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Crohn Disease: HELP
Articles by Livia Biancone
Based on 48 articles published since 2008
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Between 2008 and 2019, L. Biancone wrote the following 48 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 Treatment of peri-anal fistula in Crohn's disease. 2014

Sica, Giuseppe S / Di Carlo, Sara / Tema, Giorgia / Montagnese, Fabrizio / Del Vecchio Blanco, Giovanna / Fiaschetti, Valeria / Maggi, Giulia / Biancone, Livia. ·Giuseppe S Sica, Sara Di Carlo, Giorgia Tema, Giulia Maggi, Department of Surgery, Tor Vergata University Hospital, Rome 00133, Italy. ·World J Gastroenterol · Pubmed #25309057.

ABSTRACT: Anal fistulas are a common manifestation of Crohn's disease (CD). The first manifestation of the disease is often in the peri-anal region, which can occur years before a diagnosis, particularly in CD affecting the colon and rectum. The treatment of peri-anal fistulas is difficult and always multidisciplinary. The European guidelines recommend combined surgical and medical treatment with biologic drugs to achieve best results. Several different surgical techniques are currently employed. However, at the moment, none of these techniques appear superior to the others in terms of healing rate. Surgery is always indicated to treat symptomatic, simple, low intersphincteric fistulas refractory to medical therapy and those causing disabling symptoms. Utmost attention should be paid to correcting the balance between eradication of the fistula and the preservation of fecal continence.

3 Editorial Surgery for inflammatory bowel disease in the era of laparoscopy. 2013

Sica, Giuseppe S / Biancone, Livia. · ·World J Gastroenterol · Pubmed #23674844.

ABSTRACT: During the course of inflammatory bowel disease (IBD), surgery may be needed. Approximately 20% of patients with ulcerative colitis (UC) will require surgery, whereas up to 80% of Crohn's disease (CD) patients will undergo an operation during their lifetime. For UC patients requiring surgery, total proctocolectomy and ileoanal pouch anastomosis (IPAA) is the operation of choice as it provides a permanent cure and good quality of life. Nevertheless a permanent stoma is a good option in selected patients, especially the elderly. Minimally invasive surgery has replaced the conventional open approach in many specialized centres worldwide. Laparoscopic colectomy and restorative IPAA is rapidly becoming the standard of care in the treatment of UC requiring surgery, whilst laparoscopic ileo-cecal resection is already the new gold standard in the treatment of complicated CD of terminal ileum. Short term advantages of laparoscopic surgery includes faster recovery time and reduced requirement for analgesics. It is, however, in the long term that minimally invasive surgery has demonstrated its superiority over the open approach. A better cosmesis, a reduced number of incisional hernias and fewer adhesions are the long term advantages of laparoscopy in IBD surgery. A reduction in abdominal adhesions is of great benefit when a second operation is needed in CD and this influences positively the pregnancy rate in young women undergoing restorative IPAA. In developing the therapeutic plan for IBD patients it should be recognized that the surgical approach to the abdomen has changed and that surgical treatment of complicated IBD can be safely performed with a true minimally invasive approach with great patient satisfaction.

4 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.

5 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.).

6 Clinical Trial Early post-operative endoscopic recurrence in Crohn's disease patients: data from an Italian Group for the study of inflammatory bowel disease (IG-IBD) study on a large prospective multicenter cohort. 2014

Orlando, Ambrogio / Mocciaro, Filippo / Renna, Sara / Scimeca, Daniela / Rispo, Antonio / Lia Scribano, Maria / Testa, Anna / Aratari, Annalisa / Bossa, Fabrizio / Tambasco, Rosy / Angelucci, Erika / Onali, Sara / Cappello, Maria / Fries, Walter / D'Incà, Renata / Martinato, Matteo / Castiglione, Fabiana / Papi, Claudio / Annese, Vito / Gionchetti, Paolo / Rizzello, Fernando / Vernia, Piero / Biancone, Livia / Kohn, Anna / Cottone, Mario. ·Internal Medicine, Villa Sofia-Cervello Hospital, Palermo, Italy. Electronic address: ambrogiorlando@gmail.com. · Gastroenterology and Endoscopy Unit, ARNAS Civico Hospital, Palermo, Italy. · Internal Medicine, Villa Sofia-Cervello Hospital, Palermo, Italy. · Department of Gastroenterology, IRCCS, Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo (FG), Italy. · Department of Gastroenterology, Federico II University, Naples, Italy. · Gastroenterology Unit, San Camillo Forlanini, Rome, Italy. · Department of Gastroenterology, San Filippo Neri Hospital, Rome, Italy. · Department of Internal Medicine, Policlinico Sant'Orsola Malpighi, Bologna, Italy. · Department of Gastroenterology, Sapienza University, Rome, Italy. · Department of Gastroenterology, Tor Vergata University, Rome, Italy. · Department of Gastroenterology, Palermo University, Palermo, Italy. · Department of Gastroenterology, Messina University, Messina, Italy. · Department of Gastroenterology, Padua University, Padua, Italy. · Gastroenterology Unit II, AOU Careggi, Florence, Italy. ·J Crohns Colitis · Pubmed #24630485.

ABSTRACT: INTRODUCTION: The incidence of endoscopic recurrence (ER) in Crohn's disease following curative resection is up to 75% at 1 year. Endoscopy is the most sensitive method to detect the earliest mucosal changes and the severe ER at 1 year seems to predict a clinical relapse. METHODS: The aim of this prospective study was to evaluate the incidence of early ER 6 months after curative resection. Secondary outcome was to evaluate the role of 5-aminosalicylic acid (5-ASA) in the prevention of ER at 6 months. A total of 170 patients were included in the study. They were carried-out from the evaluation of the appearance of ER during a trial performed to assess the role of azathioprine vs. 5-ASA as early treatment of severe ER. All the patients started 5-ASA treatment 2 weeks after surgery. RESULTS: Six months after surgery ER was observed in 105 patients (62%). The endoscopic score was reported as severe in 78.1% of them (82 out of 105). At univariable analysis only ileo-colonic disease influenced the final outcome associating to a lower risk of severe ER (p=0.04; OR 0.52, 95% CI 0.277-0.974). CONCLUSION: In this prospective Italian multicenter IG-IBD study a great proportion of ER occur within 6 months from ileo-colonic resection, with a significant rate of severe ER. Furthermore this study confirms the marginal role of 5-ASA in the prevention of ER. This suggests that post-surgical endoscopic evaluation should be performed at 6 months instead of 1 year to allow an adequate early treatment.

