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18 results on '"Michele Comberlato"'

1. Use of biologics for the management of Crohn's disease: IG-IBD clinical guidelines based on the GRADE methodology

Author

Fabio Salvatore Macaluso, Claudio Papi, Ambrogio Orlando, Stefano Festa, Daniela Pugliese, Stefanos Bonovas, Claudia Pansieri, Daniele Piovani, Gionata Fiorino, Massimo Claudio Fantini, Flavio Caprioli, Marco Daperno, Alessandro Armuzzi, Lorenzo Bertani, Cristina Bezzio, Giorgia Bodini, Fabrizio Bossa, Andrea Buda, Emma Calabrese, Federica Furfaro, Salvatore Leone, Filippo Mocciaro, Sara Onali, Luca Pastorelli, Enrica Previtali, Mariabeatrice Principi, Sara Renna, Davide Giuseppe Ribaldone, Antonio Rispo, Fernando Rizzello, Simone Saibeni, Gianluca Matteo Sampietro, Edoardo Savarino, Anna Testa, Angela Variola, Angelo Viscido, Sandro Ardizzone, Livia Biancone, Maria Cappello, Fabiana Castiglione, Rachele Ciccocioppo, Michele Comberlato, Francesco Costa, Renata D'Incà, Silvio Danese, Antonio Di Sabatino, Walter Fries, Paolo Gionchetti, Giovanni Latella, Francesco Manguso, Mauro Mastronardi, Gianmichele Meucci, Monica Milla, Maria Lia Scribano, and Maurizio Vecchi

Subjects
Clinical guidelines, Crohn's disease, GRADE, IG-IBD, Hepatology, Gastroenterology, Biologics
Published
2023

2. Reduced humoral response to two doses of COVID-19 vaccine in patients with inflammatory bowel disease: Data from ESCAPE-IBD, an IG-IBD study

Author

Fabio Salvatore Macaluso, Mariabeatrice Principi, Federica Facciotti, Antonella Contaldo, Alessia Todeschini, Simone Saibeni, Cristina Bezzio, Fabiana Castiglione, Olga Maria Nardone, Rocco Spagnuolo, Massimo Claudio Fantini, Gaia Riguccio, Flavio Caprioli, Chiara Viganò, Carla Felice, Gionata Fiorino, Carmen Correale, Giorgia Bodini, Monica Milla, Giulia Scardino, Marta Vernero, Federico Desideri, Mariella Mannino, Giuseppe Rizzo, Ambrogio Orlando, Arnaldo Amato, Marta Ascolani, Giulio Calabrese, Angelo Casà, Michele Comberlato, Francesco Simone Conforti, Manuela De Bona, Maria Giulia Demarzo, Patrizia Doldo, Gabriele Dragoni, Federica Furfaro, Giacomo Mulinacci, Oriana Olmo, Nicole Piazza O'Sed, Salvatore Paba, Simona Radice, Sara Renna, Davide Giuseppe Ribaldone, Giulia Rizzuto, Macaluso, F, Principi, M, Facciotti, F, Contaldo, A, Todeschini, A, Saibeni, S, Bezzio, C, Castiglione, F, Nardone, O, Spagnuolo, R, Fantini, M, Riguccio, G, Caprioli, F, Vigano, C, Felice, C, Fiorino, G, Correale, C, Bodini, G, Milla, M, Scardino, G, Vernero, M, Desideri, F, Mannino, M, Rizzo, G, Orlando, A, Amato, A, Ascolani, M, Calabrese, G, Casa, A, Comberlato, M, Conforti, F, De Bona, M, Demarzo, M, Doldo, P, Dragoni, G, Furfaro, F, Mulinacci, G, Olmo, O, O'Sed, N, Paba, S, Radice, S, Renna, S, Ribaldone, D, Rizzuto, G, Macaluso, F. S., Principi, M., Facciotti, F., Contaldo, A., Todeschini, A., Saibeni, S., Bezzio, C., Castiglione, F., Nardone, O. M., Spagnuolo, R., Fantini, M. C., Riguccio, G., Caprioli, F., Vigano, C., Felice, C., Fiorino, G., Correale, C., Bodini, G., Milla, M., Scardino, G., Vernero, M., Desideri, F., Mannino, M., Rizzo, G., Orlando, A., Amato, A., Ascolani, M., Calabrese, G., Casa, A., Comberlato, M., Conforti, F. S., De Bona, M., Demarzo, M. G., Doldo, P., Dragoni, G., Furfaro, F., Mulinacci, G., Olmo, O., O'Sed, N. P., Paba, S., Radice, S., Renna, S., Ribaldone, D. G., and Rizzuto, G.

