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1. Clinical characteristics and outcomes of vaccinated patients hospitalised with SARS-CoV-2 breakthrough infection: Multi-IPV, a multicentre study in Northern Italy

Author

Lombardi, A, Villa, S, Colaneri, M, Scaglione, G, Bai, F, Varisco, B, Bono, V, Vena, A, Dentone, C, Russo, C, Tettamanti, M, Renisi, G, Viero, G, Azzarà, C, Mantero, M, Peyvandi, F, Bassetti, M, Marchetti, G, Muscatello, A, Nobili, A, Gori, A, Bandera, A, Bosari, S, Scudeller, L, Fusetti, G, Rusconi, L, Dell’Orto, S, Prati, D, Valenti, L, Giovannelli, S, Manunta, M, Lamorte, G, Ferarri, F, Gori., A, Mangioni, D, Alagna, L, Bozzi, G, Lombardi., A, Ungaro, R, Ancona, G, Mussa, M, Mariani, B, Bolis, M, Iannotti, N, Ludovisi, S, Comelli, A, Biscarini, S, Castelli, V, Palomba, E, Fava, M, Peri, C, Saltini, P, Itri, T, Ferroni, V, Pastore, V, Massafra, R, Liparoti, A, Muheberimana, T, Giommi, A, Bianco, R, Chitani, G, Bobbio, C, De Matteis, I, Bonomi, A, Gualtierotti, R, Ferrari, B, Rossio, R, Boasi, N, Pagliaro, E, Massimo, C, De Caro, M, Giachi, A, Montano, N, Vigone, B, Bellocchi, C, Carandina, A, Fiorelli, E, Melli, V, Tobaldini, E, Blasi, F, Aliberti, S, Spotti, M, Terranova, L, Misuraca, S, D’Adda, A, Della Fiore, S, Di Pasquale, M, Mantero., M, Contarini, M, Ori, M, Morlacchi, L, Rossetti, V, Gramegna, A, Pappalettera, M, Cavallini, M, Buscemi, A, Vicenzi, M, Rota, I, Costantino, G, Solbiati, M, Furlan, L, Mancarella, M, Colombo, G, Fanin, A, Passarella, M, Monzani, V, Canetta, C, Rovellini, A, Barbetta, L, Billi, F, Folli, C, Accordino, S, Maira, D, Hu, C, Motta, I, Scaramellini, N, Fracanzani, A, Lombardi, R, Cespiati, A, Cesari, M, Lucchi, T, Proietti, M, Calcaterra, L, Mandelli, C, Coppola, C, Cerizza, A, Pesenti, A, Grasselli, G, Galazzi, A, Nobili., A, Monti, I, Galbussera, A, Crisafulli, E, Girelli, D, Maroccia, A, Gabbiani, D, Busti, F, Vianello, A, Biondan, M, Sartori, F, Faverio, P, Pesci, A, Zucchetti, S, Bonfanti, P, Rossi, M, Beretta, I, Spolti, A, Harari, S, Elia, D, Cassandro, R, Caminati, A, Cipollone, F, Guagnano, M, D’Ardes, D, Rossi, I, Vezzani, F, Spanevello, A, Cherubino, F, Visca, D, Contoli, M, Papi, A, Morandi, L, Battistini, N, Moreo, G, Iannuzzi, P, Fumagalla, D, Leone, S, Lombardi, Andrea, Villa, Simone, Colaneri, Marta, Scaglione, Giovanni, Bai, Francesca, Varisco, Benedetta, Bono, Valeria, Vena, Antonio, Dentone, Chiara, Russo, Chiara, Tettamanti, Mauro, Renisi, Giulia, Viero, Giulia, Azzarà, Cecilia, Mantero, Marco, Peyvandi, Flora, Bassetti, Matteo, Marchetti, Giulia, Muscatello, Antonio, Nobili, Alessandro, Gori, Andrea, Bandera, Alessandra, Bosari, Silvano, Scudeller, Luigia, Fusetti, Giuliana, Rusconi, Laura, Dell’Orto, Silvia, Prati, Daniele, Valenti, Luca, Giovannelli, Silvia, Manunta, Maria, Lamorte, Giuseppe, Ferarri, Francesca, Gori. , Andrea, Mangioni, Davide, Alagna, Laura, Bozzi, Giorgio, Lombardi. , Andrea, Ungaro, Riccardo, Ancona, Giuseppe, Mussa, Marco, Mariani, Bianca Veronica, Bolis, Matteo, Iannotti, Nathalie, Ludovisi, Serena, Comelli, Agnese, Biscarini, Simona, Castelli, Valeria, Palomba, Emanuele, Fava, Marco, Peri, Carlo Alberto, Saltini, Paola, Itri, Teresa, Ferroni, Valentina, Pastore, Valeria, Massafra, Roberta, Liparoti, Arianna, Muheberimana, Toussaint, Giommi, Alessandro, Bianco, Rosaria, Chitani, Grazia Eliana, Bobbio, Chiara, De Matteis, Irene, Bonomi, Angelo Bianchi, Gualtierotti, Roberta, Ferrari, Barbara, Rossio, Raffaella, Boasi, Nadia, Pagliaro, Erica, Massimo, Costanza, De Caro, Michele, Giachi, Andrea, Montano, Nicola, Vigone, Barbara, Bellocchi, Chiara, Carandina, Angelica, Fiorelli, Elisa, Melli, Valerie, Tobaldini, Eleonora, Blasi, Francesco, Aliberti, Stefano, Spotti, Maura, Terranova, Leonardo, Misuraca, Sofia, D’Adda, Alice, Della Fiore, Silvia, Di Pasquale, Marta, Mantero. , Marco, Contarini, Martina, Ori, Margherita, Morlacchi, Letizia, Rossetti, Valeria, Gramegna, Andrea, Pappalettera, Maria, Cavallini, Mirta, Buscemi, Agata, Vicenzi, Marco, Rota, Irena, Costantino, Giorgio, Solbiati, Monica, Furlan, Ludovico, Mancarella, Marta, Colombo, Giulia, Colombo, Giorgio, Fanin, Alice, Passarella, Mariele, Monzani, Valter, Canetta, Ciro, Rovellini, Angelo, Barbetta, Laura, Billi, Filippo, Folli, Christian, Accordino, Silvia, Maira, Diletta, Hu, Cinzia Maria, Motta, Irene, Scaramellini, Natalia, Fracanzani, Anna Ludovica, Lombardi, Rosa, Cespiati, Annalisa, Cesari, Matteo, Lucchi, Tiziano, Proietti, Marco, Calcaterra, Laura, Mandelli, Clara, Coppola, Carlotta, Cerizza, Arturo, Pesenti, Antonio Maria, Grasselli, Giacomo, Galazzi, Alessandro, Nobili. , Alessandro, Monti, Igor, Galbussera, Alessia Antonella, Crisafulli, Ernesto, Girelli, Domenico, Maroccia, Alessio, Gabbiani, Daniele, Busti, Fabiana, Vianello, Alice, Biondan, Marta, Sartori, Filippo, Faverio, Paola, Pesci, Alberto, Zucchetti, Stefano, Bonfanti, Paolo, Rossi, Marianna, Beretta, Ilaria, Spolti, Anna, Harari, Sergio, Elia, Davide, Cassandro, Roberto, Caminati, Antonella, Cipollone, Francesco, Guagnano, Maria Teresa, D’Ardes, Damiano, Rossi, Ilaria, Vezzani, Francesca, Spanevello, Antonio, Cherubino, Francesca, Visca, Dina, Contoli, Marco, Papi, Alberto, Morandi, Luca, Battistini, Nicholas, Moreo, Guido Luigi, Iannuzzi, Pasqualina, Fumagalla, Daniele, Leone, Sara, Lombardi, A, Villa, S, Colaneri, M, Scaglione, G, Bai, F, Varisco, B, Bono, V, Vena, A, Dentone, C, Russo, C, Tettamanti, M, Renisi, G, Viero, G, Azzarà, C, Mantero, M, Peyvandi, F, Bassetti, M, Marchetti, G, Muscatello, A, Nobili, A, Gori, A, Bandera, A, Bosari, S, Scudeller, L, Fusetti, G, Rusconi, L, Dell’Orto, S, Prati, D, Valenti, L, Giovannelli, S, Manunta, M, Lamorte, G, Ferarri, F, Gori., A, Mangioni, D, Alagna, L, Bozzi, G, Lombardi., A, Ungaro, R, Ancona, G, Mussa, M, Mariani, B, Bolis, M, Iannotti, N, Ludovisi, S, Comelli, A, Biscarini, S, Castelli, V, Palomba, E, Fava, M, Peri, C, Saltini, P, Itri, T, Ferroni, V, Pastore, V, Massafra, R, Liparoti, A, Muheberimana, T, Giommi, A, Bianco, R, Chitani, G, Bobbio, C, De Matteis, I, Bonomi, A, Gualtierotti, R, Ferrari, B, Rossio, R, Boasi, N, Pagliaro, E, Massimo, C, De Caro, M, Giachi, A, Montano, N, Vigone, B, Bellocchi, C, Carandina, A, Fiorelli, E, Melli, V, Tobaldini, E, Blasi, F, Aliberti, S, Spotti, M, Terranova, L, Misuraca, S, D’Adda, A, Della Fiore, S, Di Pasquale, M, Mantero., M, Contarini, M, Ori, M, Morlacchi, L, Rossetti, V, Gramegna, A, Pappalettera, M, Cavallini, M, Buscemi, A, Vicenzi, M, Rota, I, Costantino, G, Solbiati, M, Furlan, L, Mancarella, M, Colombo, G, Fanin, A, Passarella, M, Monzani, V, Canetta, C, Rovellini, A, Barbetta, L, Billi, F, Folli, C, Accordino, S, Maira, D, Hu, C, Motta, I, Scaramellini, N, Fracanzani, A, Lombardi, R, Cespiati, A, Cesari, M, Lucchi, T, Proietti, M, Calcaterra, L, Mandelli, C, Coppola, C, Cerizza, A, Pesenti, A, Grasselli, G, Galazzi, A, Nobili., A, Monti, I, Galbussera, A, Crisafulli, E, Girelli, D, Maroccia, A, Gabbiani, D, Busti, F, Vianello, A, Biondan, M, Sartori, F, Faverio, P, Pesci, A, Zucchetti, S, Bonfanti, P, Rossi, M, Beretta, I, Spolti, A, Harari, S, Elia, D, Cassandro, R, Caminati, A, Cipollone, F, Guagnano, M, D’Ardes, D, Rossi, I, Vezzani, F, Spanevello, A, Cherubino, F, Visca, D, Contoli, M, Papi, A, Morandi, L, Battistini, N, Moreo, G, Iannuzzi, P, Fumagalla, D, Leone, S, Lombardi, Andrea, Villa, Simone, Colaneri, Marta, Scaglione, Giovanni, Bai, Francesca, Varisco, Benedetta, Bono, Valeria, Vena, Antonio, Dentone, Chiara, Russo, Chiara, Tettamanti, Mauro, Renisi, Giulia, Viero, Giulia, Azzarà, Cecilia, Mantero, Marco, Peyvandi, Flora, Bassetti, Matteo, Marchetti, Giulia, Muscatello, Antonio, Nobili, Alessandro, Gori, Andrea, Bandera, Alessandra, Bosari, Silvano, Scudeller, Luigia, Fusetti, Giuliana, Rusconi, Laura, Dell’Orto, Silvia, Prati, Daniele, Valenti, Luca, Giovannelli, Silvia, Manunta, Maria, Lamorte, Giuseppe, Ferarri, Francesca, Gori. , Andrea, Mangioni, Davide, Alagna, Laura, Bozzi, Giorgio, Lombardi. , Andrea, Ungaro, Riccardo, Ancona, Giuseppe, Mussa, Marco, Mariani, Bianca Veronica, Bolis, Matteo, Iannotti, Nathalie, Ludovisi, Serena, Comelli, Agnese, Biscarini, Simona, Castelli, Valeria, Palomba, Emanuele, Fava, Marco, Peri, Carlo Alberto, Saltini, Paola, Itri, Teresa, Ferroni, Valentina, Pastore, Valeria, Massafra, Roberta, Liparoti, Arianna, Muheberimana, Toussaint, Giommi, Alessandro, Bianco, Rosaria, Chitani, Grazia Eliana, Bobbio, Chiara, De Matteis, Irene, Bonomi, Angelo Bianchi, Gualtierotti, Roberta, Ferrari, Barbara, Rossio, Raffaella, Boasi, Nadia, Pagliaro, Erica, Massimo, Costanza, De Caro, Michele, Giachi, Andrea, Montano, Nicola, Vigone, Barbara, Bellocchi, Chiara, Carandina, Angelica, Fiorelli, Elisa, Melli, Valerie, Tobaldini, Eleonora, Blasi, Francesco, Aliberti, Stefano, Spotti, Maura, Terranova, Leonardo, Misuraca, Sofia, D’Adda, Alice, Della Fiore, Silvia, Di Pasquale, Marta, Mantero. , Marco, Contarini, Martina, Ori, Margherita, Morlacchi, Letizia, Rossetti, Valeria, Gramegna, Andrea, Pappalettera, Maria, Cavallini, Mirta, Buscemi, Agata, Vicenzi, Marco, Rota, Irena, Costantino, Giorgio, Solbiati, Monica, Furlan, Ludovico, Mancarella, Marta, Colombo, Giulia, Colombo, Giorgio, Fanin, Alice, Passarella, Mariele, Monzani, Valter, Canetta, Ciro, Rovellini, Angelo, Barbetta, Laura, Billi, Filippo, Folli, Christian, Accordino, Silvia, Maira, Diletta, Hu, Cinzia Maria, Motta, Irene, Scaramellini, Natalia, Fracanzani, Anna Ludovica, Lombardi, Rosa, Cespiati, Annalisa, Cesari, Matteo, Lucchi, Tiziano, Proietti, Marco, Calcaterra, Laura, Mandelli, Clara, Coppola, Carlotta, Cerizza, Arturo, Pesenti, Antonio Maria, Grasselli, Giacomo, Galazzi, Alessandro, Nobili. , Alessandro, Monti, Igor, Galbussera, Alessia Antonella, Crisafulli, Ernesto, Girelli, Domenico, Maroccia, Alessio, Gabbiani, Daniele, Busti, Fabiana, Vianello, Alice, Biondan, Marta, Sartori, Filippo, Faverio, Paola, Pesci, Alberto, Zucchetti, Stefano, Bonfanti, Paolo, Rossi, Marianna, Beretta, Ilaria, Spolti, Anna, Harari, Sergio, Elia, Davide, Cassandro, Roberto, Caminati, Antonella, Cipollone, Francesco, Guagnano, Maria Teresa, D’Ardes, Damiano, Rossi, Ilaria, Vezzani, Francesca, Spanevello, Antonio, Cherubino, Francesca, Visca, Dina, Contoli, Marco, Papi, Alberto, Morandi, Luca, Battistini, Nicholas, Moreo, Guido Luigi, Iannuzzi, Pasqualina, Fumagalla, Daniele, and Leone, Sara

Abstract

Background: Despite the well-known efficacy of anti-COVID-19 vaccines in preventing morbidity and mortality, several vaccinated individuals are diagnosed with SARS-CoV-2 breakthrough infection, which might require hospitalisation. This multicentre, observational, and retrospective study aimed to investigate the clinical characteristics and outcomes of vaccinated vs. non-vaccinated patients, both hospitalised with SARS-CoV-2 infection in 3 major hospitals in Northern Italy. Methods: Data collection was retrospective, and paper and electronic medical records of adult patients with a diagnosed SARS-CoV-2 infection were pseudo-anonymised and analysed. Vaccinated and non-vaccinated individuals were manually paired, using a predetermined matching criterion (similar age, gender, and date of hospitalisation). Demographic, clinical, treatment, and outcome data were compared between groups differing by vaccination status using Pearson's Chi-square and Mann-Whitney tests. Moreover, multiple logistic regression analyses were performed to assess the impact of vaccination status on ICU admission or intra-hospital mortality. Results: Data from 360 patients were collected. Vaccinated patients presented with a higher prevalence of relevant comorbidities, like kidney replacement therapy or haematological malignancy, despite a milder clinical presentation at the first evaluation. Non-vaccinated patients required intensive care more often than their vaccinated counterparts (8.8% vs. 1.7%, p = 0.002). Contrariwise, no difference in intra-hospital mortality was observed between the two groups (19% vs. 20%, p = 0.853). These results were confirmed by multivariable logistic regressions, which showed that vaccination was significantly associated with decreased risk of ICU admission (aOR=0.172, 95%CI: 0.039–0.542, p = 0.007), but not of intra-hospital mortality (aOR=0.996, 95%CI: 0.582–1.703, p = 0.987). Conclusions: This study provides real-world data on vaccinated patients hospitalised wit

Published
2024

2. External validation of risk scores to predict in-hospital mortality in patients hospitalized due to coronavirus disease 2019

