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1. Adalimumab Biosimilar GP2017 versus Adalimumab Originator in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study

Author

Giammarco Mocci, Giorgia Bodini, Leonardo Allegretta, Alessia Immacolata Cazzato, Stefania Chiri, Giovanni Aragona, Patrizia Perazzo, Antonio Ferronato, Maria Giovanna Graziani, Cristiano Pagnini, Costantino Zampaletta, Camilla Graziosi, Marcello Picchio, Walter Elisei, Giovanni Maconi, and Antonio Tursi

Subjects
adalimumab, biosimilar, GP2017, inflammatory bowel disease, Biology (General), QH301-705.5
Abstract

The approval of adalimumab (ADA) biosimilars for inflammatory bowel disease (IBD) has reduced the cost of treatment. While several ADA biosimilars are currently available, comparative data on the ADA biosimilar GP2017 (HyrimozTM) and its originator (HumiraTM) in IBD are lacking. We compared the efficacy and safety of GP2017 versus originator in IBD outpatients in an Italian real-life setting. This retrospective analysis enrolled consecutive IBD patients with complete clinical, laboratory, and endoscopic data. Clinical activity was assessed with the Mayo score in ulcerative colitis (UC) and the Harvey–Bradshaw Index in Crohn’s disease (CD). The primary endpoints were the induction of remission and the safety of GP2017 versus ADA originator. One hundred and thirty-four patients (30.6% with UC and 69.4% with CD, median age 38 years) were enrolled: 62 (46.3%) patients were treated with GP2017, and 72 (53.7%) with ADA originator; 118 (88.1%) patients were naïve to ADA. Clinical remission was obtained in 105 (78.4%) patients, during a median follow-up of 12 months, 82.3% and 75% in the GP2017 and ADA originator groups, respectively (p = 0.311). Treatment was well tolerated in both groups. This analysis of real-world data suggests that GP2017 and its originator are equivalent in terms of efficacy and safety in patients with IBD.

Published
2022
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2. Prognostic performance of the 'DICA' endoscopic classification and the 'CODA' score in predicting clinical outcomes of diverticular disease: an international, multicentre, prospective cohort study

Author

Antonio, Tursi, Giovanni, Brandimarte, Francesco, Di Mario, Walter, Elisei, Marcello, Picchio, Leonardo, Allegretta, Maria Laura, Annunziata, Mauro, Bafutto, Gabrio, Bassotti, Maria Antonietta, Bianco, Raffaele, Colucci, Rita, Conigliaro, Dan, Dumitrascu, Ricardo, Escalante, Luciano, Ferrini, Giacomo, Forti, Marilisa, Franceschi, Maria Giovanna, Graziani, Frank, Lammert, Giovanni, Latella, Giovanni, Maconi, Gerardo, Nardone, Lucia, Camara de Castro Oliveira, Enio, Chaves Oliveira, Alfredo, Papa, Savvas, Papagrigoriadis, Anna, Pietrzak, Stefano, Pontone, Tomas, Poskus, Giuseppe, Pranzo, Matthias Christian, Reichert, Stefano, Rodinò, Jaroslaw, Regula, Giuseppe, Scaccianoce, Franco, Scaldaferri, Roberto, Vassallo, Costantino, Zampaletta, Angelo, Zullo, Daniele, Piovani, Stefanos, Bonovas, Silvio, Danese, Paolo, Usai, Tursi, A., Brandimarte, G., Di Mario, F., Elisei, W., Picchio, M., Allegretta, L., Annunziata, M. L., Bafutto, M., Bassotti, G., Bianco, M. A., Colucci, R., Conigliaro, R., Dumitrascu, D., Escalante, R., Ferrini, L., Forti, G., Franceschi, M., Graziani, M. G., Lammert, F., Latella, G., Maconi, G., Nardone, G., Camara de Castro Oliveira, L., Chaves Oliveira, E., Papa, A., Papagrigoriadis, S., Pietrzak, A., Pontone, S., Poskus, T., Pranzo, G., Reichert, M. C., Rodino, S., Regula, J., Scaccianoce, G., Scaldaferri, F., Vassallo, R., Zampaletta, C., Zullo, A., Piovani, D., Bonovas, S., and Danese, S.

