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Crohn Disease: HELP
Articles by Alessandro Armuzzi
Based on 30 articles published since 2008
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Between 2008 and 2019, A. Armuzzi wrote the following 30 articles about Crohn Disease.
 
+ Citations + Abstracts
Pages: 1 · 2
1 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 / Anonymous3340672 / Anonymous3350672. ·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.

2 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 --

3 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.

4 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.

5 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.

6 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 / Anonymous4800794. ·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.

7 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.

8 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.

9 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.).

10 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.

11 Clinical Trial Successful induction of clinical response and remission with certolizumab pegol in Crohn's disease patients refractory or intolerant to infliximab: a real-life multicenter experience of compassionate use. 2008

Danese, Silvio / Mocciaro, Filippo / Guidi, Luisa / Scribano, Maria Lia / Comberlato, Michele / Annese, Vito / Colombo, Elisabetta / Stefanelli, Tommaso / Marzo, Manuela / Vangeli, Marcello / Pulitano', Raffaella / Manca, Aldo / Armuzzi, Alessandro / Malesci, Alberto / Prantera, Cosimo / Cottone, Mario. · ·Inflamm Bowel Dis · Pubmed #18357580.

ABSTRACT: -- No abstract --

12 Article Multidisciplinary Management of Spondyloarthritis-Related Immune-Mediated Inflammatory Disease. 2018

Rizzello, Fernando / Olivieri, Ignazio / Armuzzi, Alessandro / Ayala, Fabio / Bettoli, Vincenzo / Bianchi, Luca / Cimino, Luca / Costanzo, Antonio / Cristaudo, Antonio / D'Angelo, Salvatore / Daperno, Marco / Fostini, Anna Chiara / Galeazzi, Mauro / Gilio, Michele / Gionchetti, Paolo / Gisondi, Paolo / Lubrano, Ennio / Marchesoni, Antonio / Offidani, Annamaria / Orlando, Ambrogio / Pugliese, Daniela / Salvarani, Carlo / Scarpa, Raffaele / Vecchi, Maurizio / Girolomoni, Giampiero. ·IBD Unit, DIMEC, University of Bologna, S Orsola-Malpighi Hospital Bologna, Bologna, Italy. · Istituto Reumatologico Lucano (IReL), Potenza, Italy. · Dipartimento di Reumatologia della Regione Basilicata, Ospedale Madonna delle Grazie di Matera, Potenza, Italy. · Dipartimento di Reumatologia della Regione Basilicata, Ospedale San Carlo di Potenza, Potenza, Italy. · Fondazione BRB (Basilicata Ricerca Biomedica), Potenza, Italy. · UOC di Medicina Interna e Malattie dell'Apparato Digerente, Presidio Columbus Fondazione Policlinico Gemelli Universita' Cattolica, Rome, Italy. · UOC di Dermatologia, Dipartimento di Medicina Clinica e Chirurgia, Università di Napoli Federico II, Naples, Italy. · Department of Clinical and Experimental Dermatology, O.U. of Dermatology, Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, Italy. · U.O.C. Dermatologia, Fondazione Policlinico Tor Vergata, Tor Vergata University of Rome, Rome, Italy. · SSD di Immunologia Oculare, AUSL-IRCCS Reggio Emilia, Reggio Emilia, Italy. · Unità Dermatologia Dipartimento di Scienze Biomediche Humanitas University, Rozzano, Milan, Italy. · UOC Dermatologia IRCCS Istituto Clinico Humanitas, Rozzano, Milan, Italy. · UO Dermatologia, MST, Ambientale e Tropicale San Gallicano Dermatological Institute-IRCCS, Rome, Italy. · Istituto Reumatologico Lucano (IReL), Potenza, Italy. saldangelo@katamail.com. · Dipartimento di Reumatologia della Regione Basilicata, Ospedale Madonna delle Grazie di Matera, Potenza, Italy. saldangelo@katamail.com. · Dipartimento di Reumatologia della Regione Basilicata, Ospedale San Carlo di Potenza, Potenza, Italy. saldangelo@katamail.com. · Fondazione BRB (Basilicata Ricerca Biomedica), Potenza, Italy. saldangelo@katamail.com. · Gastroenterology Unit, Mauriziano Hospital, Turin, Italy. · Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy. · Dipartimento di Scienze Mediche, Chirurgiche e Neuroscienze, Università degli Studi di Siena, Siena, Italy. · Department of Health Science, University "Magna Grecia", Catanzaro, Italy. · IBD Unit, Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy. · Dipartimento di Medicina e Scienze della Salute "Vincenzo Tiberio", Università degli Studi del Molise, Campobasso, Italy. · U.O.C. Day Hospital di Reumatologia, ASST Gaetano Pini-CTO, Milan, Italy. · SOD Clinica di Dermatologia A.O.U. Ospedali Riuniti, Ancona, Italy. · UOSD MICI-A.O. Ospedali Riuniti "Villa Sofia-Cervello" Palermo, Palermo, Italy. · Azienda USL-IRCCS e Università di Modena e Reggio Emilia, Reggio Emilia, Italy. · UOC di Reumatologia, Università Federico II, Naples, Italy. · Department of Biomedical Science for the Health, University of Milan, Milan, Italy. · Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. ·Adv Ther · Pubmed #29516409.