Subjects
Vaccines, Hepatology, Biologic, SARS-CoV-2, Gastroenterology, Biologics, Vaccine
Abstract

Background: Patients on immunosuppressive drugs have been excluded from COVID-19 vaccines trials, creating concerns regarding their efficacy. Aims: To explore the humoral response to COVID-19 vaccines in patients with inflammatory bowel disease (IBD) Methods: Effectiveness and Safety of COVID-19 Vaccine in Patients with Inflammatory Bowel Disease (IBD) Treated with Immunomodulatory or Biological Drugs (ESCAPE-IBD) is a prospective, multicentre study promoted by the Italian Group for the study of Inflammatory Bowel Disease. We present data on serological response eight weeks after the second dose of COVID-19 vaccination in IBD patients and healthy controls (HCs). Results: 1076 patients with IBD and 1126 HCs were analyzed. Seropositivity for anti-SARS-CoV-2 IgG was reported for most IBD patients, even if with a lesser rate compared with HCs (92.1% vs. 97.9%; p

Published
2023

3. Use of biologics and small molecule drugs for the management of moderate to severe ulcerative colitis: IG-IBD clinical guidelines based on the GRADE methodology

Author

Fabio Salvatore Macaluso, Ambrogio Orlando, Claudio Papi, Stefano Festa, Daniela Pugliese, Stefanos Bonovas, Claudia Pansieri, Daniele Piovani, Gionata Fiorino, Massimo Claudio Fantini, Flavio Caprioli, Marco Daperno, Alessandro Armuzzi, Lorenzo Bertani, Cristina Bezzio, Giorgia Bodini, Fabrizio Bossa, Andrea Buda, Emma Calabrese, Federica Furfaro, Salvatore Leone, Filippo Mocciaro, Sara Onali, Luca Pastorelli, Enrica Previtali, Mariabeatrice Principi, Sara Renna, Davide Giuseppe Ribaldone, Antonio Rispo, Fernando Rizzello, Simone Saibeni, Gianluca Matteo Sampietro, Edoardo Savarino, Anna Testa, Angela Variola, Angelo Viscido, Sandro Ardizzone, Livia Biancone, Maria Cappello, Fabiana Castiglione, Rachele Ciccocioppo, Michele Comberlato, Francesco Costa, Renata D'Incà, Silvio Danese, Antonio Di Sabatino, Walter Fries, Paolo Gionchetti, Giovanni Latella, Francesco Manguso, Mauro Mastronardi, Gianmichele Meucci, Monica Milla, Maria Lia Scribano, Maurizio Vecchi, Macaluso F.S., Orlando A., Papi C., Festa S., Pugliese D., Bonovas S., Pansieri C., Piovani D., Fiorino G., Fantini M.C., Caprioli F., Daperno M., Armuzzi A., Bertani L., Bezzio C., Bodini G., Bossa F., Buda A., Calabrese E., Furfaro F., Leone S., Mocciaro F., Onali S., Pastorelli L., Previtali E., Principi M., Renna S., Ribaldone D.G., Rispo A., Rizzello F., Saibeni S., Sampietro G.M., Savarino E., Testa A., Variola A., Viscido A., Ardizzone S., Biancone L., Cappello M., Castiglione F., Ciccocioppo R., Comberlato M., Costa F., D'Inca R., Danese S., Di Sabatino A., Fries W., Gionchetti P., Latella G., Manguso F., Mastronardi M., Meucci G., Milla M., Scribano M.L., and Vecchi M.

