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2. On-treatment serum albumin level can guide long-term treatment in patients with cirrhosis and uncomplicated ascites

Author

Caraceni, P, Tufoni, M, Zaccherini, G, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Simone, L, Svegliati-Baroni, G, Fagiuoli, S, Laffi, G, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Gasbarrini, A, De Marco, R, Piano, S, Nardelli, S, Elia, C, Roncadori, A, Baldassarre, M, Bernardi, M, Domenicali, M, Giannone, F, Antognoli, A, Merli, M, Pasquale, C, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Prestianni, L, Fidone, F, Maiorca, D, Rizzotto, A, Cappa, F, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Perricone, G, Alberti, A, Cesarini, L, Mazzarelli, C, Vangeli, M, Vigano, R, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Tortora, A, Leo, P, Angelico, M, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Cacciola, I, Elia, G, Negri, E, Dallio, M, Loguercio, C, Federico, A, Conte, D, Massironi, S, Natascia Celli, G, Rendina, M, Bringiotti, R, Castellaneta, N, Salerno, F, Boccia, S, Guarisco, R, Galioto, A, Cavallin, M, Andrealli, A, Caraceni P., Tufoni M., Zaccherini G., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F. G., Levantesi F., Airoldi A., Simone L., Svegliati-Baroni G., Fagiuoli S., Laffi G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Gasbarrini A., De Marco R., Piano S., Nardelli S., Elia C., Roncadori A., Baldassarre M., Bernardi M., Domenicali M., Giannone F. A., Antognoli A., Merli M., Pasquale C., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G. M., Prestianni L., Fidone F., Maiorca D., Rizzotto A., Cappa F. M., Lanzi A., Neri E., Visani A., Mastroianni A., Perricone G., Alberti A. B., Cesarini L., Mazzarelli C., Vangeli M., Vigano R., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Tortora A., Leo P., Angelico M., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Cacciola I., Elia G., Negri E., Dallio M., Loguercio C., Federico A., Conte D., Massironi S., Natascia Celli G. B., Rendina M., Bringiotti R., Castellaneta N. M., Salerno F., Boccia S., Guarisco R., Galioto A., Cavallin M., Andrealli A., Caraceni, P, Tufoni, M, Zaccherini, G, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Simone, L, Svegliati-Baroni, G, Fagiuoli, S, Laffi, G, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Gasbarrini, A, De Marco, R, Piano, S, Nardelli, S, Elia, C, Roncadori, A, Baldassarre, M, Bernardi, M, Domenicali, M, Giannone, F, Antognoli, A, Merli, M, Pasquale, C, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Prestianni, L, Fidone, F, Maiorca, D, Rizzotto, A, Cappa, F, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Perricone, G, Alberti, A, Cesarini, L, Mazzarelli, C, Vangeli, M, Vigano, R, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Tortora, A, Leo, P, Angelico, M, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Cacciola, I, Elia, G, Negri, E, Dallio, M, Loguercio, C, Federico, A, Conte, D, Massironi, S, Natascia Celli, G, Rendina, M, Bringiotti, R, Castellaneta, N, Salerno, F, Boccia, S, Guarisco, R, Galioto, A, Cavallin, M, Andrealli, A, Caraceni P., Tufoni M., Zaccherini G., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F. G., Levantesi F., Airoldi A., Simone L., Svegliati-Baroni G., Fagiuoli S., Laffi G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Gasbarrini A., De Marco R., Piano S., Nardelli S., Elia C., Roncadori A., Baldassarre M., Bernardi M., Domenicali M., Giannone F. A., Antognoli A., Merli M., Pasquale C., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G. M., Prestianni L., Fidone F., Maiorca D., Rizzotto A., Cappa F. M., Lanzi A., Neri E., Visani A., Mastroianni A., Perricone G., Alberti A. B., Cesarini L., Mazzarelli C., Vangeli M., Vigano R., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Tortora A., Leo P., Angelico M., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Cacciola I., Elia G., Negri E., Dallio M., Loguercio C., Federico A., Conte D., Massironi S., Natascia Celli G. B., Rendina M., Bringiotti R., Castellaneta N. M., Salerno F., Boccia S., Guarisco R., Galioto A., Cavallin M., and Andrealli A.

Abstract

Background & Aims: The ANSWER study reported that long-term albumin administration in patients with cirrhosis and uncomplicated ascites improves survival. During treatment, serum albumin increased within a month and remained stable thereafter. In this post hoc analysis, we aimed to determine whether on-treatment serum albumin levels could guide therapy. Methods: Logistic regression was used to assess the association between baseline serum albumin and mortality, as well as to determine on-treatment factors associated with mortality and to predict the achievement of a given on-treatment serum albumin level. Survival was assessed by Kaplan-Meier estimates and second-order polynomial regression. Patients whose on-treatment serum albumin remained below normal were compared with a subset of patients from the control arm matched by principal score. Results: Baseline serum albumin was closely associated with 18-month mortality in untreated patients; albumin treatment almost effaced this relationship. On-treatment serum albumin and MELD-Na at month 1 were the sole independent variables associated with mortality. Second-order polynomial regression revealed that survival improved in parallel with increased 1-month on-treatment serum albumin. Kaplan-Meier estimations showed that any value of 1-month on-treatment serum albumin (0.1 g/dl intervals) in the range 2.5–4.5 g/dl discriminated patient survival. In the normal range of serum albumin, the best discriminant value was 4.0 g/dl. Compared to untreated patients, survival even improved in patients whose on-treatment serum albumin remained below normal. Conclusion: Baseline serum albumin per se should not guide the decision to start albumin therapy. Conversely, 1-month on-treatment serum albumin levels are strongly associated with outcomes and could guide the use of albumin – 4.0 g/dl being the target threshold. However, even patients whose serum albumin remains below normal benefit from long-term albumin administration. Lay

Published
2021

3. Flavonoid Intake in Relation to Colorectal Cancer Risk and Blood Bacterial DNA

Author

Speciani, M, Cintolo, M, Marino, M, Oren, M, Fiori, F, Gargari, G, Riso, P, Ciafardini, C, Mascaretti, F, Parpinel, M, Airoldi, A, Vangeli, M, Leone, P, Cantù, P, Lagiou, P, Del Bo, C, Vecchi, M, Carnevali, P, Oreggia, B, Guglielmetti, S, Bonzi, R, Bonato, G, Ferraroni, M, La Vecchia, C, Penagini, R, Mutignani, M, Rossi, M, Speciani, MC, Speciani, M, Cintolo, M, Marino, M, Oren, M, Fiori, F, Gargari, G, Riso, P, Ciafardini, C, Mascaretti, F, Parpinel, M, Airoldi, A, Vangeli, M, Leone, P, Cantù, P, Lagiou, P, Del Bo, C, Vecchi, M, Carnevali, P, Oreggia, B, Guglielmetti, S, Bonzi, R, Bonato, G, Ferraroni, M, La Vecchia, C, Penagini, R, Mutignani, M, Rossi, M, and Speciani, MC

Abstract

Flavonoids have been inversely associated to colorectal cancer (CRC) and are plausible intermediaries for the relation among gut microbiome, intestinal permeability and CRC. We analyzed the relation of flavonoid intake with CRC and blood bacterial DNA. We conducted a case–control study in Italy involving 100 incident CRC cases and 200 controls. A valid and reproducible food–frequency questionnaire was used to assess dietary habits and to estimate six flavonoid subclass intakes. We applied qPCR and 16S rRNA gene profiling to assess blood bacterial DNA. We used multiple logistic regression to derive odds ratios (ORs) of CRC and Mann–Whitney and chi-–square tests to evaluate abundance and prevalence of operational taxonomic units (OTUs) according to flavonoid intakes. Inverse associations with CRC were found for anthocyanidins (OR for the highest versus the lowest tertile = 0.24, 95% confidence interval, CI = 0.11–0.52) and flavanones (OR = 0.18, 95% CI = 0.08–0.42). We found different abundance and prevalence according to anthocyanidin and flavanone intake for OTUs referring to Oligoflexales order, Diplorickettsiaceae family, Staphylococcus, Brevundimonas, Pelomonas and Escherischia–Shigella genera, and Flavobacterium and Legionella species. The study provides evidence to a protective effect of dietary anthocyanidins and flavanones on CRC and suggests an influence of flavonoids on blood bacterial DNA, possibly through intestinal permeability changes.

Published
2022

4. Flavonoid Intake in Relation to Colorectal Cancer Risk and Blood Bacterial DNA

Author

Speciani, M.C., Cintolo, M., Marino, M., Oren, M., Fiori, F., Gargari, G., Riso, P., Ciafardini, C., Mascaretti, F., Parpinel, M., Airoldi, A., Vangeli, M., Leone, P., Cantù, P., Lagiou, P., Del Bo', C., Vecchi, M., Carnevali, P., Oreggia, B., Guglielmetti, S., Bonzi, R., Bonato, G., Ferraroni, M., La Vecchia, C., Penagini, R., Mutignani, M., and Rossi, M.

Subjects
DNA, Bacterial, 16S, Settore MED/06 - Oncologia Medica, Settore MED/42 - Igiene Generale e Applicata, microbiome, colorectal cancer, flavanone, Settore MED/01 - Statistica Medica, Anthocyanins, Risk Factors, blood, RNA, Ribosomal, 16S, Humans, Flavonoids, Ribosomal, 16S rRNA gene profiling, anthocyanidin, flavonoids, Case-Control Studies, Diet, Flavanones, Colorectal Neoplasms, Bacterial, DNA, RNA
Abstract

Flavonoids have been inversely associated to colorectal cancer (CRC) and are plausible intermediaries for the relation among gut microbiome, intestinal permeability and CRC. We analyzed the relation of flavonoid intake with CRC and blood bacterial DNA. We conducted a case-control study in Italy involving 100 incident CRC cases and 200 controls. A valid and reproducible food-frequency questionnaire was used to assess dietary habits and to estimate six flavonoid subclass intakes. We applied qPCR and 16S rRNA gene profiling to assess blood bacterial DNA. We used multiple logistic regression to derive odds ratios (ORs) of CRC and Mann-Whitney and chi--square tests to evaluate abundance and prevalence of operational taxonomic units (OTUs) according to flavonoid intakes. Inverse associations with CRC were found for anthocyanidins (OR for the highest versus the lowest tertile = 0.24, 95% confidence interval, CI = 0.11-0.52) and flavanones (OR = 0.18, 95% CI = 0.08-0.42). We found different abundance and prevalence according to anthocyanidin and flavanone intake for OTUs referring to Oligoflexales order, Diplorickettsiaceae family