7 Clinical Trial Anti-TNF-alpha treatments and obstructive symptoms in Crohn's disease: a prospective study. 2013

Condino, Giovanna / Calabrese, Emma / Zorzi, Francesca / Onali, Sara / Lolli, Elisabetta / De Biasio, Fabiola / Ascolani, Marta / Pallone, Francesco / Biancone, Livia. ·GI Unit, Department of Systems Medicine, University Tor Vergata, Rome, Italy. ·Dig Liver Dis · Pubmed #23195667.

ABSTRACT: BACKGROUND: The development of symptomatic strictures in Crohn's Disease after anti-Tumour Necrosis Factor-α antibodies is undefined. AIM: To assess, in a prospective longitudinal study, the frequency of sub/obstructions in Crohn's Disease patients after treatment with Infliximab or Adalimumab. Changes of small bowel lesions after these biological therapies were searched by ultrasonography. MATERIALS AND METHODS: From January 2007 to October 2008, 36 Crohn's Disease patients with no previous sub/obstructions were treated with either Infliximab (n=13) or Adalimumab (n=23) for ≥12months (mean follow-up duration after the first treatment 23.2±6.8months). Small Intestine Contrast Ultrasonography was performed before and after treatment in 19/36 patients. Sonographic parameters included: bowel wall thickness, lumen diameter, bowel dilation and lesion extent. RESULTS: Sub/obstructions developed in 3/36 patients treated with Infliximab (n=1) or Adalimumab (n=2), all with fibrostricturing Crohn's Disease. Sonographic parameters did not significantly change after treatment. CONCLUSIONS: Sub/obstructive symptoms may develop in one tenth of Crohn's Disease patients treated with anti-Tumour Necrosis Factor-α antibodies, with no significant sonographic changes of the small bowel lesions.

8 Clinical Trial A phase 1 open-label trial shows that smad7 antisense oligonucleotide (GED0301) does not increase the risk of small bowel strictures in Crohn’s disease. 2012

Zorzi, F / Calabrese, E / Monteleone, I / Fantini, M / Onali, S / Biancone, L / Pallone, F / Monteleone, G. ·Department of Systems Medicine, University of Rome ‘Tor Vergata’, Rome, Italy. ·Aliment Pharmacol Ther · Pubmed #22971085.

ABSTRACT: BACKGROUND: In Crohn's disease (CD), knockdown of Smad7, an inhibitor of Transforming Growth Factor (TGF)-β1 activity, with a specific antisense oligonucleotide (GED0301) seems to be safe and tolerable and associates with TGF-β1-mediated suppression of inflammatory pathways. AIM: Since TGF-β1 has pro-fibrogenic effects in many organs, we evaluated whether GED0301 treatment associates with the formation of small bowel strictures. METHODS: Fifteen patients with active, inflammatory CD, receiving oral GED0301 once daily for 7 days, were monitored for the formation of small bowel strictures by Small Intestine Contrast Ultrasonography (SICUS). Serum basic fibroblast growth factor (bFGF) and human chitinase 3-like 1 (also known as YKL-40), two markers of CD-related intestinal strictures, and matrix metalloproteinases (MMP) and tissue inhibitor 1 of MMPs (TIMP1) were analysed at day 0 and day 180 by ELISA. Crohn's disease activity index (CDAI) changes were also monitored. RESULTS: Fourteen patients completed the 6-month study; the remaining underwent intestinal resection for a severe relapse not responsive to medical treatment. No patient developed small bowel stricture and none experienced obstructive symptoms during the study period. GED0301 treatment induced no significant change in the circulating levels of bFGF, YKL-40, MMPs and TIMP1. Seven of 12 patients who reached clinical remission following GED0301 treatment maintained a CDAI < 150 at day 180. CONCLUSION: Short-term treatment of patients with Crohn's disease using GED0301 is not associated with the development of small bowel stricture, thus reinforcing the concept that this drug is safe at least at early time points.

9 Clinical Trial Phase I clinical trial of Smad7 knockdown using antisense oligonucleotide in patients with active Crohn's disease. 2012

Monteleone, Giovanni / Fantini, Massimo C / Onali, Sara / Zorzi, Francesca / Sancesario, Giulia / Bernardini, Sergio / Calabrese, Emma / Viti, Francesca / Monteleone, Ivan / Biancone, Livia / Pallone, Francesco. ·Dipartimento di Medicina Interna, Università Tor Vergata, Rome, Italy. Gi.Monteleone@Med.uniroma2.it ·Mol Ther · Pubmed #22252452.

ABSTRACT: In the gut of patients with Crohn's disease (CD), high Smad7 blocks the immune-suppressive activity of transforming growth factor (TGF)-β1, thereby contributing to amplify inflammatory signals. In vivo in mice, knockdown of Smad7 with a Smad7 antisense oligonucleotide (GED0301) attenuates experimental colitis. Here, we provide results of a phase 1 clinical, open-label, dose-escalation study of GED0301 in patients with active, steroid-dependent/resistant CD, aimed at assessing the safety and tolerability of the drug. Patients were allocated to three treatment groups receiving oral GED0301 once daily for 7 days at doses of 40, 80, or 160 mg. A total of 15 patients were enrolled. No serious adverse event was registered. GED0301 was well tolerated and no patient dropped out during the study. Twenty-five adverse events were documented in 11 patients, the majority of whom were judged to be of mild intensity and unrelated to treatment. GED0301 treatment reduced the percentage of inflammatory cytokine-expressing CCR9-positive T cells in the blood. The study shows for the first time that GED0301 is safe and well tolerated in patients with active CD.