ABSTRACT: INTRODUCTION: Immune-mediated inflammatory diseases (IMIDs) are chronic autoimmune conditions that share common pathophysiologic mechanisms. The optimal management of patients with IMIDs remains challenging because the coexistence of different conditions requires the intervention of several specialists. The aim of this study was to develop a series of statements defining overarching principles that guide the implementation of a multidisciplinary approach for the management of spondyloarthritis (SpA)-related IMIDs including SpA, psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis and uveitis. METHODS: A Delphi consensus-based approach was used to identify a core set of statements. The process included development of initial questions by a steering committee, an exhaustive search of the literature using complementary approaches to identify potential statements and two Delphi voting rounds for finalization of the statements. RESULTS: Consensus was achieved on the related nature of IMIDs, the existence of a high prevalence of multiple IMIDs in a single patient and the fact that a multidisciplinary approach can result in a more extensive evaluation and comprehensive approach to treatment. The goals of a multidisciplinary team should be to increase diagnosis of concomitant IMIDs, improve the decision-making process, and increase patient satisfaction and adherence. Early referral and diagnosis, early recognition of concomitant IMIDs and optimizing treatment to improve patient quality of life are some of the advantages of using multidisciplinary teams. To be effective, a multidisciplinary team should be equipped with the appropriate tools for diagnosis and follow-up, and at a minimum the multidisciplinary team should include a dermatologist, gastroenterologist and rheumatologist; providing psychologic support via a psychologist and involving an ophthalmologist, general practitioners and nurses in multidisciplinary care is also important. CONCLUSION: The present Delphi consensus identified a set of overarching principles that may be useful for implementation of a multidisciplinary approach for the management of SpA-related IMIDs. FUNDING: Aristea and Hippocrates.

13 Article Multiparametric Evaluation Predicts Different Mid-Term Outcomes in Crohn's Disease. 2018

Laterza, Lucrezia / Piscaglia, Anna Chiara / Minordi, Laura Maria / Scoleri, Iolanda / Larosa, Luigi / Poscia, Andrea / Ingravalle, Fabio / Amato, Arianna / Alfieri, Sergio / Armuzzi, Alessandro / Cammarota, Giovanni / Gasbarrini, Antonio / Scaldaferri, Franco. ·Internal Medicine, Gastroenterology and Liver disease Unit, Gastroenterological Area, Gastroenterological-Endocrinometabolic Sciences Department, Fondazione Policlinico A. Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy. · Endoscopy and Gastroenterology Unit, ISS, Borgo Maggiore, San Marino. · Imaging Department, Fondazione Policlinico A. Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy. · Institute of Public Health, Università Cattolica del Sacro Cuore, Rome, Italy. · Institute of Anaesthesiology, Fondazione Policlinico A. Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy. · Institute of Surgery, Fondazione Policlinico A. Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy. · Internal Medicine and Gastroenterology Unit, Complesso Integrato Columbus, Gastroenterological Area, Gastroenterological-Endocrinometabolic Sciences Department, Fondazione Policlinico A. Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy. ·Dig Dis · Pubmed #29514146.

ABSTRACT: AIM: To evaluate if a single and/or combined (clinical, endoscopic and radiological) assessment could predict clinical outcomes in Crohn's disease (CD). METHODS: We prospectively evaluated 57 CD cases who underwent both a colonoscopy and a CT-enterography (CTE). Harvey-Bradshaw Index (HBi), SES-CD (and/or Rutgeerts score) and the radiological disease activity were defined to stratify patients according to clinical, endoscopic and radiological disease activity respectively. Hospitalizations, surgery, therapeutic changes and deaths were evaluated up to 36 months (time 1) for 53 patients. RESULTS: CTE and endoscopy agreed in stratifying disease activity in 47% of cases (k = -0.05; p = 0.694), CTE and HBi in 35% (k = 0.09; p = 0.08), endoscopy and HBi in 39% (k = 0.13; p = 0.03). Taken together, CTE, endoscopy and HBi agreed only in 18% of cases (k = 0.01; p = 0.41). Among the 11 cases with mucosal healing, only 3 (27%) showed transmural healing. Patients with endoscopic activity needed significantly more changes of therapy compared to patients with endoscopic remission (p = 0.02). Patients with higher transmural or clinical activity at baseline required significantly more hospitalizations (p < 0.01). Hospitalization rate decreases with an increase in the number of parameters indicating remissions at baseline (p = 0.04). CONCLUSIONS: Clinical, endoscopic and radiological assessments offer complementary information and could predict different mid-term outcomes in CD.

14 Article Effectiveness of Mesalazine, Thiopurines and Tumour Necrosis Factor Antagonists in Preventing Post-Operative Crohn's Disease Recurrence in a Real-Life Setting. 2017

Allocca, Mariangela / Landi, Rosario / Bonovas, Stefanos / Fiorino, Gionata / Papa, Alfredo / Spinelli, Antonino / Furfaro, Federica / Peyrin-Biroulet, Laurent / Armuzzi, Alessandro / Danese, Silvio. ·IBD Center, Gastroenterology, IRCCS Humanitas, Rozzano, Milan, Italy. ·Digestion · Pubmed #28903094.

