4 results on '"Cortelezzi, C. C."'
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2. Continuous clinical remission with biologics in ulcerative colitis: the 'AURORA' comparison study
- Author
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Cassinotti, A, Mezzina, N, De Silvestri, A, Di Paolo, D, Lenti, M, Bezzio, C, Stradella, D, Mauri, M, Zadro, V, Ricci, C, Casini, V, Radice, E, Massari, A, Maconi, G, Saibeni, S, Caprioli, F, Tari, R, Fichera, M, Cortelezzi, C, Parravicini, M, Tinelli, C, Testoni, P, Pace, F, Segato, S, Invernizzi, P, Occhipinti, P, Manes, G, Di Sabatino, A, Pastorelli, L, Vecchi, M, Ardizzone, S, Cassinotti A., Mezzina N., De Silvestri A., Di Paolo D., Lenti M. V., Bezzio C., Stradella D., Mauri M., Zadro V., Ricci C., Casini V., Radice E., Massari A., Maconi G., Saibeni S., Caprioli F., Tari R., Fichera M., Cortelezzi C. C., Parravicini M., Tinelli C., Testoni P. A., Pace F., Segato S., Invernizzi P., Occhipinti P., Manes G., Di Sabatino A., Pastorelli L., Vecchi M., Ardizzone S., Cassinotti, A, Mezzina, N, De Silvestri, A, Di Paolo, D, Lenti, M, Bezzio, C, Stradella, D, Mauri, M, Zadro, V, Ricci, C, Casini, V, Radice, E, Massari, A, Maconi, G, Saibeni, S, Caprioli, F, Tari, R, Fichera, M, Cortelezzi, C, Parravicini, M, Tinelli, C, Testoni, P, Pace, F, Segato, S, Invernizzi, P, Occhipinti, P, Manes, G, Di Sabatino, A, Pastorelli, L, Vecchi, M, Ardizzone, S, Cassinotti A., Mezzina N., De Silvestri A., Di Paolo D., Lenti M. V., Bezzio C., Stradella D., Mauri M., Zadro V., Ricci C., Casini V., Radice E., Massari A., Maconi G., Saibeni S., Caprioli F., Tari R., Fichera M., Cortelezzi C. C., Parravicini M., Tinelli C., Testoni P. A., Pace F., Segato S., Invernizzi P., Occhipinti P., Manes G., Di Sabatino A., Pastorelli L., Vecchi M., and Ardizzone S.
- Abstract
Objectives Comparative trials among biological drugs for the treatment of ulcerative colitis (UC) provided conflicting results. After patent expire of infliximab originator, adalimumab, infliximab biosimilar, golimumab and vedolizumab have been approved in Italy. We compared the efficacy of these four biologics in UC according to the concept of continuous clinical remission (CCR). Methods In a retrospective, multicentre study, all UC patients treated with adalimumab, infliximab biosimilar, golimumab or vedolizumab between 2014 and 2019 were included. All drugs were compared to each other according to the 1-year CCR rate, defined as Mayo partial score ≤2, with bleeding subscore = 0, without any relapse or optimization with dose escalation, topical treatments or steroid use after first clinical remission. Results Four-hundred sixteen patients (adalimumab = 90, infliximab biosimilar = 105, golimumab = 79, vedolizumab = 142) were included. CCR was achieved in similar percentages among the groups (33%, 37%, 28%, 37%, respectively). All drugs were equivalent in biologic-naive patients, while vedolizumab was better than a second anti-TNF in prior anti-TNF agent failures. No differences were found according to type of adverse events or severe adverse events. Conclusions Based on a strict definition of clinical remission, all biologics appear equally effective at 1 year. Changing to vedolizumab is more effective than switching to another anti-TNF in TNF failures.
