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1. 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

2. Separation of Low- Versus High-grade Crohn’s Disease-associated Small Bowel Carcinomas is Improved by Invasive Front Prognostic Marker Analysis

Author

Michele Martino, Catherine Klersy, Antonietta D'Errico, Giovanni Monteleone, G. Solina, Claudia Mescoli, Massimo Rugge, Livia Biancone, Gino Roberto Corazza, Francesco Tonelli, Flavio Caprioli, Gessica Lobascio, Fernando Rizzello, Augusto Orlandi, Vincenzo Villanacci, Stefano Ferrero, Roberto Caronna, Giovanni Arpa, Laura Cantoro, Antonio Di Sabatino, Roberto Fiocca, Enrico Solcia, Maria Cristina Macciomei, Fausto Sessa, Sandro Ardizzone, Claudio Papi, Paolo Giuffrida, Gianluca M. Sampietro, Deborah Malvi, Gilberto Poggioli, Federica Grillo, Gabriella Nesi, Barbara Oreggia, Marco Paulli, Giovanni Latella, Antonio Ciardi, Marco Vincenzo Lenti, Alessandro Vanoli, Ombretta Luinetti, Paolo Fociani, Maurizio Vecchi, Renata D'Incà, Aroldo Rizzo, Arpa, Giovanni, Grillo, Federica, Giuffrida, Paolo, Nesi, Gabriella, Klersy, Catherine, Mescoli, Claudia, Lenti, Marco Vincenzo, Lobascio, Gessica, Martino, Michele, Latella, Giovanni, Malvi, Deborah, Macciomei, Maria Cristina, Fociani, Paolo, Villanacci, Vincenzo, Rizzo, Aroldo, Ferrero, Stefano, Sessa, Fausto, Orlandi, Augusto, Monteleone, Giovanni, Biancone, Livia, Cantoro, Laura, Tonelli, Francesco, Ciardi, Antonio, Poggioli, Gilberto, Rizzello, Fernando, Ardizzone, Sandro, Sampietro, Gianluca, Solina, Gaspare, Oreggia, Barbara, Papi, Claudio, D'Incà, Renata, Vecchi, Maurizio, Caprioli, Flavio, Caronna, Roberto, D'Errico, Antonietta, Fiocca, Roberto, Rugge, Massimo, Corazza, Gino Roberto, Luinetti, Ombretta, Paulli, Marco, Solcia, Enrico, Di Sabatino, Antonio, and Vanoli, Alessandro

Subjects
Male, medicine.medical_specialty, Colorectal cancer, tumor budding, Settore MED/08 - Anatomia Patologica, Adenocarcinoma, adenocarcinoma, grading, poorly differentiated cluster, Gastroenterology, tumour budding, Diagnosis, Differential, Crohn Disease, Tumor budding, Internal medicine, Intestinal Neoplasms, Intestine, Small, Prevalence, medicine, Carcinoma, Humans, Neoplasm Invasiveness, Grading (tumors), Neoplasm Staging, Retrospective Studies, Cancer staging, Settore MED/12 - Gastroenterologia, Crohn's disease, business.industry, Patient Selection, General Medicine, Middle Aged, Prognosis, medicine.disease, digestive system diseases, Italy, Female, Histopathology, Neoplasm Grading, business
Abstract

Background and Aims Crohn’s disease-associated small bowel carcinoma is a rare event, usually reported to have a severe prognosis. However, in previous investigations we have found a minority of cases displaying a relatively favourable behaviour, thus outlining the need to improve the histopathological prediction of Crohn’s disease-associated small bowel carcinoma prognosis. Methods As in recent studies on colorectal cancer, a substantial improvement in prognostic evaluations has been provided by the histological analysis of the tumour invasive front; we therefore systematically analysed the tumour budding and poorly differentiated clusters in the invasive front of 47 Crohn’s disease-associated small bowel carcinomas collected through the Small Bowel Cancer Italian Consortium. Results Both tumour budding and poorly differentiated cluster analyses proved highly effective in prognostic evaluation of Crohn’s disease-associated small bowel carcinomas. In addition, they retained prognostic value when combined with two other parameters, i.e. glandular histology and stage I/II, both known to predict a relatively favourable small bowel carcinoma behaviour. In particular, association of tumour budding and poorly differentiated clusters in a combined invasive front score allowed identification of a minor subset of cancers [12/47, 25%] characterised by combined invasive front low grade coupled with a glandular histology and a low stage [I or II] and showing no cancer-related death during a median follow-up of 73.5 months. Conclusions The improved distinction of lower- from higher-grade Crohn’s disease-associated small bowel carcinomas provided by invasive front analysis should be of potential help in choosing appropriate therapy for these rare and frequently ominous neoplasms.

