sustained clinical benefit for IBD. RESULTS: Seventy patients (64 Crohn's disease / 6 ulcerative colitis) were enrolled. The median follow-up on ustekinumab therapy was 10.7 months (range, 1.4-67.3). Twelve patients (17.1%) withdrew the treatment after a median of 7.4 months (range, 0.9-23.8). The cumulative probability of maintaining ustekinumab treatment was 97.1% at 6 months and 77.1% at 12 months. Among the 56 patients with baseline active IBD, 34 (60.7%) were in clinical remission at the last follow-up visit. Their cumulative probability of achieving clinical remission was 84.7% and 63.9% at 6 and 12 months, respectively. Two patients stopped ustekinumab for an adverse event. CONCLUSIONS: Subcutaneous ustekinumab had a good effectiveness profile for IBD patients treated for concomitant dermatological or rheumatological conditions.

23 Article Epidemiological features and disease-related concerns of a large cohort of Italian patients with active Crohn's disease. 2019

Armuzzi, Alessandro / Riegler, Gabriele / Furfaro, Federica / Baldoni, Monia / Costa, Francesco / Fortuna, Manuela / Iaquinto, Gaetano / Paese, Pietro / Papi, Claudio / Bossa, Fabrizio / Tontini, Gian Eugenio / Di Fino, Sara / Gualberti, Giuliana / Merolla, Rocco / Rizzello, Fernando. ·IBD Unit, "Presidio Columbus" Foundation Hospital "A. Gemelli IRCCS" - Sacro Cuore Catholic University, Rome, Italy. Electronic address: alearmuzzi@yahoo.com. · Unit of Gastroenterology - Reference Center for IBD - Second University of Naples, Naples, Italy. · IBD Center, Humanitas Research Hospital Rozzano, Milan, Italy. · Section of Gastroenterology, Hepatology and Digestive Endoscopy of the Department of Medicine, University of Perugia, Perugia, Italy. · University Gastroenterology Unit - Pisana University Hospital, Pisa, Italy. · Center for Rectal-Intestinal Diseases, S. Cuore Don Calabria Hospital, Negrar - Verona, Italy. · Gastroenterology and Digestive Endoscopy, Santa Rita Hospital, Atripalda, Avellino, Italy. · Gastroenterology Unit, Cosenza Civil Hospital, Cosenza, Italy. · IBD Unit, S Filippo Neri Hospital, Rome, Italy. · Division of Gastroenterology, Foundation "IRCCS Casa Sollievo della Sofferenza", San Giovanni Rotondo - Foggia, Italy. · Gastroenterology ed Endoscopy Unit, Foundation "IRCCS Ca' Granda Ospedale Maggiore" Hospital, Milan, Italy. · Medical Department, AbbVie, Rome, Italy. · IBD Unit, University of Bologna, Emilia-Romagna Region IBD Reference Center, S. Orsola-Malpighi Hospital, Bologna, Italy. ·Dig Liver Dis · Pubmed #30685416.

ABSTRACT: BACKGROUND-AIMS: The SOLE study was conducted on a large cohort of Italian patients with moderate-severe Crohn's disease (CD) to assess epidemiological and disease characteristics and their correlation with disease-related worries, treatment satisfaction and adherence, workability. METHODS: The following tools were used over 12 months to assess: Results were correlated with demographic and clinical variables with linear regression models. RESULTS: 552 patients with active CD (51% men) were recruited. Higher worries were having an ostomy bag and undergoing surgery. Variables associated with a higher RFIPC score included female sex, higher disease activity, lower treatment adherence (p < 0.001), previous surgical treatments (p = 0.003). 60% of patients claimed difficulties with activities of daily living. Lower VAS scores were reported by patients with disease duration >6years; treatment satisfaction/adherence was higher with anti-TNF-α treatment. Decreased hospitalizations during follow-up and improved workability/daily activities occurred with adalimumab, infliximab, azathioprine (p < 0.001). CONCLUSION: Worries included having an ostomy bag, undergoing surgery, developing cancer: conditions significantly associated with worsened disease activity and low treatment adherence. Higher treatment adherence scores/greater workability improvements were observed in patients treated with anti-TNF-α agents.