10 Clinical Trial Small bowel capsule endoscopy vs conventional techniques in patients with symptoms highly compatible with Crohn's disease. 2011

Petruzziello, Carmelina / Calabrese, Emma / Onali, Sara / Zuzzi, Sara / Condino, Giovanna / Ascolani, Marta / Zorzi, Francesca / Pallone, Francesco / Biancone, Livia. ·Cattedra di Gastroenterologia, Università degli Studi di Roma "Tor Vergata", Rome, Italy. ·J Crohns Colitis · Pubmed #21453883.

ABSTRACT: BACKGROUND & AIMS: The diagnostic role of Small Bowel Capsule Endoscopy (SBCE) in Crohn's Disease (CD) is under investigation. In a prospective study we investigated the diagnostic role of SBCE in patients with symptoms highly compatible with CD and undefined diagnosis after conventional techniques. METHODS: From September 2005 to May 2009, all patients with clinically suspected CD and not conclusive diagnosis after Ileocolonoscopy (IC), Small Bowel Follow Through (SBFT) and Small Intestine Contrast Ultrasonography (SICUS) were enrolled. Findings compatible with CD included: bowel wall thickness (BWT) >3mm (for SICUS), ulcers, stenosis/strictures, fistulae (for SICUS, SBFT); >5 aphtoid ulcers, deep ulcers and/or strictures (for SBCE). RESULTS: Conventional techniques did not lead to a conclusive diagnosis in 30 patients (19 F, median age 31 years, range 8-57), showing chronic diarrhoea (n=27), abdominal pain (n=23), weight loss (n=5), fever (n=5), Iron Deficiency Anaemia (IDA)(n=5) and/or perianal disease (n=4). Findings compatible but not diagnostic for small bowel CD were detected in 19 (63%) by IC in 12 (40%) by SICUS and in 15 (50%) by SBFT. SBCE showed ileal lesions in 15 (50%) patients, including findings compatible with CD in 12 (40%). SBCE retention requiring surgery was observed in 1 patient. A significant concordance was observed between SBCE and IC k=0.33 C(k)=[0.25;0.42], but not between SBCE and SICUS k=0.13 IC(k)=[0.045;0.22] and between SBCE and SBFT k=0 IC(k)=[-0.089;0.089]. CONCLUSIONS: SBCE may detect lesions compatible with small bowel CD in almost one third of patients with symptoms highly compatible with CD and not conclusive diagnosis by using conventional techniques.

11 Clinical Trial Severity of postoperative recurrence in Crohn's disease: correlation between endoscopic and sonographic findings. 2009

Calabrese, Emma / Petruzziello, Carmelina / Onali, Sara / Condino, Giovanna / Zorzi, Francesca / Pallone, Francesco / Biancone, Livia. ·Dipartimento di Medicina Interna, Università di Roma Tor Vergata, Cattedra di Gastroenterologia, Rome, Italy. ·Inflamm Bowel Dis · Pubmed #19408327.

ABSTRACT: BACKGROUND: Crohn's disease (CD) recurrence is currently assessed by ileocolonoscopy. Small intestine contrast ultrasonography (SICUS) visualizes the small bowel lesions in CD, although its role after curative resection is undefined. We aimed to investigate the accuracy of SICUS in assessing CD recurrence after ileocolonic resection when using ileocolonoscopy as a gold standard. The correlation between the bowel wall thickness (BWT) measured by SICUS and the endoscopic score of recurrence was also assessed. METHODS: The analysis included 72 CD patients with ileocolonic resection requiring ileocolonoscopy, undergoing SICUS within 6 months. Recurrence was assessed by ileocolonoscopy using the Rutgeerts' score. SICUS was performed after PEG ingestion and findings compatible with recurrence included: increased BWT (>3 mm), bowel dilation (>25 mm) or stricture (<10 mm). RESULTS: Ileocolonoscopy detected recurrence in 67/72 (93%) patients. SICUS detected findings compatible with recurrence in 62/72 (86%) patients (5 false negative (FN), 4 false positive (FP), 1 true negative (TN), 62 true positive (TP)), showing a 92.5% sensitivity, 20% specificity, and 87.5% accuracy for detecting CD recurrence. The BWT detected by SICUS was correlated with the Rutgeerts' score (P = 0.0001; r = 0.67). The median BWT, the extent of the ileal lesions, and the prestenotic dilation were higher in patients with an endoscopic degree of recurrence >or=3 versus or=3 versus : Although SICUS and ileocolonoscopy provide different views of the small bowel, SICUS shows a significant correlation with the endoscopic findings. SICUS may represent an alternative noninvasive technique for assessing CD recurrence after ileocolonic resection.

12 Article Epstein-Barr virus-positive ileal carcinomas associated with Crohn's disease. 2017

Vanoli, Alessandro / Di Sabatino, Antonio / Martino, Michele / Dallera, Elena / Furlan, Daniela / Mescoli, Claudia / Macciomei, Maria Cristina / Biancone, Livia / Neri, Benedetto / Grillo, Federica / Biletta, Elena / Rugge, Massimo / Sessa, Fausto / Paulli, Marco / Corazza, Gino Roberto / Solcia, Enrico. ·Department of Molecular Medicine, University of Pavia and San Matteo Hospital, Via Forlanini 16, 27100, Pavia, Italy. alessandro.vanoli@unipv.it. · Department of Medicine and Surgery, University of Insubria, Varese, Italy. alessandro.vanoli@unipv.it. · Department of Internal Medicine, University of Pavia and San Matteo Hospital, Pavia, Italy. · Department of Molecular Medicine, University of Pavia and San Matteo Hospital, Via Forlanini 16, 27100, Pavia, Italy. · Department of Medicine and Surgery, University of Insubria, Varese, Italy. · Pathology Unit, Department of Medicine, University of Padua, Padua, Italy. · Pathology Unit, San Camillo-Forlanini Hospital, Rome, Italy. · Department of Systems Medicine, Gastroenterology Unit, University of Rome "Tor Vergata", Rome, Italy. · Pathology Unit, Department of Surgical and Diagnostic Sciences, University of Genoa, San Martino/IST University Hospital, Genoa, Italy. ·Virchows Arch · Pubmed #28752215.