Author

Hassan, S, Ramspek, C, Ferrari, B, van Diepen, M, Rossio, R, Knevel, R, la Mura, V, Artoni, A, Martinelli, I, Bandera, A, Nobili, A, Gori, A, Blasi, F, Canetta, C, Montano, N, Rosendaal, F, Peyvandi, F, Bosari, S, Scudeller, L, Fusetti, G, Rusconi, L, Dell'Orto, S, Prati, D, Valenti, L, Giovannelli, S, Manunta, M, Lamorte, G, Ferarri, F, Muscatello, A, Mangioni, D, Alagna, L, Bozzi, G, Lombardi, A, Ungaro, R, Ancona, G, Zuglian, G, Bolis, M, Iannotti, N, Ludovisi, S, Comelli, A, Renisi, G, Biscarini, S, Castelli, V, Palomba, E, Fava, M, Fortina, V, Peri, C, Saltini, P, Viero, G, Itri, T, Ferroni, V, Pastore, V, Massafra, R, Liparoti, A, Muheberimana, T, Giommi, A, Bianco, R, De Azevedo, R, Chitani, G, Gualtierotti, R, Boasi, N, Pagliaro, E, Massimo, C, De Caro, M, Giachi, A, Vigone, B, Bellocchi, C, Carandina, A, Fiorelli, E, Melli, V, Tobaldini, E, Aliberti, S, Spotti, M, Terranova, L, Misuraca, S, D'Adda, A, Fiore, S, Di Pasquale, M, Mantero, M, Contarini, M, Ori, M, Morlacchi, L, Rossetti, V, Gramegna, A, Pappalettera, M, Cavallini, M, Buscemi, A, Vicenzi, M, Rota, I, Costantino, G, Solbiati, M, Furlan, L, Mancarella, M, Colombo, G, Fanin, A, Passarella, M, Monzani, V, Rovellini, A, Barbetta, L, Billi, F, Folli, C, Accordino, S, Maira, D, Hu, C, Motta, I, Scar-Amellini, N, Fracanzani, A, Lombardi, R, Cespiati, A, Cesari, M, Lucchi, T, Proietti, M, Calcaterra, L, Mandelli, C, Coppola, C, Cerizza, A, Maria Pesenti, A, Grasselli, G, Galazzi, A, Tet-Tamanti, M, Monti, I, Galbussera, A, Crisafulli, E, Girelli, D, Maroccia, A, Gabbiani, D, Busti, F, Vianello, A, Biondan, M, Sartori, F, Faverio, P, Pesci, A, Zucchetti, S, Bonfanti, P, Rossi, M, Beretta, I, Spolti, A, Harari, S, Elia, D, Cassandro, R, Caminati, A, Cipollone, F, Guagnano, M, D'Ardes, D, Rossi, I, Vezzani, F, Spanevello, A, Cherubino, F, Visca, D, Contoli, M, Papi, A, Morandi, L, Battistini, N, Luigi Moreo, G, Iannuzzi, P, Fumagalli, D, Leone, S, Oud, J, Baysan, M, Wigb, J, van Heurn, L, ter Haar, S, Toppenberg, A, Heerdink, L, van IJlzinga Veenstra, A, Eikenboom, A, Wubbolts, J, Uzorka, J, Lijferink, W, Meier, R, de Jonge, I, Arbous, S, de Boer, M, van der Bom, J, Dekkers, O, Hassan S., Ramspek C. L., Ferrari B., van Diepen M., Rossio R., Knevel R., la Mura V., Artoni A., Martinelli I., Bandera A., Nobili A., Gori A., Blasi F., Canetta C., Montano N., Rosendaal F. R., Peyvandi F., Bosari S., Scudeller L., Fusetti G., Rusconi L., Dell'Orto S., Prati D., Valenti L., Giovannelli S., Manunta M., Lamorte G., Ferarri F., Muscatello A., Mangioni D., Alagna L., Bozzi G., Lombardi A., Ungaro R., Ancona G., Zuglian G., Bolis M., Iannotti N., Ludovisi S., Comelli A., Renisi G., Biscarini S., Castelli V., Palomba E., Fava M., Fortina V., Peri C. A., Saltini P., Viero G., Itri T., Ferroni V., Pastore V., Massafra R., Liparoti A., Muheberimana T., Giommi A., Bianco R., De Azevedo R. M., Chitani G. E., Gualtierotti R., Boasi N., Pagliaro E., Massimo C., De Caro M., Giachi A., Vigone B., Bellocchi C., Carandina A., Fiorelli E., Melli V., Tobaldini E., Aliberti S., Spotti M., Terranova L., Misuraca S., D'Adda A., Fiore S. D., Di Pasquale M., Mantero M., Contarini M., Ori M., Morlacchi L., Rossetti V., Gramegna A., Pappalettera M., Cavallini M., Buscemi A., Vicenzi M., Rota I., Costantino G., Solbiati M., Furlan L., Mancarella M., Colombo G., Fanin A., Passarella M., Monzani V., Rovellini A., Barbetta L., Billi F., Folli C., Accordino S., Maira D., Hu C. M., Motta I., Scar-Amellini N., Fracanzani A. L., Lombardi R., Cespiati A., Cesari M., Lucchi T., Proietti M., Calcaterra L., Mandelli C., Coppola C., Cerizza A., Maria Pesenti A., Grasselli G., Galazzi A., Tet-Tamanti M., Monti I., Galbussera A. A., Crisafulli E., Girelli D., Maroccia A., Gabbiani D., Busti F., Vianello A., Biondan M., Sartori F., Faverio P., Pesci A., Zucchetti S., Bonfanti P., Rossi M., Beretta I., Spolti A., Harari S., Elia D., Cassandro R., Caminati A., Cipollone F., Guagnano M. T., D'Ardes D., Rossi I., Vezzani F., Spanevello A., Cherubino F., Visca D., Contoli M., Papi A., Morandi L., Battistini N., Luigi Moreo G., Iannuzzi P., Fumagalli D., Leone S., Oud J. A., Baysan M., Wigb J., van Heurn L. J., ter Haar S. B., Toppenberg A. G. L., Heerdink L., van IJlzinga Veenstra A. A., Eikenboom A. M., Wubbolts J., Uzorka J., Lijferink W., Meier R., de Jonge I. -B., Arbous S. M., de Boer M. G. J., van der Bom J. G., Dekkers O. M., Hassan, S, Ramspek, C, Ferrari, B, van Diepen, M, Rossio, R, Knevel, R, la Mura, V, Artoni, A, Martinelli, I, Bandera, A, Nobili, A, Gori, A, Blasi, F, Canetta, C, Montano, N, Rosendaal, F, Peyvandi, F, Bosari, S, Scudeller, L, Fusetti, G, Rusconi, L, Dell'Orto, S, Prati, D, Valenti, L, Giovannelli, S, Manunta, M, Lamorte, G, Ferarri, F, Muscatello, A, Mangioni, D, Alagna, L, Bozzi, G, Lombardi, A, Ungaro, R, Ancona, G, Zuglian, G, Bolis, M, Iannotti, N, Ludovisi, S, Comelli, A, Renisi, G, Biscarini, S, Castelli, V, Palomba, E, Fava, M, Fortina, V, Peri, C, Saltini, P, Viero, G, Itri, T, Ferroni, V, Pastore, V, Massafra, R, Liparoti, A, Muheberimana, T, Giommi, A, Bianco, R, De Azevedo, R, Chitani, G, Gualtierotti, R, Boasi, N, Pagliaro, E, Massimo, C, De Caro, M, Giachi, A, Vigone, B, Bellocchi, C, Carandina, A, Fiorelli, E, Melli, V, Tobaldini, E, Aliberti, S, Spotti, M, Terranova, L, Misuraca, S, D'Adda, A, Fiore, S, Di Pasquale, M, Mantero, M, Contarini, M, Ori, M, Morlacchi, L, Rossetti, V, Gramegna, A, Pappalettera, M, Cavallini, M, Buscemi, A, Vicenzi, M, Rota, I, Costantino, G, Solbiati, M, Furlan, L, Mancarella, M, Colombo, G, Fanin, A, Passarella, M, Monzani, V, Rovellini, A, Barbetta, L, Billi, F, Folli, C, Accordino, S, Maira, D, Hu, C, Motta, I, Scar-Amellini, N, Fracanzani, A, Lombardi, R, Cespiati, A, Cesari, M, Lucchi, T, Proietti, M, Calcaterra, L, Mandelli, C, Coppola, C, Cerizza, A, Maria Pesenti, A, Grasselli, G, Galazzi, A, Tet-Tamanti, M, Monti, I, Galbussera, A, Crisafulli, E, Girelli, D, Maroccia, A, Gabbiani, D, Busti, F, Vianello, A, Biondan, M, Sartori, F, Faverio, P, Pesci, A, Zucchetti, S, Bonfanti, P, Rossi, M, Beretta, I, Spolti, A, Harari, S, Elia, D, Cassandro, R, Caminati, A, Cipollone, F, Guagnano, M, D'Ardes, D, Rossi, I, Vezzani, F, Spanevello, A, Cherubino, F, Visca, D, Contoli, M, Papi, A, Morandi, L, Battistini, N, Luigi Moreo, G, Iannuzzi, P, Fumagalli, D, Leone, S, Oud, J, Baysan, M, Wigb, J, van Heurn, L, ter Haar, S, Toppenberg, A, Heerdink, L, van IJlzinga Veenstra, A, Eikenboom, A, Wubbolts, J, Uzorka, J, Lijferink, W, Meier, R, de Jonge, I, Arbous, S, de Boer, M, van der Bom, J, Dekkers, O, Hassan S., Ramspek C. L., Ferrari B., van Diepen M., Rossio R., Knevel R., la Mura V., Artoni A., Martinelli I., Bandera A., Nobili A., Gori A., Blasi F., Canetta C., Montano N., Rosendaal F. R., Peyvandi F., Bosari S., Scudeller L., Fusetti G., Rusconi L., Dell'Orto S., Prati D., Valenti L., Giovannelli S., Manunta M., Lamorte G., Ferarri F., Muscatello A., Mangioni D., Alagna L., Bozzi G., Lombardi A., Ungaro R., Ancona G., Zuglian G., Bolis M., Iannotti N., Ludovisi S., Comelli A., Renisi G., Biscarini S., Castelli V., Palomba E., Fava M., Fortina V., Peri C. A., Saltini P., Viero G., Itri T., Ferroni V., Pastore V., Massafra R., Liparoti A., Muheberimana T., Giommi A., Bianco R., De Azevedo R. M., Chitani G. E., Gualtierotti R., Boasi N., Pagliaro E., Massimo C., De Caro M., Giachi A., Vigone B., Bellocchi C., Carandina A., Fiorelli E., Melli V., Tobaldini E., Aliberti S., Spotti M., Terranova L., Misuraca S., D'Adda A., Fiore S. D., Di Pasquale M., Mantero M., Contarini M., Ori M., Morlacchi L., Rossetti V., Gramegna A., Pappalettera M., Cavallini M., Buscemi A., Vicenzi M., Rota I., Costantino G., Solbiati M., Furlan L., Mancarella M., Colombo G., Fanin A., Passarella M., Monzani V., Rovellini A., Barbetta L., Billi F., Folli C., Accordino S., Maira D., Hu C. M., Motta I., Scar-Amellini N., Fracanzani A. L., Lombardi R., Cespiati A., Cesari M., Lucchi T., Proietti M., Calcaterra L., Mandelli C., Coppola C., Cerizza A., Maria Pesenti A., Grasselli G., Galazzi A., Tet-Tamanti M., Monti I., Galbussera A. A., Crisafulli E., Girelli D., Maroccia A., Gabbiani D., Busti F., Vianello A., Biondan M., Sartori F., Faverio P., Pesci A., Zucchetti S., Bonfanti P., Rossi M., Beretta I., Spolti A., Harari S., Elia D., Cassandro R., Caminati A., Cipollone F., Guagnano M. T., D'Ardes D., Rossi I., Vezzani F., Spanevello A., Cherubino F., Visca D., Contoli M., Papi A., Morandi L., Battistini N., Luigi Moreo G., Iannuzzi P., Fumagalli D., Leone S., Oud J. A., Baysan M., Wigb J., van Heurn L. J., ter Haar S. B., Toppenberg A. G. L., Heerdink L., van IJlzinga Veenstra A. A., Eikenboom A. M., Wubbolts J., Uzorka J., Lijferink W., Meier R., de Jonge I. -B., Arbous S. M., de Boer M. G. J., van der Bom J. G., and Dekkers O. M.

Abstract

Background: The coronavirus disease 2019 (COVID-19) presents an urgent threat to global health. Prediction models that accurately estimate mortality risk in hospitalized patients could assist medical staff in treatment and allocating limited resources. Aims: To externally validate two promising previously published risk scores that predict in-hospital mortality among hospitalized COVID-19 patients. Methods: Two prospective cohorts were available; a cohort of 1028 patients admitted to one of nine hospitals in Lombardy, Italy (the Lombardy cohort) and a cohort of 432 patients admitted to a hospital in Leiden, the Netherlands (the Leiden cohort). The endpoint was in-hospital mortality. All patients were adult and tested COVID-19 PCR-positive. Model discrimination and calibration were assessed. Results: The C-statistic of the 4C mortality score was good in the Lombardy cohort (0.85, 95CI: 0.82−0.89) and in the Leiden cohort (0.87, 95CI: 0.80−0.94). Model calibration was acceptable in the Lombardy cohort but poor in the Leiden cohort due to the model systematically overpredicting the mortality risk for all patients. The C-statistic of the CURB-65 score was good in the Lombardy cohort (0.80, 95CI: 0.75−0.85) and in the Leiden cohort (0.82, 95CI: 0.76−0.88). The mortality rate in the CURB-65 development cohort was much lower than the mortality rate in the Lombardy cohort. A similar but less pronounced trend was found for patients in the Leiden cohort. Conclusion: Although performances did not differ greatly, the 4C mortality score showed the best performance. However, because of quickly changing circumstances, model recalibration may be necessary before using the 4C mortality score.