Published
2022

5. Blood Bacterial DNA Load and Profiling Differ in Colorectal Cancer Patients Compared to Tumor-Free Controls

Author

Mutignani, M, Penagini, R, Gargari, G, Guglielmetti, S, Cintolo, M, Airoldi, A, Leone, P, Carnevali, P, Ciafardini, C, Petrocelli, G, Mascaretti, F, Oreggia, B, Dioscoridi, L, Cavalcoli, F, Primignani, M, Pugliese, F, Bertuccio, P, Soru, P, Magistro, C, Ferrari, G, Speciani, M, Bonato, G, Bini, M, Cantù, P, Caprioli, F, Vangeli, M, Forti, E, Mazza, S, Tosetti, G, Bonzi, R, Vecchi, M, La Vecchia, C, Rossi, M, M. Mutignani, R. Penagini, G. Gargari, S. Guglielmetti, M. Cintolo, A. Airoldi, P. Leone, P. Carnevali, C. Ciafardini, G. Petrocelli, F. Mascaretti, B. Oreggia, L. Dioscoridi, F. Cavalcoli, M. Primignani, F. Pugliese, P. Bertuccio, P. Soru, C. Magistro, G. Ferrari, Michela C. Speciani, G. Bonato, M. Bini, P. Cantù, F. Caprioli, M. Vangeli, E. Forti, S. Mazza, G. Tosetti, R. Bonzi, M. Vecchi, C. La Vecchia, M. Rossi, Mutignani, M, Penagini, R, Gargari, G, Guglielmetti, S, Cintolo, M, Airoldi, A, Leone, P, Carnevali, P, Ciafardini, C, Petrocelli, G, Mascaretti, F, Oreggia, B, Dioscoridi, L, Cavalcoli, F, Primignani, M, Pugliese, F, Bertuccio, P, Soru, P, Magistro, C, Ferrari, G, Speciani, M, Bonato, G, Bini, M, Cantù, P, Caprioli, F, Vangeli, M, Forti, E, Mazza, S, Tosetti, G, Bonzi, R, Vecchi, M, La Vecchia, C, Rossi, M, M. Mutignani, R. Penagini, G. Gargari, S. Guglielmetti, M. Cintolo, A. Airoldi, P. Leone, P. Carnevali, C. Ciafardini, G. Petrocelli, F. Mascaretti, B. Oreggia, L. Dioscoridi, F. Cavalcoli, M. Primignani, F. Pugliese, P. Bertuccio, P. Soru, C. Magistro, G. Ferrari, Michela C. Speciani, G. Bonato, M. Bini, P. Cantù, F. Caprioli, M. Vangeli, E. Forti, S. Mazza, G. Tosetti, R. Bonzi, M. Vecchi, C. La Vecchia, and M. Rossi

Abstract

Inflammation and immunity are linked to intestinal adenoma (IA) and colorectal cancer (CRC) development. The gut microbiota is associated with CRC risk. Epithelial barrier dysfunction can occur, possibly leading to increased intestinal permeability in CRC patients. We conducted a case-control study including 100 incident histologically confirmed CRC cases, and 100 IA and 100 healthy subjects, matched to cases by center, sex and age. We performed 16S rRNA gene analysis of blood and applied conditional logistic regression. Further analyses were based on negative binomial distribution normalization and Random Forest algorithm. We found an overrepresentation of blood 16S rRNA gene copies in colon cancer as compared to tumor-free controls. For high levels of gene copies, community diversity was higher in colon cancer cases than controls. Bacterial taxa and operational taxonomic unit abundances were different between groups and were able to predict CRC with an accuracy of 0.70. Our data support the hypothesis of a higher passage of bacteria from gastrointestinal tract to bloodstream in colon cancer. This result can be applied on non-invasive diagnostic tests for colon cancer control.

Published
2021

6. Liver transplant recipients with Covid-19: results from an Italian multicenter cohort

Author

Mazzarelli, C., primary, Viganò, R., additional, Perricone, G., additional, Merli, M., additional, Pasulo, L., additional, Invernizzi, F., additional, Bhoori, S., additional, Morelli, M.C., additional, Patrono, D., additional, Sandro, S. Di, additional, Cortesi, P., additional, Angrisani, D., additional, De Nicola, S., additional, Vangeli, M., additional, and Belli, L.S., additional

Published
2021
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7. Liver transplant candidates and SARS-CoV-2 infection: Results from an Italian multicenter cohort

Author

Perricone, G., primary, Vigano, R., additional, Mazzarelli, C., additional, Travi, G., additional, Pasulo, L., additional, Invernizzi, F., additional, Morelli, M.C., additional, Patrono, D., additional, Sandro, S. Di, additional, De Simone, P., additional, Facchetti, R., additional, Angrisani, D., additional, De Nicola, S., additional, Airoldi, A., additional, Vangeli, M., additional, and Belli, e L.S., additional

Published
2021
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8. Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial

Author

Caraceni, P, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Boccia, S, Svegliati-Baroni, G, Fagiuoli, S, Romanelli, R, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Tortora, A, De Marco, R, Angelico, M, Cacciola, I, Elia, G, Federico, A, Massironi, S, Guarisco, R, Galioto, A, Ballardini, G, Rendina, M, Nardelli, S, Piano, S, Elia, C, Prestianni, L, Cappa, F, Cesarini, L, Simone, L, Pasquale, C, Cavallin, M, Andrealli, A, Fidone, F, Ruggeri, M, Roncadori, A, Baldassarre, M, Tufoni, M, Zaccherini, G, Bernardi, M, Domenicali, M, Giannone, F, Merli, M, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Maiorca, D, Rizzotto, A, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Alberti, A, Mazzarelli, C, Vangeli, M, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Laffi, G, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Gasbarrini, A, Leo, P, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Negri, E, Dallio, M, Loguercio, C, Conte, D, Celli, N, Bringiotti, R, Castellaneta, N, Salerno, F, Caraceni P., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F. G., Levantesi F., Airoldi A., Boccia S., Svegliati-Baroni G., Fagiuoli S., Romanelli R. G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Tortora A., De Marco R., Angelico M., Cacciola I., Elia G., Federico A., Massironi S., Guarisco R., Galioto A., Ballardini G., Rendina M., Nardelli S., Piano S., Elia C., Prestianni L., Cappa F. M., Cesarini L., Simone L., Pasquale C., Cavallin M., Andrealli A., Fidone F., Ruggeri M., Roncadori A., Baldassarre M., Tufoni M., Zaccherini G., Bernardi M., Domenicali M., Giannone F. A., Merli M., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G. M., Maiorca D., Rizzotto A., Lanzi A., Neri E., Visani A., Mastroianni A., Alberti A. B., Mazzarelli C., Vangeli M., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Laffi G., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Gasbarrini A., Leo P., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Negri E., Dallio M., Loguercio C., Conte D., Celli N., Bringiotti R., Castellaneta N. M., Salerno F., Caraceni, P, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Boccia, S, Svegliati-Baroni, G, Fagiuoli, S, Romanelli, R, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Tortora, A, De Marco, R, Angelico, M, Cacciola, I, Elia, G, Federico, A, Massironi, S, Guarisco, R, Galioto, A, Ballardini, G, Rendina, M, Nardelli, S, Piano, S, Elia, C, Prestianni, L, Cappa, F, Cesarini, L, Simone, L, Pasquale, C, Cavallin, M, Andrealli, A, Fidone, F, Ruggeri, M, Roncadori, A, Baldassarre, M, Tufoni, M, Zaccherini, G, Bernardi, M, Domenicali, M, Giannone, F, Merli, M, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Maiorca, D, Rizzotto, A, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Alberti, A, Mazzarelli, C, Vangeli, M, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Laffi, G, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Gasbarrini, A, Leo, P, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Negri, E, Dallio, M, Loguercio, C, Conte, D, Celli, N, Bringiotti, R, Castellaneta, N, Salerno, F, Caraceni P., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F. G., Levantesi F., Airoldi A., Boccia S., Svegliati-Baroni G., Fagiuoli S., Romanelli R. G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Tortora A., De Marco R., Angelico M., Cacciola I., Elia G., Federico A., Massironi S., Guarisco R., Galioto A., Ballardini G., Rendina M., Nardelli S., Piano S., Elia C., Prestianni L., Cappa F. M., Cesarini L., Simone L., Pasquale C., Cavallin M., Andrealli A., Fidone F., Ruggeri M., Roncadori A., Baldassarre M., Tufoni M., Zaccherini G., Bernardi M., Domenicali M., Giannone F. A., Merli M., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G. M., Maiorca D., Rizzotto A., Lanzi A., Neri E., Visani A., Mastroianni A., Alberti A. B., Mazzarelli C., Vangeli M., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Laffi G., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Gasbarrini A., Leo P., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Negri E., Dallio M., Loguercio C., Conte D., Celli N., Bringiotti R., Castellaneta N. M., and Salerno F.

Abstract

Background: Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients with decompensated cirrhosis. The human Albumin for the treatmeNt of aScites in patients With hEpatic ciRrhosis (ANSWER) study was designed to clarify this issue. Methods: We did an investigator-initiated multicentre randomised, parallel, open-label, pragmatic trial in 33 academic and non-academic Italian hospitals. We randomly assigned patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs (≥200 mg/day) and furosemide (≥25 mg/day) to receive either standard medical treatment (SMT) or SMT plus HA (40 g twice weekly for 2 weeks, and then 40 g weekly) for up to 18 months. The primary endpoint was 18-month mortality, evaluated as difference of events and analysis of survival time in patients included in the modified intention-to-treat and per-protocol populations. This study is registered with EudraCT, number 2008–000625–19, and ClinicalTrials.gov, number NCT01288794. Findings: From April 2, 2011, to May 27, 2015, 440 patients were randomly assigned and 431 were included in the modified intention-to-treat analysis. 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group. Overall 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meier estimates 77% vs 66%; p=0·028), resulting in a 38% reduction in the mortality hazard ratio (0·62 [95% CI 0·40–0·95]). 46 (22%) patients in the SMT group and 49 (22%) in the SMT plus HA group had grade 3–4 non-liver related adverse events. Interpretation: In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis. Funding: Italian Medicine Agency.

Published
2018

9. Sarcopenia in liver transplant candidates

Author

Mazzarelli, C., primary, Viganò, R., additional, Perricone, G., additional, Vangeli, M., additional, De Gasperi, A., additional, Mazza, E., additional, Prosperi, M., additional, Vanzulli, A., additional, Fusco, M., additional, Mariani, A., additional, Ferla, F., additional, De Carlis, L.G., additional, and Belli, L.S., additional

Published
2020
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14. The percentage of patients with HCV infection in need of a liver transplant is rapidly declining while their survival after transplantation is improving: A study based on European liver transplant registry

Author

Perricone, G., primary, Mazzarelli, C., additional, Viganò, R., additional, Duvoux, C., additional, Cortesi, P., additional, Facchetti, R., additional, Vangeli, M., additional, Karam, V., additional, Adam, R., additional, Strazzabosco, M., additional, and Belli, L.S., additional

Published
2018
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15. Transjugular intrahepatic portosystemic shunt is a safe and effective approach in cirrhotic patients with splanchnic vein thrombosis

Author

Airoldi, A., primary, De Nicola, S., additional, Perricone, G., additional, Vangeli, M., additional, Viganò, R., additional, Vercelli, R., additional, Migliorisi, C., additional, Solcia, M., additional, Barbosa, F., additional, Musca, F., additional, De Gasperi, A., additional, Belli, L.S., additional, and Rampoldi, A.G., additional

Published
2017
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16. Long-term albumin administration improves survival in patients with decompensated cirrhosis: final results of the “ANSWER” study