Subjects
medicine.medical_specialty, Prognosi, diverticular disease, Coda, Cohort Studies, Colonic, Internal medicine, Diverticulosis, Colonic, medicine, Humans, Prospective Studies, endoscopy, Prospective cohort study, Diverticuliti, Diverticulitis, Inflammation, Diverticular Diseases, Diverticulosis, medicine.diagnostic_test, business.industry, Colonoscopy, Prognosis, Diverticulum, Gastroenterology, medicine.disease, Endoscopy, Prospective Studie, Diverticular disease, Cohort Studie, business, Complication, Human, Cohort study
Abstract

ObjectiveTo investigate the predictive value of the Diverticular Inflammation and Complication Assessment (DICA) classification and to develop and validate a combined endoscopic-clinical score predicting clinical outcomes of diverticulosis, named Combined Overview on Diverticular Assessment (CODA).DesignA multicentre, prospective, international cohort study.Setting43 gastroenterology and endoscopy centres located in Europe and South America.Participants2215 patients (2198 completing the study) at the first diagnosis of diverticulosis/diverticular disease were enrolled. Patients were scored according to DICA classifications.InterventionsA 3-year follow-up was performed.Main outcome measuresTo predict the acute diverticulitis and the surgery according to DICA classification. Survival methods for censored observation were used to develop and validate a novel combined endoscopic-clinical score for predicting diverticulitis and surgery (CODA score).ResultsThe 3-year cumulative probability of diverticulitis and surgery was of 3.3% (95% CI 2.5% to 4.5%) in DICA 1, 11.6% (95% CI 9.2% to 14.5%) in DICA 2 and 22.0% (95% CI 17.2% to 28.0%) in DICA 3 (p10% and >2.5% in CODA C, respectively. The CODA score showed optimal discrimination capacity in predicting the risk of surgery in the development (c-statistic: 0.829; 95% CI 0.811 to 0.846) and validation cohort (c-statistic: 0.943; 95% CI 0.905 to 0.981).ConclusionsDICA classification has a significant role in predicting the risk of diverticulitis and surgery in patients with diverticulosis, which is significantly enhanced by the CODA score.Trial registration numberNCT02758860.

Published
2022

3. Infliximab biosimilar CT-P13 is effective and safe in treating inflammatory bowel diseases: a real-life multicenter, observational study in Italian primary inflammatory bowel disease centers

Author

Roberto Faggiani, Antonio Ferronato, Costantino Zampaletta, Leonardo Allegretta, Giuseppe Pranzo, S. Rodinò, A. Lauria, C. Ricciardelli, Giacomo Forti, Roberto Lorenzetti, Antonio Penna, Francesco Luzza, Ladislava Sebkova, Nicola Della Valle, Antonio Tursi, Marcello Picchio, Giammarco Mocci, Sara Gallina, Marilisa Franceschi, Tiziana Larussa, Simona Piergallini, and Walter Elisei

Subjects
Crohn’s disease, medicine.medical_specialty, Disease, Inflammatory bowel disease, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Interquartile range, Internal medicine, medicine, Clinical endpoint, Adverse effect, ulcerative colitis, Crohn's disease, business.industry, Biosimilar, medicine.disease, Ulcerative colitis, Infliximab, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Original Article, business, infliximab, CT-P13, medicine.drug
Abstract

Background The purpose of this study was to assess the efficacy and safety of biosimilar infliximab (IFX) CT-P13 in treating outpatients with inflammatory bowel disease (IBD) in Italian primary gastroenterology centers. Methods Consecutive IBD outpatients who completed the induction treatment were evaluated retrospectively. Clinical activity was scored according to the Mayo score for ulcerative colitis (UC) and to the Harvey-Bradshaw Index (HBI) for Crohn's disease (CD). The primary endpoint was the achievement of clinical remission (Mayo score ≤2 in UC and HBI ≤5 in CD). Secondary endpoints were clinical response to treatment, achievement of mucosal healing, and safety. Results One hundred forty-one patients (96 UC and 45 CD) were enrolled. Previous treatment with anti-tumor necrosis factor (TNF)α had been provided to 26% of UC patients and 28.9% of CD patients. Remission was achieved in 57.3% UC patients and in 75.6% CD patients during a median (interquartile range) follow up of 24 (6-24) months. Clinical response and mucosal healing were achieved in 87.5% and 75.0% of UC patients and in 84.4% and 84.2% of CD patients, respectively. By both univariate and multivariate analysis, age >40 years, presence of comorbidities, and naivety to anti-TNFα were significantly related to remission. Only one (0.7%) adverse event was reported in the CD group. Surgery was performed in 2.1% of UC patients and 6.7% of CD patients. Switching from IFX originator to biosimilar did not influence the maintenance of the clinical remission. Conclusion This study confirmed the long-term efficacy and safety of CT-P13 therapy in IBD, in both naive patients and those switching from IFX originator.

