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Crohn Disease: HELP
Articles by Silvio Danese
Based on 169 articles published since 2010
(Why 169 articles?)
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Between 2010 and 2020, S. Danese wrote the following 169 articles about Crohn Disease.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3 · 4 · 5 · 6 · 7
1 Guideline Use of corticosteroids and immunosuppressive drugs in inflammatory bowel disease: Clinical practice guidelines of the Italian Group for the Study of Inflammatory Bowel Disease. 2017

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

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

2 Guideline European consensus on the diagnosis and management of iron deficiency and anaemia in inflammatory bowel diseases. 2015

Dignass, Axel U / Gasche, Christoph / Bettenworth, Dominik / Birgegård, Gunnar / Danese, Silvio / Gisbert, Javier P / Gomollon, Fernando / Iqbal, Tariq / Katsanos, Konstantinos / Koutroubakis, Ioannis / Magro, Fernando / Savoye, Guillaume / Stein, Jürgen / Vavricka, Stephan / Anonymous4230815. ·Department of Medicine 1, Agaplesion Markus Hospital, Frankfurt, Germany Crohn Colitis Center, Frankfurt, Germany [*AD and *CG are both [shared] first authors and acted as conveners of the Consensus]. axel.dignass@fdk.info. · Department of Medicine 3, Medical University of Vienna, Austria [*AD and *CG are both [shared] first authors and acted as conveners of the Consensus]. · Department of Medicine B, University of Münster, Münster, Germany. · Department of Hematology, Institute of Medical Sciences, Uppsala University Uppsala, Sweden. · Istituto Clinico Humanitas, Rozanno, Milan, Italy. · Department of Gastroenterology, Hospital Universitario de la Princesa, IP and CIBEREHD, Madrid, Spain. · Hospital Clinico Universitario, CIBEREHD, Zaragoza, Spain. · University Hospitals Birmingham, NHS Foundation Trust, Birmingham, UK. · First Department of Internal Medicine, University Hospital of Ioannina, Ioannina, Greece. · University Hospital Heraklion, Heraklion, Crete, Greece. · Sao Joao Hospital, Porto, Portugal. · Rouen University Hospital, Rouen, France. · Crohn Colitis Center, Frankfurt, Germany. ·J Crohns Colitis · Pubmed #25518052.

ABSTRACT: -- No abstract --

3 Editorial Diagnostic Delay in Crohn's Disease: Time for Red Flags. 2016

Fiorino, Gionata / Danese, Silvio. ·Department of Gastroenterology, IBD Center, Humanitas Research Hospital, Rozzano, Milan, Italy. · Department of Gastroenterology, IBD Center, Humanitas Research Hospital, Rozzano, Milan, Italy. sdanese@hotmail.com. · Department of Biomedical Sciences, Humanitas University, Via Manzoni 113, 20089, Rozzano, Milan, Italy. sdanese@hotmail.com. ·Dig Dis Sci · Pubmed #27638835.

ABSTRACT: -- No abstract --

4 Editorial Adalimumab and Azathioprine Combination Therapy for Crohn's Disease: A Shining Diamond? 2016

Fiorino, Gionata / Danese, Silvio. ·Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan, Italy. · Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan, Italy sdanese@hotmail.com. · Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy. ·J Crohns Colitis · Pubmed #27389085.

ABSTRACT: -- No abstract --

5 Editorial Targeting lymphatics in inflammatory bowel disease. 2015

D'Alessio, Silvia / Tacconi, Carlotta / Danese, Silvio. ·Humanitas Clinical and Research Center, IBD Center, Rozzano, Italy. ·Oncotarget · Pubmed #26452136.

ABSTRACT: -- No abstract --

6 Editorial Editorial: long-term safety and efficacy of certolizumab pegol for Crohn's disease. 2014

Cesarini, M / Danese, S. ·Dipartimento di Medicina Interna e Specialità Mediche, Sapienza University of Rome, Rome, Italy. cesarini.monica@yahoo.it. ·Aliment Pharmacol Ther · Pubmed #25303376.