ABSTRACT: -- No abstract --

13 Article Small bowel carcinomas in celiac or Crohn's disease: distinctive histophenotypic, molecular and histogenetic patterns. 2017

Vanoli, Alessandro / Di Sabatino, Antonio / Martino, Michele / Klersy, Catherine / Grillo, Federica / Mescoli, Claudia / Nesi, Gabriella / Volta, Umberto / Fornino, Daniele / Luinetti, Ombretta / Fociani, Paolo / Villanacci, Vincenzo / D'Armiento, Francesco P / Cannizzaro, Renato / Latella, Giovanni / Ciacci, Carolina / Biancone, Livia / Paulli, Marco / Sessa, Fausto / Rugge, Massimo / Fiocca, Roberto / Corazza, Gino R / Solcia, Enrico. ·Department of Molecular Medicine, University of Pavia, Pavia, Italy. · Pathology Unit, IRCCS San Matteo Hospital, Pavia, Italy. · Department of Surgical and Morphological Sciences, University of Insubria, Varese, Italy. · Department of Internal Medicine, IRCCS San Matteo Hospital, University of Pavia, Pavia, Italy. · Biometry and Statistics Service, IRCCS San Matteo Hospital, Pavia, Italy. · Pathology Unit, Department of Surgical and Diagnostic Sciences, San Martino/IST University Hospital, Genova, Italy. · Pathology Unit, Department of Medicine, University of Padua, Padua, Italy. · Division of Pathological Anatomy, Department of Surgery and Translational Medicine, University of Florence, Florence, Italy. · Division of Gastroenterology, Sant'Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy. · Unit of Pathology, Luigi Sacco University Hospital, Milan, Italy. · Pathology Section, Spedali Civili Hospital, Brescia, Italy. · Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy. · Department of Gastroenterology, National Cancer Institute, Aviano, Italy. · Gastroenterology Unit, Department of Life and Environmental Sciences, University of L'Aquila, L'Aquila, Italy. · Department of Medicine and Surgery, University of Salerno, Salerno, Italy. · Department of Systems Medicine, University of Tor Vergata, Rome, Italy. ·Mod Pathol · Pubmed #28664941.

ABSTRACT: Non-familial small bowel carcinomas are relatively rare and have a poor prognosis. Two small bowel carcinoma subsets may arise in distinct immune-inflammatory diseases (celiac disease and Crohn's disease) and have been recently suggested to differ in prognosis, celiac disease-associated carcinoma cases showing a better outcome, possibly due to their higher DNA microsatellite instability and tumor-infiltrating T lymphocytes. In this study, we investigated the histological structure (glandular vs diffuse/poorly cohesive, mixed or solid), cell phenotype (intestinal vs gastric/pancreatobiliary duct type) and Wnt signaling activation (β-catenin and/or SOX-9 nuclear expression) in a series of 26 celiac disease-associated small bowel carcinoma, 25 Crohn's disease-associated small bowel carcinoma and 25 sporadic small bowel carcinoma cases, searching for new prognostic parameters. In addition, non-tumor mucosa of celiac and Crohn's disease patients was investigated for epithelial precursor changes (hyperplastic, metaplastic or dysplastic) to help clarify carcinoma histogenesis. When compared with non-glandular structure and non-intestinal phenotype, both glandular structure and intestinal phenotype were associated with a more favorable outcome at univariable or stage- and microsatellite instability/tumor-infiltrating lymphocyte-inclusive multivariable analysis. The prognostic power of histological structure was independent of the clinical groups while the non-intestinal phenotype, associated with poor outcome, was dominant among Crohn's disease-associated carcinoma. Both nuclear β-catenin and SOX-9 were preferably expressed among celiac disease-associated carcinomas; however, they were devoid, per se, of prognostic value. We obtained findings supporting an origin of celiac disease-associated carcinoma in SOX-9-positive immature hyperplastic crypts, partly through flat β-catenin-positive dysplasia, and of Crohn's disease-associated carcinoma in a metaplastic (gastric and/or pancreatobiliary-type) mucosa, often through dysplastic polypoid growths of metaplastic phenotype. In conclusion, despite their common origin in a chronically inflamed mucosa, celiac disease-associated and Crohn's disease-associated small bowel carcinomas differ substantially in histological structure, phenotype, microsatellite instability/tumor-infiltrating lymphocyte status, Wnt pathway activation, mucosal precursor lesions and prognosis.

14 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.

15 Article Crohn's Colitis: Development of a multiplex gene expression assay comparing mRNA levels of susceptibility genes. 2017

Russo, Edda / Lombardelli, Letizia / Giudici, Francesco / Cavalli, Tiziana / Ficari, Ferdinando / Fazi, Marilena / Scaringi, Stefano / Biancone, Livia / Logiodice, Federica / Nesi, Mariateresa / Latiano, Anna / Annese, Vito / Torcia, Maria Gabriella / Bechi, Paolo / Tonelli, Francesco / Piccinni, Marie-Pierre / Malentacchi, Cecilia. ·Department of Experimental and Clinical Medicine, University of Florence, Viale Pieraccini 6, 50139 Florence, Italy. Electronic address: edda.russo@unifi.it. · Department of Experimental and Clinical Medicine, University of Florence, Viale Pieraccini 6, 50139 Florence, Italy. · Department of Surgery and Translational Medicine (DCMT), Section of Surgery, University of Florence, Florence, Italy. · Department of Surgery and Translational Medicine (DCMT), Section of Surgery, University of Florence, Florence, Italy; Gastroenterology Unit SOD2, AOUC Careggi, Florence, Italy. · Department of Internal Medicine, University of Rome Tor Vergata, Rome, Italy. · Department of Experimental and Clinical Biomedical Sciences (SBSC) "Mario Serio", University of Florence, Florence, Italy. · Division of Gastroenterology, IRCCS "Casa Sollievo della Sofferenza" Hospital, San Giovanni Rotondo, Italy. · Gastroenterology Unit SOD2, AOUC Careggi, Florence, Italy. ·Clin Res Hepatol Gastroenterol · Pubmed #28365139.