Published
2022

3. Clinical factors associated with death in 3044 COVID-19 patients managed in internal medicine wards in Italy: comment

Author

Bandera, A, Nobili, A, Tettamanti, M, Harari, S, Bosari, S, Mannucci, P, Scudeller, L, Fusetti, G, Rusconi, L, Dell'Orto, S, Prati, D, Valenti, L, Giovannelli, S, Manunta, M, Lamorte, G, Ferrari, F, Gori, A, Muscatello, A, Mangioni, D, Alagna, L, Bozzi, G, Lombardi, A, Ungaro, R, Ancona, G, Zuglian, G, Bolis, M, Iannotti, N, Ludovisi, S, Comelli, A, Renisi, G, Biscarini, S, Castelli, V, Palomba, E, Fava, M, Fortina, V, Peri, C, Saltini, P, Viero, G, Itri, T, Ferroni, V, Pastore, V, Massafra, R, Liparoti, A, Muheberimana, T, Giommi, A, Bianco, R, De Azevedo, R, Chitani, G, Peyvandi, F, Gualtierotti, R, Ferrari, B, Rossio, R, Boasi, N, Pagliaro, E, Massimo, C, De Caro, M, Montano, N, Vigone, B, Bellocchi, C, Carandina, A, Fiorelli, E, Melli, V, Tobaldini, E, Blasi, F, Aliberti, S, Spotti, M, Terranova, L, Misuraca, S, D'Adda, A, Della Fiore, S, Di Pasquale, M, Contarini, M, Ori, M, Morlacchi, L, Rossetti, V, Gramegna, A, Pappalettera, M, Cavallini, M, Buscemi, A, Vicenzi, M, Rota, I, Costantino, G, Solbiati, M, Furlan, L, Mancarella, M, Colombo, G, Fanin, A, Passarella, M, Monzani, V, Canetta, C, Rovellini, A, Barbetta, L, Billi, F, Folli, C, Accordino, S, Maira, D, Hu, C, Motta, I, Scaramellini, N, Fracanzani, A, Lombardi, R, Cespiati, A, Cesari, M, Lucchi, T, Proietti, M, Calcaterra, L, Mandelli, C, Coppola, C, Cerizza, A, Pesenti, A, Grasselli, G, Galazzi, A, Monti, I, Galbussera, A, Crisafulli, E, Girelli, D, Maroccia, A, Gabbiani, D, Busti, F, Vianello, A, Biondan, M, Sartori, F, Faverio, P, Pesci, A, Zucchetti, S, Bonfanti, P, Rossi, M, Beretta, I, Spolti, A, Elia, D, Cassandro, R, Caminati, A, Cipollone, F, Guagnano, M, D'Ardes, D, Rossi, I, Vezzani, F, Spanevello, A, Cherubino, F, Visca, D, Contoli, M, Papi, A, Morandi, L, Battistini, N, Moreo, G, Iannuzzi, P, Fumagalli, D, Leone, S, Bandera A., Nobili A., Tettamanti M., Harari S., Bosari S., Mannucci P. M., Scudeller L., Fusetti G., Rusconi L., Dell'Orto S., Prati D., Valenti L., Giovannelli S., Manunta M., Lamorte G., Ferrari F., Gori A., Muscatello A., Mangioni D., Alagna L., Bozzi G., Lombardi A., Ungaro R., Ancona G., Zuglian G., Bolis M., Iannotti N., Ludovisi S., Comelli A., Renisi G., Biscarini S., Castelli V., Palomba E., Fava M., Fortina V., Peri C. A., Saltini P., Viero G., Itri T., Ferroni V., Pastore V., Massafra R., Liparoti A., Muheberimana T., Giommi A., Bianco R., De Azevedo R. M., Chitani G. E., Peyvandi F., Gualtierotti R., Ferrari B., Rossio R., Boasi N., Pagliaro E., Massimo C., De Caro M., Montano N., Vigone B., Bellocchi C., Carandina A., Fiorelli E., Melli V., Tobaldini E., Blasi F., Aliberti S., Spotti M., Terranova L., Misuraca S., D'Adda A., Della Fiore S., Di Pasquale M., Contarini M. M. M., Ori M., Morlacchi L., Rossetti V., Gramegna A., Pappalettera M., Cavallini M., Buscemi A., Vicenzi M., Rota I., Costantino G., Solbiati M., Furlan L., Mancarella M., Colombo G., Fanin A., Passarella M., Monzani V., Canetta C., Rovellini A., Barbetta L., Billi F., Folli C., Accordino S., Maira D., Hu C. M., Motta I., Scaramellini N., Fracanzani A. L., Lombardi R., Cespiati A., Cesari M., Lucchi T., Proietti M., Calcaterra L., Mandelli C., Coppola C., Cerizza A., Pesenti A. M., Grasselli G., Galazzi A., Monti I., Galbussera A. A., Crisafulli E., Girelli D., Maroccia A., Gabbiani D., Busti F., Vianello A., Biondan M., Sartori F., Faverio P., Pesci A., Zucchetti S., Bonfanti P., Rossi M., Beretta I., Spolti A., Elia D., Cassandro R., Caminati A., Cipollone F., Guagnano M. T., D'Ardes D., Rossi I., Vezzani F., Spanevello A., Cherubino F., Visca D., Contoli M., Papi A., Morandi L., Battistini N., Moreo G. L., Iannuzzi P., Fumagalli D., Leone S., Bandera, A, Nobili, A, Tettamanti, M, Harari, S, Bosari, S, Mannucci, P, Scudeller, L, Fusetti, G, Rusconi, L, Dell'Orto, S, Prati, D, Valenti, L, Giovannelli, S, Manunta, M, Lamorte, G, Ferrari, F, Gori, A, Muscatello, A, Mangioni, D, Alagna, L, Bozzi, G, Lombardi, A, Ungaro, R, Ancona, G, Zuglian, G, Bolis, M, Iannotti, N, Ludovisi, S, Comelli, A, Renisi, G, Biscarini, S, Castelli, V, Palomba, E, Fava, M, Fortina, V, Peri, C, Saltini, P, Viero, G, Itri, T, Ferroni, V, Pastore, V, Massafra, R, Liparoti, A, Muheberimana, T, Giommi, A, Bianco, R, De Azevedo, R, Chitani, G, Peyvandi, F, Gualtierotti, R, Ferrari, B, Rossio, R, Boasi, N, Pagliaro, E, Massimo, C, De Caro, M, Montano, N, Vigone, B, Bellocchi, C, Carandina, A, Fiorelli, E, Melli, V, Tobaldini, E, Blasi, F, Aliberti, S, Spotti, M, Terranova, L, Misuraca, S, D'Adda, A, Della Fiore, S, Di Pasquale, M, Contarini, M, Ori, M, Morlacchi, L, Rossetti, V, Gramegna, A, Pappalettera, M, Cavallini, M, Buscemi, A, Vicenzi, M, Rota, I, Costantino, G, Solbiati, M, Furlan, L, Mancarella, M, Colombo, G, Fanin, A, Passarella, M, Monzani, V, Canetta, C, Rovellini, A, Barbetta, L, Billi, F, Folli, C, Accordino, S, Maira, D, Hu, C, Motta, I, Scaramellini, N, Fracanzani, A, Lombardi, R, Cespiati, A, Cesari, M, Lucchi, T, Proietti, M, Calcaterra, L, Mandelli, C, Coppola, C, Cerizza, A, Pesenti, A, Grasselli, G, Galazzi, A, Monti, I, Galbussera, A, Crisafulli, E, Girelli, D, Maroccia, A, Gabbiani, D, Busti, F, Vianello, A, Biondan, M, Sartori, F, Faverio, P, Pesci, A, Zucchetti, S, Bonfanti, P, Rossi, M, Beretta, I, Spolti, A, Elia, D, Cassandro, R, Caminati, A, Cipollone, F, Guagnano, M, D'Ardes, D, Rossi, I, Vezzani, F, Spanevello, A, Cherubino, F, Visca, D, Contoli, M, Papi, A, Morandi, L, Battistini, N, Moreo, G, Iannuzzi, P, Fumagalli, D, Leone, S, Bandera A., Nobili A., Tettamanti M., Harari S., Bosari S., Mannucci P. M., Scudeller L., Fusetti G., Rusconi L., Dell'Orto S., Prati D., Valenti L., Giovannelli S., Manunta M., Lamorte G., Ferrari F., Gori A., Muscatello A., Mangioni D., Alagna L., Bozzi G., Lombardi A., Ungaro R., Ancona G., Zuglian G., Bolis M., Iannotti N., Ludovisi S., Comelli A., Renisi G., Biscarini S., Castelli V., Palomba E., Fava M., Fortina V., Peri C. A., Saltini P., Viero G., Itri T., Ferroni V., Pastore V., Massafra R., Liparoti A., Muheberimana T., Giommi A., Bianco R., De Azevedo R. M., Chitani G. E., Peyvandi F., Gualtierotti R., Ferrari B., Rossio R., Boasi N., Pagliaro E., Massimo C., De Caro M., Montano N., Vigone B., Bellocchi C., Carandina A., Fiorelli E., Melli V., Tobaldini E., Blasi F., Aliberti S., Spotti M., Terranova L., Misuraca S., D'Adda A., Della Fiore S., Di Pasquale M., Contarini M. M. M., Ori M., Morlacchi L., Rossetti V., Gramegna A., Pappalettera M., Cavallini M., Buscemi A., Vicenzi M., Rota I., Costantino G., Solbiati M., Furlan L., Mancarella M., Colombo G., Fanin A., Passarella M., Monzani V., Canetta C., Rovellini A., Barbetta L., Billi F., Folli C., Accordino S., Maira D., Hu C. M., Motta I., Scaramellini N., Fracanzani A. L., Lombardi R., Cespiati A., Cesari M., Lucchi T., Proietti M., Calcaterra L., Mandelli C., Coppola C., Cerizza A., Pesenti A. M., Grasselli G., Galazzi A., Monti I., Galbussera A. A., Crisafulli E., Girelli D., Maroccia A., Gabbiani D., Busti F., Vianello A., Biondan M., Sartori F., Faverio P., Pesci A., Zucchetti S., Bonfanti P., Rossi M., Beretta I., Spolti A., Elia D., Cassandro R., Caminati A., Cipollone F., Guagnano M. T., D'Ardes D., Rossi I., Vezzani F., Spanevello A., Cherubino F., Visca D., Contoli M., Papi A., Morandi L., Battistini N., Moreo G. L., Iannuzzi P., Fumagalli D., and Leone S.

Published
2022

4. Clinical risk scores for the early prediction of severe outocomes in patients hospitalized for COVID-19: comment

Author

Rossio, R, Tettamanti, M, Nobili, A, Harari, S, Mannucci, P, Bandera, A, Peyvandi, F, Bosari, S, Scudeller, L, Fusetti, G, Rusconi, L, Dell'Orto, S, Prati, D, Valenti, L, Giovannelli, S, Manunta, M, Lamorte, G, Ferrari, F, Gori, A, Muscatello, A, Mangioni, D, Alagna, L, Bozzi, G, Lombardi, A, Ungaro, R, Ancona, G, Zuglian, G, Bolis, M, Iannotti, N, Ludovisi, S, Comelli, A, Renisi, G, Biscarini, S, Castelli, V, Palomba, E, Fava, M, Fortina, V, Peri, C, Saltini, P, Viero, G, Itri, T, Ferroni, V, Pastore, V, Massafra, R, Liparoti, A, Muheberimana, T, Giommi, A, Bianco, R, De Azevedo, R, Chitani, G, Gualtierotti, R, Ferrari, B, Boasi, N, Pagliaro, E, Massimo, C, De Caro, M, Giachi, A, Montano, N, Vigone, B, Bellocchi, C, Carandina, A, Fiorelli, E, Melli, V, Tobaldini, E, Blasi, F, Aliberti, S, Spotti, M, Terranova, L, Misuraca, S, D'Adda, A, Fiore, S, Di Pasquale, M, Mantero, M, Contarini, M, Ori, M, Morlacchi, L, Rossetti, V, Gramegna, A, Pappalettera, M, Cavallini, M, Buscemi, A, Vicenzi, M, Rota, I, Costantino, G, Solbiati, M, Furlan, L, Mancarella, M, Colombo, G, Fanin, A, Passarella, M, Monzani, V, Canetta, C, Rovellini, A, Barbetta, L, Billi, F, Folli, C, Accordino, S, Maira, D, Hu, C, Motta, I, Scaramellini, N, Fracanzani, A, Lombardi, R, Cespiati, A, Cesari, M, Lucchi, T, Proietti, M, Calcaterra, L, Mandelli, C, Coppola, C, Cerizza, A, Pesenti, A, Grasselli, G, Galazzi, A, Monti, I, Galbussera, A, Crisafulli, E, Girelli, D, Maroccia, A, Gabbiani, D, Busti, F, Vianello, A, Biondan, M, Sartori, F, Faverio, P, Pesci, A, Zucchetti, S, Bonfanti, P, Rossi, M, Beretta, I, Spolti, A, Elia, D, Cassandro, R, Caminati, A, Cipollone, F, Guagnano, M, D'Ardes, D, Rossi, I, Vezzani, F, Spanevello, A, Cherubino, F, Visca, D, Contoli, M, Papi, A, Morandi, L, Battistini, N, Moreo, G, Iannuzzi, P, Fumagalli, D, Leone, S, Rossio R., Tettamanti M., Nobili A., Harari S., Mannucci P. M., Bandera A., Peyvandi F., Bosari S., Scudeller L., Fusetti G., Rusconi L., Dell'Orto S., Prati D., Valenti L., Giovannelli S., Manunta M., Lamorte G., Ferrari F., Gori A., Muscatello A., Mangioni D., Alagna L., Bozzi G., Lombardi A., Ungaro R., Ancona G., Zuglian G., Bolis M., Iannotti N., Ludovisi S., Comelli A., Renisi G., Biscarini S., Castelli V., Palomba E., Fava M., Fortina V., Peri C. A., Saltini P., Viero G., Itri T., Ferroni V., Pastore V., Massafra R., Liparoti A., Muheberimana T., Giommi A., Bianco R., De Azevedo R. M., Chitani G. E., Gualtierotti R., Ferrari B., Boasi N., Pagliaro E., Massimo C., De Caro M., Giachi A., Montano N., Vigone B., Bellocchi C., Carandina A., Fiorelli E., Melli V., Tobaldini E., Blasi F., Aliberti S., Spotti M., Terranova L., Misuraca S., D'Adda A., Fiore S. D., Di Pasquale M., Mantero M., Contarini M., Ori M., Morlacchi L., Rossetti V., Gramegna A., Pappalettera M., Cavallini M., Buscemi A., Vicenzi M., Rota I., Costantino G., Solbiati M., Furlan L., Mancarella M., Colombo G., Fanin A., Passarella M., Monzani V., Canetta C., Rovellini A., Barbetta L., Billi F., Folli C., Accordino S., Maira D., Hu C. M., Motta I., Scaramellini N., Fracanzani A. L., Lombardi R., Cespiati A., Cesari M., Lucchi T., Proietti M., Calcaterra L., Mandelli C., Coppola C., Cerizza A., Pesenti A. M., Grasselli G., Galazzi A., Monti I., Galbussera A. A., Crisafulli E., Girelli D., Maroccia A., Gabbiani D., Busti F., Vianello A., Biondan M., Sartori F., Faverio P., Pesci A., Zucchetti S., Bonfanti P., Rossi M., Beretta I., Spolti A., Elia D., Cassandro R., Caminati A., Cipollone F., Guagnano M. T., D'Ardes D., Rossi I., Vezzani F., Spanevello A., Cherubino F., Visca D., Contoli M., Papi A., Morandi L., Battistini N., Moreo G. L., Iannuzzi P., Fumagalli D., Leone S., Rossio, R, Tettamanti, M, Nobili, A, Harari, S, Mannucci, P, Bandera, A, Peyvandi, F, Bosari, S, Scudeller, L, Fusetti, G, Rusconi, L, Dell'Orto, S, Prati, D, Valenti, L, Giovannelli, S, Manunta, M, Lamorte, G, Ferrari, F, Gori, A, Muscatello, A, Mangioni, D, Alagna, L, Bozzi, G, Lombardi, A, Ungaro, R, Ancona, G, Zuglian, G, Bolis, M, Iannotti, N, Ludovisi, S, Comelli, A, Renisi, G, Biscarini, S, Castelli, V, Palomba, E, Fava, M, Fortina, V, Peri, C, Saltini, P, Viero, G, Itri, T, Ferroni, V, Pastore, V, Massafra, R, Liparoti, A, Muheberimana, T, Giommi, A, Bianco, R, De Azevedo, R, Chitani, G, Gualtierotti, R, Ferrari, B, Boasi, N, Pagliaro, E, Massimo, C, De Caro, M, Giachi, A, Montano, N, Vigone, B, Bellocchi, C, Carandina, A, Fiorelli, E, Melli, V, Tobaldini, E, Blasi, F, Aliberti, S, Spotti, M, Terranova, L, Misuraca, S, D'Adda, A, Fiore, S, Di Pasquale, M, Mantero, M, Contarini, M, Ori, M, Morlacchi, L, Rossetti, V, Gramegna, A, Pappalettera, M, Cavallini, M, Buscemi, A, Vicenzi, M, Rota, I, Costantino, G, Solbiati, M, Furlan, L, Mancarella, M, Colombo, G, Fanin, A, Passarella, M, Monzani, V, Canetta, C, Rovellini, A, Barbetta, L, Billi, F, Folli, C, Accordino, S, Maira, D, Hu, C, Motta, I, Scaramellini, N, Fracanzani, A, Lombardi, R, Cespiati, A, Cesari, M, Lucchi, T, Proietti, M, Calcaterra, L, Mandelli, C, Coppola, C, Cerizza, A, Pesenti, A, Grasselli, G, Galazzi, A, Monti, I, Galbussera, A, Crisafulli, E, Girelli, D, Maroccia, A, Gabbiani, D, Busti, F, Vianello, A, Biondan, M, Sartori, F, Faverio, P, Pesci, A, Zucchetti, S, Bonfanti, P, Rossi, M, Beretta, I, Spolti, A, Elia, D, Cassandro, R, Caminati, A, Cipollone, F, Guagnano, M, D'Ardes, D, Rossi, I, Vezzani, F, Spanevello, A, Cherubino, F, Visca, D, Contoli, M, Papi, A, Morandi, L, Battistini, N, Moreo, G, Iannuzzi, P, Fumagalli, D, Leone, S, Rossio R., Tettamanti M., Nobili A., Harari S., Mannucci P. M., Bandera A., Peyvandi F., Bosari S., Scudeller L., Fusetti G., Rusconi L., Dell'Orto S., Prati D., Valenti L., Giovannelli S., Manunta M., Lamorte G., Ferrari F., Gori A., Muscatello A., Mangioni D., Alagna L., Bozzi G., Lombardi A., Ungaro R., Ancona G., Zuglian G., Bolis M., Iannotti N., Ludovisi S., Comelli A., Renisi G., Biscarini S., Castelli V., Palomba E., Fava M., Fortina V., Peri C. A., Saltini P., Viero G., Itri T., Ferroni V., Pastore V., Massafra R., Liparoti A., Muheberimana T., Giommi A., Bianco R., De Azevedo R. M., Chitani G. E., Gualtierotti R., Ferrari B., Boasi N., Pagliaro E., Massimo C., De Caro M., Giachi A., Montano N., Vigone B., Bellocchi C., Carandina A., Fiorelli E., Melli V., Tobaldini E., Blasi F., Aliberti S., Spotti M., Terranova L., Misuraca S., D'Adda A., Fiore S. D., Di Pasquale M., Mantero M., Contarini M., Ori M., Morlacchi L., Rossetti V., Gramegna A., Pappalettera M., Cavallini M., Buscemi A., Vicenzi M., Rota I., Costantino G., Solbiati M., Furlan L., Mancarella M., Colombo G., Fanin A., Passarella M., Monzani V., Canetta C., Rovellini A., Barbetta L., Billi F., Folli C., Accordino S., Maira D., Hu C. M., Motta I., Scaramellini N., Fracanzani A. L., Lombardi R., Cespiati A., Cesari M., Lucchi T., Proietti M., Calcaterra L., Mandelli C., Coppola C., Cerizza A., Pesenti A. M., Grasselli G., Galazzi A., Monti I., Galbussera A. A., Crisafulli E., Girelli D., Maroccia A., Gabbiani D., Busti F., Vianello A., Biondan M., Sartori F., Faverio P., Pesci A., Zucchetti S., Bonfanti P., Rossi M., Beretta I., Spolti A., Elia D., Cassandro R., Caminati A., Cipollone F., Guagnano M. T., D'Ardes D., Rossi I., Vezzani F., Spanevello A., Cherubino F., Visca D., Contoli M., Papi A., Morandi L., Battistini N., Moreo G. L., Iannuzzi P., Fumagalli D., and Leone S.

Published
2022

5. Real-life efficacy and safety of nintedanib in systemic sclerosis-interstitial lung disease: data from an Italian multicentre study

Author

Campochiaro, C., De Luca, G., Lazzaroni, M. -G., Armentaro, G., Spinella, A., Vigone, B., Ruaro, B., Stanziola, A., Benfaremo, D., De Lorenzis, E., Moccaldi, B., Bosello, Silvia Laura, Cuomo, G., Beretta, Carlo Luigi, Zanatta, E., Giuggioli, D., Del Papa, N., Airo, P., Confalonieri, Marco, Moroncini, G., Dagna, L., Matucci-Cerinic, M., Bosello S. L. (ORCID:0000-0002-4837-447X), Beretta L. (ORCID:0000-0001-9924-2066), Confalonieri M. (ORCID:0000-0002-3708-379X), Campochiaro, C., De Luca, G., Lazzaroni, M. -G., Armentaro, G., Spinella, A., Vigone, B., Ruaro, B., Stanziola, A., Benfaremo, D., De Lorenzis, E., Moccaldi, B., Bosello, Silvia Laura, Cuomo, G., Beretta, Carlo Luigi, Zanatta, E., Giuggioli, D., Del Papa, N., Airo, P., Confalonieri, Marco, Moroncini, G., Dagna, L., Matucci-Cerinic, M., Bosello S. L. (ORCID:0000-0002-4837-447X), Beretta L. (ORCID:0000-0001-9924-2066), and Confalonieri M. (ORCID:0000-0002-3708-379X)

Abstract

Introduction Nintedanib (NTD) has been shown to be effective in systemic sclerosis (SSc)-interstitial lung disease (ILD). Here we describe the efficacy and safety of NTD in a real-life setting. Methods Patients with SSc-ILD treated with NTD were retrospectively evaluated at 12 months prior to NTD introduction; at baseline and at 12 months after NTD introduction. The following parameters were recorded: SSc clinical features, NTD tolerability, pulmonary function tests and modified Rodnan skin score (mRSS). Results 90 patients with SSc-ILD (65% female, mean age 57.6±13.4 years, mean disease duration 8.8±7.6 years) were identified. The majority were positive for anti-topoisomerase I (75%) and 77 (85%) patients were on immunosuppressants. A significant decline in %predicted forced vital capacity (%pFVC) in the 12 months prior to NTD introduction was observed in 60%. At 12 months after NTD introduction, follow-up data were available for 40 (44%) patients and they showed a stabilisation in %pFVC (64±14 to 62±19, p=0.416). The percentage of patients with significant lung progression at 12 months was significantly lower compared with the previous 12 months (60% vs 17.5%, p=0.007). No significant mRSS change was observed. Gastrointestinal (GI) side effects were recorded in 35 (39%) patients. After a mean time of 3.6±3.1 months, NTD was maintained after dose adjustment in 23 (25%) patients. In nine (10%) patients, NTD was stopped after a median time of 4.5 (1-6) months. During the follow-up, four patients died. Conclusions In a real-life clinical scenario, NTD, in combination with immunosuppressants, may stabilise lung function. GI side effects are frequent and NTD dose adjustment may be necessary to retain the drug in patients with SSc-ILD.