Published
2019
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3. PD-L1 in small bowel adenocarcinoma is associated with etiology and tumor-infiltrating lymphocytes, in addition to microsatellite instability

Author

Giovanni Arpa, Gabriella Nesi, Catherine Klersy, Carolina Ciacci, Antonietta D'Errico, Anna D'Odorico, Marco Paulli, Gino Roberto Corazza, Fausto Sessa, Valeria Barresi, Vittorio Perfetti, Federica Grillo, Vincenzo Canzonieri, Renato Cannizzaro, Roberto Fiocca, Stefano Ferrero, Luca Reggiani Bonetti, Deborah Malvi, Giovanni Latella, Paolo Pedrazzoli, Antonio Calabrò, Roberto De Giorgio, Alessandra Viglio, Fernando Rizzello, Flavio Caprioli, Roberto Caronna, Daniela Furlan, Antonino Giulio Giannone, Marco Silano, Maurizio Vecchi, Michele Martino, Francesco Tonelli, Laura Cantoro, Antonio Di Sabatino, Maria D'Armiento, Enrico Solcia, Paolo Giuffrida, Gianluca M. Sampietro, Ada Maria Florena, Giovanni Monteleone, Livia Biancone, Claudia Mescoli, G. Solina, Andrea Pietrabissa, Umberto Volta, Renata D'Incà, Ombretta Luinetti, Vincenzo Villanacci, Luca Elli, Massimo Rugge, Maria Cristina Macciomei, Paolo Fociani, Marco Astegiano, Rachele Ciccocioppo, Fabiana Zingone, Claudio Papi, Giacomo Caio, G. Sandri, Barbara Oreggia, Alessandro Vanoli, Aroldo Rizzo, Elena Biletta, Augusto Orlandi, Gilberto Poggioli, Antonio Ciardi, Marco Vincenzo Lenti, Paolo Usai, Erica Quaquarini, Donatella Santini, Sandro Ardizzone, Giuffrida, Paolo, Arpa, Giovanni, Grillo, Federica, Klersy, Catherine, Sampietro, Gianluca, Ardizzone, Sandro, Fociani, Paolo, Fiocca, Roberto, Latella, Giovanni, Sessa, Fausto, D'Errico, Antonietta, Malvi, Deborah, Mescoli, Claudia, Rugge, Massimo, Nesi, Gabriella, Ferrero, Stefano, Furlan, Daniela, Poggioli, Gilberto, Rizzello, Fernando, Macciomei, Maria C, Santini, Donatella, Volta, Umberto, De Giorgio, Roberto, Caio, Giacomo, Calabrò, Antonio, Ciacci, Carolina, D'Armiento, Maria, Rizzo, Aroldo, Solina, Gaspare, Martino, Michele, Tonelli, Francesco, Villanacci, Vincenzo, Cannizzaro, Renato, Canzonieri, Vincenzo, Florena, Ada M, Biancone, Livia, Monteleone, Giovanni, Caronna, Roberto, Ciardi, Antonio, Elli, Luca, Caprioli, Flavio, Vecchi, Maurizio, D'Incà, Renata, Zingone, Fabiana, D'Odorico, Anna, Lenti, Marco Vincenzo, Oreggia, Barbara, Reggiani Bonetti, Luca, Astegiano, Marco, Biletta, Elena, Cantoro, Laura, Giannone, Antonino G, Orlandi, Augusto, Papi, Claudio, Perfetti, Vittorio, Quaquarini, Erica, Sandri, Giancarlo, Silano, Marco, Usai, Paolo, Barresi, Valeria, Ciccocioppo, Rachele, Luinetti, Ombretta, Pedrazzoli, Paolo, Pietrabissa, Andrea, Viglio, Alessandra, Paulli, Marco, Corazza, Gino R, Solcia, Enrico, Vanoli, Alessandro, Di Sabatino, Antonio, Giuffrida P., Arpa G., Grillo F., Klersy C., Sampietro G., Ardizzone S., Fociani P., Fiocca R., Latella G., Sessa F., D'Errico A., Malvi D., Mescoli C., Rugge M., Nesi G., Ferrero S., Furlan D., Poggioli G., Rizzello F., Macciomei M.C., Santini D., Volta U., De Giorgio R., Caio G., Calabro A., Ciacci C., D'Armiento M., Rizzo A., Solina G., Martino M., Tonelli F., Villanacci V., Cannizzaro R., Canzonieri V., Florena A.M., Biancone L., Monteleone G., Caronna R., Ciardi A., Elli L., Caprioli F., Vecchi M., D'Inca R., Zingone F., D'Odorico A., Lenti M.V., Oreggia B., Reggiani Bonetti L., Astegiano M., Biletta E., Cantoro L., Giannone A.G., Orlandi A., Papi C., Perfetti V., Quaquarini E., Sandri G., Silano M., Usai P., Barresi V., Ciccocioppo R., Luinetti O., Pedrazzoli P., Pietrabissa A., Viglio A., Paulli M., Corazza G.R., Solcia E., Vanoli A., Di Sabatino A., Giuffrida, P., Arpa, G., Grillo, F., Klersy, C., Sampietro, G., Ardizzone, S., Fociani, P., Fiocca, R., Latella, G., Sessa, F., D'Errico, A., Malvi, D., Mescoli, C., Rugge, M., Nesi, G., Ferrero, S., Furlan, D., Poggioli, G., Rizzello, F., Macciomei, M. C., Santini, D., Volta, U., De Giorgio, R., Caio, G., Calabro, A., Ciacci, C., D'Armiento, M., Rizzo, A., Solina, G., Martino, M., Tonelli, F., Villanacci, V., Cannizzaro, R., Canzonieri, V., Florena, A. M., Biancone, L., Monteleone, G., Caronna, R., Ciardi, A., Elli, L., Caprioli, F., Vecchi, M., D'Inca, R., Zingone, F., D'Odorico, A., Lenti, M. V., Oreggia, B., Reggiani Bonetti, L., Astegiano, M., Biletta, E., Cantoro, L., Giannone, A. G., Orlandi, A., Papi, C., Perfetti, V., Quaquarini, E., Sandri, G., Silano, M., Usai, P., Barresi, V., Ciccocioppo, R., Luinetti, O., Pedrazzoli, P., Pietrabissa, A., Viglio, A., Paulli, M., Corazza, G. R., Solcia, E., Vanoli, A., Di Sabatino, A., and Vincenzo Lenti, Marco