ABSTRACT: BACKGROUND: Most Crohn's disease (CD) patients develop endoscopic recurrence within one year of intestinal resection. The best treatment method to prevent post-operative CD recurrence remains uncertain. METHODS: A total of 155 CD patients from 2 referral centres, who were undergoing intestinal resection with ileo-colonic anastomosis (January 2004-January 2015), were included. All subjects received preventive therapy with tumour necrosis factor antagonists (anti-TNFs), thiopurinesor mesalazine. The primary outcome was the rate of endoscopic recurrence (Rutgeerts score ≥i2) in the 3 treatment groups. RESULTS: Patients treated with anti-TNFs were at significantly lower risk of endoscopic recurrence during the follow-up than those receiving thiopurines or mesalazine (incidence rates of 2.2, 3.0 and 4.8 per 100 person-months, respectively, log-rank, p = 0.011). The median time to recurrence was significantly longer in patients treated with anti-TNFs than in those who received thiopurines or mesalazine (37.0, 13.7, and 16.8 months, respectively, log-rank, p = 0.011). Anti-TNFs were more effective than mesalazine (univariable analysis, hazard ratio [HR] 0.45, 95% CI 0.26-0.77, p = 0.004; multivariable analysis, HR 0.45, 95% CI 0.26-0.77, p = 0.004), and non-significantly superior over thiopurines. CONCLUSION: Anti-TNF therapy was the most effective strategy for the prevention of endoscopic CD recurrence.

15 Article Indicators of suboptimal tumor necrosis factor antagonist therapy in inflammatory bowel disease. 2017

Lindsay, James O / Armuzzi, Alessandro / Gisbert, Javier P / Bokemeyer, Bernd / Peyrin-Biroulet, Laurent / Nguyen, Geoffrey C / Smyth, Michael / Patel, Haridarshan. ·Department of Gastroenterology, Barts Health NHS Trust, London, United Kingdom. Electronic address: James.Lindsay@bartshealth.nhs.uk. · IBD Unit, Complesso Integrato Columbus, Gemelli Hospital Catholic University Foundation, Rome, Italy. · Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain. · Gastroenterology Practice, Minden, Germany. · CHU de Nancy - Hôpital Brabois, Vandoeuvre-lès-Nancy, France. · Mount Sinai Hospital, Toronto, Canada. · Takeda Development Centre Europe Ltd., London, United Kingdom. ·Dig Liver Dis · Pubmed #28826571.

ABSTRACT: BACKGROUND: Inflammatory bowel disease (IBD) is refractory to treatment in one-half of patients. AIMS: To evaluate the occurrence of suboptimal therapy among patients with IBD treated with tumor necrosis factor antagonists (anti-TNFs). METHODS: A multinational chart review in Europe and Canada was conducted among IBD patients diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) who initiated anti-TNF therapy between 2009 and 2013. The primary endpoint was the cumulative incidence of suboptimal therapy during a two-year follow-up period, defined by the presence of the following indicators: dose escalation, discontinuation, switching, non-biologic therapy escalation, or surgery. RESULTS: The study included 1195 anti-TNF initiators (538 UC and 657 CD). The majority of patients (64% of UC and 58% of CD) had at least one indicator of suboptimal therapy. The median time to suboptimal therapy indicator was 12.5 and 17.5 months for UC and CD patients, respectively. Among the 111 UC and 174 CD anti-TNF switchers, 51% and 56% had an indicator of suboptimal therapy, respectively. The median time to suboptimal therapy indicator with the second anti-TNF was 14.3 and 13.0 months for UC and CD patients, respectively. CONCLUSION: The majority of IBD patients showed suboptimal therapy with current anti-TNFs.

16 Article Training Programs on Endoscopic Scoring Systems for Inflammatory Bowel Disease Lead to a Significant Increase in Interobserver Agreement Among Community Gastroenterologists. 2017

Daperno, Marco / Comberlato, Michele / Bossa, Fabrizio / Armuzzi, Alessandro / Biancone, Livia / Bonanomi, Andrea G / Cassinotti, Andrea / Cosintino, Rocco / Lombardi, Giovanni / Mangiarotti, Roberto / Papa, Alfredo / Pica, Roberta / Grassano, Luca / Pagana, Guido / D'Incà, Renata / Orlando, Ambrogio / Rizzello, Fernando / Anonymous871133. ·Gastroenterology Unit, AO Ordine Mauriziano, Torino, TO, Italy. · Gastroenterology Unit, Ospedale di Bolzano, Bolzano, Italy. · Gastroenterology Unit, IRCCS 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy. · Gastroenterology Unit, Complesso integrato Columbus, Roma, Italy. · Gastroenterology Unit, Tor Vergata University, Roma, Italy. · Gastroenterology Unit, AOU Careggi, Firenze, Italy. · Gastroenterology Unit, S. Camillo-Forlanini Hospital, Roma, Italy. · Gastroenterology Unit, Cardarelli Hospital, Napoli, Italy. · Gastroenterology Unit, ASL Roma B, Ospedale Pertini, Roma, Italy. · Politecnico di Torino, Torino, Italy. · Istituto Mario Boella, Torino, Italy. · Department of Surgery, Oncology and Gastroenterology, Azienda Ospedaliera di Padova, Padova, Italy. · Internal Medicine Unit, AO Ospedali Riuniti Villa Sofia - Cervello, Palermo, Italy. · Internal Medicine Unit, Policlinic S. Orsola Malpighi and Bologna University, Bologna, Italy. ·J Crohns Colitis · Pubmed #28453758.