ABSTRACT: -- No abstract --

7 Editorial Editorial. Medical challanges in inflammatory bowel disease: quo vadis in disease complexity? 2014

Danese, Silvio / Peyrin-Biroulet, Laurent. ·IBD Center, Humanitas Research Hospital Milan Italy. sdanese@hotmail.com. ·Curr Drug Targets · Pubmed #25213176.

ABSTRACT: -- No abstract --

8 Editorial Regulatory T-cell therapy for Crohn's disease: in vivo veritas. 2012

Danese, Silvio / Fiorino, Gionata / Rutella, Sergio. ·IBD Center, Gastroenterology, Humanitas Clinical and Research Center, Milan, Italy. Electronic address: sdanese@hotmail.com. · IBD Center, Gastroenterology, Humanitas Clinical and Research Center, Milan, Italy. · Pediatric Hematology/Oncology and Transfusion Medicine, IRCCS Bambino Gesù Children's Hospital, Rome, Italy. ·Gastroenterology · Pubmed #23000230.

ABSTRACT: -- No abstract --

9 Editorial What's hot in inflammatory bowel disease in 2011? 2011

Danese, Silvio. · ·World J Gastroenterol · Pubmed #21350702.

ABSTRACT: Ulcerative colitis and Crohn's disease (CD) are the two major forms of inflammatory bowel disease (IBD). In this highlight topic series of articles, the most recent advances in the IBD field are reviewed, especially the newly described cytokines, including the therapeutic implications for their manipulation. In addition, the interplay between the intestinal microbiota and the host is reviewed, including the role of defensins and dysbiosis in CD pathogenesis. Finally, the importance of the non immune systems such as endothelial cells and the hemostatic system are highlighted as new players in IBD pathogenesis.

10 Editorial Anti TNF-alpha treatment for Crohn' disease: "ménage a trois". 2010

Danese, Silvio. · ·Curr Drug Targets · Pubmed #20214597.

ABSTRACT: -- No abstract --

11 Review Inflammatory bowel disease position statement of the Italian Society of Colorectal Surgery (SICCR): Crohn's disease. 2020

Pellino, G / Keller, D S / Sampietro, G M / Angriman, I / Carvello, M / Celentano, V / Colombo, F / Di Candido, F / Laureti, S / Luglio, G / Poggioli, G / Rottoli, M / Scaringi, S / Sciaudone, G / Sica, G / Sofo, L / Leone, S / Danese, S / Spinelli, A / Delaini, G / Selvaggi, F / Anonymous3851131. ·Colorectal Surgery, Department of Advanced Medical and Surgical Sciences, Università degli Studi della Campania "Luigi Vanvitelli", Policlinico CS, Piazza Miraglia 2, 80138, Naples, Italy. gipe1984@gmail.com. · Division of Colon and Rectal Surgery, Department of Surgery, New York-Presbyterian, Columbia University Medical Center, New York, NY, USA. · L. Sacco University Hospital, Milan, Italy. · General Surgery Unit, Azienda Ospedaliera di Padova, Padua, Italy. · Colon and Rectal Surgery Division, Humanitas Clinical and Research Center, Rozzano, Milan, Italy. · Portsmouth Hospitals NHS Trust, University of Portsmouth, Portsmouth, UK. · Surgery of the Alimentary Tract, Department of Medical and Surgical Sciences, Sant'Orsola Hospital, Alma Mater Studiorum University of Bologna, Bologna, Italy. · Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy. · Surgical Unit, Department of Surgery and Translational Medicine, University of Firenze, Florence, Italy. · Colorectal Surgery, Department of Advanced Medical and Surgical Sciences, Università degli Studi della Campania "Luigi Vanvitelli", Policlinico CS, Piazza Miraglia 2, 80138, Naples, Italy. · Minimally Invasive and Gastro-Intestinal Unit, Department of Surgery, Policlinico Tor Vergata, Rome, Italy. · Abdominal Surgery Department, Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of Rome, Rome, Italy. · CEO, Associazione nazionale per le Malattie Infiammatorie Croniche dell'Intestino "A.M.I.C.I. Onlus", Milan, Italy. · Division of Gastroenterology, IBD Center, Humanitas University, Rozzano, Milan, Italy. · Department of Surgery, "Pederzoli" Hospital, Peschiera del Garda, Verona, Italy. ·Tech Coloproctol · Pubmed #32172396.

