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1. Effectiveness and safety of vedolizumab in a matched cohort of elderly and nonelderly patients with inflammatory bowel disease: the IG-IBD LIVE study

Author

Pugliese, D., Privitera, G., Crispino, F., Mezzina, N., Castiglione, F., Fiorino, G., Laterza, L., Viola, A., Bertani, L., Caprioli, F., Cappello, M., Barberio, B., Ricci, C., Balestrieri, P., Daperno, M., Pluchino, D., Rizzello, F., Scribano, M. L., Sablich, R., Pastorelli, L., Manguso, F., Variola, A., Di Sario, A., Grossi, L., Armuzzi, A., Ribaldone, D. G., Biscaglia, G., Buda, A., Mocci, G., Viscido, A., Di Paolo, M. C., Onali, S., Rodino, S., Coletta, M., Principi, M., Miranda, A., Amato, A., Bezzio, C., Petruzzellis, C., Mazzuoli, S., Festa, S., Sartini, A., Checchin, D., Fanigliulo, L., Gallina, S., Cesarini, M., Bodini, G., Stradella, D., Spagnuolo, R., Guidi, L., Savarino, E., Scrivo, B., Soru, P., Costa, F., Fries, W., Scaldaferri, F., Allocca, M., Pellegrini, L., Massari, A., Orlando, A., Pugliese D., Privitera G., Crispino F., Mezzina N., Castiglione F., Fiorino G., Laterza L., Viola A., Bertani L., Caprioli F., Cappello M., Barberio B., Ricci C., Balestrieri P., Daperno M., Pluchino D., Rizzello F., Scribano M.L., Sablich R., Pastorelli L., Manguso F., Variola A., Di Sario A., Grossi L., Armuzzi A., Ribaldone D.G., Biscaglia G., Buda A., Mocci G., Viscido A., Di Paolo M.C., Onali S., Rodino S., Coletta M., Principi M., Miranda A., Amato A., Bezzio C., Petruzzellis C., Mazzuoli S., Festa S., Sartini A., Checchin D., Fanigliulo L., Gallina S., Cesarini M., Bodini G., Stradella D., Spagnuolo R., Guidi L., Savarino E., Scrivo B., Soru P., Costa F., Fries W., Scaldaferri F., Allocca M., Pellegrini L., Massari A., and Orlando A.

Subjects
Crohn’s disease, Ulcerative, Antibodies, Monoclonal, Humanized, biologics (IBD), immunosuppression, ulcerative colitis, Aged, Chronic Disease, Colitis, Ulcerative, Crohn Disease, Humans, Prospective Studies, Retrospective Studies, Treatment Outcome, Tumor Necrosis Factor Inhibitors, Gastrointestinal Agents, Inflammatory Bowel Diseases, Antibodies, Monoclonal, Pharmacology (medical), Humanized, Settore MED/12 - Gastroenterologia, Hepatology, Gastroenterology, Colitis
Abstract

Background: Vedolizumab registration trials were the first to include elderly patients with moderate-to-severe ulcerative colitis (UC) or Crohn’s disease (CD), but few real-life data have been reported in this population. Aims: We investigated the effectiveness and safety of vedolizumab in matched cohorts of elderly and nonelderly UC and CD patients. Methods: The Long-term Italian Vedolizumab Effectiveness (LIVE) study is a retrospective-prospective study including UC and CD patients who started vedolizumab from April 2016 to June 2017. Elderly patients (≥65 years) were matched clinically 1:2 to nonelderly patients (18–64 years); the 2 groups were followed until drug discontinuation or June 2019. Results: The study included 198 elderly (108 UC, 90 CD) and 396 matched nonelderly patients (205 UC, 191 CD). Nonelderly UC patients had a significantly higher persistence on vedolizumab compared to elderly patients (67.6% vs. 51.4%, p=0.02). No significant difference in effectiveness was observed between elderly and nonelderly CD patients (59.4% vs. 52.4%, p=0.32). Age ≥65 years was associated with lower persistence in UC; for CD, previous exposure to anti-TNF-α agents, Charlson comorbidity index >2 and moderate-to-severe clinical activity at baseline were associated with lower persistence. There were recorded 130 adverse events, with comparable rates between the two groups. A Charlson comorbidity index >2 was associated with an increased risk of adverse events. Conclusion: Vedolizumab can be considered a safe option in elderly IBD patients. Its effectiveness in elderly UC patients may be reduced, while no age-dependent effect on effectiveness was observed in CD.

Published
2022

2. OP005 The PROSIT cohort of infliximab biosimilar in IBD: a prolonged follow-up on the efficacy and safety across Italy

Author

Guidi, L., Fiorino, G., Variola, A., Manetti, N., Fries, W., Rizzuto, G., Bossa, F., Cappello, M., Biancone, L., DʼIncà, R., Cantoro, L., Castiglione, F., Principi, M., Annunziata, M.L., Di Girolamo, M., Terpin, M.M., Cortelezzi, C.C., Costa, F., Amato, A., Di Sabatino, A., Saibeni, S., Meucci, G., Petruzzellis, C., Tari, R., Gugliemi, F.W., 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.