Author

Caraceni, P., primary, Riggio, O., additional, Angeli, P., additional, Alessandria, C., additional, Neri, S., additional, Foschi, F.G., additional, Levantesi, F., additional, Airoldi, A., additional, Boccia, S., additional, Baroni, G.S., additional, Fagiuoli, S., additional, Laffi, G., additional, Cozzolongo, R., additional, Di Marco, V., additional, Sangiovanni, V., additional, Morisco, F., additional, Toniutto, P., additional, Gasbarrini, A., additional, De Marco, R., additional, De Leonardis, F., additional, Cacciola, I., additional, Elia, G., additional, Federico, A., additional, Massironi, S., additional, Guarisco, R., additional, Marin, G., additional, Ballardini, G., additional, Rendina, M., additional, Nardelli, S., additional, Piano, S., additional, Elia, C., additional, Prestianni, L., additional, Neri, E., additional, Mastroianni, A., additional, Cesarini, L., additional, Simone, L., additional, Marzioni, M., additional, Magini, G., additional, Romanelli, R.G., additional, Zappimbulso, M., additional, Calvaruso, V., additional, Parrella, G., additional, Caporaso, N., additional, Pugliese, F., additional, Tortora, A., additional, Pasquale, C., additional, Cavallin, M., additional, Andrealli, A., additional, Fidone, F., additional, Lanzi, A., additional, Vangeli, M., additional, Salerno, F., additional, Roncadori, A., additional, Tufoni, M., additional, Zaccherini, G., additional, and Bernardi, M., additional

Published
2017
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17. GENOTYPE 2 AND 3 RECCURENT HEPATITIS C AFTER LIVER TRANSPLANTATION: EXCELLENT RESULTS WITH SUBOPTIMAL DOSES OF ANTIVIRAL THERAPY

Author

Vigano, R, Ponziani, F, Belli, L, Vangeli, M, Pinzello, G, Gasbarrini, A, Pasulo, L, De Martin, E, Burra, R, Pompili, M, Colledan, M, Cillo, U, Fagiuoli, S, Vigano R, Ponziani FR, Belli LS, Vangeli M, Pinzello G, Gasbarrini A, Pasulo L, De Martin E, Burra R, Pompili M, Colledan M, Cillo U, Fagiuoli S, Vigano, R, Ponziani, F, Belli, L, Vangeli, M, Pinzello, G, Gasbarrini, A, Pasulo, L, De Martin, E, Burra, R, Pompili, M, Colledan, M, Cillo, U, Fagiuoli, S, Vigano R, Ponziani FR, Belli LS, Vangeli M, Pinzello G, Gasbarrini A, Pasulo L, De Martin E, Burra R, Pompili M, Colledan M, Cillo U, and Fagiuoli S

Published
2009

18. GENOTYPE 2 AND 3 RECCURENT HEPATITIS C AFTER LIVER TRANSPLANTATION: EXCELLENT RESULTS WITH SUBOPTIMAL DOSES OF ANTIVIRAL THERAPY

Author

Vigano R, Ponziani FR, Belli LS, Vangeli M, Pinzello G, Gasbarrini A, Pasulo L, De Martin E, Burra P, Pompili M, Colledan M, Cillo U, Fagiuoli S, Vigano, R, Ponziani, F, Belli, L, Vangeli, M, Pinzello, G, Gasbarrini, A, Pasulo, L, De Martin, E, Burra, R, Pompili, M, Colledan, M, Cillo, U, Fagiuoli, S, and Burra, P

Subjects
Hepatology, Gastroenterology
Published
2009

20. Liver transplantation for HCV cirrhosis: Improved survival in recent years and increased severity of recurrent disease in female recipients: Results of a long term retrospective study

Author

Belli, L, Burroughs, A, Burra, P, Alberti, A, Samonakis, D, Cammà, C, De Carlis, L, Minola, E, Quaglia, A, Zavaglia, C, Vangeli, M, Patch, D, Dhillon, A, Cillo, U, Guido, M, Fagiuoli, S, Giacomoni, A, Slim, O, Airoldi, A, Boninsegna, S, Davidson, B, Rolles, K, Pinzello, G, Belli, Luca S., Burroughs, Andrew K., Burra, Patrizia, Alberti, Alberto B., Samonakis, Dimitrios, Cammà, Calogero, De Carlis, Luciano, Minola, Ernesto, Quaglia, Alberto, Zavaglia, Claudio, Vangeli, Marcello, Patch, David, Dhillon, Amar, Cillo, Umberto, Guido, Maria, Fagiuoli, Stefano, Giacomoni, Alessandro, Slim, Omar A., Airoldi, Aldo, Boninsegna, Sara, Davidson, Brian R., Rolles, Keith, Pinzello, Giovambattista, Belli, L, Burroughs, A, Burra, P, Alberti, A, Samonakis, D, Cammà, C, De Carlis, L, Minola, E, Quaglia, A, Zavaglia, C, Vangeli, M, Patch, D, Dhillon, A, Cillo, U, Guido, M, Fagiuoli, S, Giacomoni, A, Slim, O, Airoldi, A, Boninsegna, S, Davidson, B, Rolles, K, Pinzello, G, Belli, Luca S., Burroughs, Andrew K., Burra, Patrizia, Alberti, Alberto B., Samonakis, Dimitrios, Cammà, Calogero, De Carlis, Luciano, Minola, Ernesto, Quaglia, Alberto, Zavaglia, Claudio, Vangeli, Marcello, Patch, David, Dhillon, Amar, Cillo, Umberto, Guido, Maria, Fagiuoli, Stefano, Giacomoni, Alessandro, Slim, Omar A., Airoldi, Aldo, Boninsegna, Sara, Davidson, Brian R., Rolles, Keith, and Pinzello, Giovambattista

Abstract

In recent years, a worsening outcome of hepatitis C virus (HCV)-positive recipients and a faster progression of recurrent disease to overt cirrhosis have been reported. Our aims were to 1) assess patient survival and development of severe recurrent disease (Ishak fibrosis score > 3) in different transplant years; and 2) model the effects of pre- and post-liver transplantation (LT) variables on the severity of recurrent disease. A multicenter retrospective analysis was conducted on 502 consecutive HCV-positive transplant recipients between January 1990 and December 2002. Protocol liver biopsies were obtained at 1, 3, 5, 7, and 10 yr post-LT ir almost 90% of the patients. All 502 patients were included in the overall survival analysis, while only the 354 patients with a follow-up longer than 1 yr were considered for the analysis of predictors of disease progression. The overall Kaplan-Meier survival rates were 78.7%, 66.3%, and 58.6%, at 12, 60, and 120 months, respectively, and a trend for a better patient survival over the years emerged from all 3 centers. The cumulative probability of developing HCV-related recurrent severe fibrosis (Ishak score 4-6) in the cohort of 354 patients who survived at least 1 yr remained unchanged over the years. Multivariate analysis indicated that older donors (P = 0.0001) and female gender of recipient (P = 0.02) were the 2 major risk factors for the development of severe recurrent disease, while the adoption of antilymphocytic preparations was associated with a less aggressive course (P = 0.03). Two of these prognostic factors, donor age and recipient gender, are easily available before LT and their combination showed an important synergy, such that a female recipient not only had a much higher probability of severe recurrent disease than a male recipient but her risk increased with the increasing age of the donor, reaching almost 100% when the age of the donor was 60 or older. In conclusion, a trend for a better patient survival

Published
2007

21. 499 GENOTYPE 2 AND 3 RECCURENT HEPATITIS C AFTER LIVER TRANSPLANTATION: EXCELLENT RESULTS WITH SUBOPTIMAL DOSES OF ANTIVIRAL THERAPY

Author

Vigano, R., primary, Ponziani, F.R., additional, Belli, L.S., additional, Vangeli, M., additional, Pinzello, G., additional, Gasbarrini, A., additional, Pasulo, L., additional, De Martin, E., additional, Burra, P., additional, Pompili, M., additional, Colledan, M., additional, Cillo, U., additional, and Fagiuoli, S., additional

Published
2009
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22. Genotypes 2 and 3 recurrent hepatitis C after liver transplantation: Excellent results with suboptimal doses of antiviral therapy

Author

Viganò, R., primary, Ponziani, F.R., additional, Belli, L., additional, Vangeli, M., additional, Pinzello, G., additional, Gasbarrini, A., additional, Pasulo, L., additional, De Martin, E., additional, Burra, P., additional, Boninsegna, S., additional, Pompili, M., additional, Colledan, M., additional, Cillo, U., additional, and Fagiuoli, S., additional

Published
2009
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23. Combined therapy with interferon and low-dose ribavirin in posttransplantation recurrent hepatitis C: A pragmatic study

Author

Alberti, A, Belli, L, Airoldi, A, De Carlis, L, Rondinara, G, Minola, E, Vangeli, M, Cernuschi, A, D'Amico, M, Forti, D, Pinzello, G, Alberti, Alberto Battista, Belli, Luca Saverio, Airoldi, Aldo, De Carlis, Luciano, Rondinara, Gianfranco, Minola, Ernesto, Vangeli, Marcello, Cernuschi, Alessandra, D'Amico, Maria, Forti, Domenico, Pinzello, Giovambattista, Alberti, A, Belli, L, Airoldi, A, De Carlis, L, Rondinara, G, Minola, E, Vangeli, M, Cernuschi, A, D'Amico, M, Forti, D, Pinzello, G, Alberti, Alberto Battista, Belli, Luca Saverio, Airoldi, Aldo, De Carlis, Luciano, Rondinara, Gianfranco, Minola, Ernesto, Vangeli, Marcello, Cernuschi, Alessandra, D'Amico, Maria, Forti, Domenico, and Pinzello, Giovambattista

Abstract

Recurrent hepatitis C is a common problem after liver transplantation that can progress to liver cirrhosis of the graft. Preliminary reports of combination treatment with interferon (IFN) and ribavirin have been promising, but long-term follow-up data are not yet available. We report our experience with 1 year of combination therapy with IFN (3 million units thrice weekly) and low-dose ribavirin (600 mg/d), followed by long-term ribavirin monotherapy in 18 patients with moderate to severe recurrent hepatitis C and a median follow-up of 32 months after the completion of combined therapy. All patients were followed up clinically and histologically at regular intervals. Overall, in an intention-to-treat analysis, 15 patients had normal alanine aminotransferase levels (biochemical end-treatment response [ETR], 83%), and 8 patients were also hepatitis C virus RNA negative in serum (virological ETR, 44%) at the end of combined treatment. At last follow-up after the completion of combined therapy (median, 32 months; range, 18 to 73 months), 13 patients were biochemical responders (biochemical long term-sustained response [LT-SR], 72%), and 5 patients also maintained viral clearance (virological LT-SR, 27%). Comparison of liver biopsy specimens before and after 12 months of combined therapy showed improvement in grading scores of at least two points in the majority of the patients (73%). Notably, a trend toward fibrotic progression was only noted in nonresponders. Regarding side effects, despite the low dose of ribavirn, almost half the patients developed hemolytic anemia requiring dose reductions. In addition, long-term ribavirin monotherapy was not associated with iron accumulation. We conclude that combined therapy with low-dose ribavirin followed by long-term ribavirin monotherapy can be recommended because it favorably modifies the natural history of recurrent hepatitis C in most patients and possibly halts histological disease progression without causing iron accumula

Published
2001

24. OC3.11.4 SUCCESSFUL INDUCTION OF CLINICAL RESPONSE AND REMISSION WITH CERTOLIZUMAB PEGOL CROHN'S DISEASE PATIENTS: A MULTI-CENTER EXPERIENCE OF COMPASSIONATE USE

Author

Danese, S., primary, Mocciaro, F., additional, Guidi, L., additional, Scribano, M.L., additional, Comberlato, M., additional, Vangeli, M., additional, Stefanelli, T., additional, Pulitano, R., additional, Manca, A., additional, Armuzzi, A., additional, Malesci, A., additional, Prantera, C., additional, and Cottone, M., additional