ABSTRACT: Background and Aims: Endoscopic outcomes are increasingly used in clinical trials and in routine practice for inflammatory bowel disease [IBD] in order to reach more objective patient evaluations than possible using only clinical features. However, reproducibility of endoscopic scoring systems used to categorize endoscopic activity has been reported to be suboptimal. The aim of this study was to analyse the inter-rated agreement of non-dedicated gastroenterologists on IBD endoscopic scoring systems, and to explore the effects of a dedicated training programme on agreement. Methods: A total of 237 physicians attended training courses on IBD endoscopic scoring systems, and they independently scored a set of IBD endoscopic videos for ulcerative colitis [with Mayo endoscopic subscore], post-operative Crohn's disease [with Rutgeerts score] and luminal Crohn's disease (with the Simple Endoscopic Score for Crohn's Disease [SESCD] and Crohn's Endoscopic Index of Severity [CDEIS]). A second round of scoring was collected after discussion about determinants of discrepancy. Interobserver agreement was measured by means of the Fleiss' kappa [kappa] or intraclass correlation coefficient [ICC] as appropriate. Results: The inter-rater agreement increased from kappa 0.51 (95% confidence interval [95% CI] 0.48-0.55) to 0.76 [95% CI 0.72-0.79] for the Mayo endoscopic subscore, and from 0.45 [95% CI 0.40-0.50] to 0.79 [0.74-0.83] for the Rutgeerts score before and after the training programme, respectively, and both differences were significant [P < 0.0001]. The ICC was 0.77 [95% CI 0.56-0.96] for SESCD and 0.76 [0.54- 0.96] for CDEIS, respectively, with only one measurement. Discussion: The basal inter-rater agreement of inexperienced gastroenterologists focused on IBD management is moderate; however, a dedicated training programme can significantly impact on inter-rater agreement, increasing it to levels expected among expert central reviewers.

17 Article The PROSIT-BIO Cohort: A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar. 2017

Fiorino, Gionata / Manetti, Natalia / Armuzzi, Alessandro / Orlando, Ambrogio / Variola, Angela / Bonovas, Stefanos / Bossa, Fabrizio / Maconi, Giovanni / DʼIncà, Renata / Lionetti, Paolo / Cantoro, Laura / Fries, Walter / Annunziata, Maria L / Costa, Francesco / Terpin, Maria M / Biancone, Livia / Cortelezzi, Claudio C / Amato, Arnaldo / Ardizzone, Sandro / Danese, Silvio / Guidi, Luisa / Rizzuto, Giulia / Massella, Arianna / Andriulli, Angelo / Massari, Alessandro / Lorenzon, Greta / Ghione, Silvia / Kohn, Anna / Ventra, Agostino / Annese, Vito / Anonymous17090893. ·1IBD Center, Department of Gastroenterology, Humanitas Research Hospital, Humanitas University, Rozzano, Italy; 2Department of Gastroenterology, AOU Careggi, Florence, Italy; 3IBD Unit, Complesso Integrato Columbus-Gemelli Hospital Catholic University Foundation, Rome, Italy; 4Department of Internal Medicine 2, IBD Unit, Riuniti Villa Sofia-Cervello Hospital, Palermo, Italy; 5Unit of Gastroenterology, Centro Malattie Retto-Intestinali, Sacro Cuore Don Calabria Hospital, Negrar, Italy; 6Gastroenterology Unit, IRCCS-CSS Hospital, San Giovanni Rotondo, Italy; 7Gastroenterology and IBD Unit, Luigi Sacco University Hospital, Milan, Italy; 8Unit of Gastroenterology, University of Padova, Padova, Italy; 9Department of Gastroenterology and Nutrition, Meyer Children's Hospital, Florence, Italy; 10Unit of Gastroenterology, S. Camillo-Forlanini Hospital, Rome, Italy; 11Clinical Unit for Chronic Bowel Disorders, University of Messina, Messina, Italy; 12Department of Gastroenterology, IRCCS Policlinico, San Donato Milanese-Milano, Italy; 13Unit of Gastroenterology, AOUP, Pisa, Italy; 14Department of Gastroenterology and Endoscopy, AO Hospital, Legnano, Italy; 15Department of Systems Medicine, Gastroenterology, University of Rome Tor Vergata, Roma, Italy; 16Unit of Gastroenterology, AOU di Circolo Fondazione Macchi, Varese, Italy; 17Department of Gastroenterology, Ospedale Valduce, Como, Italy; and 18Department of Gastroenterology, Fatebenefratelli-Oftalmico Hospital, Milano, Italy. ·Inflamm Bowel Dis · Pubmed #28092307.