- Published
- 2022
3. Therapies for inflammatory bowel disease do not pose additional risks for adverse outcomes of SARS-CoV 2 infection: an IG-IBD study
- Author
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Bezzio, C., Armuzzi, A., Furfaro, F., Ardizzone, S., Milla, M., Carparelli, S., Orlando, A., Caprioli, F. A., Castiglione, F., Vigano, C., Ribaldone, D. G., Zingone, F., Monterubbianesi, R., Imperatore, N., Festa, S., Daperno, M., Scucchi, L., Ferronato, A., Pastorelli, L., Balestrieri, P., Ricci, C., Cappello, M., Felice, C., Fiorino, G., Saibeni, S., Coppini, F., Alvisi, P., Gerardi, V., Variola, A., Mazzuoli, S., Lenti, M. V., Pugliese, D., Allocca, M., Ferretti, F., Roselli, J., Bossa, F., Giuliano, A., Piazza, N., Manes, G., Sartini, A., Buda, A., Micheli, F., Ciardo, V., Casella, G., Viscido, A., Bodini, G., Casini, V., Soriano, A., Amato, A., Grossi, L., Onali, S., Rottoli, M., Spagnuolo, R., Baroni, S., Cortelezzi, C. C., Baldoni, M., Vernero, M., Scaldaferri, F., Maconi, G., Guarino, A. D., Palermo, A., D'Inca, R., Scribano, M. L., Biancone, L., Carrozza, L., Ascolani, M., Costa, F., Di Sabatino, A., Zammarchi, I., Gottin, M., Conforti, F. S., Bezzio, Cristina, Armuzzi, Alessandro, Furfaro, Federica, Ardizzone, Sandro, Milla, Monica, Carparelli, Sonia, Orlando, Ambrogio, Caprioli, Flavio Andrea, Castiglione, Fabiana, Viganò, Chiara, Ribaldone, Davide Giuseppe, Zingone, Fabiana, Monterubbianesi, Rita, Imperatore, Nicola, Festa, Stefano, Daperno, Marco, Scucchi, Ludovica, Ferronato, Antonio, Pastorelli, Luca, Balestrieri, Paola, Ricci, Chiara, Cappello, Maria, Felice, Carla, Fiorino, Gionata, Saibeni, Simone, and Francesca Coppini, Patrizia Alvisi, Viviana Gerardi, Angela Variola, Silvia Mazzuoli, Marco Vincenzo Lenti, Daniela Pugliese, Mariangela Allocca, Francesca Ferretti, Jenny Roselli, Fabrizio Bossa, Alessandra Giuliano, Nicole Piazza, Gianpiero Manes, Alessandro Sartini, Andrea Buda, Federica Micheli, Valeria Ciardo, Giovanni Casella, Angelo Viscido, Giorgia Bodini, Valentina Casini, Alessandra Soriano, Arnaldo Amato, Laurino Grossi, Sara Onali, Matteo Rottoli, Rocco Spagnuolo, Stefania Baroni, Claudio Cortelezzi, Monia Baldoni, Marta Vernero, Franco Scaldaferri, Giovanni Maconi, Alessia Dalila Guarino, Andrea Palermo, Renata D'Incà, Maria Lia Scribano, Livia Biancone, Lucio Carrozza, Marta Ascolani, Francesco Costa, Antonio Di Sabatino, Irene Zammarchi, Matteo Gottin, Francesco Simone Conforti
- Subjects
medicine.medical_specialty ,Settore MED/12 - GASTROENTEROLOGIA ,IBD ,Population ,Ulcerative ,Disease ,Lower risk ,Asymptomatic ,Inflammatory bowel disease ,Aged ,Humans ,SARS-CoV-2 ,Tumor Necrosis Factor Inhibitors ,COVID-19 ,Colitis, Ulcerative ,Crohn Disease ,Inflammatory Bowel Diseases ,IBD Treatments and Sars‐cov‐2 Infection ,Internal medicine ,medicine ,biologics ,Pharmacology (medical) ,education ,therapy ,education.field_of_study ,Hepatology ,business.industry ,INFLAMMATORY BOWEL DISEASE ,Gastroenterology ,medicine.disease ,Colitis ,Ulcerative colitis ,Pneumonia ,Original Article ,medicine.symptom ,business ,Cohort study - Abstract
Summary Background Older age and comorbidities are the main risk factors for adverse COVID‐19 outcomes in patients with inflammatory bowel disease (IBD). The impact of IBD medications is still under investigation. Aims To assess risk factors for adverse outcomes of COVID‐19 in IBD patients and use the identified risk factors to build risk indices. Methods Observational cohort study. Univariable and multivariable logistic regression was used to identify risk factors associated with pneumonia, hospitalisation, need for ventilatory support, and death. Results Of the 937 patients (446 with ulcerative colitis [UC]) evaluated, 128 (13.7%) had asymptomatic SARS‐CoV‐2 infection, 664 (70.8%) had a favourable course, and 135 (15.5%) had moderate or severe COVID‐19. In UC patients, obesity, active disease and comorbidities were significantly associated with adverse outcomes. In patients with Crohn's disease (CD), age, obesity, comorbidities and an additional immune‐mediated inflammatory disease were identified as risk factors. These risk factors were incorporated into two indices to identify patients with UC or CD with a higher risk of adverse COVID‐19 outcomes. In multivariable analyses, no single IBD medication was associated with poor COVID‐19 outcomes, but anti‐TNF agents were associated with a lower risk of pneumonia in UC, and lower risks of hospitalisation and severe COVID‐19 in CD. Conclusion The course of COVID‐19 in patients with IBD is similar to that in the general population. IBD patients with active disease and comorbidities are at greater risk of adverse COVID‐19 outcomes. IBD medications do not pose additional risks. The risk indices may help to identify patients who should be prioritised for COVID‐19 re‐vaccination or for therapies for SARS‐CoV‐2 infection., The course of COVID‐19 in patients with IBD patients is similar to that in the general population. IBD patients with active disease and comorbidities are at greater risk of adverse COVID‐19 outcomes. IBD medications do not pose additional risks.
- Published
- 2021
4. The PROSit cohort of infliximab biosimilar in IBD: A prolonged follow-up on the effectiveness and safety across Italy
- Author
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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
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