Published
2008
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25. Neuropeptide Y plasma levels and immunological changes during academic stress

Author

Guidi, Luisa, Tricerri, A, Vangeli, M, Frasca, D, Riccardo Errani, A, Di Giovanni, A, Antico, L, Menini, E, Sciamanna, V, Magnavita, Nicola, Doria, G, Bartoloni, Carlo, Guidi, L (ORCID:0000-0003-3320-7094), Magnavita, N (ORCID:0000-0002-0988-7344), Bartoloni, C, Guidi, Luisa, Tricerri, A, Vangeli, M, Frasca, D, Riccardo Errani, A, Di Giovanni, A, Antico, L, Menini, E, Sciamanna, V, Magnavita, Nicola, Doria, G, Bartoloni, Carlo, Guidi, L (ORCID:0000-0003-3320-7094), Magnavita, N (ORCID:0000-0002-0988-7344), and Bartoloni, C

Abstract

Academic stress is a good model of psychological stress in humans for studying psychoneuroimmune correlations. We looked for correlations between psychological scores, immune tests and plasma levels of cortisol and neuropeptide Y (NPY). A group of medical students were evaluated at the beginning of the academic year (Baseline) and the day before an examination (Stress). They underwent evaluation by The Profile of Mood States (POMS), The Malaise Inventory, The Self Efficacy Scale and A Global Assessment of Recent Stress (GARS). The lymphocyte subsets, the lymphocyte proliferative response and the cytokine production were also evaluated. We detected modifications of some psychological test scores between the Baseline and Stress evaluation, a significant reduction of lymphocyte proliferation, IL-2 production and percentage of the lymphocyte CD19, and an increase in plasma cortisol levels during stress. The lymphocyte proliferation negatively correlated with the POMS score as well as the percentage of CD16+ cells with NPY plasma levels. NPY levels were not different from Baseline. The emotional and mood states seem to influence immunity.

Published
1999

27. Lack of a strong association between HLA class II, tumour necrosis factor and transporter associated with antigen processing gene polymorphisms and virological response to alpha-interferon treatment in patients with chronic hepatitis C

Author

Airoldi, A., primary, Zavaglia, C., additional, Silini, E., additional, Tinelli, C., additional, Martinetti, M., additional, Asti, M., additional, Rossini, A., additional, Vangeli, M., additional, Salvaneschi, L., additional, and Pinzello, G., additional

Published
2004
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34. Characteristics of Gastric-Vein Lymphocytes with Regard to the Immune Response to Helicobacter pylori.

Author

Tricerri, A., Guidi, L., Frasca, D., Costanzo, M., Errani, A. R., Riccioni, M. E., Barattini, P., Vangeli, M., Bartoloni, C., Coppola, R., Doria, G., and Gasbarrini, G.

Subjects
T cells, CYTOKINES, HELICOBACTER pylori, SECRETION
Abstract

Background: Between peripheral blood and tissue-infiltrating lymphocytes there is an intermediate compartment, the blood of the organ-draining vessels, which could show unusual features. The aim of the present study was to analyse the characteristics of the lymphocytes from the stomach-draining vessels and the cytokine secretion by these lymphocytes. The CagA-mediated lymphocyte activation in Helicobacter pylori-infected subjects and the humoral response to this antigen were evaluated and correlated with clinical data. Methods: We studied lymphocyte proliferation either with mitogens or with the CagA antigen and cytokine production and IgG anti-CagA by means of an enzyme-linked immunosorbent assay in peripheral blood and gastric-vein blood obtained during surgical intervention. Results: We showed higher proliferative response and cytokine production in lymphocytes from the gastric vein. The mitogenic response to the CagA antigen was highly specific but poorly sensitive for the H. pylori infection in both the compartments. The overall cytokine profile in our patients affected by non-ulcer disease was of the Th0 type. Conclusions: Gastric-vein-derived lymphocytes seem to show unusual features, as they behave like peripheral blood lymphocytes but show higher responses to all the tested stimuli. It is possible that the interaction of the lymphocytes with the mucosal environment could activate the synthetic mechanisms, making the cells more `responsive' to the stimulation. The CagA antigen is able to induce a specific T-lymphocyte response and is therefore a valid candidate antigen for the development of a vaccine. [ABSTRACT FROM AUTHOR]

Published
1999
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35. Psychoneuroimmunology and aging.

Author

Guidi, Luisa, Tricerri, Augusto, Frasca, Daniela, Vangeli, Marcello, Errani, Andrea R., Bartoloni, Carlo, Guidi, L, Tricerri, A, Frasca, D, Vangeli, M, Errani, A R, and Bartoloni, C

Subjects
PSYCHONEUROENDOCRINOLOGY, IMMUNE system, LYMPHOCYTES, CENTRAL nervous system, OLDER people, PSYCHOLOGICAL aspects of aging, AGING, IMMUNITY, PSYCHONEUROIMMUNOLOGY, PSYCHOLOGICAL stress
Abstract

Background: The senescence of the immune system is a complex phenomenon, characterized by impairment of several lymphocyte activities and generally considered a state of immune dysregulation. Aging is a condition associated with many social changes likely to induce psychological stress, which is often perceived as uncontrollable and can lead, in some cases, to clinically relevant depression. In the recent years a growing interest has been raised for the study of bidirectional interactions between the central nervous system and the immunological network (psychoneuroimmunology).Objective and Methods: We analyzed the possibility that chronic psychological distress and depression could worsen some immune functions in the aged. We postulate the neuroendocrine mechanisms of psychoimmune interaction, analyzing both the human and animal studies focused on aging.Results: The data from the literature reviewed suggest a significant impact of affective disorders on immune functions in the elderly subjects. This psychoimmune imbalance appears particularly important when the studies are carried out in otherwise healthy aged people.Conclusions: Here we reviewed the relationships between psychological stress and depression and immunological functions, with particular regard to those aspects pertinent to the aging process. The clinical relevance of these interactions remains to be elucidated, but the high frequency in the aged of autoimmune, infectious, and neoplastic diseases suggests to focus on the psychoneuroimmune interactions in the old age. We also propose some outlines for future studies concerning psychoneuroimmunology and aging. [ABSTRACT FROM AUTHOR]

Published
1998
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42. On-treatment serum albumin level can guide long-term treatment in patients with cirrhosis and uncomplicated ascites

Author

Alessandro Federico, M. Colpani, Paolo Caraceni, Marco Domenicali, Manuel Tufoni, L. Simone, A Alberti, Giovanni Raimondo, A. Risso, Antonietta Sticca, Salvatore Piano, Anna Visani, Francesco Salerno, Giacomo Laffi, Piera Rossi, Paolo Angeli, F. Fidone, Pierluigi Toniutto, Vincenza Calvaruso, Silvia Nardelli, Aldo Airoldi, Sara Massironi, Stefania Gioia, A. Roncadori, Marco Marzioni, Nicola Caporaso, N.M. Castellaneta, Stefano Fagiuoli, Francesco Giuseppe Foschi, Raffaele Cozzolongo, Maria Rendina, Irene Cacciola, Oliviero Riggio, Sergio Neri, Raffaella Viganò, Ferdinando Giannone, Chiara Mazzarelli, Maria Marsico, Giovanni Parrella, Riccardo Guarisco, Chiara Elia, F. Levantesi, M. Cavallin, Alida Andrealli, A. Pecchioli, Loredana Prestianni, Rosanna De Marco, T Gabbani, Elga Neri, S. Boccia, Arianna Lanzi, Giacomo Zaccherini, Marcello Dallio, Giovanni Perricone, Giorgio Ballardini Natascia Celli, Francesco Auriemma, Federica Mirici Cappa, Agnese Antognoli, Annalisa Tortora, Gianfranco Elia, R. Bringiotti, Francesco De Leonardis, Marcello Vangeli, Agostino Rizzotto, Dario Conte, Manuela Merli, Francesca Capretti, Mauro Bernardi, Chiara Pasquale, Pietro Leo, D. Maiorca, M. Zappimbulso, Filomena Morisco, Vincenzo Sangiovanni, Maurizio Baldassarre, Lucia Cesarini, Gianluca Svegliati-Baroni, Maria Guarino, Carmelina Loguercio, Alessandra Galioto, Antonio Mastroianni, Giorgio Maria Saracco, Antonio Gasbarrini, G. Magini, Alba Kostandini, Carlo Alessandria, Josè Petruzzi, Vito Di Marco, Silvano Fasolato, Elisa Negri, Fabio Pugliese, Mario Angelico, Daniela Campion, Caraceni P., Tufoni M., Zaccherini G., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F.G., Levantesi F., Airoldi A., Simone L., Svegliati-Baroni G., Fagiuoli S., Laffi G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Gasbarrini A., De Marco R., Piano S., Nardelli S., Elia C., Roncadori A., Baldassarre M., Bernardi M., Domenicali M., Giannone F.A., Antognoli A., Merli M., Pasquale C., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G.M., Prestianni L., Fidone F., Maiorca D., Rizzotto A., Cappa F.M., Lanzi A., Neri E., Visani A., Mastroianni A., Perricone G., Alberti A.B., Cesarini L., Mazzarelli C., Vangeli M., Vigano R., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Tortora A., Leo P., Angelico M., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Cacciola I., Elia G., Negri E., Dallio M., Loguercio C., Federico A., Conte D., Massironi S., Natascia Celli G.B., Rendina M., Bringiotti R., Castellaneta N.M., Salerno F., Boccia S., Guarisco R., Galioto A., Cavallin M., Andrealli A., Caraceni, P., Tufoni, M., Zaccherini, G., Riggio, O., Angeli, P., Alessandria, C., Neri, S., Foschi, F. G., Levantesi, F., Airoldi, A., Simone, L., Svegliati-Baroni, G., Fagiuoli, S., Laffi, G., Cozzolongo, R., Di Marco, V., Sangiovanni, V., Morisco, F., Toniutto, P., Gasbarrini, A., De Marco, R., Piano, S., Nardelli, S., Elia, C., Roncadori, A., Baldassarre, M., Bernardi, M., Domenicali, M., Giannone, F. A., Antognoli, A., Merli, M., Pasquale, C., Gioia, S., Fasolato, S., Sticca, A., Campion, D., Risso, A., Saracco, G. M., Prestianni, L., Fidone, F., Maiorca, D., Rizzotto, A., Cappa, F. M., Lanzi, A., Neri, E., Visani, A., Mastroianni, A., Perricone, G., Alberti, A. B., Cesarini, L., Mazzarelli, C., Vangeli, M., Vigano, R., Marzioni, M., Capretti, F., Kostandini, A., Magini, G., Colpani, M., Gabbani, T., Marsico, M., Zappimbulso, M., Petruzzi, J., Calvaruso, V., Parrella, G., Caporaso, N., Auriemma, F., Guarino, M., Pugliese, F., Tortora, A., Leo, P., Angelico, M., De Leonardis, F., Pecchioli, A., Rossi, P., Raimondo, G., Cacciola, I., Elia, G., Negri, E., Dallio, M., Loguercio, C., Federico, A., Conte, D., Massironi, S., Natascia Celli, G. B., Rendina, M., Bringiotti, R., Castellaneta, N. M., Salerno, F., Boccia, S., Guarisco, R., Galioto, A., Cavallin, M., Andrealli, A., Caraceni, P, Tufoni, M, Zaccherini, G, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Simone, L, Svegliati-Baroni, G, Fagiuoli, S, Laffi, G, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Gasbarrini, A, De Marco, R, Piano, S, Nardelli, S, Elia, C, Roncadori, A, Baldassarre, M, Bernardi, M, Domenicali, M, Giannone, F, Antognoli, A, Merli, M, Pasquale, C, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Prestianni, L, Fidone, F, Maiorca, D, Rizzotto, A, Cappa, F, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Perricone, G, Alberti, A, Cesarini, L, Mazzarelli, C, Vangeli, M, Vigano, R, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Tortora, A, Leo, P, Angelico, M, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Cacciola, I, Elia, G, Negri, E, Dallio, M, Loguercio, C, Federico, A, Conte, D, Massironi, S, Natascia Celli, G, Rendina, M, Bringiotti, R, Castellaneta, N, Salerno, F, Boccia, S, Guarisco, R, Galioto, A, Cavallin, M, and Andrealli, A