24 Article Unmet needs of Italian physicians managing patients with inflammatory bowel disease. 2019

Bezzio, Cristina / Imperatore, Nicola / Armuzzi, Alessandro / Rizzello, Fernando / Manes, Gianpiero / Bossa, Fabrizio / Calabrese, Emma / Caprioli, Flavio / Daperno, Marco / Mocciaro, Filippo / Orlando, Ambrogio / Papi, Claudio / Rispo, Antonio / Saibeni, Simone / Anonymous1250962. ·Gastroenterology Unit, ASST Rhodense, Rho Hospital, Rho, Italy. · Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II, Naples, Italy. · IBD Unit, Columbus Fondation, Policlinico Hospital A. Gemelli IRCCS, Catholic University of Sacred Heart, Rome, Italy. · IBD Unit, DIMEC, University of Bologna, Italy. · Division of Gastroenterology, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo (FG), 71013, Italy. · Gastroenterology Department of Systems Medicine, University of Tor Vergata, Rome, Italy. · Department of Pathophysiology and Transplantation, University of Milan and Gastroenterology and Endoscopy Unit, IRCCS Cà Granda, IRCCS Policlinico Hospital, Milan, Italy. · Hospital Mauritian Order, Turin, Italy. · Gastroenterology Unit, ARNAS Civic Hospital, Palermo, Italy. · Division of Internal Medicine 2, IBD Unit, Villa Sofia-Cervello Hospitals, Palermo, Italy. · IBD Unit, San Filippo Neri Hospital, Rome, Italy. · Gastroenterology Unit, ASST Rhodense, Rho Hospital, Rho, Italy. Electronic address: saibo@tiscali.it. ·Dig Liver Dis · Pubmed #30228075.

ABSTRACT: BACKGROUND: Little is known about the unmet needs of physicians caring for patients with inflammatory bowel disease (IBD). AIMS: This study explored the practical difficulties and needs for professional updating of Italian IBD physicians. METHODS: A questionnaire was distributed to 600 physicians attending IG-IBD meetings. RESULTS: 280 physicians completed the questionnaire (46.7%). On a 5-point Likert scale (from 1, strongly disagree to 5, strongly agree), they identified the most problematic issues in managing IBD patients as increasing bureaucracy (3.9), lack of extra-gastroenterological IBD expertise (3.4), lack of diagnostic techniques (3.1) and budget limitations (2.9). The most lacking techniques, ranked from 1 (greatest need) to 9 (lowest need), were: anti-drug antibody and trough level assays (2.7), device-assisted enteroscopy (3.1), exploration under anaesthesia (3.2), MR enterography (3.2), and bowel ultrasonography (3.3). About professional updating, respondents indicated (on a 5-point Likert scale) that helpful topics were practical medicine (4.3), managing difficult patients (4.1), and guidelines (4.0). The most desired modality for updating was residential courses on clinical practice (4.3). CONCLUSION: Several factors potentially limit the best management of IBD patients in Italy. Satisfying these unmet needs could improve care for IBD patients.

25 Article Epidemiology of inflammatory bowel disease in the Republic of San Marino: The "EPIMICI - San Marino" study. 2019

Piscaglia, Anna Chiara / Lopetuso, Loris Riccardo / Laterza, Lucrezia / Gerardi, Viviana / Sacchini, Elena / Leoncini, Emanuele / Boccia, Stefania / Stefanelli, Maria Loredana / Gasbarrini, Antonio / Armuzzi, Alessandro. ·Endoscopy and Gastroenterology Unit, State Hospital, Borgo Maggiore, San Marino. Electronic address: annachiarapiscaglia@hotmail.com. · Dept. of Gastroenterology, Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy. · Health Authority of San Marino, Borgo Maggiore, San Marino. · Section of Hygiene, Institute of Public Health, Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy. · Internal Medicine, State Hospital, Borgo Maggiore, San Marino. · IBD Unit, Presidio Columbus, Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy. ·Dig Liver Dis · Pubmed #30197187.

ABSTRACT: BACKGROUND: The burden of Crohn's disease (CD) and ulcerative colitis (UC) has never been estimated in the Republic of San Marino, the third smallest nation of the world. AIMS: To assess the occurrence and clinical features of CD and UC in San Marino during the last 35 years. METHODS: We retrospectively evaluated the prevalence, incidence, and main clinical aspects of CD and UC from 1980 to 2014, crossing data from various sources. RESULTS: Prevalence rates (per 100,000) on December 31, were 241 for CD (263 in males and 220 in females) and 311 for UC (370 in males and 255 in females). The specific incidence of UC steadily increased from 4.6 (95% CI: 1.5-10.6) in 1980-1984 to 12.4 (95% CI: 7.6-19.1) in 2010-2014; CD incidence showed a higher proportional increase, from 1.8 (95% CI: 0.2-6.6) in 1980-1984 to 17.9 (95% CI: 12.0-25.7) in 2010-2014. The main clinical features of CD and UC (activity and location at diagnosis, extra-intestinal manifestations, disease progression overtime, therapies, and hospitalizations) were analyzed. CONCLUSIONS: This study provides the first epidemiological report on CD and UC in San Marino, showing specific traits and overall higher prevalence and incidence rates than previously reported in neighbor Areas.

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