ABSTRACT: The Italian Society of Colorectal Surgery (SICCR) promoted the project reported here, which consists of a position statement of Italian colorectal surgeons to address the surgical aspects of Crohn's disease management. Members of the society were invited to express their opinions on several items proposed by the writing committee, based on evidence available in the literature. The results are presented, focusing on relevant points. The present paper is not an alternative to available guidelines; rather, it offers a snapshot of the attitudes of SICCR surgeons about the surgical treatment of Crohn's disease. The committee was able to identify some points of major disagreement and suggested strategies to improve quality of available data and acceptance of guidelines.

12 Review Statins and inflammatory bowel disease: Where do we stand? 2020

Peppas, Spyros / Piovani, Daniele / Peyrin-Biroulet, Laurent / Danese, Silvio / Bonovas, Stefanos. ·Gastroenterology Department, Naval Hospital of Athens, Athens, Greece. · Department of Biomedical Sciences, Humanitas University, Milan, Italy; IBD Center, Humanitas Clinical and Research Center - IRCCS, Milan, Italy. Electronic address: dpiovani@hotmail.com. · Department of Hepato-Gastroenterology and Inserm U954, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France. · Department of Biomedical Sciences, Humanitas University, Milan, Italy; IBD Center, Humanitas Clinical and Research Center - IRCCS, Milan, Italy. ·Eur J Intern Med · Pubmed #32151491.

ABSTRACT: Inflammatory bowel disease is a chronic autoimmune disorder of the western world that is rapidly expanding in newly industrialized countries. Novel strategies are urgently needed to prevent and improve the treatment of this costly and disabling disease. Statins are the most commonly prescribed drugs worldwide. Besides their lipid-lowering effects, statins may exert complex immunomodulatory properties and multiple pleiotropic effects including the inhibition of T-cell activation, antigen-presenting function and leukocyte infiltration of target organs which might render statins as beneficial agents for inflammatory and autoimmune conditions. In this review, we summarize the experimental findings on the topic, and critically appraise the epidemiological evidence regarding the value of statins as a potential strategy for preventing and treating inflammatory bowel disease. Several experimental studies have shown that statins reduce inflammation in animal models of colitis; however, clinical studies investigating their disease-modifying and preventive potential in IBD have demonstrated some limitations and conflicting results. The available epidemiological evidence is not yet sufficient to support the use of statin for preventing or treating inflammatory bowel disease. Additional high-quality research is warranted.

13 Review Inflammatory bowel disease (IBD) position statement of the Italian Society of Colorectal Surgery (SICCR): general principles of IBD management. 2020