Subjects
Clinical guidelines, Biological Products, IG-IBD, Hepatology, Biologic, Gastroenterology, Biologics, GRADE, Small molecule drugs, Adalimumab, Humans, Infliximab, Colitis, Ulcerative, Inflammatory Bowel Diseases, Ulcerative, Colitis, Settore MED/12, Clinical guideline
Abstract

The management of moderate to severe ulcerative colitis has undergone significant changes over the past 15 years due to the regulatory approval of several new drugs. In particular, following the approval of the first biological, i.e. infliximab, a number of further biological drugs, such as adalimumab, golimumab, vedolizumab and ustekinumab, and small molecules, such as tofacitinib, have been approved, thus enriching the therapeutic armamentarium for ulcerative colitis. Choice of therapy must take into consideration not only the need to induce and maintain disease remission according to the patient's profile, but also age, co-morbidities, and prior treatments. To guide these decisions, the Italian Group for the Study of Inflammatory Bowel Disease has developed clinical guidelines that supersede its earlier document from 2011. These new guidelines were developed following the GRADE methodology for rating the quality of the evidence and for determining the strength of the recommendations. This article presents the methodology and results, in the form of 20 statements with commentary on the use of the five biologics and tofacitinib for managing the intestinal manifestations of active ulcerative colitis and for maintaining remission. A separate technical review reports the analyses of the evidence upon which the present recommendations are based.

Published
2022

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

Author

Gionata Fiorino, Flavio Caprioli, Marco Daperno, Filippo Mocciaro, Mariabeatrice Principi, Angelo Viscido, Massimo Claudio Fantini, Ambrogio Orlando, Claudio Papi, Vito Annese, Silvio Danese, Maurizio Vecchi, Fernando Rizzello, Alessandro Armuzzi, Salvatore Leone, Enrica Previtali, Marina Aloi, Patrizia Alvisi, Elisabetta Antonelli, Sandro Ardizzone, Marco Astegiano, Monia Baldoni, Marina Beltrami, Livia Biancone, Giorgia Bodini, Andrea Buda, Fabrizio Bossa, Fiammetta Bracci, Emma Calabrese, Maria Cappello, Fabiana Castiglione, Carolina Ciacci, Michele Cicala, Rachele Ciccocioppo, Michele Comberlato, Claudio Camillo Cortelezzi, Rocco Cosintino, Francesco Costa, Giuseppe Costantino, Salvatore Cucchiara, Antonio Cuomo, Renata D’Incà, Maria Carla Di Paolo, Antonio Di Sabatino, Antonio Di Sario, Giuseppe Frieri, Walter Fries, Antonio Gasbarrini, Andrea Geccherle, Paolo Gionchetti, Maria Giovanna Graziani, Laurino Grossi, Luisa Guidi, Gianni Imperiali, Giovanni Latella, Paolo Lionetti, Gaetano Inserra, Giovanni Maconi, Francesco Manguso, Marco Marino, Mauro Mastronardi, Silvia Mazzuoli, Gianmichele Meucci, Marco Mendolaro, Monica Milla, Giammarco Mocci, Giovanni Monteleone, Francesco Neri Bortoluzzi, Cristiano Pagnini, Luca Pastorelli, Roberta Pica, Simona Piergallini, Antonello Privitera, Sara Renna, Davide Giuseppe Ribaldone, Chiara Ricci, Antonio Rispo, Rodolfo Rocca, Claudio Romano, Marco Romano, Giovanni Russo, Renato Sablich, Simone Saibeni, Edoardo Savarino, Maria Lia Scribano, Rocco Spagnuolo, Elisa Stasi, Maria Maddalena Terpin, Anna Testa, Daniela Valpiani, Angela Variola, Piero Vernia, Giovanna Vitale, Giorgio Zoli, Fiorino, G, Caprioli, F, Daperno, M, Mocciaro, F, Principi, M, Viscido, A, Fantini, Mc, Orlando, A, Papi, C, Annese, V, Danese, S, Vecchi, M, Rizzello, F, Armuzzi, A, Leone, S, Previtali, E, Aloi, M, Alvisi, P, Antonelli, E, Ardizzone, S, Astegiano, M, Baldoni, M, Beltrami, M, Biancone, L, Bodini, G, Buda, A, Bossa, F, Bracci, F, Calabrese, E, Cappello, M, Castiglione, F, Ciacci, C, Cicala, M, Ciccocioppo, R, Comberlato, M, Cortelezzi, Cc, Cosintino, R, Costa, F, Costantino, G, Cucchiara, S, Cuomo, A, D'Inca, R, Di Paolo, Mc, Di Sabatino, A, Di Sario, A, Frieri, G, Fries, W, Gasbarrini, A, Geccherle, A, Gionchetti, P, Graziani, Mg, Grossi, L, Guidi, L, Imperiali, G, Latella, G, Lionetti, P, Inserra, G, Maconi, G, Manguso, F, Marino, M, Mastronardi, M, Mazzuoli, S, Meucci, G, Mendolaro, M, Milla, M, Mocci, G, Monteleone, G, Bortoluzzi, Fn, Pagnini, C, Pastorelli, L, Pica, R, Piergallini, S, Privitera, A, Renna, S, Ribaldone, Dg, Ricci, C, Rispo, A, Rocca, R, Romano, C, Romano, M, Russo, G, Sablich, R, Saibeni, S, Savarino, E, Scribano, Ml, Spagnuolo, R, Stasi, E, Terpin, Mm, Testa, A, Valpiani, D, Variola, A, Vernia, P, Vitale, G, Zoli, G, and Gionata Fiorino, Flavio Caprioli, Marco Daperno, Filippo Mocciaro, Mariabeatrice Principi, Angelo Viscido, Massimo Claudio Fantini, Ambrogio Orlando, Claudio Papi, Vito Annese, Silvio Danesea, Maurizio Vecchi, Fernando Rizzello, Alessandro Armuzzi