Subjects
0301 basic medicine, Male, PD-L1 - small bowel adenocarcinoma - tumor-infiltrating lymphocytes - microsatellite instability, Pathology, BLOCKADE, Colorectal cancer, Lymphocyte, Small bowel adenocarcinoma, Gastroenterology, B7-H1 Antigen, Settore MED/12, 0302 clinical medicine, Crohn Disease, Intestine, Small, small bowel adenocarcinoma, Small bowel adenocarcinomas, MEDULLARY CARCINOMA, MORPHOLOGY, EXPRESSION, CANCER, biology, microsatelliteinstability, Middle Aged, medicine.anatomical_structure, Medullary carcinoma, tumor infiltrating lymphocytes, 030220 oncology & carcinogenesis, tumor-infiltrating lymphocytes, Adenocarcinoma, Female, Microsatellite Instability, PD-L1, Adult, medicine.medical_specialty, small bowel adenocarcinoma, tumor-infiltrating lymphocytes, microsatelliteinstability, Settore MED/08 - Anatomia Patologica, PD-L1, small bowel adenocarcinoma, NO, Pathology and Forensic Medicine, 03 medical and health sciences, Lymphocytes, Tumor-Infiltrating, Internal medicine, expression, Intestinal Neoplasms, Biomarkers, Tumor, medicine, Humans, PD-L1 in small bowel adenocarcinoma, MSI-H, Small bowel adenocarcinoma, expression, microsatellite instability, biomarkers, Aged, Retrospective Studies, business.industry, Tumor-infiltrating lymphocytes, biomarkers, Cancer, Correction, Microsatellite instability, medicine.disease, Celiac Disease, 030104 developmental biology, biology.protein, Etiology, business
Abstract

