Safety of Sotrovimab use in children with COVID-19: an Italian experience

被引:1
作者
Venturini, Elisabetta [1 ]
Fusani, Lara [1 ]
Vecchio, Andrea Lo [2 ]
Scarano, Sara Maria [2 ]
Garazzino, Silvia [3 ]
Pruccoli, Giulia [3 ]
Dona, Daniele [4 ]
Lancella, Laura [5 ]
Gattinara, Guido Castelli [5 ]
Galli, Luisa [1 ,6 ,7 ]
机构
[1] IRCSS Meyer Childrens Univ Hosp, Infect Dis Unit, Florence, Italy
[2] Univ Naples Federico II, Dept Translat Med Sci, Pediat Infect Dis Unit, Naples, Italy
[3] Univ Turin, Regina Margher Childrens Hosp, Dept Pediat & Publ Hlth Sci, Infect Dis Unit, Turin, Italy
[4] Univ Padua, Dept Womens & Childrens Hlth, Div Pediat Infect Dis, Padua, Italy
[5] IRCCS Bambino Gesu Children Hosp, Rome, Italy
[6] Univ Florence, Dept Hlth Sci, Florence, Italy
[7] IRCSS Meyer Childrens Hosp, Infect Dis Unit, Viale Pieraccini 24, Florence, Italy
关键词
Sotrovimab; SARS-CoV-2; omicron; monoclonal antibodies; children; covid-19; variant of concern; HIGH-RISK; SARS-COV-2;
D O I
10.1080/1120009X.2023.2250138
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Sotrovimab is a monoclonal antibody approved in adult and adolescents at high risk for COVID-19. Thirty-three children evaluated in five Italian paediatric centres received Sotrovimab infusion and were retrospectively enrolled from December 2021 to April 2022. In more than half of cases (19/33, 57.6%) Sotrovimab was prescribed off-label. Overall, the infusion was well tolerated with no significative differences in those receiving an off-label prescription. All children had a complete recovery. Data on the safety of Sotrovimab should be investigated in a larger paediatric cohort, considering the continuous selection of new SARS CoV-2 variants which may be more or less susceptible to the effects of the Sotrovimab.
引用
收藏
页码:45 / 48
页数:4
相关论文
共 19 条
[1]   Implementation and Patient Outcomes of a Pediatric COVID-19 Monoclonal Antibody Program [J].
Blind, Jill E. ;
Sapko, Matt ;
Killough, Alex ;
Thornton, Hannah ;
Watson, Joshua R. .
JOURNAL OF THE PEDIATRIC INFECTIOUS DISEASES SOCIETY, 2022, 11 (12) :565-574
[2]  
Committee for Medicinal Products for Human Use (CHMP)-EMA, 2021, ASS REP EL LILL CO L
[3]   Early Use of Sotrovimab in Children: A Case Report of an 11-Year-Old Kidney Transplant Recipient Infected with SARS-CoV-2 [J].
Di Chiara, Costanza ;
Mengato, Daniele ;
De Pieri, Marica ;
Longo, Germana ;
Benetti, Elisa ;
Venturini, Francesca ;
Giaquinto, Carlo ;
Dona, Daniele .
CHILDREN-BASEL, 2022, 9 (04)
[4]  
Food and Drug Administration, 2022, FDA UPD SOTR EM US A
[5]   Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19 A Randomized Clinical Trial [J].
Gupta, Anil ;
Gonzalez-Rojas, Yaneicy ;
Juarez, Erick ;
Casal, Manuel Crespo ;
Moya, Jaynier ;
Falci, Diego Rodrigues ;
Sarkis, Elias ;
Solis, Joel ;
Zheng, Hanzhe ;
Scott, Nicola ;
Cathcart, Andrea L. ;
Parra, Sergio ;
Sager, Jennifer E. ;
Austin, Daren ;
Peppercorn, Amanda ;
Alexander, Elizabeth ;
Yeh, Wendy W. ;
Brinson, Cynthia ;
Aldinger, Melissa ;
Shapiro, Adrienne E. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2022, 327 (13) :1236-1246
[6]   Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab [J].
Gupta, Anil ;
Gonzalez-Rojas, Yaneicy ;
Juarez, Erick ;
Casal, Manuel Crespo ;
Moya, Jaynier ;
Falci, Diego R. ;
Sarkis, Elias ;
Solis, Joel ;
Zheng, Hanzhe ;
Scott, Nicola ;
Cathcart, Andrea L. ;
Hebner, Christy M. ;
Sager, Jennifer ;
Mogalian, Erik ;
Tipple, Craig ;
Peppercorn, Amanda ;
Alexander, Elizabeth ;
Pang, Phillip S. ;
Free, Almena ;
Brinson, Cynthia ;
Aldinger, Melissa ;
Shapiro, Adrienne E. .
NEW ENGLAND JOURNAL OF MEDICINE, 2021, 385 (21) :1941-1950
[7]   Sotrovimab: First Approval [J].
Heo, Young-A .
DRUGS, 2022, 82 (04) :477-484
[8]  
Iketani S, 2022, NATURE, V604, P553, DOI 10.1038/s41586-022-04594-4
[9]   Eligibility criteria for pediatric patients who may benefit from anti SARS-CoV-2 monoclonal antibody therapy administration: an Italian inter-society consensus statement [J].
Lanari, Marcello ;
Venturini, Elisabetta ;
Pierantoni, Luca ;
Stera, Giacomo ;
Gattinara, Guido Castelli ;
Esposito, Susanna Maria Roberta ;
Favilli, Silvia ;
Franzoni, Emilio ;
Fusco, Eleonora ;
Lionetti, Paolo ;
Maffeis, Claudio ;
Marseglia, Gianluigi ;
Massella, Laura ;
Midulla, Fabio ;
Zanobini, Alberto ;
Zecca, Marco ;
Villani, Alberto ;
Staiano, Annamaria ;
Galli, Luisa .
ITALIAN JOURNAL OF PEDIATRICS, 2022, 48 (01)
[10]   Sotrovimab to prevent severe COVID-19 in high-risk patients infected with Omicron BA.2 [J].
Martin-Blondel, Guillaume ;
Marcelin, Anne-Genevieve ;
Soulie, Cathia ;
Kaisaridi, Sofia ;
Lusivika-Nzinga, Clovis ;
Dorival, Celine ;
Nailler, Laura ;
Boston, Anais ;
Melenotte, Clea ;
Cabie, Andre ;
Choquet, Christophe ;
Coustilleres, Francois ;
Martellosio, Jean-Philippe ;
Gaube, Geraldine ;
Trinh-Duc, Albert ;
Ronchetti, Anne-Marie ;
Pourcher, Valerie ;
Chauveau, Marie ;
Lacombe, Karine ;
Peiffer-Smadja, Nathan ;
Housset, Pierre ;
Perrot, Aurore ;
Pialoux, Gilles ;
Martin, Aurelie ;
Dubee, Vincent ;
Devaux, Mathilde ;
Frey, Jerome ;
Cazanave, Charles ;
Liblau, Roland ;
Carrat, Fabrice ;
Yordanov, Youri .
JOURNAL OF INFECTION, 2022, 85 (04) :E104-E108