ABSTRACT: BACKGROUND: Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn's disease. METHODS: A prospective, multicenter, cohort study using a structured database. RESULTS: Consecutive patients (313 Crohn's disease and 234 ulcerative colitis) were enrolled from 31 referral centers; 311 patients were naive to anti-tumor necrosis factor alpha, 139 had a previous exposure to biologics, and the remaining 97 were switched to CT-P13 after a mean of 18 ± 14 infusions of infliximab. The mean follow-up was 4.3 ± 2.8 months, and the total follow-up time was 195 patient-years. After 2061 infusions, 66 serious adverse events were reported (12.1%), 38 (6.9%) of them were infusion-related reactions. The biosimilar had to be stopped in 29 (5.3%) cases for severe infusion reactions (8 naive, 19 previous exposed, and 2 switch), and in further 16 patients (2.9%) for other serious adverse events. Infusion reactions were significantly more frequent in patients pre-exposed to infliximab than to other anti-tumor necrosis factor alpha (incidence rate ratio = 2.82, 95% CI: 1.05-7.9). The efficacy of the biosimilar was evaluated in 434 patients who received treatment for at least 8 weeks, using time-to-event methods for censored observations: 35 patients were primary failures (8.1%). After further 8, 16, and 24 weeks, the efficacy estimations were 95.7%, 86.4%, and 73.7% for naive, 97.2%, 85.2%, and 62.2% for pre-exposed, and 94.5%, 90.8%, and 78.9% for switch, respectively (log-rank P = 0.64). CONCLUSIONS: Although no direct comparison was performed, preliminary data on efficacy and safety of CT-P13 were in line with those of infliximab.

18 Article 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn's Disease 2016: Part 1: Diagnosis and Medical Management. 2017

Gomollón, Fernando / Dignass, Axel / Annese, Vito / Tilg, Herbert / Van Assche, Gert / Lindsay, James O / Peyrin-Biroulet, Laurent / Cullen, Garret J / Daperno, Marco / Kucharzik, Torsten / Rieder, Florian / Almer, Sven / Armuzzi, Alessandro / Harbord, Marcus / Langhorst, Jost / Sans, Miquel / Chowers, Yehuda / Fiorino, Gionata / Juillerat, Pascal / Mantzaris, Gerassimos J / Rizzello, Fernando / Vavricka, Stephan / Gionchetti, Paolo / Anonymous7610882. ·Fernando Gomollón, Professor of Medicine, Hospital Clínico Universitario "Lozano Blesa", Universidad de Zaragoza, IIS Aragón, CIBEREHD, Zaragoza, Spain. · Axel Dignass, Department of Medicine I, Agaplesion Markus Hospital, Willhelm-Epstein-Straße 4, 60431 Frankfurt/Main, Germany. · Vito Annese, Department of Emergency, Division of Gastroenterology, University Hospital Careggi, Largo Giovanni Alessandro Brambilla, 3, 50134 Florence, Italy. · Herbert Tilg, Department of Internal Medicine I, Medical University Innsbruck, Anichstrasse 35, 6020 Innsbruck, Austria. · Gert Van Assche, Division of Gastroenterology and Hepatology, University Hospitals Leuven and University of Leuven, 49 Herestraat, 3000 Leuven, Belgium. · James O. Lindsay, Department of Gastroenterology, Barts Health NHS Trust, The Royal London Hospital, Whitechapel Road, London E1 1BB, UK. · Laurent Peyrin-Biroulet, Department of Gastroenterology and Inserm U954, Nancy University Hospital, Lorraine University, 54500 Vandoeuvre-Lès-Nancy, France. · Garret J. Cullen, Department of Gastroenterology, Centre for Colorectal Disease, St. Vincent's University Hospital, 4 Dublin, Ireland. · Marco Daperno, Gastroenterology Unit, Mauriziano Hospital, Largo Turati 62, 10128 Torino, Italy. · Torsten Kucharzik, Department of Internal Medicine and Gastroenterology, Hospital Lüneburg, Bögelstraße 1, 21339 Lüneburg, Germany. · Florian Rieder, Department of Pathobiology/NC22, Lerner Research Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, 44195 Cleveland, OH, USA; Department of Gastroenterology, Hepatology and Nutrition/A3, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, 44195 Cleveland, OH, USA. · Sven Almer, Department of Medicine, Solna, Karolinska Institute, and, IBD-unit, Center for Digestive Diseases, Karolinska University Hospital, 17176 Stockholm, Sweden. · Alessandro Armuzzi, Department of Internal Medicine, IBD Unit Complesso Integrato Columbus, Gemelli Hospital Catholic University Foundation, Via Giuseppe Moscati 31, 00168 Rome, Italy. · Marcus Harbord, Imperial College, London; and Chelsea and Westminster Hospital, 369 Fulham Road, London SW10 9NH, UK. · Jost Langhorst, Department of Internal Medicine and Integrative Gastroenterology, University Duisburg-Essen, Kliniken Essen-Mitte, Am Deimelsberg 34A, 45276 Essen, Germany. · Miquel Sans, Department of Digestive Diseases, Centro Médico Teknon, 12 Vilana, 08009 Barcelona, Spain. · Yehuda Chowers, Department of Gastroenterology, Rambam Health Care Campus Rappaport Faculty Of Medicine, 8 Ha'Aliya Street, PO Box 9602, 3109601 Haifa, Israel. · Gionata Fiorino, IRCCS Humanitas Research Hospital, Department of Gastroenterology, IBD Center, Via Manzoni, 56, 20089 Rozzano, Italy. · Pascal Juillerat, Department of Gastroenterology, University Clinic for Visceral Surgery and Medicine, University Hospital Bern Inselspital, Freiburgstrasse 10, 3010 Bern, Switzerland. · Gerassimos J. Mantzaris , Department of Gastroenterology, Evangelismos Hospital, 45-47 Ypsilandou Street, 10676 Athens, Greece. · Fernando Rizzello, IBD Unit, DIMEC, University of Bologna, Via Massarenti, 9, 40138 Bologna, Italy. · Paolo Gionchetti, IBD Unit, DIMEC, University of Bologna, Via Massarenti, 9, 40138 Bologna, Italy. ·J Crohns Colitis · Pubmed #27660341.