Published
2019

4. The 'DICA' endoscopic classification for diverticular disease of the colon shows a significant interobserver agreement among community endoscopists

Author

Antonio, Tursi, Giovanni, Brandimarte, Francesco di Mario, Gerardo, Nardone, Carmelo, Scarpignato, Picchio, Marcello, Walter, Elisei, Leonardo, Allegretta, Maria Laura Annunziata, Marco, Astegiano, Fabio, Baldi, Gabrio, Bassotti, Bianco, Maria Antonietta, Ginevra, Cambie, Erminio, Capezzuto, Caroli, Alessandro, Cassieri, Claudio, Antonio Salvatore Cicu, Enrico, Ciliberto, Raffaele, Colucci, Rita, Conigliaro, Alberto, Damiani, Patrizia De Colibus, Antonio De Medici, Giovanni De Pretis, Giuseppe Del Favero, Nicola Della Valle, Luigi Di Cesare, Roberto, Faggiani, Stefania, Febbraro, Luciano, Ferrini, Serafina, Fiorella, Giacomo, Forti, Marilisa, Franceschi, Andrea, Frunzio, Bastianello, Germana’, Gian Marco Giorgetti, Maurizio, Giovannone, Maria Giovanna Graziani, Maria Antonia Lai, Giovanni, Latella, Piera Giuseppina Lecca, Daniele, Lisi, Loris Riccardo Lopetuso, Giovanni, Maconi, Enzo Domenico Mandelli, Riccardo, Marmo, Attilio, Maurano, Lorella, Pallotta, Alfredo, Papa, Francesca, Parmeggiani, Penna, ANTONIO DOMENICO, Flavia, Pigo’, Pontone, Stefano, Giuseppe, Pranzo, Cristina, Ricciardelli, Giovanni Luca Rizzo, Stefano, Rodino’, Edoardo, Savarino, Giuseppe, Scaccianoce, Franco, Scaldaferri, Luigi, Schiffino, Chiara, Semeraro, Italo, Stroppa, Riccardo, Urgesi, Vassallo, Roberto, Alessandra, Violi, Costantino, Zampaletta, Maurizio, Zilli, Angelo, Zullo, Tursi, Antonio, Brandimarte, Giovanni, Carillo, MARIO FRANCESCO, Nardone, Gerardo, Scarpignato, Carmelo, Picchio, Marcello, Elisei, Walter, Allegretta, Leonardo, Annunziata, MARIA LAURA, Astegiano, Marco, Baldi, Fabio, Bassotti, Gabrio, Bianco, Maria Antonietta, Cambie, Ginevra, Capezzuto, Erminio, Caroli, Alessandro, Cassieri, Claudio, Cicu, Antonio Salvatore, Ciliberto, Enrico, Colucci, Raffaele, Conigliaro, Rita, Damiani, Alberto, De Colibus, Patrizia, De Medici, Antonio, De Pretis, Giovanni, Del Favero, Giuseppe, Valle, Nicola Della, Di Cesare, Luigi, Faggiani, Roberto, Febbraro, Stefania, Ferrini, Luciano, Fiorella, Serafina, Forti, Giacomo, Franceschi, Marilisa, Frunzio, Andrea, Germana’, Bastianello, Giorgetti, Gian Marco, Giovannone, Maurizio, Graziani, Maria Giovanna, Lai, Maria Antonia, Latella, Giovanni, Lecca, Piera Giuseppina, Lisi, Daniele, Lopetuso, Loris Riccardo, Maconi, Giovanni, Mandelli, Enzo Domenico, Marmo, Riccardo, Maurano, Attilio, Pallotta, Lorella, Papa, Alfredo, Parmeggiani, Francesca, Penna, Antonio, Pigo’, Flavia, Pontone, Stefano, Pranzo, Giuseppe, Ricciardelli, Cristina, Rizzo, Giovanni Luca, Rodino’, Stefano, Savarino, Edoardo, Scaccianoce, Giuseppe, Scaldaferri, Franco, Schiffino, Luigi, Semeraro, Chiara, Stroppa, Italo, Urgesi, Riccardo, Vassallo, Roberto, Violi, Alessandra, Zampaletta, Costantino, Zilli, Maurizio, and Zullo, Angelo