Subjects
Male, 0301 basic medicine, Cirrhosis, ascites, complications, liver cirrhosis, serum albumin, survival, Serum albumin, Survival, Logistic regression, Gastroenterology, Biomarkers, Pharmacological, Ascites, Complications, 0302 clinical medicine, Medicine, biology, Middle Aged, Intention to Treat Analysis, Treatment Outcome, Ascite, Female, 030211 gastroenterology & hepatology, Drug Monitoring, medicine.symptom, medicine.medical_specialty, Settore MED/12 - GASTROENTEROLOGIA, Serum Albumin, Human, 03 medical and health sciences, Serum albumin level, Predictive Value of Tests, Internal medicine, Post-hoc analysis, Humans, In patient, Biological Products, Cirrhosi, Hepatology, business.industry, Albumin, medicine.disease, Long-Term Care, Survival Analysis, 030104 developmental biology, biology.protein, business, Complication
Abstract

Background & Aims: The ANSWER study reported that long-term albumin administration in patients with cirrhosis and uncomplicated ascites improves survival. During treatment, serum albumin increased within a month and remained stable thereafter. In this post hoc analysis, we aimed to determine whether on-treatment serum albumin levels could guide therapy. Methods: Logistic regression was used to assess the association between baseline serum albumin and mortality, as well as to determine on-treatment factors associated with mortality and to predict the achievement of a given on-treatment serum albumin level. Survival was assessed by Kaplan-Meier estimates and second-order polynomial regression. Patients whose on-treatment serum albumin remained below normal were compared with a subset of patients from the control arm matched by principal score. Results: Baseline serum albumin was closely associated with 18-month mortality in untreated patients; albumin treatment almost effaced this relationship. On-treatment serum albumin and MELD-Na at month 1 were the sole independent variables associated with mortality. Second-order polynomial regression revealed that survival improved in parallel with increased 1-month on-treatment serum albumin. Kaplan-Meier estimations showed that any value of 1-month on-treatment serum albumin (0.1 g/dl intervals) in the range 2.5–4.5 g/dl discriminated patient survival. In the normal range of serum albumin, the best discriminant value was 4.0 g/dl. Compared to untreated patients, survival even improved in patients whose on-treatment serum albumin remained below normal. Conclusion: Baseline serum albumin per se should not guide the decision to start albumin therapy. Conversely, 1-month on-treatment serum albumin levels are strongly associated with outcomes and could guide the use of albumin – 4.0 g/dl being the target threshold. However, even patients whose serum albumin remains below normal benefit from long-term albumin administration. Lay summary: The ANSWER study has shown that long-term albumin administration improves survival and prevents the occurrence of major complications in patients with cirrhosis and ascites. This study shows that the achievement of these beneficial effects is related to a significant increase in serum albumin concentration. Even though the best results follow the achievement of a serum albumin concentration of 4 g/dl, a survival benefit is also achieved in patients who fail to normalise serum albumin.

Published
2020

43. Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial

Author

Caraceni, Paolo, Riggio, Oliviero, Angeli, Paolo, Alessandria, Carlo, Neri, Sergio, Foschi, Francesco G, Levantesi, Fabio, Airoldi, Aldo, Boccia, Sergio, Svegliati-Baroni, Gianluca, Fagiuoli, Stefano, Romanelli, Roberto G, Cozzolongo, Raffaele, Di Marco, Vito, Sangiovanni, Vincenzo, Morisco, Filomena, Toniutto, Pierluigi, Tortora, Annalisa, De Marco, Rosanna, Angelico, Mario, Cacciola, Irene, Elia, Gianfranco, Federico, Alessandro, Massironi, Sara, Guarisco, Riccardo, Galioto, Alessandra, Ballardini, Giorgio, Rendina, Maria, Nardelli, Silvia, Piano, Salvatore, Elia, Chiara, Prestianni, Loredana, Cappa, Federica Mirici, Cesarini, Lucia, Simone, Loredana, Pasquale, Chiara, Cavallin, Marta, Andrealli, Alida, Fidone, Federica, Ruggeri, Matteo, Roncadori, Andrea, Baldassarre, Maurizio, Tufoni, Manuel, Zaccherini, Giacomo, Bernardi, Mauro, Domenicali, Marco, Giannone, Ferdinando A, Merli, Manuela, Gioia, Stefania, Fasolato, Silvano, Sticca, Antonietta, Campion, Daniela, Risso, Alessandro, Saracco, Giorgio M, Maiorca, Daniela, Rizzotto, Agostino, Lanzi, Arianna, Neri, Elga, Visani, Anna, Mastroianni, Antonio, Alberti, Alberto B, Mazzarelli, Chiara, Vangeli, Marcello, Marzioni, Marco, Capretti, Francesca, Kostandini, Alba, Magini, Giulia, Colpani, Maria, Laffi, Giacomo, Gabbani, Tommaso, Marsico, Maria, Zappimbulso, Marianna, Petruzzi, Josè, Calvaruso, Vincenza, Parrella, Giovanni, Caporaso, Nicola, Auriemma, Francesco, Guarino, Maria, Pugliese, Fabio, Gasbarrini, Antonio, Leo, Pietro, De Leonardis, Francesco, Pecchioli, Alessandra, Rossi, Piera, Raimondo, Giovanni, Negri, Elisa, Dallio, Marcello, Loguercio, Carmelina, Conte, Dario, Celli, Natascia, Bringiotti, Roberto, Castellaneta, Nicola M, Salerno, Francesco, ANSWER Study Investigators, Caraceni, Paolo, Riggio, Oliviero, Angeli, Paolo, Alessandria, Carlo, Neri, Sergio, Foschi, Francesco G, Levantesi, Fabio, Airoldi, Aldo, Boccia, Sergio, Svegliati-Baroni, Gianluca, Fagiuoli, Stefano, Romanelli, Roberto G, Cozzolongo, Raffaele, Di Marco, Vito, Sangiovanni, Vincenzo, Morisco, Filomena, Toniutto, Pierluigi, Tortora, Annalisa, De Marco, Rosanna, Angelico, Mario, Cacciola, Irene, Elia, Gianfranco, Federico, Alessandro, Massironi, Sara, Guarisco, Riccardo, Galioto, Alessandra, Ballardini, Giorgio, Rendina, Maria, Nardelli, Silvia, Piano, Salvatore, Elia, Chiara, Prestianni, Loredana, Cappa, Federica Mirici, Cesarini, Lucia, Simone, Loredana, Pasquale, Chiara, Cavallin, Marta, Andrealli, Alida, Fidone, Federica, Ruggeri, Matteo, Roncadori, Andrea, Baldassarre, Maurizio, Tufoni, Manuel, Zaccherini, Giacomo, Bernardi, Mauro, Domenicali, Marco, Giannone, Ferdinando A, Merli, Manuela, Gioia, Stefania, Fasolato, Silvano, Sticca, Antonietta, Campion, Daniela, Risso, Alessandro, Saracco, Giorgio M, Maiorca, Daniela, Rizzotto, Agostino, Lanzi, Arianna, Neri, Elga, Visani, Anna, Mastroianni, Antonio, Alberti, Alberto B, Mazzarelli, Chiara, Vangeli, Marcello, Marzioni, Marco, Capretti, Francesca, Kostandini, Alba, Magini, Giulia, Colpani, Maria, Laffi, Giacomo, Gabbani, Tommaso, Marsico, Maria, Zappimbulso, Marianna, Petruzzi, Josè, Calvaruso, Vincenza, Parrella, Giovanni, Caporaso, Nicola, Auriemma, Francesco, Guarino, Maria, Pugliese, Fabio, Gasbarrini, Antonio, Leo, Pietro, De Leonardis, Francesco, Pecchioli, Alessandra, Rossi, Piera, Raimondo, Giovanni, Negri, Elisa, Dallio, Marcello, Loguercio, Carmelina, Conte, Dario, Celli, Natascia, Bringiotti, Roberto, Castellaneta, Nicola M, Salerno, Francesco, Caraceni P1, Riggio O2, Angeli P3, Alessandria C4, Neri S5, Foschi FG6, Levantesi F7, Airoldi A8, Boccia S9, Svegliati-Baroni G10, Fagiuoli S11, Romanelli RG12, Cozzolongo R13, Di Marco Vito, Sangiovanni V15, Morisco F16, Toniutto P17, Tortora A18, De Marco R19, Angelico M20, Cacciola I21, Elia G22, Federico A23, Massironi S24, Guarisco R25, Galioto A26, Ballardini G27, Rendina M28, Nardelli S2, Piano S3, Elia C4, Prestianni L5, Cappa FM6, Cesarini L8, Simone L9, Pasquale C2, Cavallin M3, Andrealli A4, Fidone F5, Ruggeri M29, Roncadori A30, Baldassarre M1, Tufoni M1, Zaccherini G1, Bernardi M31, Domenicali M, Giannone FA, Merli M, Gioia S, Fasolato S, Sticca A, Campion D, Risso A, Saracco GM, Maiorca D, Rizzotto A, Lanzi A, Neri E, Visani A, Mastroianni A, Alberti AB, Mazzarelli C, Vangeli M, Marzioni M, Capretti F, Kostandini A, Magini G, Colpani M, Laffi G, Gabbani T, Marsico M, Zappimbulso M, Petruzzi J, Calvaruso Vincenza, Parrella G, Caporaso N, Auriemma F, Guarino M, Pugliese F, Gasbarrini A, Leo P, De Leonardis F, Pecchioli A, Rossi P, Raimondo G, Negri E, Dallio M, Loguercio C, Conte D, Celli N, Bringiotti R, Castellaneta NM, Salerno F., Caraceni P, Riggio O, Angeli P, Alessandria C, Neri S, Foschi FG, Levantesi F, Airoldi A, Boccia S, Svegliati-Baroni G, Fagiuoli S, Romanelli RG, Cozzolongo R, Di Marco V, Sangiovanni V, Morisco F, Toniutto P, Tortora A, De Marco R, Angelico M, Cacciola I, Elia G, Federico A, Massironi S, Guarisco R, Galioto A, Ballardini G, Rendina M, Nardelli S, Piano S, Elia C, Prestianni L, Cappa FM, Cesarini L, Simone L, Pasquale C, Cavallin M, Andrealli A, Fidone F, Ruggeri M, Roncadori A, Baldassarre M, Tufoni M, Zaccherini G, Bernardi M, Domenicali M, Giannone FA, Merli M, Gioia S, Fasolato S, Sticca A, Campion D, Risso A, Saracco GM, Maiorca D, Rizzotto A, Lanzi A, Neri E, Visani A, Mastroianni A, Alberti AB, Mazzarelli C, Vangeli M, Marzioni M, Capretti F, Kostandini A, Magini G, Colpani M, Laffi G, Gabbani T, Marsico M, Zappimbulso M, Petruzzi J, Calvaruso V, Parrella G, Caporaso N, Auriemma F, Guarino M, Pugliese F, Gasbarrini A, Leo P, De Leonardis F, Pecchioli A, Rossi P, Raimondo G, Negri E, Dallio M, Loguercio C, Conte D, Celli N, Bringiotti R, Castellaneta NM, Salerno F., Caraceni, P, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Boccia, S, Svegliati-Baroni, G, Fagiuoli, S, Romanelli, R, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Tortora, A, De Marco, R, Angelico, M, Cacciola, I, Elia, G, Federico, A, Massironi, S, Guarisco, R, Galioto, A, Ballardini, G, Rendina, M, Nardelli, S, Piano, S, Elia, C, Prestianni, L, Cappa, F, Cesarini, L, Simone, L, Pasquale, C, Cavallin, M, Andrealli, A, Fidone, F, Ruggeri, M, Roncadori, A, Baldassarre, M, Tufoni, M, Zaccherini, G, Bernardi, M, Domenicali, M, Giannone, F, Merli, M, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Maiorca, D, Rizzotto, A, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Alberti, A, Mazzarelli, C, Vangeli, M, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Laffi, G, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Gasbarrini, A, Leo, P, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Negri, E, Dallio, M, Loguercio, C, Conte, D, Celli, N, Bringiotti, R, Castellaneta, N, and Salerno, F