Published
2023

6. POS0948 PATTERNS OF DISEASE PROGRESSION IN SYSTEMIC SCLEROSIS PATIENTS WITH INTERSTITIAL LUNG DISEASE

Author

Santaniello, A., primary, Bellocchi, C., additional, Bosello, S. L., additional, De Lorenzis, E., additional, Natalello, G., additional, Del Papa, N., additional, Cavalli, S., additional, Benfaremo, D., additional, De Luca, G., additional, Campochiaro, C., additional, Cavagna, L., additional, Codullo, V., additional, Montanelli, G., additional, Severino, A., additional, Caronni, M., additional, Vigone, B., additional, Montecucco, C., additional, Dagna, L., additional, Moroncini, G., additional, Caporali, R., additional, and Beretta, L., additional

Published
2023
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7. Clinical factors associated with death in 3044 COVID-19 patients managed in internal medicine wards in Italy: comment

Author

Bandera, A., Nobili, A., Tettamanti, M., Harari, S., Bosari, S., Mannucci, P. M., Scudeller, L., Fusetti, G., Rusconi, L., Dell'Orto, S., Prati, D., Valenti, L., Giovannelli, S., Manunta, M., Lamorte, G., Ferrari, F., Gori, A., Muscatello, A., Mangioni, D., Alagna, L., Bozzi, G., Lombardi, A., Ungaro, R., Ancona, G., Zuglian, G., Bolis, M., Iannotti, N., Ludovisi, S., Comelli, A., Renisi, G., Biscarini, S., Castelli, V., Palomba, E., Fava, M., Fortina, V., Peri, C. A., Saltini, P., Viero, G., Itri, T., Ferroni, V., Pastore, V., Massafra, R., Liparoti, A., Muheberimana, T., Giommi, A., Bianco, R., De Azevedo, R. M., Chitani, G. E., Peyvandi, F., Gualtierotti, R., Ferrari, B., Rossio, R., Boasi, N., Pagliaro, E., Massimo, C., De Caro, M., Montano, N., Vigone, B., Bellocchi, C., Carandina, A., Fiorelli, E., Melli, V., Tobaldini, E., Blasi, F., Aliberti, S., Spotti, M., Terranova, L., Misuraca, S., D'Adda, A., Della Fiore, S., Di Pasquale, M., Contarini, M. M. M., Ori, M., Morlacchi, L., Rossetti, V., Gramegna, A., Pappalettera, M., Cavallini, M., Buscemi, A., Vicenzi, M., Rota, I., Costantino, G., Solbiati, M., Furlan, L., Mancarella, M., Colombo, G., Fanin, A., Passarella, M., Monzani, V., Canetta, C., Rovellini, A., Barbetta, L., Billi, F., Folli, C., Accordino, S., Maira, D., C. M., Hu, Motta, I., Scaramellini, N., Fracanzani, A. L., Lombardi, R., Cespiati, A., Cesari, M., Lucchi, T., Proietti, M., Calcaterra, L., Mandelli, C., Coppola, C., Cerizza, A., Pesenti, A. M., Grasselli, G., Galazzi, A., Monti, I., Galbussera, A. A., Crisafulli, E., Girelli, D., Maroccia, A., Gabbiani, D., Busti, F., Vianello, A., Biondan, M., Sartori, F., Faverio, P., Pesci, A., Zucchetti, S., Bonfanti, P., Rossi, M., Beretta, I., Spolti, A., Elia, D., Cassandro, R., Caminati, A., Cipollone, F., Guagnano, M. T., D'Ardes, D., Rossi, I., Vezzani, F., Spanevello, A., Cherubino, F., Visca, D., Contoli, M., Papi, A., Morandi, L., Battistini, N., Moreo, G. L., Iannuzzi, P., Fumagalli, D., Leone, S., Bandera, A, Nobili, A, Tettamanti, M, Harari, S, Bosari, S, Mannucci, P, Scudeller, L, Fusetti, G, Rusconi, L, Dell'Orto, S, Prati, D, Valenti, L, Giovannelli, S, Manunta, M, Lamorte, G, Ferrari, F, Gori, A, Muscatello, A, Mangioni, D, Alagna, L, Bozzi, G, Lombardi, A, Ungaro, R, Ancona, G, Zuglian, G, Bolis, M, Iannotti, N, Ludovisi, S, Comelli, A, Renisi, G, Biscarini, S, Castelli, V, Palomba, E, Fava, M, Fortina, V, Peri, C, Saltini, P, Viero, G, Itri, T, Ferroni, V, Pastore, V, Massafra, R, Liparoti, A, Muheberimana, T, Giommi, A, Bianco, R, De Azevedo, R, Chitani, G, Peyvandi, F, Gualtierotti, R, Ferrari, B, Rossio, R, Boasi, N, Pagliaro, E, Massimo, C, De Caro, M, Montano, N, Vigone, B, Bellocchi, C, Carandina, A, Fiorelli, E, Melli, V, Tobaldini, E, Blasi, F, Aliberti, S, Spotti, M, Terranova, L, Misuraca, S, D'Adda, A, Della Fiore, S, Di Pasquale, M, Contarini, M, Ori, M, Morlacchi, L, Rossetti, V, Gramegna, A, Pappalettera, M, Cavallini, M, Buscemi, A, Vicenzi, M, Rota, I, Costantino, G, Solbiati, M, Furlan, L, Mancarella, M, Colombo, G, Fanin, A, Passarella, M, Monzani, V, Canetta, C, Rovellini, A, Barbetta, L, Billi, F, Folli, C, Accordino, S, Maira, D, Hu, C, Motta, I, Scaramellini, N, Fracanzani, A, Lombardi, R, Cespiati, A, Cesari, M, Lucchi, T, Proietti, M, Calcaterra, L, Mandelli, C, Coppola, C, Cerizza, A, Pesenti, A, Grasselli, G, Galazzi, A, Monti, I, Galbussera, A, Crisafulli, E, Girelli, D, Maroccia, A, Gabbiani, D, Busti, F, Vianello, A, Biondan, M, Sartori, F, Faverio, P, Pesci, A, Zucchetti, S, Bonfanti, P, Rossi, M, Beretta, I, Spolti, A, Elia, D, Cassandro, R, Caminati, A, Cipollone, F, Guagnano, M, D'Ardes, D, Rossi, I, Vezzani, F, Spanevello, A, Cherubino, F, Visca, D, Contoli, M, Papi, A, Morandi, L, Battistini, N, Moreo, G, Iannuzzi, P, Fumagalli, D, and Leone, S

Subjects
Adult, medicine.medical_specialty, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Critical Care, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Ce - Letter to the Editor, MEDLINE, Cohort Studies, Hospital, Internal Medicine, Medicine, Humans, Hospital Mortality, Intensive care medicine, Aged, Aged, 80 and over, business.industry, SARS-CoV-2, COVID-19, Middle Aged, Respiration, Artificial, Hospitals, Hospitalization, Survival Rate, Italy, Emergency Medicine, business, Human
Abstract

During the COVID-19 2020 outbreak, a large body of data has been provided on general management and outcomes of hospitalized COVID-19 patients. Yet, relatively little is known on characteristics and outcome of patients managed in Internal Medicine Units (IMU). To address this gap, the Italian Society of Internal Medicine has conducted a nationwide cohort multicentre study on death outcome in adult COVID-19 patients admitted and managed in IMU. This study assessed 3044 COVID-19 patients at 41 referral hospitals across Italy from February 3rd to May 8th 2020. Demographics, comorbidities, organ dysfunction, treatment, and outcomes including death were assessed. During the study period, 697 patients (22.9%) were transferred to intensive care units, and 351 died in IMU (death rate 14.9%). At admission, factors independently associated with in-hospital mortality were age (OR 2.46, p = 0.000), productive cough (OR 2.04, p = 0.000), pre-existing chronic heart failure (OR 1.58, p = 0.017) and chronic obstructive pulmonary disease (OR 1.17, p = 0.048), the number of comorbidities (OR 1.34, p = 0.000) and polypharmacy (OR 1.20, p = 0.000). Of note, up to 40% of elderly patients did not report fever at admission. Decreasing PaO

Published
2022

8. POS0890 NINTEDANIB REAL-LIFE EFFICACY AND SAFETY IN SYSTEMIC SCLEROSIS (SSc)-INTERTISTIAL LUNG DISEASE (ILD): AN ITALIAN MULTICENTRE PRELIMINARY STUDY.

Author

Campochiaro, C., primary, De Luca, G., additional, Lazzaroni, M. G., additional, Armentaro, G., additional, Spinella, A., additional, Vigone, B., additional, Ruaro, B., additional, Stanziola, A., additional, Benfaremo, D., additional, De Lorenzis, E., additional, Benvenuti, F., additional, Bosello, S. L., additional, Moroncini, G., additional, Cuomo, G., additional, Confalonieri, M., additional, Beretta, L., additional, Zanatta, E., additional, Giuggioli, D., additional, Del Papa, N., additional, Airò, P., additional, Dagna, L., additional, and Matucci-Cerinic, M., additional

Published
2022
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10. Early Phases of COVID-19 Are Characterized by a Reduction in Lymphocyte Populations and the Presence of Atypical Monocytes

Author

Lombardi, A, Trombetta, E, Cattaneo, A, Castelli, V, Palomba, E, Tirone, M, Mangioni, D, Lamorte, G, Manunta, M, Prati, D, Ceriotti, F, Gualtierotti, R, Costantino, G, Aliberti, S, Scaravilli, V, Grasselli, G, Gori, A, Porretti, L, Bandera, A, Bosari, S, Scudeller, L, Fusetti, G, Rusconi, L, Dell'Orto, S, Valenti, L, Giovannelli, S, Muscatello, A, Alagna, L, Bozzi, G, Ungaro, R, Itri, T, Ferroni, V, Pastore, V, Massafra, R, Rondolini, I, Peyvandi, F, Ferrari, B, Rossio, R, Corona, E, Rampi, N, Massimo, C, Montano, N, Vigone, B, Bellocchi, C, Fiorelli, E, Melli, V, Tobaldini, E, Blasi, F, Spotti, M, Simonetta, E, Terranova, L, Amati, F, Miele, C, Misuraca, S, D'Adda, A, Fiore, S, Di Pasquale, M, Contarini, M, Ori, M, Morlacchi, L, Rossetti, V, Gramegna, A, Pappalettera, M, Cavallini, M, Vigni, A, Vicenzi, M, Rota, I, Solbiati, M, Furlan, L, Mancarella, M, Colombo, G, Fanin, A, Monzani, V, Rovellini, A, Barbetta, L, Billi, F, Folli, C, Baldini, M, Motta, I, Scaramellini, N, Fracanzani, A, Lombardi, R, Iuculano, F, Cesari, M, Proietti, M, Calcaterra, L, Nobili, A, Tettamanti, M, Monti, I, Lombardi A., Trombetta E., Cattaneo A., Castelli V., Palomba E., Tirone M., Mangioni D., Lamorte G., Manunta M., Prati D., Ceriotti F., Gualtierotti R., Costantino G., Aliberti S., Scaravilli V., Grasselli G., Gori A., Porretti L., Bandera A., Bosari S., Scudeller L., Fusetti G., Rusconi L., Dell'Orto S., Valenti L., Giovannelli S., Muscatello A., Alagna L., Bozzi G., Ungaro R., Itri T., Ferroni V., Pastore V., Massafra R., Rondolini I., Peyvandi F., Ferrari B., Rossio R., Corona E., Rampi N., Massimo C., Montano N., Vigone B., Bellocchi C., Fiorelli E., Melli V., Tobaldini E., Blasi F., Spotti M., Simonetta E., Terranova L., Amati F., Miele C., Misuraca S., D'Adda A., Fiore S. D., Di Pasquale M., Contarini M. M. M., Ori M., Morlacchi L., Rossetti V., Gramegna A., Pappalettera M., Cavallini M., Vigni A., Vicenzi M., Rota I., Solbiati M., Furlan L., Mancarella M., Colombo G., Fanin A., Monzani V., Rovellini A., Barbetta L., Billi F., Folli C., Baldini M., Motta I., Scaramellini N., Fracanzani A. L., Lombardi R., Iuculano F., Cesari M., Proietti M., Calcaterra L., Nobili A., Tettamanti M., Monti I., Lombardi, A, Trombetta, E, Cattaneo, A, Castelli, V, Palomba, E, Tirone, M, Mangioni, D, Lamorte, G, Manunta, M, Prati, D, Ceriotti, F, Gualtierotti, R, Costantino, G, Aliberti, S, Scaravilli, V, Grasselli, G, Gori, A, Porretti, L, Bandera, A, Bosari, S, Scudeller, L, Fusetti, G, Rusconi, L, Dell'Orto, S, Valenti, L, Giovannelli, S, Muscatello, A, Alagna, L, Bozzi, G, Ungaro, R, Itri, T, Ferroni, V, Pastore, V, Massafra, R, Rondolini, I, Peyvandi, F, Ferrari, B, Rossio, R, Corona, E, Rampi, N, Massimo, C, Montano, N, Vigone, B, Bellocchi, C, Fiorelli, E, Melli, V, Tobaldini, E, Blasi, F, Spotti, M, Simonetta, E, Terranova, L, Amati, F, Miele, C, Misuraca, S, D'Adda, A, Fiore, S, Di Pasquale, M, Contarini, M, Ori, M, Morlacchi, L, Rossetti, V, Gramegna, A, Pappalettera, M, Cavallini, M, Vigni, A, Vicenzi, M, Rota, I, Solbiati, M, Furlan, L, Mancarella, M, Colombo, G, Fanin, A, Monzani, V, Rovellini, A, Barbetta, L, Billi, F, Folli, C, Baldini, M, Motta, I, Scaramellini, N, Fracanzani, A, Lombardi, R, Iuculano, F, Cesari, M, Proietti, M, Calcaterra, L, Nobili, A, Tettamanti, M, Monti, I, Lombardi A., Trombetta E., Cattaneo A., Castelli V., Palomba E., Tirone M., Mangioni D., Lamorte G., Manunta M., Prati D., Ceriotti F., Gualtierotti R., Costantino G., Aliberti S., Scaravilli V., Grasselli G., Gori A., Porretti L., Bandera A., Bosari S., Scudeller L., Fusetti G., Rusconi L., Dell'Orto S., Valenti L., Giovannelli S., Muscatello A., Alagna L., Bozzi G., Ungaro R., Itri T., Ferroni V., Pastore V., Massafra R., Rondolini I., Peyvandi F., Ferrari B., Rossio R., Corona E., Rampi N., Massimo C., Montano N., Vigone B., Bellocchi C., Fiorelli E., Melli V., Tobaldini E., Blasi F., Spotti M., Simonetta E., Terranova L., Amati F., Miele C., Misuraca S., D'Adda A., Fiore S. D., Di Pasquale M., Contarini M. M. M., Ori M., Morlacchi L., Rossetti V., Gramegna A., Pappalettera M., Cavallini M., Vigni A., Vicenzi M., Rota I., Solbiati M., Furlan L., Mancarella M., Colombo G., Fanin A., Monzani V., Rovellini A., Barbetta L., Billi F., Folli C., Baldini M., Motta I., Scaramellini N., Fracanzani A. L., Lombardi R., Iuculano F., Cesari M., Proietti M., Calcaterra L., Nobili A., Tettamanti M., and Monti I.