ABSTRACT: This paper is the first in a series of two publications relating to the European Crohn's and Colitis Organisation [ECCO] evidence-based consensus on the diagnosis and management of Crohn's disease and concerns the methodology of the consensus process, and the classification, diagnosis and medical management of active and quiescent Crohn's disease. Surgical management as well as special situations including management of perianal Crohn's disease of this ECCO Consensus are covered in a subsequent second paper [Gionchetti et al JCC 2016].

19 Article Fecal HMGB1 Reveals Microscopic Inflammation in Adult and Pediatric Patients with Inflammatory Bowel Disease in Clinical and Endoscopic Remission. 2016

Palone, Francesca / Vitali, Roberta / Cucchiara, Salvatore / Mennini, Maurizio / Armuzzi, Alessandro / Pugliese, Daniela / DʼIncà, Renata / Barberio, Brigida / Stronati, Laura. ·*Department of Radiation Biology and Human Health, ENEA, Rome, Italy; †Department of Pediatrics and Infantile Neuropsychiatry, Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Rome, Italy; ‡Inflammatory Bowel Disease Unit, Complesso Integrato Columbus, Gemelli Hospital Catholic University Foundation, Rome, Italy; §Department of Surgical, Oncological and Gastroenterological Sciences, Azienda Ospedaliera-Università degli Studi di Padova, Padova, Italy; and ‖Department of Cellular Biotechnology and Hematology, Sapienza University of Rome, Rome, Italy. ·Inflamm Bowel Dis · Pubmed #27755215.

ABSTRACT: BACKGROUND: Fecal high mobility group box 1 (HMGB1) has been suggested to be a novel noninvasive biomarker of gut inflammation. We aimed to assess the reliability of fecal HMGB1, compared with fecal calprotectin (FC), in detecting intestinal inflammation in pediatric and adult patients with inflammatory bowel disease (IBD) and to evaluate the accuracy of HMGB1 in identifying patients with IBD in clinical and endoscopic remission who still have histologic features of inflammation. METHODS: Stool samples from 85 children with IBD (49 Crohn's disease [CD] and 36 ulcerative colitis [UC] and 119 adults [57 Crohn's disease and 62 ulcerative colitis]) were analyzed for the study. Age-matched healthy subjects were used as controls. Fecal HMGB1 and fecal calprotectin were detected through western blot and ELISA, respectively. RESULTS: Fecal HMGB1 expression was significantly increased in pediatric and adult patients with Crohn's disease and ulcerative colitis and strongly correlated with the disease severity. Fecal calprotectin and HMGB1 significantly correlated in pediatric (r: 0.60, P < 0.001) and adult (r: 0.72, P < 0.001) IBD patients. Moreover, in patients with clinical and endoscopic remission only fecal HMGB1 showed a strong match with the degree of histological scores of inflammation (CGHAS/IGHAS for Crohn's disease and Geboes Score for ulcerative colitis). CONCLUSIONS: Fecal HMGB1 is confirmed to be a reliable biomarker of intestinal inflammation; indeed, it significantly correlates with fecal calprotectin in pediatric and adult IBD patients. Moreover, only fecal HMGB1 identifies histologic inflammation in subjects with IBD in clinical and endoscopic remission.

20 Article Faecal calprotectin assay after induction with anti-Tumour Necrosis Factor α agents in inflammatory bowel disease: Prediction of clinical response and mucosal healing at one year. 2014

Guidi, Luisa / Marzo, Manuela / Andrisani, Gianluca / Felice, Carla / Pugliese, Daniela / Mocci, Giammarco / Nardone, Olga / De Vitis, Italo / Papa, Alfredo / Rapaccini, Gianlodovico / Forni, Franca / Armuzzi, Alessandro. ·Internal Medicine and Gastroenterology Unit, Complesso Integrato Columbus, Catholic University of Rome, Italy. Electronic address: lguidi@rm.unicatt.it. · Internal Medicine and Gastroenterology Unit, Complesso Integrato Columbus, Catholic University of Rome, Italy. · Laboratory Diagnostics Unit, Complesso Integrato Columbus, Catholic University of Rome, Italy. ·Dig Liver Dis · Pubmed #25096964.

ABSTRACT: BACKGROUND: Faecal calprotectin levels correlate with inflammation in inflammatory bowel disease. We evaluated the role of faecal calprotectin after anti-Tumour Necrosis Factor α induction in inflammatory bowel disease patients to predict therapeutic effect at one year. METHODS: Faecal calprotectin levels were measured in stools of 63 patients before and after induction of anti-Tumour Necrosis Factor α therapy. Clinical activity, measured by clinical indices, was assessed before and after biologic treatment. Clinical responders after induction were included in the study and colonoscopy was performed before and after one year of treatment to assess mucosal healing. RESULTS: 63 patients (44 Crohn's disease, 19 ulcerative colitis) were prospectively included (41.2% males, mean age at diagnosis 33 years). A sustained clinical response during the first year was observed in 57% of patients; median faecal calprotectin was 106 μg/g after induction versus 308 μg/g pre-induction (p<0.0001). Post-induction faecal calprotectin was significantly lower in responders versus non-responders (p=0.0002). Post-induction faecal calprotectin had 83% sensitivity and 74% specificity (cut-off ≤ 168 μg/g) for predicting a sustained clinical response at one year (p=0.0001); also, sensitivity was 79% and specificity 57% (cut-off ≤ 121 μg/g) for predicting mucosal healing (p=0.0001). CONCLUSIONS: In inflammatory bowel disease faecal calprotectin assay after anti-Tumour Necrosis Factor α induction can be used as a marker to predict sustained clinical response and mucosal healing at one year.

