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2. Luspatercept for the treatment of anaemia in non-transfusion-dependent β-thalassaemia (BEYOND): a phase 2, randomised, double-blind, multicentre, placebo-controlled trial

Author

Ali T Taher, Maria Domenica Cappellini, Antonis Kattamis, Ersi Voskaridou, Silverio Perrotta, Antonio G Piga, Aldo Filosa, John B Porter, Thomas D Coates, Gian Luca Forni, Alexis A Thompson, Immacolata Tartaglione, Khaled M Musallam, Jay T Backstrom, Oriana Esposito, Ana Carolina Giuseppi, Wen-Ling Kuo, Dimana Miteva, Jennifer Lord-Bessen, Aylin Yucel, Tatiana Zinger, Jeevan K Shetty, Vip Viprakasit, Jassada Buaboonnam, Supachai Ekwattanakit, Archrob Khunhapinant, Efthalia Loka, Maria Moraki, Pagona Flevari, Maria Dimopoulou, Vasiliki Bartzi, Hisham Daadaa, Georges El Hasbani, Suzanne Koussa, Federica Ammendola, Saverio Scianguetta, Marta Puglia, Ilaria Ferrara, Giovanni Ferrero, Carmen Gaglioti, Filomena Longo, Silvia Turrini, Vincenzo Voi, Elena Cassinerio, Anna De, Giovanna Graziadei, Alessia Marcon, Margherita Migone De Amicis, Irene Motta, Patrizia Cinque, Bruno Pannone, Paolo Ricchi, Manuela Balocco, Paola Carrara, Francesco Della Rovere, Martina Lamagna, Valeria Pinto, Sabrina Quintino, Perla Eleftheriou, Maciej Garbowski, Arne de Kreuk, Susan Carson, Christopher Denton, Tom Hofstra, Sayany Veluswamy, John Wood, Sherif Badawy, Rachel Bercovitz, Rukhmi Bhat, Diane Calamaras, Robert Liem, Astrid Mack, Taher, Ali T, Cappellini, Maria Domenica, Kattamis, Antoni, Voskaridou, Ersi, Perrotta, Silverio, Piga, Antonio G, Filosa, Aldo, Porter, John B, Coates, Thomas D, Forni, Gian Luca, Thompson, Alexis A, Tartaglione, Immacolata, Musallam, Khaled M, Backstrom, Jay T, Esposito, Oriana, Giuseppi, Ana Carolina, Kuo, Wen-Ling, Miteva, Dimana, Lord-Bessen, Jennifer, Yucel, Aylin, Zinger, Tatiana, Shetty, Jeevan K, and Viprakasit, Vip

Subjects
Adult, Male, Settore MED/09 - Medicina Interna, Activin Receptors, Type II, Hemoglobin E, Recombinant Fusion Proteins, beta-Thalassemia, Hematology, Immunoglobulin Fc Fragments, Treatment Outcome, Double-Blind Method, alpha-Globins, Quality of Life, Unit, Cardarelli Hospital, Humans, Thalassemia, Female, Settore MED/15 - Malattie del Sangue
Abstract

Background In patients with non-transfusion-dependent beta-thalassaemia, haemoglobin concentrations lower than 10 g/dL are associated with a higher risk of morbidity, mortality, and impaired quality of life. No drugs are specifically approved for anaemia management in patients with non-transfusion-dependent beta-thalassaemia, other than transfusion therapy administered infrequently in accordance with patients' needs. We assessed the efficacy and safety of luspatercept versus placebo in patients with non-transfusion-dependent beta-thalassaemia.Methods We did a phase 2, randomised, double-blind, multicentre, placebo-controlled trial in 12 centres in six countries (Thailand [n=1], Lebanon [n=1], Greece [n=2], Italy [n=5], the UK [n=1], and the USA [n=2]). Eligible patients were aged 18 years or older, had confirmed diagnosis of beta-thalassaemia or haemoglobin E/beta-thalassaemia (concomitant a-globin deletion, mutation, or duplication were allowed), and a baseline haemoglobin concentration of 10.0 g/dL or lower. All patients were non-transfusion-dependent. Patients were randomly assigned (2:1) to luspatercept or placebo using an interactive response technology system and stratified by baseline haemoglobin concentration (>= 8.5 g/dL vs = 3 vs

Published
2022

3. Italian patients with hemoglobinopathies exhibit a 5-fold increase in age-standardized lethality due to SARS-CoV-2 infection

Author

Sabrina Quintino, Filomena Longo, Maurizio Miano, Vincenzo Voi, Maria Caterina Putti, Margerita Migone De Amicis, Monica Fortini, Susanna Barella, Barbara Gianesin, Federico Bonetti, Andrea Beccaria, Manuela Balocco, Andrea Piolatto, Saveria Campisi, Rosamaria Rosso, Angelantonio Vitucci, Valentina Carrai, Alessandra Quota, Zelia Borsellino, Antonio Piga, Maddalena Casale, Anna Rita Denotti, Michela Ribersani, Maria Rita Gamberini, Domenico Roberti, Alberto Piperno, Roberto Lisi, Carmelo Fidone, Maria Domenica Cappellini, Sabrina Bagnato, Anna De Giovanni, Micol Quaresima, Valeria Maria, Lorella Pitrolo, Marco Marziali, Giovanna Graziadei, Carmen Gaglioti, Aldo Filosa, Chiara Dal Zotto, Lucia De Franceschi, Irene Motta, Immacolata Tartaglione, Francesco Arcioni, Aurelio Maggio, Marilena Serra, Giovan Battista Ruffo, Massimo Gentile, Elisa De Michele, Anna Spasiano, Paolo Ricchi, Antonella Massa, Silverio Perrotta, R. Mariani, Gian Luca Forni, Longo, Filomena, Gianesin, Barbara, Voi, Vincenzo, Motta, Irene, Pinto, Valeria Maria, Piolatto, Andrea, Spasiano, Anna, Ruffo, Giovan Battista, Gamberini, Maria Rita, Barella, Susanna, Mariani, Raffaella, Fidone, Carmelo, Rosso, Rosamaria, Casale, Maddalena, Roberti, Domenico, Dal Zotto, Chiara, Vitucci, Angelantonio, Bonetti, Federico, Pitrolo, Lorella, Quaresima, Micol, Ribersani, Michela, Quota, Alessandra, Arcioni, Francesco, Campisi, Saveria, Massa, Antonella, De Michele, Elisa, Lisi, Roberto, Miano, Maurizio, Bagnato, Sabrina, Gentile, Massimo, Carrai, Valentina, Putti, Maria Caterina, Serra, Marilena, Gaglioti, Carmen, Migone De Amicis, Margerita, Graziadei, Giovanna, De Giovanni, Anna, Ricchi, Paolo, Balocco, Manuela, Quintino, Sabrina, Borsellino, Zelia, Fortini, Monica, Denotti, Anna Rita, Tartaglione, Immacolata, Beccaria, Andrea, Marziali, Marco, Maggio, Aurelio, Perrotta, Silverio, Piperno, Alberto, Filosa, Aldo, Cappellini, Maria Domenica, De Franceschi, Lucia, Piga, Antonio, and Forni, Gian Luca

Subjects
Sars-CoV-2, business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Sars-CoV-2, hemoglobinopathies, Medicine, hemoglobinopathies,SARS-CoV-2 infection, Lethality, Hematology, hemoglobinopathies, business, Virology
Published
2022

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