Published
2017
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3. The PROSit cohort of infliximab biosimilar in IBD: A prolonged follow-up on the effectiveness and safety across Italy

Author

Armuzzi, A. (ORCID:0000-0003-1572-0118), Fiorino, G., Variola, A., Manetti, N., Fries, W., Orlando, A., Maconi, G., Bossa, F., Cappello, M., Biancone, L., Cantoro, L., Costa, F., D'Inca, R., Lionetti, P., Principi, M., Castiglione, F., Annunziata, M. L., Di Sabatino, A., Di Girolamo, M., Terpin, M. M., Cortelezzi, C. C., Saibeni, S., Amato, A., Ardizzone, S., Guidi, L. (ORCID:0000-0003-3320-7094), Danese, S., Massella, A., Ventra, A., Rizzuto, G., Massari, A., Perri, F., Annese, V., Saettone, S., Tari, R., Petruzzellis, C., Meucci, G., Imperiali, G., Guglielmi, F. W., Mazzuoli, S., Caserta, L., Parodi, M. C., Colli, A., Ronchetti, A., Pugliese, D., Geccherle, A., Rogai, F., Milani, S., Renna, S., Cassinotti, A., Andriulli, A., Martino, G., Scrivo, B., Troncone, E., Kohn, A., Bertani, L., Lorenzon, G., Ghione, S., Nardone, O., Vecchi, M., Bertani, A., Bosani, M. A., Bezzio, C., Salerno, R., Armuzzi, A. (ORCID:0000-0003-1572-0118), Fiorino, G., Variola, A., Manetti, N., Fries, W., Orlando, A., Maconi, G., Bossa, F., Cappello, M., Biancone, L., Cantoro, L., Costa, F., D'Inca, R., Lionetti, P., Principi, M., Castiglione, F., Annunziata, M. L., Di Sabatino, A., Di Girolamo, M., Terpin, M. M., Cortelezzi, C. C., Saibeni, S., Amato, A., Ardizzone, S., Guidi, L. (ORCID:0000-0003-3320-7094), Danese, S., Massella, A., Ventra, A., Rizzuto, G., Massari, A., Perri, F., Annese, V., Saettone, S., Tari, R., Petruzzellis, C., Meucci, G., Imperiali, G., Guglielmi, F. W., Mazzuoli, S., Caserta, L., Parodi, M. C., Colli, A., Ronchetti, A., Pugliese, D., Geccherle, A., Rogai, F., Milani, S., Renna, S., Cassinotti, A., Andriulli, A., Martino, G., Scrivo, B., Troncone, E., Kohn, A., Bertani, L., Lorenzon, G., Ghione, S., Nardone, O., Vecchi, M., Bertani, A., Bosani, M. A., Bezzio, C., and Salerno, R.

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 naïve 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
2019

4. Prospective observational study on inflammatory bowel disease patients treated with infliximab biosimilars: preliminary results of the PROSIT-BIO cohort of the IG-IBD

Author

Fiorino, G., Manetti, N., Variola, A., Bossa, F., Rizzuto, G., Guidi, L., Maconi, G., Ghione, S., Cantoro, L., Lorenzon, G., Fries, W., Annunziata, M. L., Costa, F., Terpin, M. M., Principi, B., Cortelezzi, C., Biancone, L., Amato, A., Occhipinti, P., Mazzuoli, S., Ardizzone, S., Di Girolamo, M., Alvisi, P., Meucci, G., Caserta, L., Saibeni, S., Petruzzellis, C., Ronchetti, A., Cappello, M., Castiglione, F., Danese, S., Massella, A., Varvara, D., Orlando, A., Armuzzi, A., Massari, A., Lionetti, P., Kohn, A., Renata D'Incà, Vecchi, M., Bertani, L., Annese, V., Fiorino, G, Manetti, N, Variola, A, Bossa, F, Rizzuto, G, Guidi, L, Maconi, G, Ghione, S, Cantoro, L, Lorenzon, G, Fries, W, Annunziata, Ml, Costa, F, Terpin, Mm, Principi, B, Cortelezzi, C, Biancone, L, Amato, A, Occhipinti, P, Mazzuoli, S, Ardizzone, S, Di Girolamo, M, Alvisi, P, Meucci, G, Caserta, L, Saibeni, S, Petruzzellis, C, Ronchetti, A, Cappello, M, Castiglione, F, Danese, S, Massella, A, Varvara, D, Orlando, A, Armuzzi, A, Massari, A, Lionetti, P, Kohn, A, D'Inca, R, Vecchi, M, Bertani, L, and Annese, V

