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1. Two-year effectiveness and safety of golimumab in ulcerative colitis: An IG-IBD study

Author

Fernando Rizzello, Antonio Ferronato, Luisa Moser, Stefano Festa, Chiara Ricci, Giorgia Bodini, Silvia Mazzuoli, Giuseppe Privitera, Francesca Rogai, R. Sablich, Angela Variola, Claudio Camillo Cortelezzi, Daniela Pugliese, Laurino Grossi, Maria Cappello, Lucrezia Laterza, Anna Viola, Maria Di Girolamo, Fabrizio Bossa, Giammarco Mocci, Antonino Carlo Privitera, Mariabeatrice Principi, Marco Daperno, Simone Saibeni, Rocco Spagnuolo, Mariangela Allocca, Greta Lorenzon, Sara Traini, Alessandro Armuzzi, G. Tapete, Filippo Mocciaro, and Pugliese D, Privitera G, Rogai F, Variola A, Viola A, Laterza L, Privitera AC, Allocca M, Bossa F, Cappello M, Daperno M, Lorenzon G, Mazzuoli S, Principi M, Sablich R, Moser L, Ferronato A, Traini S, Tapete G, Bodini G, Di Girolamo M, Grossi L, Mocci G, Rizzi C, Saibeni S, Festa S, Spagnuolo R, Cortelezzi CC, Mocciaro F, Rizzello F, Armuzzi A

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, naïve, Golimumab, Persistence (computer science), 03 medical and health sciences, Young Adult, 0302 clinical medicine, remission, Gastrointestinal Agents, Internal medicine, medicine, Humans, Prospective Studies, Aged, Retrospective Studies, ulcerative colitis, business.industry, Tumor Necrosis Factor-alpha, Inflammatory Bowel Disease, Gastroenterology, Antibodies, Monoclonal, persistence, Middle Aged, medicine.disease, Ulcerative colitis, Oncology, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Colitis, Ulcerative, Female, Original Article, business, medicine.drug, Follow-Up Studies, IBD Ulcerative colitis Golimumab TNF-inhibitors
Abstract

Background Few data exist regarding the long‐term effectiveness of golimumab in ulcerative colitis. No data have been reported on real‐world continuous clinical response. Objective This study aimed to describe the long‐term outcomes in a large cohort of patients on golimumab who had ulcerative colitis. Methods Consecutive patients with active ulcerative colitis, started on golimumab, were enrolled and prospectively followed up. The primary end point was to evaluate the long‐term persistence on golimumab therapy. Results A total of 173 patients with ulcerative colitis were studied. Of these, 79.2% were steroid dependent, and 46.3% were naïve to anti‐tumour necrosis factor alpha agents. The median duration of golimumab therapy was 52 weeks (range: 4–142 weeks). The cumulative probability of maintaining golimumab treatment was 47.3% and 22.5% at 54 and 108 weeks, respectively. Biological‐naïve status (odds ratio [OR] = 3.02, 95% confidence interval [CI]: 1.44–6.29; p = 0.003) and being able to discontinue steroids at Week 8 (OR = 3.32, 95% CI: 1.34–8.30; p = 0.010) and Week 14 (OR = 2.94, 95% CI: 1.08–8.02; p = 0.036) were associated with longer persistence on therapy. At Week 54, 65/124 (52.4%) postinduction responders were in continuous clinical response. A continuous clinical response was associated with a lower likelihood of golimumab discontinuation throughout the subsequent year of therapy (p