ABSTRACT: Crohn's disease (CD) is a multifactorial immunologically mediated disease. In this study we explored, for the first time, the efficacy of the Multiplex Gene Assay technology for detecting mRNA expression profile of 24 selected CD related genes in endoscopic biopsies and surgical specimens from CD patients with colonic localization of the disease. The polymorphisms of genes most frequently associated with CD were also analysed in DNA samples from the same patients. The analysis of endoscopic samples showed increased expression of 7 genes in inflamed mucosa compared to non-inflamed mucosa and suggests the activation of the autophagy process and of a Th17 adaptive response. The analysis of surgical specimens showed increased expression of 16 genes in inflamed tissue compared to non-inflamed internal controls and revealed the activation of immune-adaptive Th17 response in association with a Th1 response. Furthermore, an increased expression of genes involved in ionic transport and signal transduction was found in inflamed mucosa compared to non-inflamed internal controls. This study confirms the activation of Th17 and Th1 adaptive-immune response also in colonic CD. It should be stressed that these responses have been disclosed in biopsy tissue, while only Th17 differentiation is revealed in endoscopic tissue. Interestingly, the polymorphisms analysis revealed that a homozygous genotype is associated to a more complicated clinical course.

16 Article Small Bowel Carcinomas in Coeliac or Crohn's Disease: Clinico-pathological, Molecular, and Prognostic Features. A Study From the Small Bowel Cancer Italian Consortium. 2017

Vanoli, Alessandro / Di Sabatino, Antonio / Furlan, Daniela / Klersy, Catherine / Grillo, Federica / Fiocca, Roberto / Mescoli, Claudia / Rugge, Massimo / Nesi, Gabriella / Fociani, Paolo / Sampietro, Gianluca / Ardizzone, Sandro / Luinetti, Ombretta / Calabrò, Antonio / Tonelli, Francesco / Volta, Umberto / Santini, Donatella / Caio, Giacomo / Giuffrida, Paolo / Elli, Luca / Ferrero, Stefano / Latella, Giovanni / Ciardi, Antonio / Caronna, Roberto / Solina, Gaspare / Rizzo, Aroldo / Ciacci, Carolina / D'Armiento, Francesco P / Salemme, Marianna / Villanacci, Vincenzo / Cannizzaro, Renato / Canzonieri, Vincenzo / Reggiani Bonetti, Luca / Biancone, Livia / Monteleone, Giovanni / Orlandi, Augusto / Santeusanio, Giuseppe / Macciomei, Maria C / D'Incà, Renata / Perfetti, Vittorio / Sandri, Giancarlo / Silano, Marco / Florena, Ada M / Giannone, Antonino G / Papi, Claudio / Coppola, Luigi / Usai, Paolo / Maccioni, Antonio / Astegiano, Marco / Migliora, Paola / Manca, Rachele / Martino, Michele / Trapani, Davide / Cerutti, Roberta / Alberizzi, Paola / Riboni, Roberta / Sessa, Fausto / Paulli, Marco / Solcia, Enrico / Corazza, Gino R. ·Department of Surgical and Morphological Sciences, University of Insubria, Varese, Italy. · Internal Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Italy. · Biometry and Statistics Service, San Matteo Hospital, Pavia, Italy. · Pathology Unit, Department of Surgical and Diagnostic Sciences, San Martino/IST University Hospital, Genova, Italy. · Pathology Unit, Department of Medicine, University of Padua, Padua, Italy. · Division of Pathological Anatomy, Department of Surgery and Translational Medicine, University of Florence, Florence, Italy. · Units of Pathology. · IBD Surgery. · Gastroenterology, Luigi Sacco University Hospital, Milan, Italy. · Departments of Molecular Medicine. · Departments of Experimental and Clinical Biomedical Sciences. · Surgery and Translational Medicine, University of Florence, Florence, Italy. · Divisions of Gastroenterology. · Pathology, Sant'Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy. · Center for Prevention and Diagnosis of Coeliac Disease, Fondazione IRCCS Ca' Granda, Milan, Italy. · Division of Pathology, Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy. · Gastroenterology Unit, Department of Life and Enviromental Sciences, University of L'Aquila, L'Aquila, Italy. · Departments of Radiological, Oncological, Pathological Sciences. · Surgical Sciences, Umberto I Hospital, La Sapienza University, Rome, Italy. · Units of General Surgery. · Pathology, Cervello Hospital, Palermo, Italy. · Department of Medicine and Surgery, University of Salerno, Salerno, Italy. · Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy. · Pathology Section, Spedali Civili Hospital, Brescia, Italy. · Departments of Gastroenterology. · Pathology, National Cancer Institute, Aviano, Italy. · Section of Pathology, Department of Diagnostic Medicine and Public Health, University of Modena and Reggio Emilia, Modena, Italy. · Departments of Systems Medicine. · Biopathology and Image Diagnostics, University of Tor Vergata, Rome, Italy. · Pathology Unit, San Camillo-Forlanini Hospital, Rome, Italy. · Gastroenterology Section, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy. · Internal Medicine, S.S. Annunziata Hospital, ASST-Pavia, Varzi, Italy. · Clinical Nutrition Unit, Sant'Eugenio Hospital, Rome, Italy. · Unit of Human Nutrition and Health, Istituto Superiore di Sanità, Rome, Italy. · Institute of Pathologic Anatomy, Giaccone University Hospital, University of Palermo, Palermo, Italy. · Units of IBD. · Pathologic Anatomy, San Filippo Neri Hospital, Rome, Italy. · Department of Internal Medicine, University of Cagliari, Cagliari, Italy. · Pathology Unit, SS. Trinità Hospital, Cagliari, Italy. · General and Specialistic Surgery, Città della Salute e della Scienza-Molinette Hospital, Turin, Italy. · Unit of Pathological Anatomy, Sant'Andrea Hospital, Vercelli, Italy. ·J Crohns Colitis · Pubmed #28333239.