Published
2020

11. Clinical risk scores for the early prediction of severe outocomes in patients hospitalized for COVID-19: comment

Author

Rossio R., Tettamanti M., Nobili A., Harari S., Mannucci P. M., Bandera A., Peyvandi F., Bosari S., Scudeller L., Fusetti G., Rusconi L., Dell'Orto S., Prati D., Valenti L., Giovannelli S., Manunta M., Lamorte G., Ferrari F., Gori A., Muscatello A., Mangioni D., Alagna L., Bozzi G., Lombardi A., Ungaro R., Ancona G., Zuglian G., Bolis M., Iannotti N., Ludovisi S., Comelli A., Renisi G., Biscarini S., Castelli V., Palomba E., Fava M., Fortina V., Peri C. A., Saltini P., Viero G., Itri T., Ferroni V., Pastore V., Massafra R., Liparoti A., Muheberimana T., Giommi A., Bianco R., De Azevedo R. M., Chitani G. E., Gualtierotti R., Ferrari B., Boasi N., Pagliaro E., Massimo C., De Caro M., Giachi A., Montano N., Vigone B., Bellocchi C., Carandina A., Fiorelli E., Melli V., Tobaldini E., Blasi F., Aliberti S., Spotti M., Terranova L., Misuraca S., D'Adda A., Fiore S. D., Di Pasquale M., Mantero M., Contarini M., Ori M., Morlacchi L., Rossetti V., Gramegna A., Pappalettera M., Cavallini M., Buscemi A., Vicenzi M., Rota I., Costantino G., Solbiati M., Furlan L., Mancarella M., Colombo G., Fanin A., Passarella M., Monzani V., Canetta C., Rovellini A., Barbetta L., Billi F., Folli C., Accordino S., Maira D., Hu C. M., Motta I., Scaramellini N., Fracanzani A. L., Lombardi R., Cespiati A., Cesari M., Lucchi T., Proietti M., Calcaterra L., Mandelli C., Coppola C., Cerizza A., Pesenti A. M., Grasselli G., Galazzi A., Monti I., Galbussera A. A., Crisafulli E., Girelli D., Maroccia A., Gabbiani D., Busti F., Vianello A., Biondan M., Sartori F., Faverio P., Pesci A., Zucchetti S., Bonfanti P., Rossi M., Beretta I., Spolti A., Elia D., Cassandro R., Caminati A., Cipollone F., Guagnano M. T., D'Ardes D., Rossi I., Vezzani F., Spanevello A., Cherubino F., Visca D., Contoli M., Papi A., Morandi L., Battistini N., Moreo G. L., Iannuzzi P., Fumagalli D., Leone S., Rossio, R, Tettamanti, M, Nobili, A, Harari, S, Mannucci, P, Bandera, A, Peyvandi, F, Bosari, S, Scudeller, L, Fusetti, G, Rusconi, L, Dell'Orto, S, Prati, D, Valenti, L, Giovannelli, S, Manunta, M, Lamorte, G, Ferrari, F, Gori, A, Muscatello, A, Mangioni, D, Alagna, L, Bozzi, G, Lombardi, A, Ungaro, R, Ancona, G, Zuglian, G, Bolis, M, Iannotti, N, Ludovisi, S, Comelli, A, Renisi, G, Biscarini, S, Castelli, V, Palomba, E, Fava, M, Fortina, V, Peri, C, Saltini, P, Viero, G, Itri, T, Ferroni, V, Pastore, V, Massafra, R, Liparoti, A, Muheberimana, T, Giommi, A, Bianco, R, De Azevedo, R, Chitani, G, Gualtierotti, R, Ferrari, B, Boasi, N, Pagliaro, E, Massimo, C, De Caro, M, Giachi, A, Montano, N, Vigone, B, Bellocchi, C, Carandina, A, Fiorelli, E, Melli, V, Tobaldini, E, Blasi, F, Aliberti, S, Spotti, M, Terranova, L, Misuraca, S, D'Adda, A, Fiore, S, Di Pasquale, M, Mantero, M, Contarini, M, Ori, M, Morlacchi, L, Rossetti, V, Gramegna, A, Pappalettera, M, Cavallini, M, Buscemi, A, Vicenzi, M, Rota, I, Costantino, G, Solbiati, M, Furlan, L, Mancarella, M, Colombo, G, Fanin, A, Passarella, M, Monzani, V, Canetta, C, Rovellini, A, Barbetta, L, Billi, F, Folli, C, Accordino, S, Maira, D, Hu, C, Motta, I, Scaramellini, N, Fracanzani, A, Lombardi, R, Cespiati, A, Cesari, M, Lucchi, T, Proietti, M, Calcaterra, L, Mandelli, C, Coppola, C, Cerizza, A, Pesenti, A, Grasselli, G, Galazzi, A, Monti, I, Galbussera, A, Crisafulli, E, Girelli, D, Maroccia, A, Gabbiani, D, Busti, F, Vianello, A, Biondan, M, Sartori, F, Faverio, P, Pesci, A, Zucchetti, S, Bonfanti, P, Rossi, M, Beretta, I, Spolti, A, Elia, D, Cassandro, R, Caminati, A, Cipollone, F, Guagnano, M, D'Ardes, D, Rossi, I, Vezzani, F, Spanevello, A, Cherubino, F, Visca, D, Contoli, M, Papi, A, Morandi, L, Battistini, N, Moreo, G, Iannuzzi, P, Fumagalli, D, and Leone, S

Subjects
Male, Outcome Assessment, Disease, 030204 cardiovascular system & hematology, Respiratory failure, 0302 clinical medicine, Risk Factors, Epidemiology, Early prediction, Outcome Assessment, Health Care, 030212 general & internal medicine, Framingham Risk Score, Respiration, Area under the curve, Middle Aged, Hospitalization, Survival Rate, Italy, Artificial, Emergency Medicine, Female, Clinical risk factor, 2019-20 coronavirus outbreak, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Ce - Letter to the Editor, MEDLINE, Risk Assessment, 03 medical and health sciences, Predictive Value of Tests, Internal medicine, Internal Medicine, medicine, Intubation, Intratracheal, Humans, In patient, Derivation, COVID-19, Risk prediction model, SARS-CoV 2, Selection (genetic algorithm), Aged, Retrospective Studies, SARS-CoV-2, business.industry, Retrospective cohort study, Respiration, Artificial, Im - Original, Health Care, Intratracheal, ROC Curve, Intubation, business
Abstract

Coronavirus disease of 2019 (COVID-19) is associated with severe acute respiratory failure. Early identification of high-risk COVID-19 patients is crucial. We aimed to derive and validate a simple score for the prediction of severe outcomes. A retrospective cohort study of patients hospitalized for COVID-19 was carried out by the Italian Society of Internal Medicine. Epidemiological, clinical, laboratory, and treatment variables were collected at hospital admission at five hospitals. Three algorithm selection models were used to construct a predictive risk score: backward Selection, Least Absolute Shrinkage and Selection Operator (LASSO), and Random Forest. Severe outcome was defined as the composite of need for non-invasive ventilation, need for orotracheal intubation, or death. A total of 610 patients were included in the analysis, 313 had a severe outcome. The subset for the derivation analysis included 335 patients, the subset for the validation analysis 275 patients. The LASSO selection identified 6 variables (age, history of coronary heart disease, CRP, AST, D-dimer, and neutrophil/lymphocyte ratio) and resulted in the best performing score with an area under the curve of 0.79 in the derivation cohort and 0.80 in the validation cohort. Using a cut-off of 7 out of 13 points, sensitivity was 0.93, specificity 0.34, positive predictive value 0.59, and negative predictive value 0.82. The proposed score can identify patients at low risk for severe outcome who can be safely managed in a low-intensity setting after hospital admission for COVID-19.

Published
2021

12. COVID-19 Network: the response of an Italian Reference Institute to research challenges about a new pandemia

Author

Bosari, S., Scudeller, L., Fusetti, G., Rusconi, L., Dell Orto, S., Prati, D., Valenti, L., Lamorte, G., Manunta, M., Baselli, G., Santoro, L., Gori, A., Bandera, A., Muscatello, A., Mangioni, D., Alagna, L., Bozzi, G., Lombardi, A., Ungaro, R., Itri, T., Ferroni, V., Pastore, V., Massafra, R., Rondolini, I., Peyvandi, F., Gualtierotti, R., Ferrari, B., Rossio, R., Corona, E., Rampi, N., Massimo, C., Montano, N., Vigone, B., Bellocchi, C., Fiorelli, E., Melli, V., Tobaldini, E., Blasi, F., Aliberti, S., Spotti, M., Simonetta, E., Terranova, L., Amati, F., Miele, C., Misuraca, S., D'Adda, A., Della Fiore, S., Di Pasquale, M., Contarini, M.M.M., Ori, M., Morlacchi, L., Rossetti, V., Gramegna, A., Pappalettera, M., Cavallini, M., Vigni, A., Vicenzi, M., Rota, I., Costantino, G., Solbiati, M., Furlan, L., Mancarella, M., Colombo, G., Fanin, A., Monzani, V., Rovellini, A., Barbetta, L., Billi, F., Folli, C., Baldini, M., Motta, I., Scaramellini, N., Fracanzani, A.L., Lombardi, R., Iuculano, F., Cesari, M., Proietti, M., Calcaterra, L., Nobili, A., Tettamanti, M., Monti, I., and Pesenti, A.

Published
2020
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13. COVID-19 Network: the response of an Italian Reference Institute to research challenges about a new pandemia

Author

Bandera, A., primary, Aliberti, S., additional, Gualtierotti, R., additional, Baldini, M., additional, Blasi, F., additional, Cesari, M., additional, Costantino, G., additional, Fracanzani, A.L., additional, Gori, A., additional, Montano, N., additional, Monzani, V., additional, Nobili, A., additional, Peyvandi, F., additional, Pesenti, A., additional, Prati, D., additional, Valenti, L., additional, Fusetti, G., additional, Scudeller, L., additional, Bosari, S., additional, Rusconi, L., additional, Dell Orto, S., additional, Lamorte, G., additional, Manunta, M., additional, Baselli, G., additional, Santoro, L., additional, Bandera, A., additional, Muscatello, A., additional, Mangioni, D., additional, Alagna, L., additional, Bozzi, G., additional, Lombardi, A., additional, Ungaro, R., additional, Itri, T., additional, Ferroni, V., additional, Pastore, V., additional, Massafra, R., additional, Rondolini, I., additional, Ferrari, B., additional, Rossio, R., additional, Corona, E., additional, Rampi, N., additional, Massimo, C., additional, Vigone, B., additional, Bellocchi, C., additional, Fiorelli, E., additional, Melli, V., additional, Tobaldini, E., additional, Spotti, M., additional, Simonetta, E., additional, Terranova, L., additional, Amati, F., additional, Miele, C., additional, Misuraca, S., additional, D'Adda, A., additional, Della Fiore, S., additional, Di Pasquale, M., additional, Contarini, M.M.M., additional, Ori, M., additional, Morlacchi, L., additional, Rossetti, V., additional, Gramegna, A., additional, Pappalettera, M., additional, Cavallini, M., additional, Vigni, A., additional, Vicenzi, M., additional, Rota, I., additional, Solbiati, M., additional, Furlan, L., additional, Mancarella, M., additional, Colombo, G., additional, Fanin, A., additional, Rovellini, A., additional, Barbetta, L., additional, Billi, F., additional, Folli, C., additional, Motta, I., additional, Scaramellini, N., additional, Lombardi, R., additional, Iuculano, F., additional, Proietti, M., additional, Calcaterra, L., additional, Tettamanti, M., additional, and Monti, I., additional

Published
2020
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16. OP0137 GENOME-WIDE WHOLE-BLOOD TRANSCRIPTOME PROFILING IN A LARGE EUROPEAN COHORT OF SYSTEMIC SCLEROSIS PATIENTS

Author

Beretta, L., primary, Barturen, G., additional, Vigone, B., additional, Bellocchi, C., additional, Hunzelmann, N., additional, Delanghe, E., additional, Kovács, L., additional, Cervera, R., additional, Gerosa, M., additional, Ortega Castro, R., additional, Almeida, I., additional, Cornec, D., additional, Chizzolini, C., additional, Pers, J. O., additional, Makowska, Z., additional, Buttgereit, A., additional, Lesche, R., additional, Kerick, M., additional, Alarcon-Riquelme, M., additional, and Martin Ibanez, J., additional

Published
2020
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17. Genome-wide whole blood transcriptome profiling in a large European cohort of systemic sclerosis patients

Author

European Commission, Beretta, L., Barturen, Guillermo, Vigone, B, Bellocchi, C., Hunzelmann, Nicolas, De Langhe, E., Cervera, R., Gerosa, M., Kovács, L., Ortega Castro, R., Almeida, I., Cornec, D., Chizzolini, C., Pers, J.O., Makowska, Z., Lesche, R., Kerick, Martin, Alarcón-Riquelme, M. E., Martín, J., European Commission, Beretta, L., Barturen, Guillermo, Vigone, B, Bellocchi, C., Hunzelmann, Nicolas, De Langhe, E., Cervera, R., Gerosa, M., Kovács, L., Ortega Castro, R., Almeida, I., Cornec, D., Chizzolini, C., Pers, J.O., Makowska, Z., Lesche, R., Kerick, Martin, Alarcón-Riquelme, M. E., and Martín, J.

Abstract

Objectives: The analysis of annotated transcripts from genome-wide expression studies may help to understand the pathogenesis of complex diseases, such as systemic sclerosis (SSc). We performed a whole blood (WB) transcriptome analysis on RNA collected in the context of the European PRECISESADS project, aiming at characterising the pathways that differentiate SSc from controls and that are reproducible in geographically diverse populations. Methods: Samples from 162 patients and 252 controls were collected in RNA stabilisers. Cases and controls were divided into a discovery (n=79+163; Southern Europe) and validation cohort (n=83+89; Central-Western Europe). RNA sequencing was performed by an Illumina assay. Functional annotations of Reactome pathways were performed with the Functional Analysis of Individual Microarray Expression (FAIME) algorithm. In parallel, immunophenotyping of 28 circulating cell populations was performed. We tested the presence of differentially expressed genes/pathways and the correlation between absolute cell counts and RNA transcripts/FAIME scores in regression models. Results significant in both populations were considered as replicated. Results: Overall, 15 224 genes and 1277 functional pathways were available; of these, 99 and 225 were significant in both sets. Among replicated pathways, we found a deregulation in type-I interferon, Toll-like receptor cascade, tumour suppressor p53 protein function, platelet degranulation and activation. RNA transcripts or FAIME scores were jointly correlated with cell subtypes with strong geographical differences; neutrophils were the major determinant of gene expression in SSc-WB samples. Conclusions: We discovered a set of differentially expressed genes/pathways validated in two independent sets of patients with SSc, highlighting a number of deregulated processes that have relevance for the pathogenesis of autoimmunity and SSc.

Published
2020

19. Brief report: Successful pregnancies but a higher risk of preterm births in systemic sclerosis: An Italian multicentric study

Author

Taraborelli M, Ramoni V, Brucato A, Airò P, Bajocchi G, Bellisai F, Biasi D, Blagojevic J, Canti V, Caporali R, Caramaschi P, Chiarolanza I, Codullo V, Cozzi F, Cutolo M, De Santis M, De Vita S, Di Poi E, Doria A, Faggioli P, Favaro M, Ferraccioli G, Ferri C, Foti R, Gerosa A, Gerosa M, Giacuzzo S, GianiL, Giuggioli D, Imazio M, Iudici M, Iuliano A, Leonardi R, Limonta M, Lojacono A, Lubatti C, Matucci Cerinic M, Mazzone A, Meroni M, Meroni PL, Mosca M, Motta M, Muscarà M, Nava S, Padovan M, Pagani G, Paolazzi G, Peccatori S, Ravagnani V, Riccieri V, Rosato E, Rovere Querini P, Salsano F, Santaniello A, Scorza R, Tani C, Valesini G, Vanoli M, Vigone B, Zeni S, Tincani A, on behalf ofthe IMPRESS Investigators, CUOMO, Giovanna, VALENTINI, Gabriele, Taraborelli, M, Ramoni, V, Brucato, A, Airò, P, Bajocchi, G, Bellisai, F, Biasi, D, Blagojevic, J, Canti, V, Caporali, R, Caramaschi, P, Chiarolanza, I, Codullo, V, Cozzi, F, Cuomo, Giovanna, Cutolo, M, De Santis, M, De Vita, S, Di Poi, E, Doria, A, Faggioli, P, Favaro, M, Ferraccioli, G, Ferri, C, Foti, R, Gerosa, A, Gerosa, M, Giacuzzo, S, Gianil, Giuggioli, D, Imazio, M, Iudici, M, Iuliano, A, Leonardi, R, Limonta, M, Lojacono, A, Lubatti, C, Matucci Cerinic, M, Mazzone, A, Meroni, M, Meroni, Pl, Mosca, M, Motta, M, Muscarà, M, Nava, S, Padovan, M, Pagani, G, Paolazzi, G, Peccatori, S, Ravagnani, V, Riccieri, V, Rosato, E, Rovere Querini, P, Salsano, F, Santaniello, A, Scorza, R, Tani, C, Valentini, Gabriele, Valesini, G, Vanoli, M, Vigone, B, Zeni, S, Tincani, A, and on behalf ofthe IMPRESS, Investigators

Abstract

OBJECTIVE: To assess fetal and maternal outcomes in women with systemic sclerosis (SSc). METHODS: Prospectively collected data on 99 women with SSc from 25 Italian centers were analyzed retrospectively. Women with SSc were observed during 109 pregnancies (from 2000 to 2011), and outcomes were compared to those in the general obstetric population (total of 3,939 deliveries). The maternal age at conception was a mean ± SD 31.8 ± 5.3 years, and the median disease duration at conception was 60 months (range 2-193 months). RESULTS: SSc patients, compared to the general obstetric population, had a significantly increased frequency of preterm deliveries (25% versus 12%) and severe preterm deliveries (

Published
2012

20. Preliminary analysis of the Very Early Diagnosis of Systemic Sclerosis (VEDOSS) EUSTAR multicentre study: evidence for puffy fingers as a pivotal sign for suspicion of systemic sclerosis

Author

Minier, T., Guiducci, S., Bellando-Randone, S., Bruni, C., Lepri, G., Czirjak, L., Distler, O., Walker, U. A., Fransen, J., Allanore, Y., Denton, C., Cutolo, M., Tyndall, A., Muller-Ladner, U., Matucci-Cerinic, M., Airo, P., Zingarelli, S., Ananieva, L., Desinova, O., Ancuta, C. M., Belibou, C. I., Avouac, J., Becvar, R., Skacelova, S., Beretta, L., Vigone, B., Caramaschi, P., Sabbagh, D., Carpentier, P., Damjanov, N., Simic-Pasalic, K., Distler, J. H. W., Farge-Bancel, D., Hadj-Khelifa, S., Foti, R., Di Gangi, M., De La Pena Lefebvre, P. G., Hachulla, E., Salvador, M. J., Kayser, C., Camargo, C. Z., Kumanovics, G., Li, M., Xu, D., Marasini, B., Belloli, L., Maurer, B., Mayer, M., Mihai, C., Gherghe, A. M., Riccieri, V., Stefanantoni, K., Salsano, F., Rosato, E., Senecal, J. -L., Koenig, M., Senet, P., Frances, C., Sipek, A., Stankovic, A., Stamenkovic, B., Smith, V., Tarner, I. H., Wiland, P., University of Zurich, and Matucci-Cerinic, Marco