Small bowel adenocarcinomas (SBAs) are often associated with poor prognosis and have limited therapeutic options. Programmed cell death protein-1 (PD-1)/programmed cell death ligand 1 (PD-L1) pathway blockade is an effective treatment in many microsatellite instability-high (MSI-H) solid tumors. We aimed at investigating PD-L1 and PD-1 expression in non-hereditary, non-ampullary SBAs, associated with celiac disease (CeD), Crohn’s disease (CrD), or sporadic, recruited through the Small Bowel Cancer Italian Consortium. We assessed PD-L1 and PD-1 by immunohistochemistry in a series of 121 surgically resected SBAs, including 34 CeD-SBAs, 49 CrD-SBAs, and 38 sporadic SBAs. PD-L1 and PD-1 expression was correlated with several clinico-pathological features, such as the etiology, microsatellite instability status, and tumor-infiltrating lymphocyte (TIL) density. The prevalence of PD-L1 positivity according to combined positive score (CPS) was 26% in the whole cohort of SBAs, with significantly (p = 0.001) higher percentage (35%) in both CeD-SBAs and CrD-SBAs in comparison with sporadic SBAs (5%). CPS ≥ 1 SBAs were significantly (p = 0.013) more frequent in MSI-H cases (41%) than in non-MSI-H ones (18%); however, 15 CPS ≥ 1 microsatellite stable SBAs were also identified. CPS ≥ 1 SBAs showed higher TIL and PD-1+ immune cell density, more frequently medullary histotype, as well as a better outcome in comparison with CPS < 1 cases. This study demonstrates an increased proportion of PD-L1+ cases in both CeD-SBAs and CrD-SBAs in comparison with sporadic SBAs. In addition, the identification of a subset of PD-L1+ microsatellite stable SBAs supports the need to ascertain additional biomarkers of response to immune checkpoint inhibitors along with MSI-H.

Published
2020

4. 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

5. Disease patterns in late-onset ulcerative colitis: Results from the IG-IBD 'AGED study'

Author

Gionata Fiorino, Anna Viola, Maria Cappello, Vito Annese, Anna Kohn, R. Monterubbianesi, Renata D'Incà, Daniela Pugliese, Natalia Manetti, Fabrizio Bossa, Claudio Papi, L. Samperi, Gaetano Inserra, Francesca Calella, Mariabeatrice Principi, Giammarco Mocci, Giovanni Casella, Antonella Contaldo, Alessandro Armuzzi, Fabiana Castiglione, Antonino Carlo Privitera, Andrea Magarotto, Francesco Manguso, Annalisa Aratari, Stefanos Bonovas, Angela Alibrandi, Federica Furfaro, Flavio Caprioli, Matilde Rea, Laura Cantoro, Silvio Danese, Giuseppe Scalisi, Sandro Ardizzone, Simone Saibeni, Walter Fries, I. Frankovic, Fries, Walter, Viola, Anna, Manetti, Natalia, Frankovic, Iri, Pugliese, Daniela, Monterubbianesi, Rita, Scalisi, Giuseppe, Aratari, Annalisa, Cantoro, Laura, Cappello, Maria, Samperi, Leonardo, Saibeni, Simone, Casella, Giovanni, Mocci, Giammarco, Rea, Matilde, Furfaro, Federica, Contaldo, Antonella, Magarotto, Andrea, Calella, Francesca, Manguso, Francesco, Inserra, Gaetano, Privitera, Antonino C, Principi, Mariabeatrice, Castiglione, Fabiana, Caprioli, Flavio, Ardizzone, Sandro, Danese, Silvio, Papi, Claudio, Bossa, Fabrizio, Kohn, Anna, Armuzzi, Alessandro, D'Incà, Renata, Annese, Vito, Alibrandi, Angela, Bonovas, Stefano, Fiorino, Gionata, Fries, W, Viola, A, Manetti, N, Frankovic, I, Pugliese, D, Monterubbianesi, R, Scalisi, G, Aratari, A, Cantoro, L, Cappello, M, Samperi, L, Saibeni, S, Casella, G, Mocci, G, Rea, M, Furfaro, F, Contaldo, A, Magarotto, A, Calella, F, Manguso, F, Inserra, G, Privitera, Ac, Principi, M, Castiglionen, F, Caprioli, F, Ardizzone, S, Danese, S, Papi, C, Bossa, F, Kohn, A, Armuzzi, A, D'Inca, R, Annese, V, Alibrandi, A, Bonovas, S, and Fiorino, G

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Disease, Gastroenterology, Severity of Illness Index, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Risk Factors, Internal medicine, Severity of illness, medicine, Humans, Immunologic Factors, Young adult, Age of Onset, Steroid, Thiopurines, Colectomy, Outcome, Tumors, Aged, Retrospective Studies, Steroids, Surgery, Hepatology, Thiopurine, business.industry, Retrospective cohort study, Middle Aged, medicine.disease, Ulcerative colitis, Natural history, Logistic Models, Italy, Disease Presentation, 030220 oncology & carcinogenesis, Disease Progression, 030211 gastroenterology & hepatology, Colitis, Ulcerative, Female, Age of onset, business
Abstract

Background: Late-onset UC represents an important issue for the near future, but its outcomes and relative therapeutic strategies are yet poorly studied. Aim: To better define the natural history of late-onset ulcerative colitis. Methods: In a multicenter retrospective study, we investigated the disease presentation and course in the first 3 years in 1091 UC patients divided into 3 age-groups: diagnosis >65 years, 40-64 years, and

Published
2017

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