Published
2021

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

3. The PROSIT Cohort of Infliximab Biosimilar in IBD: A Prolonged Follow-up on the Effectiveness and Safety Across Italy

Author

A. Armuzzi, Silvio Danese, Maurizio Vecchi, Fabiana Castiglione, Gianmichele Meucci, Gionata Fiorino, M. Di Girolamo, Natalia Manetti, Sandro Ardizzone, Simone Saibeni, A. Ronchetti, Sara Renna, Giovanni Maconi, Agostino Colli, Giulia Rizzuto, Anna Kohn, Paolo Lionetti, Silvia Ghione, Angela Variola, Agostino Ventra, O. Nardone, Stefano Milani, Silvia Mazzuoli, Maria M. Terpin, Renata D'Incà, V. F. Annese, A. Di Sabatino, A. Orlando, Francesco Perri, Andrea Cassinotti, R. Salerno, Arnaldo Amato, Daniela Pugliese, Lorenzo Bertani, A. Geccherle, S. Saettone, Francesco William Guglielmi, Angelo Andriulli, Francesca Rogai, Fabrizio Bossa, Claudio Camillo Cortelezzi, L. Caserta, E. Troncone, Livia Biancone, Francesco Costa, R. Tari, M. Bosani, Alessandro Massari, Arianna Massella, Maria Cappello, B. Scrivo, Walter Fries, Maria Laura Annunziata, Mariabeatrice Principi, Cristina Bezzio, Laura Cantoro, M.C. Parodi, Gianni Imperiali, Carlo Petruzzellis, Greta Lorenzon, G. Martino, Luisa Guidi, A. Bertani, Armuzzi, Alessandro, Fiorino, Gionata, Variola, Angela, Manetti, Natalia, Fries, Walter, Orlando, Ambrogio, Maconi, Giovanni, Bossa, Fabrizio, Cappello, Maria, Biancone, Livia, Cantoro, Laura, Costa, Francesco, D'Incà, Renata, Lionetti, Paolo, Principi, Mariabeatrice, Castiglione, Fabiana, Annunziata, Maria L, Di Sabatino, Antonio, Di Girolamo, Maria, Terpin, Maria M, Cortelezzi, Claudio C, Saibeni, Simone, Amato, Arnaldo, Ardizzone, Sandro, Guidi, Luisa, Danese, Silvio, Massella, Arianna, Ventra, Agostino, Rizzuto, Giulia, Massari, Alessandro, Perri, Francesco, Annese, Vito, Guidi, L, Fiorino, G, Variola, A, Manetti, N, Fries, W, Rizzuto, G, Bossa, F, Cappello, M, Biancone, L, D'Inca, R, Cantoro, L, Castiglione, F, Principi, M, Annunziata, Ml, Di Girolamo, M, Terpin, Mm, Cortelezzi, Cc, Costa, F, Amato, A, Di Sabatino, A, Saibeni, S, Meucci, G, Petruzzellis, C, Tari, R, Gugliemi, Fw, Armuzzi, A, Danese, S, Geccherle, A, Rogai, F, Ventra, A, Orlando, A, Andriulli, A, Scrivo, B, Troncone, E, Caccaro, R, Kohn, A, Nardone, O, and Annese, V

Subjects
0301 basic medicine, Adult, Male, medicine.medical_specialty, Adolescent, Settore MED/12 - GASTROENTEROLOGIA, Biosimilar, Crohn's disease, CT-P13, Inflammatory bowel disease, Inflectra, Infliximab, Remsima, Ulcerative colitis, Antibodies, Monoclonal, Female, Follow-Up Studies, Gastrointestinal Agents, Humans, Inflammatory Bowel Diseases, Italy, Prognosis, Prospective Studies, Young Adult, Antibodies, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Monoclonal, medicine, Immunology and Allergy, Prospective cohort study, business.industry, ulcerative colitis, inflammatory bowel disease, biosimilar, Settore MED/09 - MEDICINA INTERNA, Gastroenterology, medicine.disease, 030104 developmental biology, Cohort, 030211 gastroenterology & hepatology, Calprotectin, business, Cohort study, medicine.drug
Abstract