Subjects
Male, Anti-nuclear antibody, Pulmonary Fibrosis, 2745 Rheumatology, Scleroderma, Microscopic Angioscopy, Cohort Studies, Antinuclear, Immunology and Allergy, skin and connective tissue diseases, integumentary system, 10051 Rheumatology Clinic and Institute of Physical Medicine, Middle Aged, Connective tissue disease, Autoantibodies, Disease Activity, Outcomes research, Systemic Sclerosis, Adult, Antibodies, Antinuclear, Early Diagnosis, Female, Fingers, Humans, Raynaud Disease, Scleroderma, Systemic, Skin Ulcer, Telangiectasis, Cohort, 2723 Immunology and Allergy, musculoskeletal diseases, medicine.medical_specialty, Immunology, 610 Medicine & health, General Biochemistry, Genetics and Molecular Biology, Antibodies, Rheumatology, 1300 General Biochemistry, Genetics and Molecular Biology, Internal medicine, medicine, 2403 Immunology, business.industry, Systemic, Autoantibody, medicine.disease, Surgery, stomatognathic diseases, Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5], Observational study, business, Rheumatism
Abstract

Item does not contain fulltext OBJECTIVES: The EULAR (European League Against Rheumatism) Scleroderma Trials and Research Group (EUSTAR) has identified preliminary criteria for very early diagnosis of systemic sclerosis (SSc). Our aim was to assess the prevalence of each proposed diagnostic item in a large observational patient cohort with Raynaud's phenomenon (RP). METHODS: Baseline data of 469 RP patients enrolled into the Very Early Diagnosis of Systemic Sclerosis (VEDOSS) cohort are presented. RESULTS: 68% of all RP patients were antinuclear antibody (ANA) positive. ANA+ RP patients more frequently had previous or current puffy fingers (PuFi) (38.5% and 23.3%, p

Published
2014

21. Brief Report: Successful pregnancies but a higher riskof preterm births in patients with systemic sclerosis: An Italian multicenterstudy

Author

Taraborelli, M, Ramoni, V, Brucato, A, Airò, P, Bajocchi, G, Bellisai, F, Biasi, D, Blagojevic, J, Canti, V, Caporali, R, Caramaschi, P, Chiarolanza, I, Codullo, V, Cozzi, Franco, Cuomo, G, Cutolo, M, De Santis, M, De Vita, S, Di Poi, E, Doria, Andrea, Faggioli, P, Favaro, M, Ferraccioli, G, Ferri, C, Foti, R, Gerosa, A, Gerosa, M, Giacuzzo, S, Giani, L, Giuggioli, D, Imazio, M, Iudici, M, Iuliano, A, Leonardi, R, Limonta, M, Lojacono, A, Lubatti, C, Matucci Cerinic, M, Mazzone, A, Meroni, M, Meroni, Pl, Mosca, M, Motta, M, Muscarà, M, Nava, S, Padovan, M, Pagani, G, Paolazzi, G, Peccatori, S, Ravagnani, V, Riccieri, V, Rosato, E, Rovere Querini, P, Salsano, F, Santaniello, A, Scorza, R, Tani, C, Valentini, G, Valesini, G, Vanoli, M, Vigone, B, Zeni, S, and Tincani, A.

Published
2012

23. Real-life efficacy and safety of nintedanib in systemic sclerosis-interstitial lung disease: data from an Italian multicentre study

Author

Corrado Campochiaro, Giacomo De Luca, Maria-Grazia Lazzaroni, Giuseppe Armentaro, Amelia Spinella, Barbara Vigone, Barbara Ruaro, Anna Stanziola, Devis Benfaremo, Enrico De Lorenzis, Beatrice Moccaldi, Silvia Laura Bosello, Giovanna Cuomo, Lorenzo Beretta, Elisabetta Zanatta, Dilia Giuggioli, Nicoletta Del Papa, Paolo Airo, Marco Confalonieri, Gianluca Moroncini, Lorenzo Dagna, Marco Matucci-Cerinic, Campochiaro, C, De Luca, G, Lazzaroni, Mg, Armentaro, G, Spinella, A, Vigone, B, Ruaro, B, Stanziola, A, Benfaremo, D, De Lorenzis, E, Moccaldi, B, Bosello, Sl, Cuomo, G, Beretta, L, Zanatta, E, Giuggioli, D, Del Papa, N, Airo, P, Confalonieri, M, Moroncini, G, Dagna, L, Matucci-Cerinic, M., Campochiaro, C., De Luca, G., Lazzaroni, M. -G., Armentaro, G., Spinella, A., Vigone, B., Ruaro, B., Stanziola, A., Benfaremo, D., De Lorenzis, E., Moccaldi, B., Bosello, S. L., Cuomo, G., Beretta, L., Zanatta, E., Giuggioli, D., Del Papa, N., Airo, P., Confalonieri, M., Moroncini, G., and Dagna, L.

Subjects
pulmonary fibrosi, Settore MED/16 - REUMATOLOGIA, Rheumatology, pulmonary fibrosis, biological therapy, Immunology, scleroderma, systemic, therapeutics, Immunology and Allergy, scleroderma, systemic
Abstract

IntroductionNintedanib (NTD) has been shown to be effective in systemic sclerosis (SSc)-interstitial lung disease (ILD). Here we describe the efficacy and safety of NTD in a real-life setting.MethodsPatients with SSc-ILD treated with NTD were retrospectively evaluated at 12 months prior to NTD introduction; at baseline and at 12 months after NTD introduction. The following parameters were recorded: SSc clinical features, NTD tolerability, pulmonary function tests and modified Rodnan skin score (mRSS).Results90 patients with SSc-ILD (65% female, mean age 57.6±13.4 years, mean disease duration 8.8±7.6 years) were identified. The majority were positive for anti-topoisomerase I (75%) and 77 (85%) patients were on immunosuppressants. A significant decline in %predicted forced vital capacity (%pFVC) in the 12 months prior to NTD introduction was observed in 60%. At 12 months after NTD introduction, follow-up data were available for 40 (44%) patients and they showed a stabilisation in %pFVC (64±14 to 62±19, p=0.416). The percentage of patients with significant lung progression at 12 months was significantly lower compared with the previous 12 months (60% vs 17.5%, p=0.007). No significant mRSS change was observed. Gastrointestinal (GI) side effects were recorded in 35 (39%) patients. After a mean time of 3.6±3.1 months, NTD was maintained after dose adjustment in 23 (25%) patients. In nine (10%) patients, NTD was stopped after a median time of 4.5 (1–6) months. During the follow-up, four patients died.ConclusionsIn a real-life clinical scenario, NTD, in combination with immunosuppressants, may stabilise lung function. GI side effects are frequent and NTD dose adjustment may be necessary to retain the drug in patients with SSc-ILD.

Published
2023

24. Comparison of different sets of immunological tests to identify treatable immunodeficiencies in adult bronchiectasis patients

Author

Stefano Aliberti, Francesco Amati, Andrea Gramegna, Barbara Vigone, Martina Oriano, Giovanni Sotgiu, Marco Mantero, Edoardo Simonetta, Laura Saderi, Anna Stainer, Serena Tammaro, Paola Marchisio, Eva Polverino, James D. Chalmers, Francesco Blasi, Institut Català de la Salut, [Aliberti S, Amati F] Dept of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy. IRCCS Humanitas Research Hospital, Respiratory Unit, Rozzano, Italy. [Gramegna A, Oriano M] Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Respiratory Unit and Cystic Fibrosis Adult Center, Milan, Italy. Dept of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy. [Vigone B] Scleroderma Unit, Referral Center for Systemic Autoimmune Diseases, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy. [Sotgiu G] Clinical Epidemiology and Medical Statistics Unit, Dept of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy. [Polverino E] Servei de Pneumologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Immunodeficiència, Pulmonary and Respiratory Medicine, Respiratory Tract Diseases::Bronchial Diseases::Bronchiectasis [DISEASES], Immune System Diseases::Immunologic Deficiency Syndromes::Common Variable Immunodeficiency [DISEASES], Other subheadings::/diagnosis [Other subheadings], enfermedades del sistema inmune::síndromes de inmunodeficiencia::inmunodeficiencia variable común [ENFERMEDADES], Otros calificadores::/diagnóstico [Otros calificadores], enfermedades respiratorias::enfermedades bronquiales::bronquiectasia [ENFERMEDADES], Bronquièctasi
Abstract

BackgroundThe reported prevalence of immunodeficiencies in bronchiectasis patients is variable depending on the frequency and extent of immunological tests performed. European Respiratory Society guidelines recommend a minimum bundle of tests. Broadening the spectrum of immunological tests could increase the number of patients diagnosed with an immunodeficiency and those who could receive specific therapy. The primary objective of the present study was to assess the performance of different sets of immunological tests in diagnosing any, primary, secondary or treatable immunodeficiencies in adults with bronchiectasis.MethodsAn observational, cross-sectional study was conducted at the Bronchiectasis Program of the Policlinico University Hospital in Milan, Italy, from September 2016 to June 2019. Adult outpatients with a clinical and radiological diagnosis of bronchiectasis underwent the same immunological screening during the first visit when clinically stable consisting of: complete blood count; immunoglobulin (Ig) subclass tests for IgA, IgG, IgM and IgG; total IgE; lymphocyte subsets; and HIV antibodies. The primary endpoint was the prevalence of patients with any immunodeficiencies using five different sets of immunological tests.ResultsA total of 401 bronchiectasis patients underwent the immunological screening. A significantly different prevalence of bronchiectasis patients diagnosed with any, primary or secondary immunodeficiencies was found across different bundles. 44.6% of bronchiectasis patients had a diagnosis of immunodeficiency when IgG subclasses and lymphocyte subsets were added to the minimum bundle suggested by the guidelines.ConclusionA four-fold increase in the diagnosis of immunodeficiencies can be found in adults with bronchiectasis when IgG subclasses and lymphocyte subsets are added to the bundle of tests recommended by guidelines.

Published
2021
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25. Brief Report: Successful pregnancies but a higher risk of preterm births in patients with systemic sclerosis: An Italian multicenter study

Author

Mara, Taraborelli, Veronique, Ramoni, Antonio, Brucato, Paolo, Airo, Gianluigi, Bajocchi, Francesca, Bellisai, Domenico, Biasi, Jelena, Blagojevic, Valentina, Canti, Roberto, Caporali, Paola, Caramaschi, Ilaria, Chiarolanza, Veronica, Codullo, Franco, Cozzi, Giovanna, Cuomo, Maurizio, Cutolo, Maria De Santis, Salvatore De Vita, Emma Di Poi, Andrea, Doria, Paola, Faggioli, Maria, Favaro, Gianfranco, Ferraccioli, Clodoveo, Ferri, Rosario, Foti, Alessandro, Gerosa, Maria, Gerosa, Sarah, Giacuzzo, Leopoldo, Giani, Dilia, Giuggioli, Massimo, Imazio, Michele, Iudici, Annamaria, Iuliano, Roberto, Leonardi, Massimiliano, Limonta, Andrea, Lojacono, Chiara, Lubatti, Marco Matucci Cerinic, Antonino, Mazzone, Marianna, Meroni, Pier Luigi Meroni, Marta, Mosca, Mario, Motta, Marina, Muscara, Simona, Nava, Melissa, Padovan, Giorgio, Pagani, Giuseppe, Paolazzi, Susanna, Peccatori, Viviana, Ravagnani, Riccieri, Valeria, Rosato, Edoardo, Patrizia Rovere Querini, Salsano, Felice, Alessandro, Santaniello, Raffaella, Scorza, Chiara, Tani, Gabriele, Valentini, Valesini, Guido, Massimo, Vanoli, Barbara, Vigone, Silvana, Zeni, Angela, Tincani, Impress, Investigators, Behalf Of The Impress Investigators, O. n., Taraborelli, M, Ramoni, V, Brucato, A, Airo, P, Bajocchi, G, Bellisai, F, Biasi, D, Blagojevic, J, Canti, V, Caporali, R, Caramaschi, P, Chiarolanza, I, Codullo, V, Cozzi, F, Cuomo, G, Cutolo, M, De Santis, M, De Vita, S, Di Poi, E, Doria, A, Faggioli, P, Favaro, M, Ferraccioli, G, Ferri, C, Foti, R, Gerosa, A, Gerosa, M, Giacuzzo, S, Giani, L, Giuggioli, D, Imazio, M, Iudici, M, Iuliano, A, Leonardi, R, Limonta, M, Lojacono, A, Lubatti, C, Matucci Cerinic, M, Mazzone, A, Meroni, M, Meroni, Pl, Mosca, M, Motta, M, Muscara, M, Nava, S, Padovan, M, Pagani, G, Paolazzi, G, Peccatori, S, Ravagnani, V, Riccieri, V, Rosato, E, ROVERE QUERINI, Patrizia, Salsano, F, Santaniello, A, Scorza, R, Tani, C, Valentini, G, Valesini, G, Vanoli, M, Vigone, B, Zeni, S, and Tincani, A.

Subjects
Adult, Risk, Pediatrics, medicine.medical_specialty, Settore MED/16 - REUMATOLOGIA, systemic sclerosis, Birth weight, Immunology, Population, Intrauterine growth restriction, Scleroderma, Rheumatology, Pregnancy, Female, Fetal Growth Retardation, Humans, Infant, Newborn, Pregnancy Outcome, Premature Birth, Prevalence, Retrospective Studies, Scleroderma, Systemic, medicine, Immunology and Allergy, scleroderma, Pharmacology (medical), education, disease, education.field_of_study, pregnancies, business.industry, Systemic, Infant, Retrospective cohort study, Odds ratio, Newborn, medicine.disease, history, women, Premature birth, Gestation, pregnancy, business
Abstract

Objective To assess fetal and maternal outcomes in women with systemic sclerosis (SSc). Methods Prospectively collected data on 99 women with SSc from 25 Italian centers were analyzed retrospectively. Women with SSc were observed during 109 pregnancies (from 2000 to 2011), and outcomes were compared to those in the general obstetric population (total of 3,939 deliveries). The maternal age at conception was a mean ± SD 31.8 ± 5.3 years, and the median disease duration at conception was 60 months (range 2–193 months). Results SSc patients, compared to the general obstetric population, had a significantly increased frequency of preterm deliveries (25% versus 12%) and severe preterm deliveries (

Published
2012

26. Improving organisation to improve care: ERN ReCONNET organisational reference model for systemic sclerosis patients' care pathway.

Author

Talarico R, Marinello D, Palla I, Cannizzo S, Galetti I, Farrington S, Aguilera S, Andersen J, Ceccatelli E, Cornet A, Cutillas G, Esteves M, Frank C, Leite C, Niehaus G, Perez Gomez E, Polfliet K, Sandulescu S, Schriemer R, Barsotti S, Bellando-Randone S, Beretta L, Bernardino V, Boleto G, Bombardieri S, Burmester G, Cavazzana I, Codullo V, Cutolo M, Dalm V, Damian L, Della Rossa A, Doria A, Farhat MM, Fonseca JE, Hachulla E, Houssiau F, Grazia Lazzaroni M, Limper M, Lorenzoni V, Montecucco C, Mosca M, Mouthon L, Müeller-Ladner U, Pha M, Ponte C, Spierings J, Sulli A, Taulaigo AV, Ticciati S, Tincani A, Toplak N, Trieste L, van Hagen PM, van Laar J, Vanthuyne M, Vigone B, de Vries-Bouwstra JK, Zen M, Turchetti G, Smith V, and Matucci Cerinic M

Abstract

Objective: To optimise the organisation of care and encourage the adoption of good clinical practices, the RarERN Path © methodology was designed within ERN ReCONNET. The aim of our work was to report the application of RarERN Path © on systemic sclerosis within the ERN ReCONNET centres, providing a feasible and flexible organisational reference model for optimising the systemic sclerosis care pathway in different countries., Methods: RarERN Path © is a six-phase methodology which enables the creation of a reference organisational model co-designed on the basis of the expertise of different stakeholders. It foresees six phases, ranging from the map of existing patients' care pathways and patients' stories, to the consensus on a common organisational patient care pathways, and its key performance indicators definition., Results: The agreed reference model highlights the importance of having an organisational flow for referrals that foresees how patients may access directly the specialised unit from the different referrals. Specific specialised visits were considered as mandatory to be organised and they included cardiologist, pneumologist, gastroenterologist, psychologist, nephrologist, dermatologist, wound care specialist/nurses and other healthcare professionals (such as nurses, social workers and nutritional counselling). Moreover, specific services related to therapy were highlighted as strongly recommended to be organised, mainly represented by infusion therapy and wound care, as well as occupation therapy and physiotherapy., Conclusion: The organisational model emerged from our investigation emphasises that the organisation of specific services for systemic sclerosis treatment should be organised as a solid support for implementing the existing recommendations on systemic sclerosis management in real life., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article., (© The Author(s) 2024.)

Published
2024
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27. Molecular characterisation of lupus low disease activity state (LLDAS) and DORIS remission by whole-blood transcriptome-based pathways in a pan-European systemic lupus erythematosus cohort.