Pellino, G / Keller, D S / Sampietro, G M / Annese, V / Carvello, M / Celentano, V / Coco, C / Colombo, F / Cracco, N / Di Candido, F / Franceschi, M / Laureti, S / Mattioli, G / Pio, L / Sciaudone, G / Sica, G / Villanacci, V / Zinicola, R / Leone, S / Danese, S / Spinelli, A / Delaini, G / Selvaggi, F / Anonymous691078. ·Colorectal Surgery, Department of Advanced Medical and Surgical Sciences, Università Degli Studi Della Campania "Luigi Vanvitelli", Policlinico CS, Piazza Miraglia 2, 80138, Naples, Italy. gipe1984@gmail.com. · Division of Colon and Rectal Surgery, Department of Surgery, NewYork-Presbyterian, Columbia University Medical Center, New York, USA. · L. Sacco University Hospital Milano, Milan, Italy. · Gastroenterology Unit, DEA-Medicina E Chirurgia Generale E D'Urgenza, University Hospital Careggi, Firenze, Italy. · Colon and Rectal Surgery Division, Humanitas Clinical and Research Center, Rozzano, Milan, Italy. · Portsmouth Hospitals NHS Trust, Portsmouth, UK. · University of Portsmouth, Portsmouth, UK. · UOC Chirurgia Generale 2, Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy. · Department of General Surgery, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy. · IBD Surgery, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy. · Surgery of the Alimentary Tract, Sant'Orsola Hospital, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy. · Pediatric Surgery Unit, Istituto Giannina Gaslini, and Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, Genoa, Italy. · Pediatric Surgery Department, Hôpital Robert-Debré and Université de Paris, Paris, France. · Colorectal Surgery, Department of Advanced Medical and Surgical Sciences, Università Degli Studi Della Campania "Luigi Vanvitelli", Policlinico CS, Piazza Miraglia 2, 80138, Naples, Italy. · Minimally Invasive and Gastro-Intestinal Unit, Department of Surgery, Policlinico Tor Vergata, Rome, Italy. · Institute of Pathology, Spedali Civili Brescia, Brescia, Italy. · Department of Emergency Surgery, University Hospital Parma, Parma, Italy. · CEO, Associazione Nazionale Per Le Malattie Infiammatorie Croniche Dell'Intestino "A.M.I.C.I. Onlus", Milan, Italy. · Division of Gastroenterology, IBD Center, Humanitas University, Rozzano, Milan, Italy. · Department of Surgery, "Pederzoli" Hospital, Peschiera del Garda, Verona, Italy. ·Tech Coloproctol · Pubmed #31983044.

ABSTRACT: The Italian Society of Colorectal Surgery (SICCR) promoted the project reported here, which consists of a Position Statement of Italian colorectal surgeons to address the surgical aspects of inflammatory bowel disease management. Members of the society were invited to express their opinions on several items proposed by the writing committee, based on evidence available in the literature. The results are presented, focusing on relevant points. The present paper is not an alternative to available guidelines; rather, it offers a snapshot of the attitudes of SICCR surgeons about the general principles of surgical treatment of inflammatory bowel disease. The committee was able to identify some points of major disagreement and suggested strategies to improve quality of available data and acceptance of guidelines.

14 Review The role of integrins in the pathogenesis of inflammatory bowel disease: Approved and investigational anti-integrin therapies. 2020

Dotan, Iris / Allez, Matthieu / Danese, Silvio / Keir, Mary / Tole, Swati / McBride, Jacqueline. ·Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. · Department of Gastroenterology, Hôpital Saint-Louis, AP-HP, INSERM U1160, University Denis Diderot, Paris, France. · Gastrointestinal Immunopathology Laboratory and IBD Unit, Humanitas Clinical and Research Center, Milan, Italy. · Department of Research and Early Development, Genentech, South San Francisco, California. · Department of Product Development, Genentech, South San Francisco, California. ·Med Res Rev · Pubmed #31215680.

ABSTRACT: Inflammatory bowel disease (IBD) is characterized by uncontrolled inflammation in the gastrointestinal tract. The underlying pathobiology of IBD includes an increase in infiltrating gut-homing lymphocytes. Although lymphocyte homing is typically a tightly regulated and stepwise process involving multiple integrins and adhesion molecules expressed on endothelial cells, the distinct roles of integrin-expressing immune cells is not fully understood in the pathology of IBD. In this review, we detail the involvement of integrins expressed on specific lymphocyte subsets in the pathogenesis of IBD and discuss the current status of approved and investigational integrin-targeted therapies.