Subjects
Liver Cirrhosis, Male, Time Factors, Cirrhosis, Kaplan-Meier Estimate, law.invention, ascites, 0302 clinical medicine, Hepatorenal syndrome, Randomized controlled trial, Furosemide, law, Ascites, Clinical endpoint, Paracentesis, Diuretics, albumin, decompensated cirrhosi, Mineralocorticoid Receptor Antagonists, Settore MED/12 - Gastroenterologia, Medicine (all), Hazard ratio, General Medicine, Middle Aged, Survival Rate, 030220 oncology & carcinogenesis, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, Quality-Adjusted Life Years, medicine.symptom, Hyponatremia, medicine.medical_specialty, 03 medical and health sciences, Albumins, Internal medicine, medicine, Humans, Survival rate, albumin, Aged, business.industry, cirrhosis, medicine.disease, Clinical trial, albumin, cirrhosis, ascites, liver decompensation, Quality of Life, Hyperkalemia, business, Esophagus Varices, Portal Hypertension, Varicosis
Abstract

Background Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients with decompensated cirrhosis. The human Albumin for the treatmeNt of aScites in patients With hEpatic ciRrhosis (ANSWER) study was designed to clarify this issue. Methods We did an investigator-initiated multicentre randomised, parallel, open-label, pragmatic trial in 33 academic and non-academic Italian hospitals. We randomly assigned patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs (≥200 mg/day) and furosemide (≥25 mg/day) to receive either standard medical treatment (SMT) or SMT plus HA (40 g twice weekly for 2 weeks, and then 40 g weekly) for up to 18 months. The primary endpoint was 18-month mortality, evaluated as difference of events and analysis of survival time in patients included in the modified intention-to-treat and per-protocol populations. This study is registered with EudraCT, number 2008–000625–19, and ClinicalTrials.gov, number NCT01288794. Findings From April 2, 2011, to May 27, 2015, 440 patients were randomly assigned and 431 were included in the modified intention-to-treat analysis. 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group. Overall 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meier estimates 77% vs 66%; p=0·028), resulting in a 38% reduction in the mortality hazard ratio (0·62 [95% CI 0·40–0·95]). 46 (22%) patients in the SMT group and 49 (22%) in the SMT plus HA group had grade 3–4 non-liver related adverse events. Interpretation In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis. Funding Italian Medicine Agency. Copyright © 2018 Elsevier Ltd. All rights reserved.

Published
2018

44. Hepatitis C virus recurrence after liver transplantation: a 10-year evaluation

Author

Roberto Di Donato, Mauro Bernardi, Marcello Vangeli, Antonio Daniele Pinna, Luciano De Carlis, Luca S. Belli, Stefania Lorenzini, Ranka Vukotic, Arrigo F G Cicero, Matteo Cescon, Arianna Martello Panno, Pietro Andreone, Gian Luca Grazi, Stefano Gitto, Aldo Airoldi, Lucia Brodosi, Gitto S, Belli LS, Vukotic R, Lorenzini S, Airoldi A, Cicero AF, Vangeli M, Brodosi L, Martello Panno A, Di Donato R, Cescon M, Grazi GL, De Carlis L, Pinna AD, Bernardi M, Andreone P., Gitto, S, Belli, L, Vukotic, R, Lorenzini, S, Airoldi, A, Cicero, A, Vangeli, M, Brodosi, L, Panno, A, Di Donato, R, Cescon, M, Grazi, G, De Carlis, L, Pinna, A, Bernardi, M, and Andreone, P

Subjects
Male, Time Factors, medicine.medical_treatment, Hepacivirus, Kaplan-Meier Estimate, Liver transplantation, Ten-year survival, Gastroenterology, Risk Factors, Recurrence, Retrospective Studie, Odds Ratio, Multivariate Analysi, General Medicine, Hepatitis C, Middle Aged, Exact test, Treatment Outcome, Italy, ANTIVIRAL TERAPHY, HEPATITIS C, SURVIVAL, Drug Therapy, Combination, Female, Viral hepatitis, LIVER TRANSPLANTATION, HEPATITIS C RECURRENCE, Human, Adult, medicine.medical_specialty, Logistic Model, Time Factor, Antiviral treatment, Hepatitis C virus recurrence, Antiviral Agents, NO, Hepatitis C, Liver transplantation, hepatitis C virus recurrence, Antiviral treatment, Ten-year survival, End Stage Liver Disease, Internal medicine, medicine, Humans, Retrospective Cohort Study, Survival rate, Survival analysis, Proportional Hazards Models, Retrospective Studies, Antiviral Agent, Chi-Square Distribution, Hepaciviru, Proportional hazards model, business.industry, Risk Factor, medicine.disease, Surgery, Transplantation, Logistic Models, Multivariate Analysis, Proportional Hazards Model, Virus Activation, business
Abstract

AIM: To evaluate the predictors of 10-year survival of patients with hepatitis C recurrence. /// METHODS: Data from 358 patients transplanted between 1989 and 2010 in two Italian transplant centers and with evidence of hepatitis C recurrence were analyzed. A χ 2, Fisher's exact test and Kruskal Wallis' test were used for categorical and continuous variables, respectively. Survival analysis was performed at 10 years after transplant using the Kaplan-Meier method, and a log-rank test was used to compare groups. A p level less than 0.05 was considered significant for all tests. Multivariate analysis of the predictive role of different variables on 10-year survival was performed by a stepwise Cox logistic regression./// RESULTS: The ten-year survival of the entire popu lation was 61.2%. Five groups of patients were identified according to the virological response or lack of a response to antiviral treatment and, among those who were not treated, according to the clinical status (mild hepatitis C recurrence, "too sick to be treated" and patients with comorbidities contraindicating the treatment). While the 10-year survival of treated and untreated patients was not different (59.1% vs 64.7%, p = 0.192), patients with a sustained virological response had a higher 10-year survival rate than both the "non-responders" (84.7% vs 39.8%, p < 0.0001) and too sick to be treated (84.7% vs 0%, p < 0.0001). Sustained virological responders had a survival rate comparable to patients untreated with mild recurrence (84.7% vs 89.3%). A sustained virological response and young donor age were independent predictors of 10-year survival./// CONCLUSION: Sustained virological response significantly increased long-term survival. Awaiting the interferon-free regimen global availability, antiviral treatment might be questionable in selected subjects with mild hepatitis C recurrence.

Published
2015

45. Etrolizumab versus infliximab for the treatment of moderately to severely active ulcerative colitis (GARDENIA): a randomised, double-blind, double-dummy, phase 3 study