Author

Parodis I, Lindblom J, Barturen G, Ortega-Castro R, Cervera R, Pers JO, Genre F, Hiepe F, Gerosa M, Kovács L, De Langhe E, Piantoni S, Stummvoll G, Vasconcelos C, Vigone B, Witte T, Alarcón-Riquelme ME, and Beretta L

Subjects
Humans, Female, Adult, Male, Middle Aged, Severity of Illness Index, Cohort Studies, Lupus Erythematosus, Systemic drug therapy, Lupus Erythematosus, Systemic blood, Lupus Erythematosus, Systemic genetics, Remission Induction, Transcriptome
Abstract

Objectives: To unveil biological milieus underlying low disease activity (LDA) and remission versus active systemic lupus erythematosus (SLE)., Methods: We determined differentially expressed pathways (DEPs) in SLE patients from the PRECISESADS project (NTC02890121) stratified into patients fulfilling and not fulfilling the criteria of (1) Lupus LDA State (LLDAS), (2) Definitions of Remission in SLE remission, and (3) LLDAS exclusive of remission., Results: We analysed data from 321 patients; 40.8% were in LLDAS, and 17.4% in DORIS remission. After exclusion of patients in remission, 28.3% were in LLDAS. Overall, 604 pathways differed significantly in LLDAS versus non-LLDAS patients with an false-discovery rate-corrected p (q)<0.05 and a robust effect size (dr)≥0.36. Accordingly, 288 pathways differed significantly between DORIS remitters and non-remitters (q<0.05 and dr≥0.36). DEPs yielded distinct molecular clusters characterised by differential serological, musculoskeletal, and renal activity. Analysis of partially overlapping samples showed no DEPs between LLDAS and DORIS remission. Drug repurposing potentiality for treating SLE was unveiled, as were important pathways underlying active SLE whose modulation could aid attainment of LLDAS/remission, including toll-like receptor (TLR) cascades, Bruton tyrosine kinase (BTK) activity, the cytotoxic T lymphocyte antigen 4 (CTLA-4)-related inhibitory signalling, and the nucleotide-binding oligomerization domain leucine-rich repeat-containing protein 3 (NLRP3) inflammasome pathway., Conclusions: We demonstrated for the first time molecular signalling pathways distinguishing LLDAS/remission from active SLE. LLDAS/remission was associated with reversal of biological processes related to SLE pathogenesis and specific clinical manifestations. DEP clustering by remission better grouped patients compared with LLDAS, substantiating remission as the ultimate treatment goal in SLE; however, the lack of substantial pathway differentiation between the two states justifies LLDAS as an acceptable goal from a biological perspective., Competing Interests: Competing interests: IP has received research funding and/or honoraria from Amgen, AstraZeneca, Aurinia, Elli Lilly, Gilead, GlaxoSmithKline, Janssen, Novartis, Otsuka, and Roche., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2024
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28. Transcutaneous auricular branch vagal nerve stimulation as a non-invasive add-on therapeutic approach for pain in systemic sclerosis.

Author

Bellocchi C, Carandina A, Della Torre A, Turzi M, Arosio B, Marchini M, Vigone B, Scatà C, Beretta L, Rodrigues GD, Tobaldini E, and Montano N

Subjects
Humans, Pain Management, Quality of Life, Pain etiology, Transcutaneous Electric Nerve Stimulation, Vagus Nerve Stimulation, Scleroderma, Systemic complications, Scleroderma, Systemic therapy
Abstract

Objective: Systemic sclerosis (SSc) is an autoimmune disease with health-related quality of life (HRQoL) high impairment. Pain is of paramount importance to be targeted by therapeutical approaches. Our study aim was to perform an add-on device-based non-invasive neuromodulatory treatment through transcutaneous auricular vagal nerve stimulation (tVNS) in patients with SSc, assessing its effects on pain as primary endpoint and on inflammation, cardiovascular autonomic control and HRQoL., Methods: Thirty-two patients with SSc were enrolled based on reported pain assessed through Numeric Rating Scale (NRS). Twenty-one (90% with limited cutaneous SSc) completed a randomised, cross-over, patient-blind trial, in which interventional and active control were used in random order for 4 weeks, interspersed with 4 weeks washout. NRS, Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) Item4 for pain interference, heart rate variability (HRV), serum cytokines and HRQoL questionnaires (Health Assessment Questionnaire, Patient Health Questionnaire-9, University of California, Los Angeles Gastrointestinal Tract, Pittsburgh Sleep Quality Index) were assessed at baseline, at T1 (after 1 month of tVNS or active control), at T2 (after washout) and at T3 (after 1 month of active control or tVNS). T-test for paired data and Wilcoxon signed-rank test for non-normally distributed parameters were performed to compare the effect of tVNS and active control., Results: NRS pain was significantly reduced by tVNS and not by active control (Mean±SD: -27.7%±21.3% vs -7.7%±26.3%, p=0.002). Interleukin-6 was downregulated in tVNS versus active control (p=0.029). No significant differences were observed in tVNS versus active control for PROMIS-29 Item4, QoL scales and HRV with both spectral and symbolic analyses., Conclusion: tVNS demonstrated to be a safe and non-invasive add-on tool to reduce pain in SSc., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2023
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29. Real-life efficacy and safety of nintedanib in systemic sclerosis-interstitial lung disease: data from an Italian multicentre study.

Author

Campochiaro C, De Luca G, Lazzaroni MG, Armentaro G, Spinella A, Vigone B, Ruaro B, Stanziola A, Benfaremo D, De Lorenzis E, Moccaldi B, Bosello SL, Cuomo G, Beretta L, Zanatta E, Giuggioli D, Del Papa N, Airo P, Confalonieri M, Moroncini G, Dagna L, and Matucci-Cerinic M

Subjects
Humans, Female, Adult, Middle Aged, Aged, Male, Retrospective Studies, Immunosuppressive Agents therapeutic use, Lung Diseases, Interstitial, Scleroderma, Systemic drug therapy
Abstract

Introduction: Nintedanib (NTD) has been shown to be effective in systemic sclerosis (SSc)-interstitial lung disease (ILD). Here we describe the efficacy and safety of NTD in a real-life setting., Methods: Patients with SSc-ILD treated with NTD were retrospectively evaluated at 12 months prior to NTD introduction; at baseline and at 12 months after NTD introduction. The following parameters were recorded: SSc clinical features, NTD tolerability, pulmonary function tests and modified Rodnan skin score (mRSS)., Results: 90 patients with SSc-ILD (65% female, mean age 57.6±13.4 years, mean disease duration 8.8±7.6 years) were identified. The majority were positive for anti-topoisomerase I (75%) and 77 (85%) patients were on immunosuppressants. A significant decline in %predicted forced vital capacity (%pFVC) in the 12 months prior to NTD introduction was observed in 60%. At 12 months after NTD introduction, follow-up data were available for 40 (44%) patients and they showed a stabilisation in %pFVC (64±14 to 62±19, p=0.416). The percentage of patients with significant lung progression at 12 months was significantly lower compared with the previous 12 months (60% vs 17.5%, p=0.007). No significant mRSS change was observed. Gastrointestinal (GI) side effects were recorded in 35 (39%) patients. After a mean time of 3.6±3.1 months, NTD was maintained after dose adjustment in 23 (25%) patients. In nine (10%) patients, NTD was stopped after a median time of 4.5 (1-6) months. During the follow-up, four patients died., Conclusions: In a real-life clinical scenario, NTD, in combination with immunosuppressants, may stabilise lung function. GI side effects are frequent and NTD dose adjustment may be necessary to retain the drug in patients with SSc-ILD., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2023
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30. Expert opinion and patients' in-depth interviews on the impact of pulmonary complications in systemic sclerosis.

Author

Caminati A, Vigone B, Cozzaglio S, De Nigris P, Galetti I, Nunzio SD, Verzeletti V, Cighetti J, Garbagnati C, Paleari L, Tabaglio E, and Pirri S

Subjects
Caregivers, Communication, Humans, Quality of Life, Scleroderma, Systemic complications
Abstract

Objective: To qualitatively explore the perceptions and opinions of experts dealing with systemic sclerosis (SSc) and patients with SSc on the impact of the disease and pulmonary complications on economic status, psycho-social wellbeing and the diagnostic and therapeutic journey, and to identify which strategies/interventions may be useful to address patients' and their family's needs., Methods: An expert meeting was conducted using the NGT to discuss the consequences of pulmonary complications on the Italian SSc community. The direct experience of five patients with SSc and pulmonary complications was described through in-depth interviews conducted by psychologists., Results: The experts' meeting and patients' in-depth interviews underline the complexity of SSc and the consequences of pulmonary involvement on patients' and caregivers' health-related quality of life, working ability, psychological wellbeing and social interactions. Panellists suggest that improved communication between physicians, associations and institutions could help protect the working status of patients with SSc. Granting patients disability benefits, providing access to part-time jobs and productivity-focused training could also help decrease the economic burden of the disease. A multidisciplinary approach is recommended to reduce treatment burden, together with the implementation of standard diagnostic and therapeutic paths and increased use of telemedicine via platforms that ensure secure health data sharing. Both patients and caregivers may benefit from psychological support., Conclusion: SSc and pulmonary fibrosis have profound consequences on patients' and caregivers' health-related quality of life, working ability, psychological wellbeing and social interactions. Some activities may help patients and families deal with these aspects of the disease.

Published
2021
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31. Integrative Analysis Reveals a Molecular Stratification of Systemic Autoimmune Diseases.

Author

Barturen G, Babaei S, Català-Moll F, Martínez-Bueno M, Makowska Z, Martorell-Marugán J, Carmona-Sáez P, Toro-Domínguez D, Carnero-Montoro E, Teruel M, Kerick M, Acosta-Herrera M, Le Lann L, Jamin C, Rodríguez-Ubreva J, García-Gómez A, Kageyama J, Buttgereit A, Hayat S, Mueller J, Lesche R, Hernandez-Fuentes M, Juarez M, Rowley T, White I, Marañón C, Gomes Anjos T, Varela N, Aguilar-Quesada R, Garrancho FJ, López-Berrio A, Rodriguez Maresca M, Navarro-Linares H, Almeida I, Azevedo N, Brandão M, Campar A, Faria R, Farinha F, Marinho A, Neves E, Tavares A, Vasconcelos C, Trombetta E, Montanelli G, Vigone B, Alvarez-Errico D, Li T, Thiagaran D, Blanco Alonso R, Corrales Martínez A, Genre F, López Mejías R, Gonzalez-Gay MA, Remuzgo S, Ubilla Garcia B, Cervera R, Espinosa G, Rodríguez-Pintó I, De Langhe E, Cremer J, Lories R, Belz D, Hunzelmann N, Baerlecken N, Kniesch K, Witte T, Lehner M, Stummvoll G, Zauner M, Aguirre-Zamorano MA, Barbarroja N, Castro-Villegas MC, Collantes-Estevez E, de Ramon E, Díaz Quintero I, Escudero-Contreras A, Fernández Roldán MC, Jiménez Gómez Y, Jiménez Moleón I, Lopez-Pedrera R, Ortega-Castro R, Ortego N, Raya E, Artusi C, Gerosa M, Meroni PL, Schioppo T, De Groof A, Ducreux J, Lauwerys B, Maudoux AL, Cornec D, Devauchelle-Pensec V, Jousse-Joulin S, Jouve PE, Rouvière B, Saraux A, Simon Q, Alvarez M, Chizzolini C, Dufour A, Wynar D, Balog A, Bocskai M, Deák M, Dulic S, Kádár G, Kovács L, Cheng Q, Gerl V, Hiepe F, Khodadadi L, Thiel S, de Rinaldis E, Rao S, Benschop RJ, Chamberlain C, Dow ER, Ioannou Y, Laigle L, Marovac J, Wojcik J, Renaudineau Y, Borghi MO, Frostegård J, Martín J, Beretta L, Ballestar E, McDonald F, Pers JO, and Alarcón-Riquelme ME

Subjects
Adult, Aged, Antiphospholipid Syndrome genetics, Antiphospholipid Syndrome immunology, Arthritis, Rheumatoid genetics, Arthritis, Rheumatoid immunology, Autoimmune Diseases immunology, Case-Control Studies, Cluster Analysis, Cross-Sectional Studies, Epigenomics, Female, Humans, Inflammation immunology, Interferons immunology, Lupus Erythematosus, Systemic genetics, Lupus Erythematosus, Systemic immunology, Male, Middle Aged, Mixed Connective Tissue Disease genetics, Mixed Connective Tissue Disease immunology, Scleroderma, Systemic genetics, Scleroderma, Systemic immunology, Sjogren's Syndrome genetics, Sjogren's Syndrome immunology, Undifferentiated Connective Tissue Diseases genetics, Undifferentiated Connective Tissue Diseases immunology, Autoimmune Diseases classification, Autoimmune Diseases genetics, Epigenome, Gene Expression Profiling
Abstract

Objective: Clinical heterogeneity, a hallmark of systemic autoimmune diseases, impedes early diagnosis and effective treatment, issues that may be addressed if patients could be classified into groups defined by molecular pattern. This study was undertaken to identify molecular clusters for reclassifying systemic autoimmune diseases independently of clinical diagnosis., Methods: Unsupervised clustering of integrated whole blood transcriptome and methylome cross-sectional data on 955 patients with 7 systemic autoimmune diseases and 267 healthy controls was undertaken. In addition, an inception cohort was prospectively followed up for 6 or 14 months to validate the results and analyze whether or not cluster assignment changed over time., Results: Four clusters were identified and validated. Three were pathologic, representing "inflammatory," "lymphoid," and "interferon" patterns. Each included all diagnoses and was defined by genetic, clinical, serologic, and cellular features. A fourth cluster with no specific molecular pattern was associated with low disease activity and included healthy controls. A longitudinal and independent inception cohort showed a relapse-remission pattern, where patients remained in their pathologic cluster, moving only to the healthy one, thus showing that the molecular clusters remained stable over time and that single pathogenic molecular signatures characterized each individual patient., Conclusion: Patients with systemic autoimmune diseases can be jointly stratified into 3 stable disease clusters with specific molecular patterns differentiating different molecular disease mechanisms. These results have important implications for future clinical trials and the study of nonresponse to therapy, marking a paradigm shift in our view of systemic autoimmune diseases., (© 2020, American College of Rheumatology.)

Published
2021
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32. Letter to the editor: Immunomodulation by phosphodiesterase-4 inhibitor in COVID-19 patients.

Author

Santaniello A, Vigone B, and Beretta L

Subjects
Betacoronavirus, COVID-19, Cyclic Nucleotide Phosphodiesterases, Type 4, Cytokines, Humans, Immunomodulation, SARS-CoV-2, Coronavirus Infections, Pandemics, Phosphodiesterase 4 Inhibitors, Pneumonia, Viral
Abstract

Competing Interests: Declaration of competing interest The authors declare no conflict of interest.

Published
2020
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33. Genome-wide whole blood transcriptome profiling in a large European cohort of systemic sclerosis patients.

Author

Beretta L, Barturen G, Vigone B, Bellocchi C, Hunzelmann N, De Langhe E, Cervera R, Gerosa M, Kovács L, Ortega Castro R, Almeida I, Cornec D, Chizzolini C, Pers JO, Makowska Z, Lesche R, Kerick M, Alarcón-Riquelme ME, and Martin J

Subjects
Adult, Aged, Cohort Studies, Europe, Female, Gene Expression Profiling, Genome-Wide Association Study, Humans, Immunophenotyping, Interferon Type I blood, Male, Microarray Analysis, Middle Aged, Sequence Analysis, RNA, Toll-Like Receptors blood, Autoimmunity genetics, Scleroderma, Systemic genetics, Signal Transduction genetics, Transcriptome genetics
Abstract

Objectives: The analysis of annotated transcripts from genome-wide expression studies may help to understand the pathogenesis of complex diseases, such as systemic sclerosis (SSc). We performed a whole blood (WB) transcriptome analysis on RNA collected in the context of the European PRECISESADS project, aiming at characterising the pathways that differentiate SSc from controls and that are reproducible in geographically diverse populations., Methods: Samples from 162 patients and 252 controls were collected in RNA stabilisers. Cases and controls were divided into a discovery (n=79+163; Southern Europe) and validation cohort (n=83+89; Central-Western Europe). RNA sequencing was performed by an Illumina assay. Functional annotations of Reactome pathways were performed with the Functional Analysis of Individual Microarray Expression (FAIME) algorithm. In parallel, immunophenotyping of 28 circulating cell populations was performed. We tested the presence of differentially expressed genes/pathways and the correlation between absolute cell counts and RNA transcripts/FAIME scores in regression models. Results significant in both populations were considered as replicated., Results: Overall, 15 224 genes and 1277 functional pathways were available; of these, 99 and 225 were significant in both sets. Among replicated pathways, we found a deregulation in type-I interferon, Toll-like receptor cascade, tumour suppressor p53 protein function, platelet degranulation and activation. RNA transcripts or FAIME scores were jointly correlated with cell subtypes with strong geographical differences; neutrophils were the major determinant of gene expression in SSc-WB samples., Conclusions: We discovered a set of differentially expressed genes/pathways validated in two independent sets of patients with SSc, highlighting a number of deregulated processes that have relevance for the pathogenesis of autoimmunity and SSc., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2020
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34. Identification of a Shared Microbiomic and Metabolomic Profile in Systemic Autoimmune Diseases.