15 Review Management of patients with complex perianal fistulas in Crohn's disease: Optimal patient flow in the Italian clinical reality. 2019

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

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

16 Review Use of Cross-Sectional Imaging for Tight Monitoring of Inflammatory Bowel Diseases. 2019

Allocca, Mariangela / Danese, Silvio / Laurent, Valérie / Peyrin-Biroulet, Laurent. ·Inflammatory Bowel Disease Centre, Humanitas Clinical and Research Centre, Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy. · Department of Radiology, Nancy University Hospital, Lorraine University, Vandœuvre-lès-Nancy, France. · Department of Gastroenterology, Inserm NGERE, University Hospital of Nancy, Lorraine University, Nancy, France. Electronic address: peyrinbiroulet@gmail.com. ·Clin Gastroenterol Hepatol · Pubmed #31812657.

ABSTRACT: A treat-to-target strategy with close monitoring of intestinal inflammation is recommended in inflammatory bowel disease (IBD). Ileocolonoscopy remains the gold standard for assessing disease activity in IBD but is a relatively invasive procedure and is impossible to repeat in the context of tight monitoring strategies. In addition to biomarkers, cross-sectional imaging increasingly is used in these patients. Computed tomography is limited by the use of radiation, while the use of magnetic resonance enterography (MRE) is limited by its cost and access. There is growing interest in bowel ultrasound that represents a cost-effective, noninvasive, and well-tolerated modality in clinical practice, but it is operator dependent. Compared with ileocolonoscopy and MRE, bowel US has been shown to have the same level of accuracy in assessing and monitoring disease activity for both CD and UC and thus can be considered a point-of-care test. Diffusion-weighted imaging (DWI) is a MR imaging technique that increasingly is used in both IBD and non-IBD conditions and has been shown to be a valuable and accurate tool for assessing and monitoring IBD activity. Compared with conventional MRE, DWI is quicker, less time consuming, may not require intravenous contrast agent, fasting, bowel cleansing, oral preparation, or rectal preparation. This review discusses the role of these cross-sectional imaging techniques for the management of patients with IBD. In the near future, the value of DWI and ultrasound in assessing IBD will require further investigation in the era of transmural healing in CD and complete mucosal healing, including histologic remission, in ulcerative colitis.

17 Review Anti-TNF biosimilars in Crohn's Disease: a patient-centric interdisciplinary approach. 2019

Peyrin-Biroulet, Laurent / Danese, Silvio / Cummings, Fraser / Atreya, Raja / Greveson, Kay / Pieper, Burkhard / Kang, Taegyun. ·a Department of gastroenterology, Nancy University Hospital, Lorraine University , Nancy , France. · b IBD center department of gastroenterology and Humanitas University, Humanitas Research Hospital , Milan , Italy. · c IBD Center and Department of Biomedical Sciences, University Hospital Southampton , Southampton , UK. · d Medical Department 1, University of Erlangen-Nürnberg , Erlangen , Germany. · e Center for Gastroenterology, Royal Free Hospital , London , UK. · f Scientific Affairs Biosimilars, Biogen International GmbH , Baar , Switzerland. · g Medical Affairs, Samsung Bioepis Co., Ltd , Incheon , Republic of Korea. ·Expert Rev Gastroenterol Hepatol · Pubmed #31322440.