Subjects
medicine.medical_specialty, Anti-TNF Biosimilars Crohn’s disease Inflammatory bowel disease Tumor necrosis factor alpha Ulcerative colitis, Inflammatory bowel disease, Antibodies, 03 medical and health sciences, Anti-TNFα, 0302 clinical medicine, Medical, Monoclonal, Adalimumab, medicine, Humans, Intensive care medicine, Biosimilar Pharmaceuticals, Societies, Medical, Randomized Controlled Trials as Topic, Biosimilars, Crohn's disease, Hepatology, business.industry, Tumor necrosis factor alpha, Tumor Necrosis Factor-alpha, Gastroenterology, Antibodies, Monoclonal, Biosimilar, anti-TNFα, biosimilars, crohn's disease, inflammatory bowel disease, tumor necrosis factor alpha, ulcerative colitis, medicine.disease, Inflammatory Bowel Diseases, Ulcerative colitis, Infliximab, Italy, 030220 oncology & carcinogenesis, Position paper, 030211 gastroenterology & hepatology, business, Societies, Patient education, medicine.drug
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.

Published
2019

5. PC.01.4 PREVALENCE OF ANAEMIA IN INFLAMMATORY BOWEL DISEASE: PRELIMINARY RESULTS OF THE OBSERVATIONAL ITALIAN MULTICENTRE IG-IBD STUDY RIDART 1

Author

Paolo Giuffrida, Renata D'Incà, Marco Astegiano, E. Ponzo, Fabrizio Bossa, D. Mazzucco, Andrea Buda, E. Villa, Gabrio Bassotti, Nicola Aronico, A. Pieraccini, R. Caccaro, Walter Fries, S. Nardelli, R. Fontana, Maria Lia Scribano, Piero Vernia, A. Di Sabatino, Michela Masotti, Fernando Rizzello, Fabiana Castiglione, A. Orlando, G. Ghigliazza, A. Manca, L. Sidoli, C. Valerii, Michele Comberlato, V. Neve, R. Cannatelli, Anna Testa, Giorgia Bodini, T. Pinto Vraca, Monica Milla, Mariabeatrice Principi, Gabriele Riegler, Paola Iovino, Gino Roberto Corazza, Giulia Rizzuto, Claudio Ricci, Fabio Monica, S. Saimbeni, Carolina Ciacci, Maria Cristina Neri, Sara Cococcia, Marco Vincenzo Lenti, Gaetano Bergamaschi, and Caterina Mengoli

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Gastroenterology, medicine, Observational study, business, medicine.disease, Inflammatory bowel disease
Published
2019
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6. Use of corticosteroids and immunosuppressive drugs in inflammatory bowel disease: Clinical practice guidelines of the Italian Group for the Study of Inflammatory Bowel Disease

Author

Mario Cottone, Livia Biancone, Walter Fries, Marco Daperno, Anna Kohn, Fernando Rizzello, Vito Annese, Claudio Papi, Alessandro Armuzzi, Sandro Ardizzone, Paolo Gionchetti, Silvio Danese, Renata D'Incà, Ambrogio Orlando, Maurizio Vecchi, Fabiana Castiglione, Michele Comberlato, 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, Gionchetti, P, Rizzello, F, Annese, V, Armuzzi, A, Biancone, L, Castiglione, F, Comberlato, M, Cottone, M, Danese, S, Daperno, M, D'Inca, R, Fries, W, Kohn, A, Orlando, A, Papi, C, Vecchi, M, and Ardizzone, S