Author

Bellocchi C, Fernández-Ochoa Á, Montanelli G, Vigone B, Santaniello A, Quirantes-Piné R, Borrás-Linares I, Gerosa M, Artusi C, Gualtierotti R, Segura-Carrettero A, Alarcón-Riquelme ME, and Beretta L

Abstract

Dysbiosis has been described in systemic autoimmune diseases (SADs), including systemic lupus erythematosus (SLE), Sjögren's syndrome (SjS), and primary anti-phosholipid syndrome (PAPS), however the biological implications of these associations are often elusive. Stool and plasma samples from 114 subjects, including in SLE ( n = 27), SjS ( n = 23), PAPs ( n = 11) and undifferentiated connective tissue (UCTD, n = 26) patients, and geographically-matched healthy controls (HCs, n = 27), were collected for microbiome (16s rRNA gene sequencing) and metabolome (high-performance liquid chromatography coupled to mass spectrometry) analysis to identify shared characteristics across diseases. Out of 130 identified microbial genera, a subset of 29 bacteria was able to differentiate study groups (area under receiver operating characteristics (AUROC) = 0.730 ± 0.025). A fair classification was obtained with a subset of 41 metabolic peaks out of 254 (AUROC = 0.748 ± 0.021). In both models, HCs were well separated from SADs, while UCTD largely overlapped with the other diseases. In all of the SADs pro-tolerogenic bacteria were reduced, while pathobiont genera were increased. Metabolic alterations included two clusters comprised of: (a) members of the acylcarnitine family, positively correlating with a Prevotella-enriched cluster and negatively correlating with a butyrate-producing bacteria-enriched cluster; and (b) phospholipids, negatively correlating with butyrate-producing bacteria. These findings demonstrate a strong interaction between intestinal microbiota and metabolic function in patients with SADs., Competing Interests: The authors declare no conflict of interest.

Published
2019
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35. Abatacept to treat chronic intestinal pseudo-obstruction in five systemic sclerosis patients with a description of the index case.

Author

Vigone B and Beretta L

Abstract

Chronic intestinal pseudo-obstruction is a severe complication of systemic sclerosis. Inflammatory neuropathy and immunological alterations have a prominent role in the development of systemic sclerosis-related chronic intestinal pseudo-obstruction and immunomodulation might be beneficial in this context. An accidental observation of a patient with juvenile arthritis and a biopsy-proven diagnosis of autoimmune ganglionitis led us to experiment with a new approach to treat systemic sclerosis-related chronic intestinal pseudo-obstruction. In our arthritis patient, the severity and frequency of recurrent episodes of chronic intestinal pseudo-obstruction and aspiration pneumonia were reduced whenever steroids were used to treat arthritic flares, which dramatically improved with abatacept therapy. A systemic sclerosis patient presented typical chronic intestinal pseudo-obstruction features that were neither controlled by dietary interventions nor by prokinetics and were often complicated by acute episodes (5-year) requiring hospitalization. Increased food tolerance was observed whenever parenteral steroids were used during hospitalization. An adequate long-term control of symptoms was then obtained with the use of intramuscular methylprednisolone 20 mg/day; however, symptoms promptly recurred after tapering. Following this motivating example, immunomodulation with abatacept was started. Symptoms were then well controlled and steroids could be weaned off without further acute episodes of sub-occlusion. We postulate that inflammatory neuropathy resembling myenteric ganglionitis may be suspected in selected systemic sclerosis patients with chronic intestinal pseudo-obstruction features. Immunomodulation with drugs that act on T function and restore the regulatory/effector T cell balance may be beneficial in these subjects. The outcomes of four additional systemic sclerosis patients with severe and refractory symptoms of intestinal pseudo-obstruction successfully treated with abatacept are also presented., Competing Interests: Declaration of conflicting interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2018.)

Published
2019
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36. When and how ruling out cystic fibrosis in adult patients with bronchiectasis.

Author

Gramegna A, Aliberti S, Seia M, Porcaro L, Bianchi V, Castellani C, Melotti P, Sorio C, Consalvo E, Franceschi E, Amati F, Contarini M, Gaffuri M, Roncoroni L, Vigone B, Bellofiore A, Del Monaco C, Oriano M, Terranova L, Patria MF, Marchisio P, Assael BM, and Blasi F

Abstract

Background: Bronchiectasis is the final result of different processes and most of the guidelines advocate for a careful evaluation of those etiologies which might be treated or might change patients' management, including cystic fibrosis (CF)., Main Body: CFTR mutations have been reported with higher frequency in bronchiectasis population. Although ruling out CF is considered as a main step for etiological screening in bronchiectasis, CF testing lacks of a standardized approach both from a research and clinical point of view. In this review a list of most widely used tests in CF is provided., Conclusions: Exclusion of CF is imperative for patients with bronchiectasis and CFTR testing should be implemented in usual screening for investigating bronchiectasis etiology. Physicians taking care of bronchiectasis patients should be aware of CFTR testing and its limitations in the adult population. Further studies on CFTR expression in human lung and translational research might elucidate the possible role of CFTR in the pathogenesis of bronchiectasis., Competing Interests: Not applicable.Not applicable.The authors declare that they have no competing interests. Prof. Francesco Blasi is Editor-in-Chief of Multidisciplinary Respiratory Medicine, whereas Prof. Stefano Aliberti is Associate editor of Multidisciplinary Respiratory Medicine and Guest Editor of the Supplement on Bronchiectasis.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Published
2018
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37. Microbial and metabolic multi-omic correlations in systemic sclerosis patients.

Author

Bellocchi C, Fernández-Ochoa Á, Montanelli G, Vigone B, Santaniello A, Milani C, Quirantes-Piné R, Borrás-Linares I, Ventura M, Segura-Carrettero A, Alarcón-Riquelme ME, and Beretta L

Subjects
Adult, Aged, Case-Control Studies, Female, Gastrointestinal Microbiome, Humans, Male, Middle Aged, Genomics, Metabolomics, Proteomics, Scleroderma, Systemic metabolism, Scleroderma, Systemic microbiology
Abstract

Intestinal microbiota has been associated with systemic autoimmune diseases, yet the functional consequences of these associations are elusive. We characterized the fecal microbiota (16S rRNA gene amplification and sequencing) and the plasma metabolome (high-performance liquid chromatography coupled to mass spectrometry) in 59 patients with systemic sclerosis (SSc) and 28 healthy controls (HCs). Microbial and metabolic data were cross-correlated to find meaningful associations after extensive data mining analysis and internal validation. Our data show that a reduced model of nine bacteria is capable of differentiating HCs from SSc patients. SSc gut microbiota is characterized by a reduction in protective butyrate-producing bacteria and by an increase in proinflammatory noxious genera, especially Desulfovibrio. From the metabolic point of view, a multivariate model with 17 metabolite intermediates well distinguished cases from controls. The most interesting peaks we found were identified as glycerophospholipid metabolites and benzene derivatives. The microbial and metabolic data showed significant interactions between Desulfovibrio and alpha-N-phenylacetyl-l-glutamine and 2,4-dinitrobenzenesulfonic acid. Our data suggest that in SSc, intestinal microbiota is characterized by proinflammatory alterations subtly entwined with the metabolic state. Desulfovibrio is a relevant actor in gut dysbiosis that may promote intestinal damage and influence amino acid metabolism., (© 2018 The Authors. Annals of the New York Academy of Sciences published by Wiley Periodicals Inc. on behalf of The New York Academy of Sciences.)

Published
2018
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38. Serum microRNA screening and functional studies reveal miR-483-5p as a potential driver of fibrosis in systemic sclerosis.

Author

Chouri E, Servaas NH, Bekker CPJ, Affandi AJ, Cossu M, Hillen MR, Angiolilli C, Mertens JS, van den Hoogen LL, Silva-Cardoso S, van der Kroef M, Vazirpanah N, Wichers CGK, Carvalheiro T, Blokland SLM, Giovannone B, Porretti L, Marut W, Vigone B, van Roon JAG, Beretta L, Rossato M, and Radstake TRDJ

Subjects
Adult, Aged, Cohort Studies, Female, Fibrosis, Genetic Testing, Humans, Male, Middle Aged, Up-Regulation, Endothelial Cells physiology, Fibroblasts physiology, MicroRNAs genetics, Scleroderma, Systemic genetics, Skin pathology
Abstract

Objective: MicroRNAs (miRNAs) are regulatory molecules, which have been addressed as potential biomarkers and therapeutic targets in rheumatic diseases. Here, we investigated the miRNA signature in the serum of systemic sclerosis (SSc) patients and we further assessed their expression in early stages of the disease., Methods: The levels of 758 miRNAs were evaluated in the serum of 26 SSc patients as compared to 9 healthy controls by using an Openarray platform. Three miRNAs were examined in an additional cohort of 107 SSc patients and 24 healthy donors by single qPCR. MiR-483-5p expression was further analysed in the serum of patients with localized scleroderma (LoS) (n = 22), systemic lupus erythematosus (SLE) (n = 33) and primary Sjögren's syndrome (pSS) (n = 23). The function of miR-483-5p was examined by transfecting miR-483-5p into primary human dermal fibroblasts and pulmonary endothelial cells., Results: 30 miRNAs were significantly increased in patients with SSc. Of these, miR-483-5p showed reproducibly higher levels in an independent SSc cohort and was also elevated in patients with preclinical-SSc symptoms (early SSc). Notably, miR-483-5p was not differentially expressed in patients with SLE or pSS, whereas it was up-regulated in LoS, indicating that this miRNA could be involved in the development of skin fibrosis. Consistently, miR-483-5p overexpression in fibroblasts and endothelial cells modulated the expression of fibrosis-related genes., Conclusions: Our findings showed that miR-483-5p is up-regulated in the serum of SSc patients, from the early stages of the disease onwards, and indicated its potential function as a fine regulator of fibrosis in SSc., (Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Published
2018
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39. Preliminary safety and efficacy profile of prucalopride in the treatment of systemic sclerosis (SSc)-related intestinal involvement: results from the open label cross-over PROGASS study.

Author

Vigone B, Caronni M, Severino A, Bellocchi C, Baldassarri AR, Fraquelli M, Montanelli G, Santaniello A, and Beretta L

Subjects
Adult, Aged, Benzofurans adverse effects, Constipation diagnosis, Cross-Over Studies, Female, Gastrointestinal Diseases diagnosis, Gastrointestinal Diseases drug therapy, Gastrointestinal Diseases epidemiology, Humans, Laxatives adverse effects, Middle Aged, Scleroderma, Systemic diagnosis, Treatment Outcome, Benzofurans therapeutic use, Constipation drug therapy, Constipation epidemiology, Laxatives therapeutic use, Scleroderma, Systemic drug therapy, Scleroderma, Systemic epidemiology
Abstract

Background: Prokinetics are used to treat enteric dismotility symptoms in systemic sclerosis (SSc) patients, but they often lack adequate efficacy. The most effective prokinetics belonging to the serotonin (5-HT 4 ) receptor agonists class were withdrawn due to cardiac toxicity in relation to modest 5-HT 4 receptor affinity. Prucalopride is a high-affinity 5-HT 4 receptor agonist with no major cardiac issues, for which the efficacy in SSc has not yet been assessed., Methods: Forty patients with self-reported mild to moderately severe enteric symptoms were enrolled in a cross-over 2 × 2 study. Subjects were randomized 1:1 to prucalopride 2 mg/day or no treatment for one month and vice versa after a 2-week washout period. Before and after each sequence the patients compiled the University of California Los Angeles gastrointestinal tract (UCLA GIT) 2.0 questionnaire and the numbers of complete intestinal movements were recorded. Oro-cecal transit time (OCTT) was evaluated by lactulose breath test in a subgroup of patients. Data were evaluated by mixed linear models corrected for the number of laxatives used during the study periods., Results: There were 29 subjects who completed the study; 7 subjects withdrew due to side-effects and 4 subjects were not compliant with the study procedures. As compared to dummy treatment, prucalopride was associated with more intestinal evacuations (p < 0.001), improvement of UCLA GIT constipation (-0.672 ± 0.112 vs 0.086 ± 0.115; p < 0.001), reflux (-0.409 ± 0.094 vs 0.01 ± 0.096; p < 0.005) and bloating (-0.418 ± 0.088 vs -0.084 ± 0.09; p = 0.01) scores. Treatment was ranked moderately to more than moderately effective by 22 patients (72.4%). OCTT was significantly reduced during prucalopruide consumption (prucalopride: -20.1 ± 20.1 vs no treatment: 45.8 ± 21.3 minutes; treatment effect = -65.9 minutes; p = 0.035)., Conclusions: The safety profile of prucalopride in SSc is similar to what is known from the literature. In patients with mild to severe gastrointestinal problems, prucalopride may be effective in treating dismotility symptoms, increasing the number of complete bowel movements and improving bowel transit, reducing reflux disease and bloating., Trial Registration: EU Clinical Trial Registry, EudraCT2012-005348-92 . Registered on 19 February 2013.

Published
2017
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40. Role of class II human leucocyte antigens in the progression from early to definite systemic sclerosis.

Author

Vigone B, Santaniello A, Marchini M, Montanelli G, Caronni M, Severino A, and Beretta L

Subjects
Adult, Alleles, Disease Progression, Female, HLA-D Antigens immunology, HLA-DQ Antigens genetics, HLA-DQ Antigens immunology, HLA-DQ alpha-Chains genetics, HLA-DQ alpha-Chains immunology, HLA-DQ beta-Chains genetics, HLA-DQ beta-Chains immunology, HLA-DRB1 Chains genetics, HLA-DRB1 Chains immunology, Histocompatibility Antigens Class II, Humans, Male, Middle Aged, Prognosis, Proportional Hazards Models, Prospective Studies, Scleroderma, Systemic immunology, HLA-D Antigens genetics, Scleroderma, Systemic genetics
Abstract

Objective: HLAs have been extensively associated with SSc susceptibility but their role in the progression of the disease is poorly understood. In 2013 the ACR and European League Against Rheumatism (EULAR) jointly defined criteria for the classification of SSc that allow the early identification of definite SSc patients. In this study we investigated the role of HLA class II antigens in the progression from early to definite SSc., Methods: One hundred and fifty-eight subjects with early SSc according to LeRoy and Medsger criteria and no other manifestation indicative of definite SSc at referral were considered. All the patients underwent high-resolution HLA class II typing and the appraisal of definite SSc was retrospectively conducted in a prospective manner. Lifetime analysis was conducted to gauge the effect of genetic and clinical characteristics on progression of the disease., Results: The median estimated time to progression was 45 months from referral; the 5 and 10 year estimates of progression were 59.8% and 80%, respectively. ACAs were associated with a reduced risk of progression [median survival 55 vs 23 months for ACA-positive vs ACA-negative patients, P = 0.035; hazard ratio (HR) 0.67 (95% CI 0.458, 0.979)]. HLA alleles within the HLA DQ5-DR1 haplotype [HLA-DRB1*0101-HLA-DQA1*0101(4)-HLA-DQB1*0501] reduced the risk of progression of the disease [median survival 108 vs 44 months for DQ5-DR1 carriers vs DQ5-DR1 non-carriers; HR 0.388 (CI 0.211, 0.712), P = 0.001, corrected P = 0.014]. In multivariate models, the effect of genetics was found to be independent of ACA positivity or other baseline factors; additive risks were observed when the DQ5-DR1 haplotype and ACA were jointly considered., Conclusion: HLA class II alleles within the HLA DQ5-DR1 haplotype are associated with lower rates of progression from early to definite SSc., (© The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Published
2015
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41. Brief report: successful pregnancies but a higher risk of preterm births in patients with systemic sclerosis: an Italian multicenter study.

Author

Taraborelli M, Ramoni V, Brucato A, Airò P, Bajocchi G, Bellisai F, Biasi D, Blagojevic J, Canti V, Caporali R, Caramaschi P, Chiarolanza I, Codullo V, Cozzi F, Cuomo G, Cutolo M, De Santis M, De Vita S, Di Poi E, Doria A, Faggioli P, Favaro M, Ferraccioli G, Ferri C, Foti R, Gerosa A, Gerosa M, Giacuzzo S, Giani L, Giuggioli D, Imazio M, Iudici M, Iuliano A, Leonardi R, Limonta M, Lojacono A, Lubatti C, Matucci-Cerinic M, Mazzone A, Meroni M, Meroni PL, Mosca M, Motta M, Muscarà M, Nava S, Padovan M, Pagani G, Paolazzi G, Peccatori S, Ravagnani V, Riccieri V, Rosato E, Rovere-Querini P, Salsano F, Santaniello A, Scorza R, Tani C, Valentini G, Valesini G, Vanoli M, Vigone B, Zeni S, and Tincani A

Subjects
Adult, Female, Humans, Infant, Newborn, Pregnancy, Pregnancy Outcome, Prevalence, Retrospective Studies, Risk, Fetal Growth Retardation epidemiology, Premature Birth epidemiology, Scleroderma, Systemic physiopathology
Abstract

Objective: To assess fetal and maternal outcomes in women with systemic sclerosis (SSc)., Methods: Prospectively collected data on 99 women with SSc from 25 Italian centers were analyzed retrospectively. Women with SSc were observed during 109 pregnancies (from 2000 to 2011), and outcomes were compared to those in the general obstetric population (total of 3,939 deliveries). The maternal age at conception was a mean ± SD 31.8 ± 5.3 years, and the median disease duration at conception was 60 months (range 2-193 months)., Results: SSc patients, compared to the general obstetric population, had a significantly increased frequency of preterm deliveries (25% versus 12%) and severe preterm deliveries (<34 weeks of gestation) (10% versus 5%), intrauterine growth restriction (6% versus 1%), and babies with very-low birth weight (5% versus 1%). Results of multivariable analysis showed that corticosteroid use was associated with preterm deliveries (odds ratio [OR] 3.63, 95% confidence interval [95% CI] 1.12-11.78), whereas the use of folic acid (OR 0.30, 95% CI 0.10-0.91) and presence of anti-Scl-70 antibodies (OR 0.26, 95% CI 0.08-0.85) were protective. The disease remained stable in most SSc patients, but there were 4 cases of progression of disease within 1 year from delivery, all in anti-Scl-70 antibody-positive women, 3 of whom had a disease duration of <3 years., Conclusion: Women with SSc can have successful pregnancies, but they have a higher-than-normal risk of preterm delivery, intrauterine growth restriction, and babies with very-low birth weight. Progression of the disease during or after pregnancy is rare, but possible. High-risk multidisciplinary management should be standard for these patients, and pregnancy should be avoided in women with severe organ damage and postponed in women with SSc of recent onset, particularly if the patient is positive for anti-Scl-70 antibodies., (Copyright © 2012 by the American College of Rheumatology.)

Published
2012
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