ABSTRACT:

18 Review Approaches to Integrating Biomarkers Into Clinical Trials and Care Pathways as Targets for the Treatment of Inflammatory Bowel Diseases. 2019

Dulai, Parambir S / Peyrin-Biroulet, Laurent / Danese, Silvio / Sands, Bruce E / Dignass, Axel / Turner, Dan / Mantzaris, Gerassimos / Schölmerich, Juergen / Mary, Jean-Yves / Reinisch, Walter / Sandborn, William J. ·Division of Gastroenterology, University of California San Diego, La Jolla, California. Electronic address: pdulai@ucsd.edu. · Department of Gastroenterology, Nancy University Hospital, Lorraine University, Nancy, France. · Department of Biomedical Sciences, Humanitas University, Humanitas Clinical and Research Centre, Milan, Italy. · Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York. · Department of Medicine I, Agaplesion Markus Hospital and Crohn Colitis Clinical Research Center Rhein-Main, Frankfurt/Main, Germany. · Institute of Paediatric Gastroenterology, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel. · Department of Gastroenterology, Evaggelismos-Ophthalmiatreion Athinon-Polycliniki, Athens, Greece. · Goethe University, Frankfurt, Germany. · INSERM UMR, Paris Diderot University, Saint Louis Hospital, Paris, France. · Universitätsklinik für Innere Medizin III, Vienna, Austria. · Division of Gastroenterology, University of California San Diego, La Jolla, California. ·Gastroenterology · Pubmed #31228441.

ABSTRACT: BACKGROUND & AIMS: There is no consensus on the best way to integrate biomarkers into inflammatory bowel disease (IBD) research and clinical practice. The International Organization for the Study of Inflammatory Bowel Disease aimed to outline biomarker definitions, categories, and operating properties required for their use in registration trials and clinical practice. Using fecal calprotectin as an example, we provide a framework for biomarker development and validation in patients with IBD. METHODS: We reviewed international society guidelines, regulatory agency guidance documents, and standardized reporting guidelines for biomarkers, in combination with publications on fecal calprotectin levels in patients with IBD. We assessed the validity of fecal calprotectin to serve as a surrogate biomarker of IBD activity and outlined a framework for further validation and development of biomarkers. RESULTS: No endpoints have been fully validated as surrogates of risk of disease complications; mucosal healing is the most valid endpoint used to determine risk of disease complications. Fecal level of calprotectin has not been validated as a biomarker for IBD activity because of lack of technical and clinical reliability, assessment of performance when used as a replacement for endoscopy, and assessment of responsiveness to changes in disease states. The level of fecal calprotectin can be used only as a prognostic factor for disease recurrence in patients in remission after medical or surgical treatment. CONCLUSIONS: We reviewed guidelines, regulatory documents, and publications to identify properties required for the development of biomarkers of IBD activity and areas in need of clarification from regulatory agencies and societies. We propose a path forward for research of biomarkers for IBD.

19 Review JAK selectivity for inflammatory bowel disease treatment: does it clinically matter? 2019

Danese, Silvio / Argollo, Marjorie / Le Berre, Catherine / Peyrin-Biroulet, Laurent. ·IBD Centre, Humanitas Clinical Research Centre, Rozzano, Milan, Italy. · Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy. · Gastroenterology, Universidade Federal de São Paulo, São Paulo, Brazil. · Gastroenterology, Nancy-Universite, Nancy, Lorraine, France. · Inserm U954 and Department of Hepato-Gastroenterology, University Hospital of Nancy-Brabois, Vandoeuvre-lès-Nancy, France. · Université Henri Poincaré 1, Vandoeuvre-lès-Nancy, France. ·Gut · Pubmed #31227590.

ABSTRACT: The two major forms of inflammatory bowel disease (IBD), encompassing Crohn's disease (CD) and ulcerative colitis (UC), are chronic immune-mediated conditions characterised by an increased production of pro-inflammatory cytokines that act as critical drivers of intestinal inflammation. Anti-cytokine therapy has been shown to improve clinical outcomes in IBD. Janus kinases (JAKs) are tyrosine kinases that bind different intracellular cytokine receptors, leading to phosphorylation of signal transducer and activation of transcription molecules implicated on targeted gene transcription. Four isoforms of JAKs have been described: JAK1, JAK2, JAK3 and TYK2. Oral JAK inhibitors (JAKi) have been developed as synergic anti-cytokine therapy in IBD, showing different selectivity towards JAK isoforms. Tofacitinib, a pan-JAK inhibitor, has been recently approved for the treatment of moderate-to-severe UC. With the aim of improving the benefit: risk ratio of this drug class, several second-generation subtype-selective JAKi are under development. However, whether selective inhibition of JAK isoforms is associated with an increased clinical efficacy and/or a better safety profile remains debatable. The aim of this review is to critically review the preclinical and clinical data for the differential selectivity of JAK inhibitors and to summarise the potential clinical implications of the selective JAK inhibitors under development for UC and CD.