BACKGROUND We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13. METHODS A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings. RESULTS Eight hundred ten patients with inflammatory bowel disease (IBD) (452 Crohn's disease [CD]) were enrolled. Four hundred fifty-nine patients were naive to anti-TNFα (group A), 196 had a previous exposure (group B), and the remaining 155 were switched to CT-P13 (group C). All patients were included in the safety evaluation with a mean follow-up of 345 ± 215 days and a total number of 6501 infusions. One hundred fifty-four SAEs were reported (19%), leading to cessation of the biosimilar in 103 subjects (12.7%). Infusion reactions were 71, leading to cessation of the biosimilar in 53 subjects (6.5%), being significantly more frequent in patients pre-exposed to anti-TNFα (P = 0.017). The efficacy of therapy was calculated in 754 IBD patients, with a mean follow-up of 329 ± 202 days. Forty-eight patients had a primary failure (6.4%), and 188 (25.6%) lost response during follow-up. Six hundred twenty-eight (364 CD) and 360 IBD patients (222 CD) completed the follow-up at 6 and 12 months, respectively. At 12 months, patients without loss of response were 71%, 64%. and 82% in groups A, B, and C, respectively (log rank P = 0.01). Clinical/endoscopic scores and inflammatory biomarkers dropped significantly in CD and UC patients (P = 0.01 and P < 0.0001) compared with baseline. CONCLUSIONS In this large prospective cohort, no further signals of difference in safety and effectiveness of CT-P13 in IBD has been observed.

Published
2018

4. The PROSIT-BIO Cohort: A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar

Author

Fiorino, Gionata, Manetti, Natalia, Armuzzi, Alessandro, Orlando, Ambrogio, Variola, Angela, Bonovas, Stefanos, Bossa, Fabrizio, Maconi, Giovanni, D'Incà, Renata, Lionetti, Paolo, Cantoro, Laura, Fries, Walter, Annunziata, Maria L., Costa, Francesco, Terpin, Maria M., Biancone, Livia, Cortelezzi, Claudio C., Amato, Arnaldo, Ardizzone, Sandro, Danese, Silvio, Guidi, Luisa, Rizzuto, Giulia, Massella, Arianna, Andriulli, Angelo, Massari, Alessandro, Lorenzon, Greta, Ghione, Silvia, Kohn, Anna, Ventra, Agostino, Annese, Vito, Principi, Mariabeatrice, Di Girolamo, Maria, Bertani, Angela, Saettone, Silvia, Tari, Roberto, Petruzzellis, Carlo, Guglielmi, Francesco W., Mazzuoli, Silvia, Cappello, Maria, Viola, Anna, Castiglione, Fabiana, Nardone, Olga, Di Sabatino, Antonio, Saibeni, Simone, Bezzio, Cristina, Caserta, Luigi, Parodi, Maria Caterina, Meucci, Gianmichele, Colli, Agostino, Ronchetti, Anna, Vecchi, Maurizio, Bertani, Lorenzo, Bosani, Matteo A., Tronconi, Edoardo, Imperiali, Gianni, Salerno, Raffaele, Rogai, Francesca, Milani, Stefano, Pugliese, Daniela, Renna, Sara, Geccherle, Andrea, Martino, Giuseppina, Cassinotti, Andrea, Fiorino, G, Manetti, N, Armuzzi, A, Orlando, A, Variola, A, Bonovas, S, Bossa, F, Maconi, G, D'Inca, R, Lionetti, P, Cantoro, L, Fries, W, Annunziata, Ml, Costa, F, Terpin, Mm, Biancone, L, Cortelezzi, Cc, Amato, A, Ardizzone, S, Danese, S, Guidi, L, Rizzuto, G, Massella, A, Andriulli, A, Massari, A, Lorenzon, G, Ghione, S, Kohn, A, Ventra, A, and Annese, V

Subjects
Male, Databases, Factual, Ulcerative, Rate ratio, Inflammatory bowel disease, 0302 clinical medicine, Crohn Disease, Monoclonal, Immunology and Allergy, Prospective Studies, Remsima, Prospective cohort study, Infusions, Intravenous, biosimilar, Crohn's disease, CT-P13, inflammatory bowel disease, Inflectra, Infliximab, ulcerative colitis, Gastroenterology, Adolescent, Adult, Antibodies, Monoclonal, Biosimilar Pharmaceuticals, Colitis, Ulcerative, Female, Gastrointestinal Agents, Humans, Treatment Outcome, Young Adult, Colitis, Ulcerative colitis, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Intravenous, Cohort study, medicine.drug, medicine.medical_specialty, Infusions, Crohn's disease, ulcerative colitis, inflammatory bowel disease, Infliximab, Remsima, Inflectra, biosimilar, CT-P13, Antibodies, 03 medical and health sciences, Databases, Internal medicine, medicine, Adverse effect, Factual, business.industry, Settore MED/09 - MEDICINA INTERNA, medicine.disease, business
Abstract

