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2 results on '"Maria Maddalena Terpin"'

1. Granulocyte-Monocyte Apheresis in Steroid-Dependent, Azathioprine-Intolerant/Resistant Moderate Ulcerative Colitis: A Prospective Multicenter Study

Author

Gianni Imperiali, Arnaldo Amato, Maria Maddalena Terpin, Ivo Beverina, Aurora Bortoli, Massimo Devani, Chiara Viganò, and Study Group on IBD (GSMII)

Subjects
Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Background. Granulocyte-monocyte apheresis has been proposed for the treatment of ulcerative colitis, although it is limited by costs and variability of results. Aim. To assess effectiveness of granulocyte-monocyte apheresis in patients with steroid-dependent, azathioprine-intolerant/resistant moderate ulcerative colitis. Methods. Consecutive patients fulfilling inclusion criteria were prospectively enrolled, treated by apheresis, and followed up for 12 months. The primary end point of the study was steroid-free clinical remission at 12 months, with no need for biologic therapy or surgery. Results. From January to December 2013, 33 patients were enrolled. After one year of follow-up, 12 (36%) patients had clinical remission, were steroid-free, and had no need for biological therapy or surgery; 3 (9%) cases showed a clinical response (but not clinical remission). Moreover, 12 (36%) patients required biologic therapy, 4 (12%) underwent colectomy, and in the other 2 (6%) a reduction, but not withdrawal, of steroid dose was achieved. Conclusions. Our study shows that a standard course of granulocyte-monocyte apheresis is associated with a 36% steroid-free clinical remission in patients with steroid-dependent, azathioprine-intolerant or resistant moderate ulcerative colitis. Apheresis might represent an alternative to biologic therapy or surgery in this specific subgroup of patients. This trial is registered with Clinicaltrial.gov NCT03189888.

Published
2017
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2. 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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