Subjects
medicine.medical_specialty, IBD, Disease, Guideline, Guidelines, Inflammatory bowel disease, Gastroenterology, Biological drugs, 03 medical and health sciences, 0302 clinical medicine, Adrenal Cortex Hormones, Internal medicine, Medical, medicine, Corticosteroid, Corticosteroids, Humans, In patient, 030212 general & internal medicine, Crohn's disease, Immunosuppressors, Ulcerative colitis, Hepatology, Societies, Medical, Settore MED/12 - Gastroenterologia, Ulcerative coliti, business.industry, Remission Induction, Inflammatory Bowel Diseases, medicine.disease, digestive system diseases, Clinical Practice, Italy, Immunosuppressor, Immunosuppressive Agents, 030211 gastroenterology & hepatology, business, Societies
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.

Published
2017

7. Patient and physician views on the quality of care for inflammatory bowel disease after one-year follow-up: Results from SOLUTION-2, a prospective IG-IBD study

Author

Claudio Camillo Cortelezzi, Michele Comberlato, Luisa Spina, Gaetano Inserra, A. Losco, D. Morganti, Renato Sablich, P. Politi, Luisa Guidi, Aurora Bortoli, Stefano Marconi, Marco Daperno, G. Grasso, Anna Kohn, Monica Milla, Giorgia Bodini, Luca Ferraris, and Sandro Ardizzone

Subjects
Adult, Male, medicine.medical_specialty, Longitudinal study, Adolescent, Inflammatory bowel disease, Quality of care, QUOTE-IBD, Hepatology, Gastroenterology, Psychological intervention, Young Adult, 03 medical and health sciences, Age Distribution, 0302 clinical medicine, Patient satisfaction, Physicians, Surveys and Questionnaires, Internal medicine, medicine, Humans, Longitudinal Studies, Prospective Studies, 030212 general & internal medicine, Sex Distribution, Young adult, Prospective cohort study, Aged, Quality of Health Care, Aged, 80 and over, business.industry, Middle Aged, Inflammatory Bowel Diseases, medicine.disease, Logistic Models, Italy, Patient Satisfaction, Cohort, Physical therapy, Female, 030211 gastroenterology & hepatology, business, Follow-Up Studies
Abstract

Background and aims Perception of quality of care is important in the management of patients with chronic diseases, particularly inflammatory bowel disease. Aims and methods This longitudinal study aimed to investigate variations of the Quality of Care through the Patients' Eyes (QUOTE-IBD) questionnaire scores one year after the basal evaluation in the Studio Osservazionale quaLita cUre malatTIe crOniche intestiNali (SOLUTION-1) study. Results Of the cohort of 992 patients, 936 were evaluable. The QUOTE-IBD score overcame satisfactory levels of more than the 80%, overall and in all subdomains except for the “Continuity of Care” sub-dimension (mean, 8.3; standard deviation, 1.49), scored satisfactory only by 34% of the patients. No significant changes in satisfaction were recorded overall, or considering patients subgroups. Significant differences were found at the end of the follow-up between physicians’ and patients’ perceptions of quality of care, with the former over-rating their performance in “Continuity of Cares” and under-rating “Costs”, “Competence”, and “Accessibility” sub-domains of the score (p Conclusion Perceived quality of care in a large cohort of Italian patients with inflammatory bowel disease remains unchanged after one-year follow-up and was not significantly affected by disease activity or therapeutic interventions. Differences between physicians’ and patients’ perceptions of quality of care should be taken into account.

Published
2017

8. Tu1938 Endoscopic Training Leads to a Significant Increase in Agreement of Endoscopic Scoring for Inflammatory Bowel Disease (IBD): Final Results of the Igibdendo Educational Project

Author

Luca Grassano, R. Cosintino, Roberta Pica, Ambrogio Orlando, Giovanni Lombardi, Marco Daperno, Livia Biancone, Andrea Bonanomi, Matteo Rabagliati, Fernando Rizzello, Alfredo Papa, Roberto Mangiarotti, Guido Pagana, Fabrizio Bossa, Mauro Gasparini, Renata D'Incà, and Michele Comberlato

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Gastroenterology, Medicine, business, medicine.disease, Inflammatory bowel disease, Endoscopic training
Published
2016
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9. Inter-observer agreement in endoscopic scoring systems: preliminary report of an ongoing study from the Italian Group for Inflammatory Bowel Disease (IG-IBD)