20 Review Interleukin-23 Blockers: Born to be First-line Biologic Agents in Inflammatory Bowel Disease? 2019

Argollo, Marjorie C / Allocca, Mariangela / Furfaro, Federica / Peyrin-Biroulet, Laurent / Danese, Silvio. ·IBD Centre, Humanitas Clinical and Research Centre, Rozzano, Milan, Italy. · Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy. · Department of Gastroenterology and Inserm U954, Nancy University Hospital, Lorraine University, Vandoeuvre, France. ·Curr Pharm Des · Pubmed #31092171.

ABSTRACT: Over the past decades, the advent of anti-TNF agents has dramatically changed the treatment algorithms for IBD. However, primarily and more importantly, secondary loss of response to anti-TNF agents, is often observed. Thus, new treatment options have been actively explored and some have already been incorporated in the current clinical practice. Among the class of anti-cytokine agents, the anti-IL12/IL23 monoclonal antibodies (mAbs) have been first presented, in clinical practice, by the anti-p40 mAb ustekinumab in Crohn's disease (CD). More selective anti-IL23 agents (anti-p19) have shown efficacy and are being further developed, in contrast to agents inhibiting IL-17 downstream, which have failed in IBD clinical trials despite their clear efficacy in psoriasis.

21 Review Detection and management of early stage inflammatory bowel disease: an update for clinicians. 2019

Loy, Laura / Roda, Giulia / Fiorino, Gionata / Allocca, Mariangela / Furfaro, Federica / Argollo, Marjorie / Peyrin-Biroulet, Laurent / Danese, Silvio. ·a IBD Center, Department of Gastroenterology , Humanitas Research Hospital , Rozzano, Milan , Italy. · b Department of Hepato-Gastroenterology and Inserm U954 , University Hospital of Nancy, Lorraine University , Vandoeuvre-lès-Nancy , France. · c Department of Biomedical Sciences , Humanitas Rozzano , Milan , Italy. ·Expert Rev Gastroenterol Hepatol · Pubmed #31007098.

ABSTRACT: INTRODUCTION: Inflammatory bowel diseases, which include Crohn's disease and ulcerative colitis, are lifetime chronic and progressive disorders of poorly known etiology. Over the past few decades, new therapeutic approaches, including early and more aggressive intervention with immunomodulators and biological agents have offered the possibility of a favorable modification in the natural history of inflammatory bowel diseases. Area covered: Here, we review the literature about the effectiveness of early detection and intervention in adult inflammatory bowel diseases patients. Expert commentary: Detecting and managing early stages of inflammatory bowel diseases represents an effective strategy to avoid disease progression in selected patients. Primary care physicians may play a key role in attaining these outcomes by recognizing the signs and symptoms early and making timely referrals. Moreover, early therapeutic intervention with complete disease control may allow dose reduction or even treatment withdrawal in the maintenance phase, reducing side effects, costs, and also improving quality of life.

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

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

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

23 Review Biosimilars of Adalimumab in Inflammatory Bowel Disease: Are we Ready for that? 2019

Argollo, Marjorie / Fiorino, Gionata / Gilardi, Daniela / Furfaro, Federica / Roda, Giulia / Loy, Laura / Allocca, Mariangela / Peyrin-Biroulet, Laurent / Danese, Silvio. ·IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Institute, Rozzano, Milan, Italy. · Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy. · Department of Gastroenterology and Inserm U954, Nancy University Hospital, Lorraine University, Vandoeuvre, France. ·Curr Pharm Des · Pubmed #30864505.