21 Article Role of HMGB1 as a suitable biomarker of subclinical intestinal inflammation and mucosal healing in patients with inflammatory bowel disease. 2014

Palone, Francesca / Vitali, Roberta / Cucchiara, Salvatore / Pierdomenico, Maria / Negroni, Anna / Aloi, Marina / Nuti, Federica / Felice, Carla / Armuzzi, Alessandro / Stronati, Laura. ·*Department of Radiobiology and Human Health, ENEA, Rome, Italy; †Department of Pediatrics and Infantile Neuropsychiatry, Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Rome, Italy; and ‡IBD Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy. ·Inflamm Bowel Dis · Pubmed #24983978.

ABSTRACT: BACKGROUND: Noninvasive biomarkers of high- and low-grade intestinal inflammation and of mucosal healing (MH) in patients with inflammatory bowel disease are currently lacking. We have recently shown that fecal high mobility group box 1 (HMGB1) protein is a novel biomarker of gut inflammation. We aimed at investigating in a mouse model if HMGB1 was able to foresee both a clinically evident and a subclinical gut inflammation and if its normalization indicated MH. We also aimed at confirming the results in patients with Crohn's disease (CD) and ulcerative colitis. METHODS: C57BL6/J mice were treated with increasing doses of dextran sodium sulphate to induce colitis of different severity degrees; 28 with CD, 23 with ulcerative colitis, and 17 controls were also enrolled. Fecal HMGB1 was analyzed by enzyme-linked immunosorbent assay and immunoblotting. RESULTS: Fecal HMGB1 increased by 5-, 11-, 18-, and 24-folds with dextran sodium sulphate doses of 0.25%, 0.50%, 1%, and 4%, respectively, showing that the protein detected a high-grade and a subclinical inflammation. After a recovery time of 4-week posttreatment, HMGB1 returned to control levels, paralleling MH. In patients, fecal HMGB1 significantly correlated with endoscopic indexes (Simple Endoscopic Score for Crohn's Disease [SES-CD], endoscopic Mayo subscore), but not with the disease activity indexes (Crohn's disease Activity Index, partial Mayo score). CONCLUSIONS: Fecal HMGB1 is a robust noninvasive biomarker of clinically overt and subclinical gut inflammation; it can also be a surrogate marker of MH. We suggest the use of fecal HMGB1 to monitor the disease course and assess therapy outcomes in inflammatory bowel disease.

22 Article Occurrence of inflammatory bowel disease in central Italy: a study based on health information systems. 2014

Di Domenicantonio, Riccardo / Cappai, Giovanna / Arcà, Massimo / Agabiti, Nera / Kohn, Anna / Vernia, Piero / Biancone, Livia / Armuzzi, Alessandro / Papi, Claudio / Davoli, Marina. ·Department of Epidemiology, Regional Health Service, Rome, Italy. Electronic address: r.didomenicantonio@deplazio.it. · Department of Epidemiology, Regional Health Service, Rome, Italy. · Division of Gastroenterology, AO San Camillo Forlanini, Rome, Italy. · Department of Internal Medicine and Medical Specialties, Gastroenterology Unit, Sapienza University of Rome, Rome, Italy. · Department of Internal Medicine, Gastroenterology Unit, University Tor Vergata, Rome, Italy. · IBD Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy. · Division of Gastroenterology, AO San Filippo Neri, Rome, Italy. ·Dig Liver Dis · Pubmed #24890621.

ABSTRACT: BACKGROUND: The burden of inflammatory bowel diseases, including Crohn's disease and ulcerative colitis, has never been estimated in Italy using administrative data sources. Our objective was to measure the occurrence of inflammatory bowel diseases in the Lazio region (Italy) using administrative data and to test the sensitivity of the Crohn's disease case-finding algorithm with respect to clinical diagnosis. METHODS: We conducted a population-based cross-sectional study identifying prevalent and incident cases. We estimated occurrence rates of inflammatory bowel diseases using hospital discharges or activation of copayment exemptions. Sensitivity was calculated from 2358 subjects with clinical diagnosis of Crohn's disease. RESULTS: Exemptions identified more than 20% of the cases. Prevalence rates (per 100,000) on December 31, 2009 for males and females were 177 and 144 for ulcerative colitis and 91 and 81 for Crohn's disease, respectively. The incidence rates during the years 2008-2009 were 14.5 and 12.2 for ulcerative colitis and 7.4 and 6.5 for Crohn's disease for males and females, respectively. The sensitivity of the administrative sources was 82.2%. CONCLUSIONS: Health and population data sources allow the estimation of inflammatory bowel diseases occurrence. The age-specific peaks of diagnosis were consistent with those reported in other studies. Sensitivity may be affected by temporal changes in the quality of the data sources.