Author

Andrea Cassinotti, R. Cosintino, Roberta Pica, Renata D'Incà, Michele Comberlato, Marco Daperno, Fabrizio Bossa, Roberto Mangiarotti, Fernando Rizzello, Alfredo Papa, Livia Biancone, Ambrogio Orlando, Giovanni Lombardi, Andrea Bonanomi, Daperno M, Comberlato M, Bossa F, Biancone L, Bonanomi AG, Cassinotti A, Cosintino R, Lombardi G, Mangiarotti R, Papa A, Pica R, Rizzello F, D'Incà R, and Orlando A

Subjects
Male, medicine.medical_specialty, ENDOSCOPY, Intraclass correlation, Inter observer agreement, IBD, Disease, Inflammatory bowel disease, Gastroenterology, Severity of Illness Index, Endoscopy, Gastrointestinal, Inflammatory Bowel disease, Cohen's kappa, Crohn Disease, Preliminary report, Adrenal Cortex Hormones, Internal medicine, Surveys and Questionnaires, medicine, Humans, Observer Variation, Settore MED/12 - Gastroenterologia, Hepatology, business.industry, Data Collection, Settore MED/09 - MEDICINA INTERNA, Process Assessment, Health Care, medicine.disease, Inflammatory Bowel Diseases, Ulcerative colitis, Confidence interval, Italy, Colitis, Ulcerative, Female, business
Abstract

a b s t r a c t 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 sco- ring 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.

Published
2014

10. Prevention of post-operative recurrence of Crohn’s disease requires adequate mucosal concentration of mesalazine

Author

A Andreoli, Giancarlo Palumbo, Giacomo Carlo Sturniolo, Michele Comberlato, Giuseppe Frieri, M.T. Pimpo, Francesco Tonelli, Giovanni Corrao, Renzo Caprilli, and Annese

Subjects
medicine.medical_specialty, Crohn's disease, Hepatology, business.industry, Gastroenterology, Lumen (anatomy), Ileum, Anastomosis, medicine.disease, Ulcerative colitis, chemistry.chemical_compound, medicine.anatomical_structure, Mesalazine, chemistry, Sulfasalazine, Internal medicine, medicine, Pharmacology (medical), Complication, business, medicine.drug
Abstract

Background : Surgical resection of Crohn’s disease is followed by early recurrence in a high percentage of patients. Mesalazine has been shown to be effective in the prevention of post-operative recurrence, but some 50% of patients under treatment recur at 3 years of follow-up. Aim : To establish whether the mucosal concentration of mesalazine might affect the development of post-operative recurrence. Methods : Colon-ileoscopy was performed in 25 consecutive patients resected for Crohn’s disease. The mean time from surgery was 14 months. After the operation, all patients were taking oral mesalazine (Asacol, 2.4 g/day). Ten patients showed signs of endoscopic recurrence (apthae, ulcers, narrowing of the lumen) in the neoterminal ileum, five of whom also showed juxta-anastomotic colonic involvement. Fifteen patients were free of recurrence. At endoscopy, four biopsies were taken from the perianastomotic area (two specimens at the ileal site and two specimens at the colonic site of the anastomosis). The specimens were weighed and immediately frozen at −80 °C. Mesalazine concentration (ng/mg) was measured in tissue homogenates by high- performance liquid chromatography with electrochemical detection. Fisher’s exact test was used for the statistical analysis. Results : The mean value of mucosal mesalazine concentration, expressed as ng/mg of tissue, was significantly lower in patients with recurrence than in those without recurrence both in the ileum (mean ± s.d.: 21.6 ± 28.3 vs. 70.9 ± 47.4; P = 0.007) and in the colon (25.8 ± 26.4 vs. 60.3 ± 32.5; P = 0.010). Conclusions : The mucosal conentration of mesalazine in the juxta-anastomatic area is significantly lower in patients with recurrence than in those free of recurrence. These data could suggest an association between mucosal mesalazine concentrations and the clinical effectiveness of the drug.