ABSTRACT: Background and Aims: An increased risk of small bowel carcinoma [SBC] has been reported in coeliac disease [CD] and Crohn's disease [CrD]. We explored clinico-pathological, molecular, and prognostic features of CD-associated SBC [CD-SBC] and CrD-associated SBC [CrD-SBC] in comparison with sporadic SBC [spo-SBC]. Methods: A total of 76 patients undergoing surgical resection for non-familial SBC [26 CD-SBC, 25 CrD-SBC, 25 spo-SBC] were retrospectively enrolled to investigate patients' survival and histological and molecular features including microsatellite instability [MSI] and KRAS/NRAS, BRAF, PIK3CA, TP53, HER2 gene alterations. Results: CD-SBC showed a significantly better sex-, age-, and stage-adjusted overall and cancer-specific survival than CrD-SBC, whereas no significant difference was found between spo-SBC and either CD-SBC or CrD-SBC. CD-SBC exhibited a significantly higher rate of MSI and median tumour-infiltrating lymphocytes [TIL] than CrD-SBC and spo-SBC. Among the whole SBC series, both MSI─which was the result of MLH1 promoter methylation in all but one cases─and high TIL density were associated with improved survival at univariable and stage-inclusive multivariable analysis. However, only TILs retained prognostic power when clinical subgroups were added to the multivariable model. KRAS mutation and HER2 amplification were detected in 30% and 7% of cases, respectively, without prognostic implications. Conclusions: In comparison with CrD-SBC, CD-SBC patients harbour MSI and high TILs more frequently and show better outcome. This seems mainly due to their higher TIL density, which at multivariable analysis showed an independent prognostic value. MSI/TIL status, KRAS mutations and HER2 amplification might help in stratifying patients for targeted anti-cancer therapy.

17 Article Colonic metaplasia of the neo-terminal ileum in Crohn's Disease. 2017

Biancone, Livia / Albertoni, Laura / Ascolani, Marta / Mescoli, Claudia / Rugge, Massimo. ·Department of Systems Medicine, Unit of Gastroenterology, University of Rome "Tor Vergata", Rome, Italy. Electronic address: biancone@med.uniroma2.it. · Department of Medicine, DIMED, Pathology Unit, University of Padova, Padova, Italy. · Department of Systems Medicine, Unit of Gastroenterology, University of Rome "Tor Vergata", Rome, Italy. ·Dig Liver Dis · Pubmed #28283377.

ABSTRACT: -- No abstract --

18 Article Nutritional status and bioelectrical phase angle assessment in adult Crohn disease patients receiving anti-TNFα therapy. 2017

Emerenziani, Sara / Biancone, Livia / Guarino, Michele Pier Luca / Balestrieri, Paola / Stasi, Elisa / Ribolsi, Mentore / Rescio, Maria Paola / Altomare, Annamaria / Cocca, Silvia / Pallone, Francesco / Cicala, Michele. ·Unit of Digestive Disease of Campus Bio Medico University of Rome, Italy. Electronic address: s.emerenziani@unicampus.it. · Department of Systems Medicine, Università "Tor Vergata" of Rome, Italy. · Unit of Digestive Disease of Campus Bio Medico University of Rome, Italy. ·Dig Liver Dis · Pubmed #28096060.

ABSTRACT: BACKGROUND: Altered body composition is frequently observed in Crohn's disease (CD) patients. AIMS: To investigate the nutritional status, and the effect of different therapeutic regimes in adult CD patients. METHODS: Fat free mass (FFM) and BIA-derived phase angle (PhA) were assessed in 45 CD patients, 22 on conventional therapy (CT) and 23 on maintenance therapy with infliximab (MT). Nutritional status was also assessed in 12 CD patients before and following the induction protocol with infliximab. BIA data of CD patients were compared with those of 20 healthy asymptomatic volunteers. In CD patients C Reactive Protein (CRP) and albuminaemia dosage were obtained. RESULTS: The mean values of PhA and of FFM were significantly lower in CT patients when compared with control group and MT patients. Following infliximab treatment FFM increased, although not significantly, while mean phase angle value significantly increased from 4.6±0.3 to 6.2±0.4 (p<0.05). CRP was significantly lower in MT patients compared to that in CT patients. CONCLUSION: CD patients on conventional therapy showed a lower FFM and a lower mean phase angle score compared to those on infliximab therapy. Following infliximab treatment the mean phase angle score normalized. PhA is a reliable nutritional indicator in IBD patients and could be considered as an additional tool for assessing response to treatment.

19 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.

20 Article Polymorphisms in MIR122, MIR196A2, and MIR124A Genes are Associated with Clinical Phenotypes in Inflammatory Bowel Diseases. 2017

Ciccacci, Cinzia / Politi, Cristina / Biancone, Livia / Latini, Andrea / Novelli, Giuseppe / Calabrese, Emma / Borgiani, Paola. ·Department of Biomedicine and Prevention, Genetics Section, University of Rome "Tor Vergata", 00133, Rome, Italy. · Gastroenterology Unit, Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy. · Department of Biomedicine and Prevention, Genetics Section, University of Rome "Tor Vergata", 00133, Rome, Italy. borgiani@med.uniroma2.it. ·Mol Diagn Ther · Pubmed #27718165.

ABSTRACT: BACKGROUND: Inflammatory bowel diseases (IBDs), including Crohn's disease (CD) and ulcerative colitis (UC), are multifactorial disorders that result from a dysregulated inflammatory response to environmental factors in genetically predisposed individuals. Recently, microRNAs (miRNAs) have been shown to be involved in the development of IBDs. AIMS: We investigated common variants in five miRNA genes in a cohort of Italian IBD patients, to evaluate their possible role in the disease's susceptibility and phenotype manifestations. METHODS: The analysis included 267 CD patients, 207 UC patients, and 298 matched healthy controls. Polymorphisms in the MIR122, MIR499, MIR146A, MIR196A2, and MIR124A genes were evaluated by allelic discrimination assay. RESULTS: We did not find associations between mir polymorphisms and IBD susceptibility. In both diseases, rs17669 and rs11614913 (MIR122 and MIR196A2) seem to contribute to clinical phenotypes: ileal location in CD (odds ratio [OR] = 1.82, p = 0.03; OR = 0.51, p = 0.01), and left-sided extent in UC (OR = 0.43, p = 0.05; OR = 0.28, p = 0.002). In CD, the MIR124A polymorphism (rs531564) contributed to colon location (p = 0.03, OR = 2.74). Finally, the variant allele of rs11614913 was associated with early age at onset in both diseases (p = 0.05 and p = 0.02). CONCLUSIONS: We showed for the first time that polymorphisms in MIR122, MIR196A2, and MIR124A could play a role in clinical phenotype modulation in IBD.