23 Article Development of psoriasis scalp with alopecia during treatment of Crohn's disease with infliximab and rapid response to both diseases to ustekinumab. 2013

Andrisani, G / Marzo, M / Celleno, L / Guidi, L / Papa, A / Gasbarrini, A / Armuzzi, A. ·IBD Unit, Complesso Integrato Columbus-Gemelli Hospital, School of Medicine, Catholic University of the Sacred Heart, Rome, Italy. gianluca.andrisani@gmail.com. ·Eur Rev Med Pharmacol Sci · Pubmed #24174369.

ABSTRACT: Anti tumor necrosis factor antibodies are used to treat both psoriasis and inflammatory bowel disease. Several paradoxical cases of psoriatic skin lesions induced by tumor necrosis factor antagonist therapy have been described in IBD patients in the recent years. Ustekinumab, a fully human anti-interleukin-12/-23 monoclonal antibody, is the first drug of a new class of biologic therapy approved for the treatment of moderate to severe plaque psoriasis. Data on the efficacy of ustekinumab in patients with moderate-to-severe Crohn's disease, especially in patients previously treated with infliximab, have been recently published. We report about the effectiveness of ustekinumab in the treatment of both severe scalp psoriasis lesions with alopecia and active Crohn's disease.

24 Article FOXP3⁺ T regulatory cell modifications in inflammatory bowel disease patients treated with anti-TNFα agents. 2013

Guidi, Luisa / Felice, Carla / Procoli, Annabella / Bonanno, Giuseppina / Martinelli, Enrica / Marzo, Manuela / Mocci, Giammarco / Pugliese, Daniela / Andrisani, Gianluca / Danese, Silvio / De Vitis, Italo / Papa, Alfredo / Armuzzi, Alessandro / Rutella, Sergio. ·Department of Internal Medicine, Inflammatory Bowel Disease Unit, Complesso Integrato Columbus, Catholic University, Largo Gemelli 8, 00168 Rome, Italy. ·Biomed Res Int · Pubmed #24063002.

ABSTRACT: Treg modulation has been hypothesized as one of the mechanisms by which antitumor necrosis factor α (TNFα) agents exert their action in rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). However, data in IBD are still conflicting. We evaluated CD4⁺CD25⁺FOXP3⁺ (Tregs) by flow cytometry in peripheral blood from 32 adult IBD patient before (T0) and after the induction of anti-TNFα therapy (T1). Eight healthy controls (HCs) were included. We also evaluated the number of FOXP3⁺ cells in the lamina propria (LP) in biopsies taken in a subset of patients and controls. Treg frequencies were significantly increased in peripheral blood from our patients after anti-TNFα therapy compared to T0. T1 but not T0 levels were higher than HC. The increase was detectable only in clinical responders to the treatment. A negative correlation was found among delta Treg levels and the age of patients or disease duration and with the activity score of Crohn's disease (CD). No significant differences were found in LP FOXP3⁺ cells. Our data suggest the possibility that in IBD patients the treatment with anti-TNFα may affect Treg percentages and that Treg modifications may correlate with clinical response, but differently in early versus late disease.

25 Article Prevention of postoperative recurrence with azathioprine or infliximab in patients with Crohn's disease: an open-label pilot study. 2013

Armuzzi, Alessandro / Felice, Carla / Papa, Alfredo / Marzo, Manuela / Pugliese, Daniela / Andrisani, Gianluca / Federico, Francesco / De Vitis, Italo / Rapaccini, Gian Lodovico / Guidi, Luisa. ·IBD Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy. Electronic address: alearmuzzi@yahoo.com. ·J Crohns Colitis · Pubmed #23810678.

ABSTRACT: BACKGROUND AND AIMS: Patients with Crohn's disease (CD) often require surgery over their clinical course. However, endoscopic and clinical recurrence of disease appear respectively in up to 80% and 30% of patients after one year. Thus, a prophylactic treatment is needed to reduce the possibility of recurrence. Both azathioprine and infliximab have been demonstrated to be effective, but head to head studies have not been performed so far. Aim of this open-label prospective study was to analyse endoscopic, histological and clinical recurrence after one year of treatment with azathioprine or infliximab as postoperative therapies in CD patients with "high risk" of recurrence. METHODS: Consecutive CD patients who underwent curative ileocolonic resection were randomized (1:1) to receive infliximab (standard induction and maintenance schedule) or azathioprine (2.5 mg/kg/day) for 1 year. Co-primary endpoints were endoscopic, histological and clinical recurrence after 12 months of therapy. RESULTS: Twenty-two consecutive CD patients (15 male; median age 32 years, IQR 22-38) were enrolled after curative ileocolonic resection. Eleven patients were treated with infliximab and 11 received azathioprine. Among patients treated with azathioprine, 4/10 (40%) had endoscopic recurrence compared to 1/11 (9%) in the infliximab group (p=0.14). Eight out of 10 (80%) among those who received azathioprine had severe histological activity, whereas 2/11 (18%) in the infliximab group presented histological recurrence (p=0.008). No significant clinical differences were found between the two groups. CONCLUSIONS: Infliximab was more effective than azathioprine in reducing histological, but not endoscopic and clinical recurrence after curative ileocolonic resection in "high risk" CD patients.

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