Published
1999
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11. Tu1998 Effectiveness of a Training Program on Motivational Interviewing (MI) Skills Applied to Inflammatory Bowel Disease (IBD) Management

Author

Flavio Caprioli, Valerio Quercia, Salvatore Leone, Marco Daperno, Massimo Fantini, Michele Comberlato, and Filippo Mocciaro

Subjects
medicine.medical_specialty, Hepatology, business.industry, Gastroenterology, Motivational interviewing, medicine, Physical therapy, medicine.disease, Training program, business, Inflammatory bowel disease
Published
2016
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12. Sa1221 Increasing Interobserver Agreement on IBD Endoscopic Scoring Systems: Results From the IGIBDEndo Educational Program

Author

Renata D'Incà, Andrea Cassinotti, Michele Comberlato, Fernando Rizzello, Andrea Bonanomi, Roberto Mangiarotti, Fabrizio Bossa, Livia Biancone, Marco Daperno, Alessandro Armuzzi, R. Cosintino, Roberta Pica, Ambrogio Orlando, Alfredo Papa, and Giovanni Lombardi

Subjects
medicine.medical_specialty, Hepatology, business.industry, media_common.quotation_subject, Gastroenterology, medicine, Medical physics, business, Educational program, Agreement, media_common
Published
2014
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13. PC.01.8 INCREASING INTEROBSERVER AGREEMENT ON IBD ENDOSCOPIC SCORING SYSTEMS: RESULTS FROM THE IGIBDENDO EDUCATIONAL PROGRAM

Author

Roberto Mangiarotti, Simone Saibeni, Andrea Bonanomi, L. Biancone, R. Cosintino, A. Orlando, Michele Comberlato, Fabrizio Bossa, G. Lombardi, Renata D'Incà, Marco Daperno, A. Armuzzi, and Alfredo Papa

Subjects
medicine.medical_specialty, Hepatology, business.industry, Gastroenterology, medicine, Medical physics, business, Educational program
Published
2014
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14. P.05.1 QUALITY OF CARE IN INFLAMMATORY BOWEL DISEASE IN ITALY ACCORDING TO IBD CHARACTERISTICS: INITIAL RESULTS FROM SOLUTION TRIAL (AN ONGOING PROSPECTIVE IG-IBD STUDY)

Author

Gaetano Inserra, Stefano Marconi, A. Losco, Michele Comberlato, Silvio Danese, Anna Kohn, Luisa Guidi, P. Lecis, Sandro Ardizzone, Claudio Camillo Cortelezzi, Enrico Colombo, P. Politi, Marco Daperno, R. Sablich, and Aurora Bortoli

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Gastroenterology, medicine, Physical therapy, Quality of care, medicine.disease, business, Inflammatory bowel disease
Published
2012
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15. OC.12.2 PATIENTS' AND PHYSICIANS' VIEWS ON QUALITY OF CARE IN INFLAMMATORY BOWEL DISEASE: INITIAL RESULTS FROM AN ONGOING PROSPECTIVE IG-IBD STUDY

Author

Aurora Bortoli, Marco Daperno, Giovanni Casella, Patrizia Doldo, Anna Kohn, P. Politi, F. Boni, Fabiana Castiglione, Stefano Marconi, Fabrizio Bossa, D. Valpiani, Manuela Merli, Michele Comberlato, A. Orlando, and Renata D'Incà

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Family medicine, Gastroenterology, medicine, Quality of care, medicine.disease, business, Inflammatory bowel disease
Published
2012
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16. W1245 Successful Induction of Clinical Response and Remission with Certolizumab Pegol in Crohn's Disease Patients Who Are Primary Non-Responders or Intolerant to Infliximab: A Real Life Multi-Center Experience of Compassionate Use

Author

Luisa Guidi, Mario Cottone, Raffaella Pulitanò, Michele Comberlato, Maria Lia Scribano, Alberto Malesci, Marcello Vangeli, Cosimo Prantera, Filippo Mocciaro, Aldo Manca, Alessandro Armuzzi, and Silvio Danese

Subjects
medicine.medical_specialty, Crohn's disease, Hepatology, business.industry, Gastroenterology, Compassionate Use, medicine.disease, Infliximab, Non responders, Internal medicine, medicine, Physical therapy, Certolizumab pegol, business, medicine.drug
Published
2008
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17. OC3.11.4 SUCCESSFUL INDUCTION OF CLINICAL RESPONSE AND REMISSION WITH CERTOLIZUMAB PEGOL CROHN'S DISEASE PATIENTS: A MULTI-CENTER EXPERIENCE OF COMPASSIONATE USE

Author

Alberto Malesci, A. Manca, F. Mocciaro, Maria Lia Scribano, Michele Comberlato, Marcello Vangeli, Tommaso Stefanelli, R. Pulitano, Silvio Danese, Cosimo Prantera, A. Armuzzi, Mario Cottone, and Luisa Guidi