ABSTRACT: INTRODUCTION: Biosimilars present a considerable potential to reduce costs related to clinical management allowing health-care providers to reinvest this money, leading to a wider access to an effective biological treatment with monoclonal antibodies (mAb). Infliximab biosimilars have already been incorporated in daily clinical practice and are currently used in all indications for which the reference product (RP) was approved. Areas covered: In the next few years, also adalimumab biosimilars will become available for the treatment of inflammatory bowel disease (IBD). In fact, several of them (ABP501, BI 695501, GP2017, and SB5) have been approved by the European Medicines Agency (EMA) with the same indications of the reference product (Humira ®). Initial preclinical data proved a strong similarity between all biosimilars and the RP. Moreover, phase 3 studies in rheumatoid arthritis and psoriasis showed no differences in terms of efficacy, safety, and immunogenicity. Data on IBD patients are urgently needed. Expert opinion: Biosimilars of adalimumab showed equivalent clinical efficacy to the RP in other immunemediated diseases. However, defining the ideal patient's profile to receive or to be switched to a biosimilar, choosing one biosimilar vs. another, or cross-switching among biosimilars, will become the next challenge in IBD.

24 Review Anti-adhesion Molecules in IBD: Does Gut Selectivity Really Make the Difference? 2019

D'Amico, Ferdinando / Roda, Giulia / Peyrin-Biroulet, Laurent / Danese, Silvio. ·IBD Centre, Humanitas Clinical and Research Centre, Rozzano, Milan, Italy. · Department of Gastroenterology and Inserm U954, Nancy University Hospital, Lorraine University, Vandoeuvre, France. · Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy. ·Curr Pharm Des · Pubmed #30848193.

ABSTRACT: Inflammatory Bowel Disease is lifetime chronic progressive inflammatory disease. A considerable portion of patients, do not respond or lose response or experience side effect to "traditional" biological treatment such as anti-tumor necrosis factor (TNF)-α agents. The concept that the blockade of T cell traffic to the gut controls inflammation has stimulated the development of new drugs which selectively targets molecules involved in controlling cell homing to the intestine. The result is the reduction of the chronic inflammatory infiltration in the gut. In this regard, anti-adhesion molecules represent a new class of drugs for patients who don't respond or lose response to traditional therapy. Moreover, some of these molecules such as vedolizumab, offer the advantage to target the delivery of a drug to the gut (gut selectivity) which could increase clinical efficacy and limit potential adverse events. In this article, we will give an overview of the current data on anti-adhesion molecules in Inflammatory Bowel Diseases.

25 Review Anti-fibrotic Drugs for Crohn's Disease: Ready for Prime Time? 2019

Argollo, Marjorie / Gilardi, Daniela / Roda, Giulia / Fiorino, Gionata / Peyrin-Biroulet, Laurent / Danese, Silvio. ·IBD Centre, Humanitas Clinical and Research Centre, Rozzano, Milan, Italy. · Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy. · Department of Gastroenterology and Inserm U954, Nancy University Hospital, Lorraine University, Vandoeuvre, France. ·Curr Pharm Des · Pubmed #30848192.

ABSTRACT: Intestinal fibrosis, driven by chronic inflammation in Crohn's disease, can be defined as an excessive accumulation of extracellular matrix in the affected gut segment ultimately leading to an impaired wound healing and cumulative tissue damage, possibly resulting in organ dysfunction, formation of stenotic lesions and necessity of surgical intervention. Despite continuous advances in developing novel treatment modalities targeting different pathways to control chronic gut inflammation in CD, no effective anti-fibrotic agents have been released, to date. Thus, a better understanding of the molecular and cellular mechanisms underlying intestinal fibrosis is key to move this area of investigation forward.

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