Published
2016

6. 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

7. 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

8. Insights into Mesalazine Use in Clinical Practice of Young Gastroenterologists.

Author

Nardone OM, Marasco G, Lopetuso LR, Mocci G, Pastorelli L, Petruzzellis C, Scaldaferri F, and On Behalf Of The Italian Association Of Young Gastroenterologist And Endoscopist Aggei

Abstract

Background: Mesalazine is among the medications most prescribed by gastroenterologists, with variable and controversial use in different settings. We aimed to explore the use of mesalazine in the clinical practice of young gastroenterologists., Methods: A web-based electronic survey was distributed to all participants of the National Meeting of the Italian Young Gastroenterologist and Endoscopist Association., Results: A total of 101 participants took part in the survey, with a majority (54.4%) being aged >30 years, 63.4% of whom were trainees in academic hospitals, and 69.3% of whom were involved in the clinical management of inflammatory bowel disease (IBD). While both non-dedicated and IBD physicians generally agreed on the appropriate dose of mesalazine for mild ulcerative colitis (UC), significant differences were observed between the two groups for moderate-severe ulcerative colitis (UC). Additionally, in IBD patients who were starting immuno-modulators and/or biologics, 80% of IBD-dedicated physicians continued to prescribe mesalazine, compared to 45.2% of non-dedicated physicians ( p = 0.002). Indeed, 48.4% of non-dedicated IBD physicians did not acknowledge mesalazine for colorectal cancer chemoprevention. With regards to Crohn's disease, it is mainly used by 30.1% of IBD physicians for preventing postoperative recurrence of Crohn's disease. Finally, 57.4% used mesalazine for symptomatic uncomplicated diverticular disease, and 84.2% did not recommend its use for irritable bowel syndrome., Conclusions: This survey showed heterogeneous behaviors in the daily use of mesalazine, mainly in the management of IBD. Educational programs and novel studies are needed to clarify its use.

Published
2023
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9. Serrated polyps: innocent or guilty?

Author

Mansilla-Vivar R, Petruzzellis C, Olivari N, Milluzzo SM, Grassano A, Cesari P, Zorzi F, and Spada C

Subjects
Colonoscopy, Humans, Hyperplasia, Adenoma pathology, Adenomatous Polyps diagnosis, Adenomatous Polyps etiology, Adenomatous Polyps pathology, Colonic Polyps diagnosis, Colonic Polyps etiology, Colorectal Neoplasms diagnosis, Colorectal Neoplasms etiology
Abstract

Serrated lesions represent a group of lesions with different genetic and biological features causing important clinical repercussions. Three types of serrated lesions are identified: hyperplastic, sessile adenomas (with and without dysplasia) and traditional serrated adenomas. Such lesions are now recognized as precancerous lesions.The carcinogenic process of serrated lesions follows a pathway including: alterations concerning activation of mitogen and protein kinase regulating the extracellular signal of other intracellular kinases (MAPK-ERK), inhibition of the apoptosis and hypermethylation of DNA and instability of microsatellites. Like for adenomatous polyps, the risk factors for serrated lesions are environmental factors, related to lifestyle and diet. The cancerogenic risk is increased by excessive alcohol consumption, obesity and poor intake of folate. When a high number of colorectal polyps with architecture serrated is diagnosed, it could be considered as serrated polyposis syndrome (SPS). According the most recent ESGE guidelines, the diagnostic criteria of the SPS, are: at least 5 polyps resected proximal to the sigmoid colon, 2 of which> 10 mm, or >20 serrated lesions of any size distributed in the entire colon. This condition presents a high risk for personal and/or familiar CRC, for this reason a regular screening colonoscopy should be performed in these patients and in their first-degree relatives.

Published
2021

10. Effects of SARS-CoV-2 emergency measures on high-risk lesions detection: a multicentre cross-sectional study.

Author

Furnari M, Eusebi LH, Savarino E, Petruzzellis C, Esposito G, Maida M, Ricciardiello L, Pecere S, Buda A, De Bona M, Spada C, Di Giulio E, Costamagna G, Boskoski I, and Giannini EG

Subjects
COVID-19 epidemiology, COVID-19 transmission, Cross-Sectional Studies, Digestive System Neoplasms epidemiology, Emergencies, Humans, Italy, Retrospective Studies, Time-to-Treatment, COVID-19 prevention & control, Delayed Diagnosis statistics & numerical data, Digestive System Neoplasms diagnosis, Endoscopy, Infection Control
Abstract

Competing Interests: Competing interests: Beyond the conduction of this study, IB declares to be: consultant for Apollo Endosurgery, Cook Medical and Boston Scientific; board member for Endo Tools; research grant recipient from Apollo Endosurgery; GC declares to be: consultant for and food and beverage compensation from Cook Medical, Boston Scientific and Olympus; ES declares to be: lecturer or consultant for Takeda, Janssen, Abbvie, MSD, Sofar, Malesci, Sandoz, Reckitt Benckiser and Medtronic; board member for Frasenius Kabi and BMS; research grant recipient from Unifarco, Sila and Sofar.

Published
2021
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