Subjects
Pediatrics, medicine.medical_specialty, Crohn's disease, Hepatology, business.industry, Gastroenterology, Medicine, Compassionate Use, Center (algebra and category theory), Certolizumab pegol, business, medicine.disease, medicine.drug
Published
2008
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18. Use of biosimilars in inflammatory bowel disease: Statements of the Italian Group for Inflammatory Bowel Disease

Author

Annese, V, Vecchi, M, on behalf of the Italian Group for the Study of, Ibd, Bossa, F, Calabrese, E, Daperno, M, Rizzello, F, Rispo, A, Saibeni, S, Armuzzi, A, Biancone, L, Castiglione, F, Comberlato, M, Cucchiara, S, Danese, S, D’Incà, R, Fiorino, G, Fries, W, Gionchetti, P, Kohn, A, Latella, Giovanni, Meucci, G, Orlando, A, Papi, C, Principi, B., M. Vecchi, V. Annese, behalf of the Italian Group for the Study of IBD, On, Bossa, IG IBD Governing B. o. a. r. d. Collaborators: F., Calabrese, E., Daperno, M., Rizzello, F., Rispo, A., Saibeni, S., Armuzzi, A., Biancone, L., Castiglione, F., Comberlato, M., Cucchiara, S., Danese, S., D'Incà, R., Gionata, Fiorino, Walter, Frie, Gionchetti, P., Kohn, A., Latella, G., Meucci, G., Orlando, A., Papi, C., Principi, B., Annese, V, Vecchi, M, Castiglione, Fabiana, on behalf of the Italian Group for the Study of, Ibd, IG IBD Governing, Board, Vito Annese, Maurizio Vecchi, on behalf of the Italian Group for the Study of IBD (IG-IBD) [.., Fabrizio Bossa, Emma Calabrese, Marco Daperno, Fernando Rizzello, Antonio Rispo, Simone Saibeni, Alessandro Armuzzi, Livia Biancone, Fabiana Castiglione, Michele Comberlato, Salvatore Cucchiara, Silvio Danese, Renata D’Incà, Gionata Fiorino, Walter Frie, Paolo Gionchetti, Anna Kohn, Giovanni Latella, Gimmy Meucci, Ambrogio Orlando, Claudio Papi, Beatrice Principi, and …]

Subjects
Adult, Male, medicine.medical_specialty, Settore MED/12 - GASTROENTEROLOGIA, Guidelines as Topic, Risk Assessment, Gastroenterology, Inflammatory bowel disease, Anti-TNFα, Gastrointestinal Agents, Internal medicine, medicine, Humans, Intensive care medicine, Biosimilar Pharmaceuticals, Drug Approval, Societies, Medical, Anti-TNFα, Biosimilars, Crohn's disease, Inflammatory bowel disease, Ulcerative colitis, Biosimilars, Ankylosing spondylitis, Crohn's disease, Gastrointestinal agent, Hepatology, business.industry, Biosimilar, Antibodies, Monoclonal, Inflammatory Bowel Diseases, medicine.disease, Ulcerative colitis, Infliximab, Treatment Outcome, Italy, Rheumatoid arthritis, Female, business, Follow-Up Studies, Forecasting, medicine.drug
Abstract

The introduction of biological therapies, particularly anti-TNFα agents, has revolutionized the management of inflammatory bowel disease in those cases which are refractory to conventional treatment; however these drugs are not risk-free and their use has substantially increased the cost of treatment. As marketing protection expires for original, first-generation biopharmaceuticals, lower-cost “copies” of these drugs produced by competitor companies—referred to as biosimilars—are already entering the market. In September 2013, the European Medicines Agency approved two infliximab biosimilars for treatment of adult and paediatric inflammatory bowel disease patients, a decision based largely on efficacy and safety data generated in studies of patients with ankylosing spondylitis and rheumatoid arthritis. For many clinicians, extrapolation practices and the general question of interchangeability between biosimilars and reference biologics are cause for concern. In the present paper, the Italian Group for inflammatory bowel disease presents its statements on these issues, with emphasis on the peculiar clinical characteristics of inflammatory bowel disease and the importance of providing physicians and patients with adequate information and guarantees on the safety and efficacy of these new drugs in the specific setting of inflammatory bowel disease.

Published
2014

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