21 Article Post-operative recurrence of Crohn's disease: A prospective study at 5 years. 2016

Onali, Sara / Calabrese, Emma / Petruzziello, Carmelina / Lolli, Elisabetta / Ascolani, Marta / Ruffa, Alessandra / Sica, Giuseppe / Rossi, Alessandra / Chiaramonte, Carlo / Pallone, Francesco / Biancone, Livia. ·GI Unit, Department of Systems Medicine, University of Rome "Tor Vergata", Italy. · Surgical Unit, Department of Surgery, University of Rome "Tor Vergata", Italy. · Department of Statistic, University of Rome "Tor Vergata", Italy. · GI Unit, Department of Systems Medicine, University of Rome "Tor Vergata", Italy. Electronic address: biancone@med.uniroma2.it. ·Dig Liver Dis · Pubmed #26905749.

ABSTRACT: BACKGROUND: We aimed to prospectively assess whether endoscopic recurrence severity at 1 year in Crohn's disease is predictive of clinical recurrence within 5 years. METHODS: Clinical recurrence (Crohn's Disease Activity Index>150) was assessed yearly for 5 years in Crohn's disease patients undergoing ileo-colonic resection. At 1 year, recurrence was assessed by colonoscopy (Rutgeerts' score ≥i1 or ≥2i) and small intestine contrast ultrasonography. RESULTS: 40 patients were included (23 males, median age 39 [16-69] years). Clinical recurrence occurred within 5 years in 16 (40%) patients (years 1, 2, 3, 4, 5: 2 [5%]; 10 [25%]; 4 [10%]; 2 [5%]; 4 [10%], respectively). At 1 year, endoscopic recurrence (score≥i1) occurred in 39 (97.5%) patients (score≥i2: 33 [82.5%]). Ultrasound detected lesions compatible with recurrence in 39/40 (97.5%) patients. Endoscopic score at 1 year was correlated with clinical score at 2 years (p=0.007; r=0.41). Endoscopic score at 1 year was higher in patients with (n=10) vs without (n=30) clinical recurrence at 2 years (3 [2-4] vs 2 [0-4]; p=0.003). Higher endoscopic score (>i2) at 1 year was a risk factor for clinical recurrence within 5 years (OR=0.18; 95% CI 0.04-0.71; p=0.008). CONCLUSIONS: In Crohn's disease, severity of endoscopic recurrence at 1 year remains a predictive marker of clinical recurrence within 5 years. Small intestine contrast ultrasonography is useful for assessing 1-year recurrence.

22 Article Autophagy and inflammatory bowel disease: Association between variants of the autophagy-related IRGM gene and susceptibility to Crohn's disease. 2015

Rufini, Sara / Ciccacci, Cinzia / Di Fusco, Davide / Ruffa, Alessandra / Pallone, Francesco / Novelli, Giuseppe / Biancone, Livia / Borgiani, Paola. ·Department of Biomedicine and Prevention, Genetics Section, University of Rome "Tor Vergata", Italy. Electronic address: sara.rufini@hotmail.it. · Department of Biomedicine and Prevention, Genetics Section, University of Rome "Tor Vergata", Italy. · Gastroenterology Unit, Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy. ·Dig Liver Dis · Pubmed #26066377.

ABSTRACT: BACKGROUND: Crohn's disease and ulcerative colitis are inflammatory bowel diseases involving a genetically determined inappropriate mucosal immune response towards luminal antigens, including resident bacterial flora. Recent studies identified susceptibility genes involved in autophagy. AIMS: We analyzed known autophagic loci (IRGM, ULK1 and AMBRA1) previously described as associated with inflammatory bowel diseases or with other autoimmune and/or inflammatory disorders in a sample of Italian inflammatory bowel diseases patients in order to confirm their possible involvement and relative contribution in the disease. METHODS: We performed a case-control association study, a sub-phenotype correlation and a haplotype analysis. The analysis included 263 Crohn's disease, 206 ulcerative colitis patients and 245 matched healthy controls. Five polymorphisms were genotyped by allelic discrimination assays. RESULTS: IRGM was the most strongly associated with Crohn's disease susceptibility [rs13361189: P=0.011, OR=1.66 [95% CI: (1.12-2.45)]; rs4958847: P=0.05, OR=1.43 [95% CI: (1-2.03)]. The SNP rs13361189 was also found to increase the risk of Crohn's disease clinical sub-phenotype (fibrostricturing behaviour, ileal disease, perianal disease, intestinal resection). These findings suggest that IRGM variants may modulate clinical characteristics of Crohn's disease. CONCLUSIONS: Our study confirms IRGM rs13361189 and rs4958847 polymorphisms to be important for Crohn's disease susceptibility and phenotype modulation, in accordance with previous findings.

23 Article Laparoscopic ileocolic resection for Crohn's disease associated with midgut malrotation. 2014

Fiorani, Cristina / Biancone, Livia / Tema, Giorgia / Porokhnavets, Kristina / Tesauro, Manfredi / Gaspari, Achille L / Sica, Giuseppe S. ·Department of Surgery, Tor Vergata University of Rome, Rome, Italy. · Department of Medicine, Tor Vergata University of Rome, Rome, Italy. ·JSLS · Pubmed #25419109.

ABSTRACT: Midgut malrotation is an anomaly of fetal intestinal rotation. Its incidence in adults is rare. A case of midgut malrotation in a 51-year-old man with complicated Crohn's disease of the terminal ileum is presented. Symptoms, diagnosis, and treatment are reviewed. Preoperative workup led to correct surgical planning that ultimately allowed a successful laparoscopic resection.

