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1. Transition of inflammatory bowel disease patients from pediatric to adult care: an observational study on a joint-visits approach

Author

Antonio Corsello, Daniela Pugliese, Fiammetta Bracci, Daniela Knafelz, Bronislava Papadatou, Marina Aloi, Salvatore Cucchiara, Luisa Guidi, Antonio Gasbarrini, and Alessandro Armuzzi

Subjects
Transition, Pediatric IBD, Crohn’s disease, Ulcerative colitis, TRAQ, SIBDQ, Pediatrics, RJ1-570
Abstract

Abstract Background Transition from pediatric to adult care of patients affected by Inflammatory Bowel Disease (IBD) is a critical step that needs specific care and multidisciplinary involvement. The aim of our study was to evaluate the outcome of the transition process of a cohort of IBD patients, exploring their readiness and the possible impact on quality of life. Methods This observational study followed transitioned IBD patients from pediatric to adult care. Transition was carried-out through combined visits, jointly performed by the pediatrician and the adult gastroenterologist. Clinical data were collected before and after transition. A subgroup of patients was submitted to an anonymous online questionnaire of 38 items based on the validated questionnaires TRAQ and SIBDQ within the first 6 months from the beginning of the transition process. Results Eighty-two patients with IBD were enrolled, with a mean age at transition of 20.2±2.7 years. Before transition, 40.2% of patients already had major surgery and 64.6% started biologics. At transition, 24% of patients were in moderate to severe active phase of their disease and 40% of them had already been treated with ≥ 2 biologics. The mean score of the TRAQ questionnaires collected is 3.4±1.5 and the mean score of SIBDQ is 53.9±9.8. A significant association was found between a TRAQ mean score > 3 and a SIBDQ > 50 (p=0.0129). Overall, 75% of patients had a positive opinion of the transition model adopted. Conclusions A strong association has been found between TRAQ and SIBDQ questionnaires, showing how transition readiness has a direct impact on the quality of life of the young adult with IBD.

Published
2021
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2. Epidemiological trends of pediatric IBD in Italy: A 10-year analysis of the Italian society of pediatric gastroenterology, hepatology and nutrition registry

Author

Patrizia Alvisi, Flavio Labriola, Luca Scarallo, Paolo Gandullia, Daniela Knafelz, Matteo Bramuzzo, Giovanna Zuin, Maria Rosa Pastore, Maria Teresa Illiceto, Erasmo Miele, Francesco Graziano, Claudio Romano, Daniela Bartoletti, Salvatore Oliva, Serena Arrigo, Fiammetta Bracci, Sara Renzo, Anna Agrusti, Marina Aloi, Paolo Lionetti, Salvatore Accomando, Claudia Banzato, Graziano Barera, Marco Brunero, Pier Luigi Calvo, Angelo Campanozzi, Mara Cananzi, Mara Corpino, Rita Cozzali, Gianluigi De Angelis, Costantino De Giacomo, Dario Dilillo, Enrico Felici, Simona Gatti, Valentina Motta, Lorenzo Norsa, Paolo Maria Pavanello, Andrea Pession, Silvia Provera, Alberto Ravelli, Antonio Maria Ricci, Silvia Salvatore, Caterina Strisciuglio, Alvisi P., Labriola F., Scarallo L., Gandullia P., Knafelz D., Bramuzzo M., Zuin G., Pastore M.R., Illiceto M.T., Miele E., Graziano F., Romano C., Bartoletti D., Oliva S., Arrigo S., Bracci F., Renzo S., Agrusti A., Aloi M., Lionetti P., Accomando S., Banzato C., Barera G., Brunero M., Calvo P.L., Campanozzi A., Cananzi M., Corpino M., Cozzali R., De Angelis G., De Giacomo C., Dilillo D., Felici E., Gatti S., Motta V., Norsa L., Pavanello P.M., Pession A., Provera S., Ravelli A., Ricci A.M., Salvatore S., Strisciuglio C., Alvisi, P., Labriola, F., Scarallo, L., Gandullia, P., Knafelz, D., Bramuzzo, M., Zuin, G., Pastore, M. R., Illiceto, M. T., Miele, E., Graziano, F., Romano, C., Bartoletti, D., Oliva, S., Arrigo, S., Bracci, F., Renzo, S., Agrusti, A., Aloi, M., Lionetti, P., Accomando, S., Banzato, C., Barera, G., Brunero, M., Calvo, P. L., Campanozzi, A., Cananzi, M., Corpino, M., Cozzali, R., De Angelis, G., De Giacomo, C., Dilillo, D., Felici, E., Gatti, S., Motta, V., Norsa, L., Pavanello, P. M., Pession, A., Provera, S., Ravelli, A., Ricci, A. M., Salvatore, S., and Strisciuglio, C.

Subjects
Registrie, Delayed Diagnosis, Hepatology, Delayed Diagnosi, Gastroenterology, Pediatric IBD, Epidemiological trend, Inflammatory Bowel Diseases, Settore MED/38 - Pediatria Generale E Specialistica, Crohn Disease, Italy, Epidemiological trends, Humans, Colitis, Ulcerative, Registries, Child, Human
Abstract

Introduction: The present study aimed at evaluating Italian epidemiological trends of pediatric inflammatory bowel diseases (IBD) over the period 2009–2018. Materials and methods: Data from 1969 patients enrolled in the Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition Registry, by 49 pediatric IBD centers throughout the country, were analyzed, comparing three different time intervals (2009–2012, 2013–2015, 2016–2018). Results: The number of new IBD diagnoses ranged from 175 to 219 per year, evenly distributed over the examined period of time. From 2009 to 2018, the minimal incidence ranged from 1.59 to 2.04 /105 inhabitants aged < 18 years, with an overall slight predominance of ulcerative colitis (UC) over Crohn's disease (CD) (ratio: 1.1). Mean diagnostic delay was 6.8 months for CD and 4.1 months for UC, with a significant reduction for CD when comparing the three-time intervals (p =0.008). The most frequent disease locations according to the Paris classification were ileocolonic for CD (41.3%) and pancolitis for UC (54.6%). Conclusions: The minimal incidence rate in Italy seems to have stabilized over the last two decades, even if it has increased when compared to previous reports. UC is still slightly more prevalent than CD in our country. Diagnostic delay significantly decreased for CD, reflecting an improved diagnostic capacity.

Published
2022

3. 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

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