Subjects
medicine.medical_specialty, Scoring system, Colon, Settore MED/12 - GASTROENTEROLOGIA, agreement, colonoscopy, diverticular disease of the colon, endoscopic classification, Video Recording, Colonoscopy, Agreement, Diverticular disease of the colon, Endoscopic classification, Diverticulitis, Colonic, Diverticulosis, Colonic, Humans, Observer Variation, Predictive Value of Tests, Reproducibility of Results, Retrospective Studies, Severity of Illness Index, Terminology as Topic, Single item, Colonic, Internal medicine, medicine, Diverticulitis, Diverticulosis, medicine.diagnostic_test, business.industry, Gastroenterology, Expert group, Diverticular disease, Community setting, business, Kappa
Abstract

Background & Aim: An endoscopic classification of Diverticular Disease (DD), called DICA (Diverticular Inflammation and Complication Assessment) is currently available. It scores severity of the disease as DICA 1, DICA 2 and DICA 3. Our aim was to assess the agreement levels for this classification among an endoscopist community setting.Methods: A total of 66 endoscopists independently scored a set of DD endoscopic videos. The percentages of overall agreement on the DICA score and a free-marginal multirater kappa (κ) coefficient were reported as statistical measures of the inter-rater agreement.Results: The overall agreement levels were: 70.2% for DICA 1, 70.5% for DICA 2, 81.3% for DICA 3. The free marginal κ was: 0.553 for DICA 1, 0.558 for DICA 2, 0.719 for DICA 3. The agreement levels among the expert group were: 78.8% for DICA 1, 80.2% for DICA 2, 88.5% for DICA 3. The free marginal κ among the expert group were: 0.682 for DICA 1, 0.712 for DICA 2, 0.828 for DICA 3. The agreement of expert raters on the single item of the DICA classification was superior to the agreement of the overall group.Conclusions: The overall inter-rater agreement for DICA score in this study ranges from moderate to good, with a significant improvement in the expert subgroup of raters. Diverticular Inflammation and Complication Assessment is a simple and reproducible endoscopic scoring system.

Published
2019

5. Infliximab biosimilar CT-P13 is effective and safe in treating inflammatory bowel diseases: a real-life multicenter, observational study in Italian primary inflammatory bowel disease centers.

Author

Tursi A, Mocci G, Faggiani R, Allegretta L, Valle ND, Forti G, Franceschi M, Ferronato A, Gallina S, Larussa T, Luzza F, Lorenzetti R, Penna A, Rodino S, Sebkova L, Lauria A, Piergallini S, Pranzo G, Ricciardelli C, Zampaletta C, Elisei W, and Picchio M

Abstract

Background: The purpose of this study was to assess the efficacy and safety of biosimilar infliximab (IFX) CT-P13 in treating outpatients with inflammatory bowel disease (IBD) in Italian primary gastroenterology centers., Methods: Consecutive IBD outpatients who completed the induction treatment were evaluated retrospectively. Clinical activity was scored according to the Mayo score for ulcerative colitis (UC) and to the Harvey-Bradshaw Index (HBI) for Crohn's disease (CD). The primary endpoint was the achievement of clinical remission (Mayo score ≤2 in UC and HBI ≤5 in CD). Secondary endpoints were clinical response to treatment, achievement of mucosal healing, and safety., Results: One hundred forty-one patients (96 UC and 45 CD) were enrolled. Previous treatment with anti-tumor necrosis factor (TNF)α had been provided to 26% of UC patients and 28.9% of CD patients. Remission was achieved in 57.3% UC patients and in 75.6% CD patients during a median (interquartile range) follow up of 24 (6-24) months. Clinical response and mucosal healing were achieved in 87.5% and 75.0% of UC patients and in 84.4% and 84.2% of CD patients, respectively. By both univariate and multivariate analysis, age >40 years, presence of comorbidities, and naivety to anti-TNFα were significantly related to remission. Only one (0.7%) adverse event was reported in the CD group. Surgery was performed in 2.1% of UC patients and 6.7% of CD patients. Switching from IFX originator to biosimilar did not influence the maintenance of the clinical remission., Conclusion: This study confirmed the long-term efficacy and safety of CT-P13 therapy in IBD, in both naïve patients and those switching from IFX originator., Competing Interests: Conflict of Interest: None

Published
2019
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