Background: Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn's disease. Methods: A prospective, multicenter, cohort study using a structured database. Results: Consecutive patients (313 Crohn's disease and 234 ulcerative colitis) were enrolled from 31 referral centers 311 patients were naive to anti-tumor necrosis factor alpha, 139 had a previous exposure to biologics, and the remaining 97 were switched to CT-P13 after a mean of 18 6 14 infusions of infliximab. The mean follow-up was 4.3 6 +/- 2.8 months, and the total follow-up time was 195 patient-years. After 2061 infusions, 66 serious adverse events were reported (12.1%), 38 (6.9%) of them were infusion-related reactions. The biosimilar had to be stopped in 29 (5.3%) cases for severe infusion reactions (8 naive, 19 previous exposed, and 2 switch), and in further 16 patients (2.9%) for other serious adverse events. Infusion reactions were significantly more frequent in patients pre-exposed to infliximab than to other anti-tumor necrosis factor alpha (incidence rate ratio = 2.82, 95% CI: 1.05-7.9). The efficacy of the biosimilar was evaluated in 434 patients who received treatment for at least 8 weeks, using time-to-event methods for censored observations: 35 patients were primary failures (8.1%). After further 8, 16, and 24 weeks, the efficacy estimations were 95.7%, 86.4%, and 73.7% for naive, 97.2%, 85.2%, and 62.2% for pre-exposed, and 94.5%, 90.8%, and 78.9% for switch, respectively (log-rank P = 0.64). Conclusions: Although no direct comparison was performed, preliminary data on efficacy and safety of CT-P13 were in line with those of infliximab.

Published
2017

5. A Prolonged Follow-Up on the Efficacy and Safety of Infliximab Biosimilar CT-P13 in IBD Across Italy: The Prosit Cohort

Author

Francesco William Guglielmi, Angela Variola, Arnaldo Amato, Angelo Andriulli, Mariabeatrice Principi, Maria M. Terpin, Francesca Rogai, Renata D'Incà, Silvio Danese, Maria Laura Annunziata, Fabrizio Bossa, Roberto Tari, Fabiana Castiglione, Laura Cantoro, Antonio Di Sabatino, Maria Di Girolamo, Alessandro Armuzzi, Claudio Camillo Cortelezzi, R. Caccaro, Natalia Manetti, Gionata Fiorino, Luisa Guidi, Carlo Petruzzellis, Anna Kohn, Walter Fries, Francesco Costa, Livia Biancone, Ambrogio Orlando, G. Meucci, Giulia Rizzuto, Simone Saibeni, Agostino Ventra, Edoardo Troncone, Maria Cappello, B. Scrivo, Andrea Geccherle, Daniela Pugliese, Olga Maria Nardone, Vito Annese, Armuzzi, A, Fiorino, G, Variola, A, Manetti, N, Fries, W, Rizzuto, G, Bossa, F, Cappello, M, Biancone, L, D'Inca, R, Cantoro, L, Castiglione, F, Principi, M, Annunziata, Ml, Di Girolamo, M, Terpin, Mm, Cortelezzi, Cc, Costa, F, Amato, A, Di Sabatino, A, Saibeni, S, Meucci, G, Petruzzellis, C, Tari, R, Guglielmi, Fw, Guidi, L, Danese, S, Rogai, F, Geccherle, A, Ventra, A, Orlando, A, Andriulli, A, Scrivo, B, Troncone, E, Caccaro, R, Kohn, A, Nardone, Om, Pugliese, D, and Annese, V

Subjects
0301 basic medicine, medicine.medical_specialty, Hepatology, business.industry, Gastroenterology, Biosimilar, Pharmacology, Infliximab, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, Cohort, medicine, business, medicine.drug
Published
2017
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