24 Article Inter-observer agreement in endoscopic scoring systems: preliminary report of an ongoing study from the Italian Group for Inflammatory Bowel Disease (IG-IBD). 2014

Daperno, Marco / Comberlato, Michele / Bossa, Fabrizio / Biancone, Livia / Bonanomi, Andrea G / Cassinotti, Andrea / Cosintino, Rocco / Lombardi, Giovanni / Mangiarotti, Roberto / Papa, Alfredo / Pica, Roberta / Rizzello, Fernando / D'Incà, Renata / Orlando, Ambrogio. ·Gastroenterology Unit, Mauriziano Hospital Turin, Italy. Electronic address: mdaperno@teletu.it. · Bolzano Hospital, Bolzano, Italy. · Cancer Research and Cure Institute "Casa Sollievo Sofferenza", San Giovanni Rotondo (FG), Italy. · University Tor Vergata, Rome, Italy. · University Hospital "Careggi", Florence, Italy. · University Hospital "L. Sacco", Milan, Italy. · "San Camillo-Forlanini" Hospitals, Rome, Italy. · Hospital "Cardarelli", Naples, Italy. · Catholic University "S. Cuore", Columbus Integrated Complex, Rome, Italy. · "Sandro Pertini" Hospital, Rome, Italy. · University of Bologna, "S. Orsola Malpighi" Hospital, Bologna, Italy. · University of Padua, Padua, Italy. · United Hospitals "Villa Sofia-Cervello", Palermo, Italy. ·Dig Liver Dis · Pubmed #25154049.

ABSTRACT: BACKGROUND: Endoscopic activity has become a therapeutic endpoint in inflammatory bowel disease. Aim of this study was to evaluate inter-observer agreement for endoscopic scores in a real-life setting. METHODS: 14 gastroenterologists with experience in inflammatory bowel disease care and endoscopic scoring reviewed videos of ulcerative colitis (n=13) and postoperative (n=10) and luminal (n=8) Crohn's disease. The Mayo subscore for ulcerative colitis, Rutgeerts score for postoperative Crohn's disease, Crohn's disease endoscopic index of severity (CDEIS), and the simple endoscopic score-Crohn's disease (SES-CD) for luminal Crohn's disease were calculated. A subset of five endoscopic clips were assessed by 30 general gastroenterologists without specific experience in endoscopic scores. Kappa statistics and intraclass correlation coefficients were used to measure agreement. RESULTS: Mayo subscore agreement was suboptimal: kappas were 0.53 (95% confidence interval 0.47-0.56) and 0.71 (0.67-0.76) for the two groups. Rutgeerts score agreement was fair: kappas were 0.57 (0.51-0.65) and 0.67 (0.60-0.72). Agreements for CDEIS and SES-CD were good: intraclass correlation coefficients for the two groups were 0.83 (0.54-1.00) and 0.67 (0.36-0.97) for CDEIS and 0.93 (0.76-1.00) and 0.68 (0.35-0.97) for SES-CD, respectively. CONCLUSION: The reproducibility of endoscopic scores in inflammatory bowel disease remains suboptimal, which could potentially have major effects on therapeutic choices.

25 Article Colonic phenotype of the ileum in Crohn's disease: a prospective study before and after ileocolonic resection. 2014

Ascolani, Marta / Mescoli, Claudia / Palmieri, Giampiero / Sica, Giuseppe / Calabrese, Emma / Petruzziello, Carmelina / Onali, Sara / Albertoni, Laura / Lolli, Elisabetta / Condino, Giovanna / Pallone, Francesco / Rugge, Massimo / Biancone, Livia. ·*Gastroenterology Unit, Department of Systems Medicine, University of Rome "Tor Vergata", Roma, Italy; †Department of Medicine, DIMED, Pathology Unit, University of Padova, Padova, Italy; and ‡Pathology Unit, Department of Surgery, and §Surgical Unit, Department of Surgery, University of Rome "Tor Vergata", Roma, Italy. ·Inflamm Bowel Dis · Pubmed #25054336.

ABSTRACT: BACKGROUND: Colonic metaplasia has been described in pouchitis. In a prospective study, we investigated whether colonic phenotype may develop in Crohn's disease (CD) ileum. The expression of sulfomucins (colonic mucin), sialomucins, and CD10 (small intestine mucin and phenotype) was evaluated before and after ileocolonic resection for CD. METHODS: From February 2007 to March 2010, 22 patients with CD undergoing surgery were enrolled. Clinical (Crohn's Disease Activity Index >150) and endoscopic recurrence (Rutgeerts score ≥1) rates were assessed at 6 and 12 months. Ileal samples were taken at surgery (T0), at 6 (T1), and 12 months (T2) for histology, histochemistry (High Iron Diamine-Alcian Blue), and immunohistochemistry (anti-CD10). RESULTS: In 22 patients, recurrence was assessed at 6 and 12 months (clinical recurrence 9% and 18%; endoscopic recurrence 73% and 77%). In all 22 patients, ileal samples were taken at 6 and 12 months (involved area in patients with recurrence). In 19 of 22 (86.3%) patients, the involved ileum was also studied at surgery. At T0, T1, and T2, the expression of sialomucins and CD10 (small intestine mucin and phenotype) was comparable and higher (P < 0.0001) than the expression of sulfomucins (colonic mucin) (mean [range], T0:82 [35-100] versus 75 [0-100] versus 16 [0-50]; T1:96 [60-100] versus 94.7 [50-100] versus 3.89 [0-40]; T2:93.3 [60-100] versus 88.1 [25-100] versus 6.6 [0-40]). The expression of small-intestine mucin and phenotype was higher at T1 (P = 0.025) versus T0 (P = 0.026). Differently, the expression of colonic mucin was lower at T1 versus T0 (P = 0.027). CONCLUSIONS: In CD, the ileum involved by severe/established lesions develops a "metaplastic" colonic mucosa phenotype. Differently, CD ileum with no lesions or with early recurrence maintains the "native" small intestine type mucin secretion and phenotype.

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