Author

Silvio Danese, Jean-Frederic Colombel, Milan Lukas, Javier P Gisbert, Geert D'Haens, Bu'hussain Hayee, Remo Panaccione, Hyun-Soo Kim, Walter Reinisch, Helen Tyrrell, Young S Oh, Swati Tole, Akiko Chai, Kirsten Chamberlain-James, Meina Tao Tang, Stefan Schreiber, Nazimuddin Aboo, Tariq Ahmad, Xavier Aldeguer Mante, Matthieu Allez, Sven Almer, Romain Altwegg, Montserrat Andreu Garcia, Ramesh Arasaradnam, Sandro Ardizzone, Alessandro Armuzzi, Ian Arnott, Guy Aumais, Irit Avni-Biron, Peter Barrow, Ian Beales, Fernando Bermejo San Jose, Abraham Bezuidenhout, Livia Biancone, Michael Blaeker, Stuart Bloom, Bernd Bokemeyer, Fabrizio Bossa, Peter Bossuyt, Guillaume Bouguen, Yoram Bouhnik, Gerd Bouma, Raymond Bourdages, Arnaud Bourreille, Christian Boustiere, Tomas Brabec, Stephan Brand, Carsten Buening, Anthony Buisson, Guillaume Cadiot, Xavier Calvet Calvo, Franck Carbonnel, Daniel Carpio, Jae Hee Cheon, Naoki Chiba, Camelia Chioncel, Nicoleta-Claudia Cimpoeru, Martin Clodi, Gino Roberto Corazza, Rocco Cosintino, Jose Cotter, Thomas Creed, Fraser Cummings, Gian Luigi de' Angelis, Marc De Maeyer, Milind Desai, Etienne Desilets, Pierre Desreumaux, Olivier Dewit, Johanna Dinter, Ecaterina Daniela Dobru, Tomas Douda, Dan Lucian Dumitrascu, Matthias Ebert, Ana Echarri Piudo, Magdy Elkhashab, Chang Soo Eun, Brian Feagan, Roland Fejes, Catarina Fidalgo, Sigal Fishman, Bernard Flourié, Sharyle Fowler, Walter Fries, Csaba Fulop, Mathurin Fumery, Gyula G Kiss, Sonja Gassner, Daniel Gaya, Bastianello Germanà, Liliana Simona Gheorghe, Cyrielle Gilletta de Saint Joseph, Paolo Gionchetti, Adrian-Eugen Goldis, Raquel Gonçalves, Jean-Charles Grimaud, Tibor Gyökeres, Herve Hagege, Andrei Haidar, Heinz Hartmann, Peter Hasselblatt, Buhussain Hayee, Xavier Hebuterne, Per Hellström, Pieter Hindryckx, Helena Hlavova, Frank Hoentjen, Stefanie Howaldt, Ludek Hrdlicka, Kyu Chan Huh, Maria Isabel Iborra Colomino, Florentina Ionita-Radu, Peter Irving, Jørgen Jahnsen, ByungIk Jang, Jeroen Jansen, Seong Woo Jeon, Rodrigo Jover Martinez, Pascal Juillerat, Per Karlén, Arthur Kaser, Radan Keil, Deepak Kejariwal, Dan Keret, Reena Khanna, Dongwoo Kim, Duk Hwan Kim, Hyo-Jong Kim, Joo Sung Kim, Kueongok Kim, Kyung-Jo Kim, Sung Kook Kim, Young-Ho Kim, Jochen Klaus, Anna Kohn, Vladimir Kojecky, Ja Seol Koo, Robert Kozak, Milan Kremer, Tunde Kristof, Frederik Kruger, David Laharie, Adi Lahat-zok, Evgeny Landa, Jonghun Lee, Kang-Moon Lee, Kook Lae Lee, YooJin Lee, Frank Lenze, Wee Chian Lim, Jimmy Limdi, James Lindsay, Pilar Lopez Serrano, Edouard Louis, Stefan Lueth, Giovanni Maconi, Fazia Mana, Steven Mann, John Mansfield, Santino Marchi, Marco Marino, John Marshall, Maria Dolores Martin Arranz, Radu-Bogdan Mateescu, John McLaughlin, Simon McLaughlin, Ehud Melzer, Jessica Mertens, Paul Mitrut, Tamas Molnar, Vinciane Muls, Pushpakaran Munuswamy, Charles Murray, Timna Naftali, Visvakuren Naidoo, Yusuf Nanabhay, Lucian Negreanu, Augustin Nguyen, Thomas Ochsenkuehn, Ambrogio Orlando, Julian Panes Diaz, Maya Paritsky, Dong Il Park, Jihye Park, Luca Pastorelli, Markus Peck-Radosavljevic, Farhad Peerani, Javier Perez Gisbert, Laurent Peyrin-Biroulet, Laurence Picon, Marieke Pierik, Terry Ponich, Francisco Portela, Maartens Jeroen Prins, Istvan Racz, Khan Fareed Rahman, Jean-Marie Reimund, Max Reinshagen, Xavier Roblin, Rodolfo Rocca, Francesca Rogai, Gerhard Rogler, Agnes Salamon, Ennaliza Salazar, Zoltan Sallo, Sunil Samuel, Miquel de los Santos Sans Cuffi, Edoardo Vincenzo Savarino, Vincenzo Savarino, Guillaume Savoye, Andrada Seicean, Christian Selinger, David Martins Serra, Hang Hock Shim, SungJae Shin, Britta Siegmund, Jesse Siffledeen, Wayne Simmonds, Jan Smid, Jose Sollano, Geun Am Song, Alexander Speight, Ioan Sporea, Dirk Staessen, George Stancu, Alan Steel, David Stepek, Victor Stoica, Andreas Sturm, Gyorgy Szekely, Teck Kiang Tan, Carlos Taxonera Samso, John Thomson, Michal Tichy, Gabor Tamas Toth, Zsolt Tulassay, Marcello Vangeli, Marta Varga, Ana Vieira, Stephanie Viennot, Erica Villa, Petr Vitek, Harald Vogelsang, Petr Vyhnalek, Peter Wahab, Jens Walldorf, Byong Duk Ye, Christopher Ziady, Danese S., Colombel J.-F., Lukas M., Gisbert J.P., D'Haens G., Hayee B., Panaccione R., Kim H.-S., Reinisch W., Tyrrell H., Oh Y.S., Tole S., Chai A., Chamberlain-James K., Tang M.T., Schreiber S., Aboo N., Ahmad T., Aldeguer Mante X., Allez M., Almer S., Altwegg R., Andreu Garcia M., Arasaradnam R., Ardizzone S., Armuzzi A., Arnott I., Aumais G., Avni-Biron I., Barrow P., Beales I., Bermejo San Jose F., Bezuidenhout A., Biancone L., Blaeker M., Bloom S., Bokemeyer B., Bossa F., Bossuyt P., Bouguen G., Bouhnik Y., Bouma G., Bourdages R., Bourreille A., Boustiere C., Brabec T., Brand S., Buening C., Buisson A., Cadiot G., Calvet Calvo X., Carbonnel F., Carpio D., Cheon J.H., Chiba N., Chioncel C., Cimpoeru N.-C., Clodi M., Corazza G.R., Cosintino R., Cotter J., Creed T., Cummings F., de' Angelis G.L., De Maeyer M., Desai M., Desilets E., Desreumaux P., Dewit O., Dinter J., Dobru E.D., Douda T., Dumitrascu D.L., Ebert M., Echarri Piudo A., Elkhashab M., Eun C.S., Feagan B., Fejes R., Fidalgo C., Fishman S., Flourie B., Fowler S., Fries W., Fulop C., Fumery M., G Kiss G., Gassner S., Gaya D., Germana B., Gheorghe L.S., Gilletta de Saint Joseph C., Gionchetti P., Goldis A.-E., Goncalves R., Grimaud J.-C., Gyokeres T., Hagege H., Haidar A., Hartmann H., Hasselblatt P., Hebuterne X., Hellstrom P., Hindryckx P., Hlavova H., Hoentjen F., Howaldt S., Hrdlicka L., Huh K.C., Iborra Colomino M.I., Ionita-Radu F., Irving P., Jahnsen J., Jang B., Jansen J., Jeon S.W., Jover Martinez R., Juillerat P., Karlen P., Kaser A., Keil R., Kejariwal D., Keret D., Khanna R., Kim D., Kim D.H., Kim H.-J., Kim J.S., Kim K., Kim K.-J., Kim S.K., Kim Y.-H., Klaus J., Kohn A., Kojecky V., Koo J.S., Kozak R., Kremer M., Kristof T., Kruger F., Laharie D., Lahat-zok A., Landa E., Lee J., Lee K.-M., Lee K.L., Lee Y., Lenze F., Lim W.C., Limdi J., Lindsay J., Lopez Serrano P., Louis E., Lueth S., Maconi G., Mana F., Mann S., Mansfield J., Marchi S., Marino M., Marshall J., Martin Arranz M.D., Mateescu R.-B., McLaughlin J., McLaughlin S., Melzer E., Mertens J., Mitrut P., Molnar T., Muls V., Munuswamy P., Murray C., Naftali T., Naidoo V., Nanabhay Y., Negreanu L., Nguyen A., Ochsenkuehn T., Orlando A., Panes Diaz J., Paritsky M., Park D.I., Park J., Pastorelli L., Peck-Radosavljevic M., Peerani F., Perez Gisbert J., Peyrin-Biroulet L., Picon L., Pierik M., Ponich T., Portela F., Prins M.J., Racz I., Rahman K.F., Reimund J.-M., Reinshagen M., Roblin X., Rocca R., Rogai F., Rogler G., Salamon A., Salazar E., Sallo Z., Samuel S., Sans Cuffi M.D.L.S., Savarino E.V., Savarino V., Savoye G., Seicean A., Selinger C., Serra D.M., Shim H.H., Shin S., Siegmund B., Siffledeen J., Simmonds W., Smid J., Sollano J., Song G.A., Speight A., Sporea I., Staessen D., Stancu G., Steel A., Stepek D., Stoica V., Sturm A., Szekely G., Tan T.K., Taxonera Samso C., Thomson J., Tichy M., Toth G.T., Tulassay Z., Vangeli M., Varga M., Vieira A., Viennot S., Villa E., Vitek P., Vogelsang H., Vyhnalek P., Wahab P., Walldorf J., Ye B.D., and Ziady C.

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Population, Antibodies, Monoclonal, Humanized, Injections, Subcutaneou, Placebo, Severity of Illness Index, Gastroenterology, Young Adult, Double-Blind Method, Internal medicine, Gastrointestinal Agent, Clinical endpoint, medicine, education, Adverse effect, Aged, Aged, 80 and over, education.field_of_study, Hepatology, business.industry, Middle Aged, medicine.disease, Ulcerative colitis, Infliximab, Treatment Outcome, Etrolizumab, Concomitant, Colitis, Ulcerative, Female, business, Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5], Human, medicine.drug
Abstract

Item does not contain fulltext BACKGROUND: Etrolizumab is a gut-targeted anti-β7 integrin monoclonal antibody. In a previous phase 2 induction study, etrolizumab significantly improved clinical remission versus placebo in patients with moderately to severely active ulcerative colitis. We aimed to compare the safety and efficacy of etrolizumab with infliximab in patients with moderately to severely active ulcerative colitis. METHODS: We conducted a randomised, double-blind, double-dummy, parallel-group, phase 3 study (GARDENIA) across 114 treatment centres worldwide. We included adults (age 18-80 years) with moderately to severely active ulcerative colitis (Mayo Clinic total score [MCS] of 6-12 with an endoscopic subscore of ≥2, a rectal bleeding subscore of ≥1, and a stool frequency subscore of ≥1) who were naive to tumour necrosis factor inhibitors. Patients were required to have had an established diagnosis of ulcerative colitis for at least 3 months, corroborated by both clinical and endoscopic evidence, and evidence of disease extending at least 20 cm from the anal verge. Participants were randomly assigned (1:1) to receive subcutaneous etrolizumab 105 mg once every 4 weeks or intravenous infliximab 5 mg/kg at 0, 2, and 6 weeks and every 8 weeks thereafter for 52 weeks. Randomisation was stratified by baseline concomitant treatment with corticosteroids, concomitant treatment with immunosuppressants, and baseline disease activity. All participants and study site personnel were masked to treatment assignment. The primary endpoint was the proportion of patients who had both clinical response at week 10 (MCS ≥3-point decrease and ≥30% reduction from baseline, plus ≥1-point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1) and clinical remission at week 54 (MCS ≤2, with individual subscores ≤1); efficacy was analysed using a modified intention-to-treat population (all randomised patients who received at least one dose of study drug). GARDENIA was designed to show superiority of etrolizumab over infliximab for the primary endpoint. This trial is registered with ClinicalTrials.gov, NCT02136069, and is now closed to recruitment. FINDINGS: Between Dec 24, 2014, and June 23, 2020, 730 patients were screened for eligibility and 397 were enrolled and randomly assigned to etrolizumab (n=199) or infliximab (n=198). 95 (48%) patients in the etrolizumab group and 103 (52%) in the infliximab group completed the study through week 54. At week 54, 37 (18·6%) of 199 patients in the etrolizumab group and 39 (19·7%) of 198 in the infliximab group met the primary endpoint (adjusted treatment difference -0·9% [95% CI -8·7 to 6·8]; p=0·81). The number of patients reporting one or more adverse events was similar between treatment groups (154 [77%] of 199 in the etrolizumab group and 151 [76%] of 198 in the infliximab group); the most common adverse event in both groups was ulcerative colitis (55 [28%] patients in the etrolizumab group and 43 [22%] in the infliximab group). More patients in the etrolizumab group reported serious adverse events (including serious infections) than did those in the infliximab group (32 [16%] vs 20 [10%]); the most common serious adverse event was ulcerative colitis (12 [6%] and 11 [6%]). There was one death during follow-up, in the infliximab group due to a pulmonary embolism, which was not considered to be related to study treatment. INTERPRETATION: To our knowledge, this trial is the first phase 3 maintenance study in moderately to severely active ulcerative colitis to use infliximab as an active comparator. Although the study did not show statistical superiority for the primary endpoint, etrolizumab performed similarly to infliximab from a clinical viewpoint. FUNDING: F Hoffmann-La Roche.

Published
2022

46. Successful induction of clinical response and remission with certolizumab pegol in Crohn's disease patients refractory or intolerant to infliximab: a real-life multicenter experience of compassionate use

Author

Manuela Marzo, Vito Annese, Michele Comberlato, Tommaso Stefanelli, Silvio Danese, Elisabetta Colombo, Alberto Malesci, Alessandro Armuzzi, Aldo Manca, Luisa Guidi, Mario Cottone, Marcello Vangeli, Cosimo Prantera, Raffaella Pulitanò, Maria Lia Scribano, Filippo Mocciaro, Danese, S., Mocciaro, F., Guidi, L., Scribano, M. L., Comberlato, M., Annese, V., Colombo, E., Stefanelli, T., Marzo, M., Vangeli, M., Pulitano', R., Manca, A., Armuzzi, A., Malesci, A., Prantera, C., Cottone, M., Danese S, Mocciaro F, Guidi L, Scribano ML, Comberlato M, Annese V, Colombo E, Stefanelli T, Marzo M, Vangeli M, Pulitanò R, Manca A, Armuzzi A, Malesci A, Prantera C, and Cottone M

Subjects
medicine.medical_specialty, Crohn's disease, therapy, business.industry, Gastroenterology, Compassionate Use, medicine.disease, Certolizumab, Infliximab, Clinical trial, Pharmacotherapy, Refractory, Certolizumab, Crohn's disease, Refractory, Internal medicine, medicine, Immunology and Allergy, Certolizumab pegol, business, medicine.drug
Published
2008

47. Lack of a strong association between HLA class II, tumour necrosis factor and transporter associated with antigen processing gene polymorphisms and virological response toα-interferon treatment in patients with chronic hepatitis C.

Author

Airoldi, A., Zavaglia, C., Silini, E., Tinelli, C., Martinetti, M., Asti, M., Rossini, A., Vangeli, M., Salvaneschi, L., and Pinzello, G.

Subjects
*HLA histocompatibility antigens, *GENETIC polymorphisms, *HEPATITIS C virus, *HEPATITIS viruses, *NUCLEIC acids, *GENETIC research, *POLYMERASE chain reaction
Abstract

The aim of the study was to investigate whether polymorphisms of the HLA class II, tumour necrosis factor (TNF) and transporter associated with antigen processing (TAP) genes influence the response toα-interferon in patients with chronic hepatitis C. Twenty-seven sustained responders and 55 non-responders toα-interferon monotherapy were investigated. HLA-DRB1, DQA1, DQB1, TNFA, TNFB, TAP1 and TAP2 alleles were determined by PCR-based molecular techniques. Sustained virological response was defined as undetectable serum hepatitis C virus (HCV) RNA for at least 3 years after the end of treatment. Probability (P) values were corrected for the number of alleles tested (Pc). Viral genotype 1b was more frequent in responders than in non-responders (56% vs. 26%,P = 0.009). HLA-DQB1*02 occurred less frequently in responders than in non-responders (14.8% vs. 29%,Pc not significant). HLA-DRB1*11 and DQB1*0602 were found in 22.2% and 9.3% of responders and in 10.9% and 1.8% of non-responders, respectively (Pc not significant). There was no difference in the distribution of TNF alleles in the two groups. Twenty-four (88.8%) responder patients as compared with 34 (61.8%) non-responders were TAP1*0101 homozygous (Pc not significant). Thus, in European Caucasoids with chronic hepatitis C, we could not demonstrate a strong association between HLA class II, TNF, and TAP gene polymorphisms and response to interferon treatment. [ABSTRACT FROM AUTHOR]

Published
2004
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48. Liver transplantation for HCV cirrhosis: Improved survival in recent years and increased severity of recurrent disease in female recipients: Results of a long term retrospective study

Author

Umberto Cillo, Maria Guido, Dimitrios Samonakis, Aldo Airoldi, Luca S. Belli, Keith Rolles, Brian R. Davidson, Andrew K. Burroughs, Claudio Zavaglia, Giovambattista Pinzello, Stefano Fagiuoli, Ernesto Minola, Patrizia Burra, David Patch, S. Boninsegna, Luciano De Carlis, Marcello Vangeli, Amar P. Dhillon, Alessandro Giacomoni, A Alberti, Calogero Cammà, Alberto Quaglia, Omar A. Slim, Belli, L, Burroughs, A, Burra, P, Alberti, A, Samonakis, D, Cammà, C, De Carlis, L, Minola, E, Quaglia, A, Zavaglia, C, Vangeli, M, Patch, D, Dhillon, A, Cillo, U, Guido, M, Fagiuoli, S, Giacomoni, A, Slim, O, Airoldi, A, Boninsegna, S, Davidson, B, Rolles, K, and Pinzello, G

Subjects
Liver Cirrhosis, Adult, Male, medicine.medical_specialty, Time Factors, Cirrhosis, Time Factor, Liver Cirrhosi, medicine.medical_treatment, Tissue Donor, Longitudinal Studie, Kaplan-Meier Estimate, Sex Factor, Liver transplantation, Severity of Illness Index, Cohort Studies, Sex Factors, Risk Factors, Recurrence, Retrospective Studie, Internal medicine, Severity of illness, Humans, Medicine, Age Factor, Longitudinal Studies, Risk factor, Retrospective Studies, Transplantation, Hepatology, business.industry, Risk Factor, Age Factors, Retrospective cohort study, Hepatitis C, Middle Aged, medicine.disease, Tissue Donors, Liver Transplantation, Surgery, Disease Progression, Female, Cohort Studie, business, Human, Cohort study
Abstract

In recent years, a worsening outcome of hepatitis C virus (HCV)-positive recipients and a faster progression of recurrent disease to overt cirrhosis have been reported. Our aims were to 1) assess patient survival and development of severe recurrent disease (Ishak fibrosis score > 3) in different transplant years; and 2) model the effects of pre- and post-liver transplantation (LT) variables on the severity of recurrent disease. A multicenter retrospective analysis was conducted on 502 consecutive HCV-positive transplant recipients between January 1990 and December 2002. Protocol liver biopsies were obtained at 1, 3, 5, 7, and 10 yr post-LT ir almost 90% of the patients. All 502 patients were included in the overall survival analysis, while only the 354 patients with a follow-up longer than 1 yr were considered for the analysis of predictors of disease progression. The overall Kaplan-Meier survival rates were 78.7%, 66.3%, and 58.6%, at 12, 60, and 120 months, respectively, and a trend for a better patient survival over the years emerged from all 3 centers. The cumulative probability of developing HCV-related recurrent severe fibrosis (Ishak score 4-6) in the cohort of 354 patients who survived at least 1 yr remained unchanged over the years. Multivariate analysis indicated that older donors (P = 0.0001) and female gender of recipient (P = 0.02) were the 2 major risk factors for the development of severe recurrent disease, while the adoption of antilymphocytic preparations was associated with a less aggressive course (P = 0.03). Two of these prognostic factors, donor age and recipient gender, are easily available before LT and their combination showed an important synergy, such that a female recipient not only had a much higher probability of severe recurrent disease than a male recipient but her risk increased with the increasing age of the donor, reaching almost 100% when the age of the donor was 60 or older. In conclusion, a trend for a better patient survival was observed in more recent years but the cumulative probability of developing severe recurrent disease remained unchanged. The combination of a female recipient receiving an older graft emerged as a strong risk factor for a severe recurrence. © 2007 AASLD

Published
2007

49. Combined therapy with interferon and low-dose ribavirin in posttransplantation recurrent hepatitis C: a pragmatic study

Author

Aldo Airoldi, Alessandra Cernuschi, Domenico Forti, Ernesto Minola, Gianfranco Rondinara, Luciano De Carlis, A Alberti, Giovambattista Pinzello, Marcello Vangeli, Luca S. Belli, Maria D'Amico, Alberti, A, Belli, L, Airoldi, A, De Carlis, L, Rondinara, G, Minola, E, Vangeli, M, Cernuschi, A, D'Amico, M, Forti, D, and Pinzello, G

Subjects
Liver Cirrhosis, Male, Cirrhosis, medicine.medical_treatment, Administration, Oral, Liver transplantation, Gastroenterology, Cohort Studies, chemistry.chemical_compound, Postoperative Complications, Recurrence, medicine.diagnostic_test, Middle Aged, Treatment Outcome, Liver biopsy, Drug Therapy, Combination, Female, Human, Adult, medicine.medical_specialty, Combination therapy, Liver Cirrhosi, Injections, Subcutaneous, Alpha interferon, Injections, Subcutaneou, Antiviral Agents, Drug Administration Schedule, Statistics, Nonparametric, Follow-Up Studie, Internal medicine, Ribavirin, medicine, Humans, Aged, Antiviral Agent, Transplantation, Hepatology, Dose-Response Relationship, Drug, business.industry, Interferon-alpha, Hepatitis C, Chronic, medicine.disease, Liver Transplantation, chemistry, Immunology, Surgery, Postoperative Complication, Cohort Studie, business, Follow-Up Studies
Abstract

Recurrent hepatitis C is a common problem after liver transplantation that can progress to liver cirrhosis of the graft. Preliminary reports of combination treatment with interferon (IFN) and ribavirin have been promising, but long-term follow-up data are not yet available. We report our experience with 1 year of combination therapy with IFN (3 million units thrice weekly) and low-dose ribavirin (600 mg/d), followed by long-term ribavirin monotherapy in 18 patients with moderate to severe recurrent hepatitis C and a median follow-up of 32 months after the completion of combined therapy. All patients were followed up clinically and histologically at regular intervals. Overall, in an intention-to-treat analysis, 15 patients had normal alanine aminotransferase levels (biochemical end-treatment response [ETR], 83%), and 8 patients were also hepatitis C virus RNA negative in serum (virological ETR, 44%) at the end of combined treatment. At last follow-up after the completion of combined therapy (median, 32 months; range, 18 to 73 months), 13 patients were biochemical responders (biochemical long term-sustained response [LT-SR], 72%), and 5 patients also maintained viral clearance (virological LT-SR, 27%). Comparison of liver biopsy specimens before and after 12 months of combined therapy showed improvement in grading scores of at least two points in the majority of the patients (73%). Notably, a trend toward fibrotic progression was only noted in nonresponders. Regarding side effects, despite the low dose of ribavirn, almost half the patients developed hemolytic anemia requiring dose reductions. In addition, long-term ribavirin monotherapy was not associated with iron accumulation. We conclude that combined therapy with low-dose ribavirin followed by long-term ribavirin monotherapy can be recommended because it favorably modifies the natural history of recurrent hepatitis C in most patients and possibly halts histological disease progression without causing iron accumulation.

Published
2001

50. Gastrointestinal Ultrasound in Infectious Diseases: A Comprehensive Review.

Author

Aprile F, Vangeli M, Allocca M, Zilli A, Argollo MC, D'amico F, Parigi TL, Danese S, and Furfaro F

Subjects
Humans, Gastrointestinal Tract diagnostic imaging, Communicable Diseases diagnostic imaging, Ultrasonography methods, Gastrointestinal Diseases diagnostic imaging
Abstract

Infectious diseases affecting the gastrointestinal tract often present diagnostic challenges due to the variability in clinical manifestations and overlapping symptoms. Ultrasound imaging has emerged as a valuable tool in the assessment of gastrointestinal pathologies, offering non-invasive and real-time visualization of anatomical structures. This review aims to explore the role of ultrasound in the diagnosis and management of infectious diseases involving the gastrointestinal tract. We discuss the imaging features of various infectious etiologies, such as bacterial, viral, and parasitic infections, highlighting characteristic findings on ultrasound scans. Additionally, we provide insights into the utility of ultrasound for the assessment of treatment response. Through a comprehensive analysis of existing literature and clinical case studies, this review underscores the significance of ultrasound imaging as a frontline modality in the diagnosis and management of infectious diseases affecting the gastrointestinal tract.

Published
2024
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