Uptake and safety of Sotrovimab for prevention of severe COVID-19 in a cohort and self-controlled case series study
Abstract Background Sotrovimab is a neutralising monoclonal antibody (nMAB) currently available to treat extremely clinically vulnerable COVID-19 patients in England. Trials have shown it to have mild to moderate side effects, however, evidence regarding its safety in real-world settings remains ins...
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Nature Portfolio
2025-01-01
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| Series: | Communications Medicine |
| Online Access: | https://doi.org/10.1038/s43856-024-00720-7 |
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| author | Martina Patone Andrew JHL Snelling Holly Tibble Carol Coupland Aziz Sheikh Julia Hippisley-Cox |
| author_facet | Martina Patone Andrew JHL Snelling Holly Tibble Carol Coupland Aziz Sheikh Julia Hippisley-Cox |
| author_sort | Martina Patone |
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| description | Abstract Background Sotrovimab is a neutralising monoclonal antibody (nMAB) currently available to treat extremely clinically vulnerable COVID-19 patients in England. Trials have shown it to have mild to moderate side effects, however, evidence regarding its safety in real-world settings remains insufficient. Methods Descriptive and multivariable logistic regression analyses were conducted to evaluate uptake, and a self-controlled case series analysis performed to measure the risk of hospital admission (hospitalisation) associated with 49 pre-specified suspected adverse outcomes in the period 2–28 days post-Sotrovimab treatment among eligible patients treated between December 11, 2021 and May 24, 2022. Results Here we show that among treated and untreated eligible individuals, the mean ages (54.6 years, SD: 16.1 vs 54.1, SD: 18.3) and sex distribution (women: 60.9% vs 58.1%; men: 38.9% vs 41.1%) are similar. There are marked variations in uptake between ethnic groups, which is higher amongst individuals categorised ethnically as Indian (15.0%; 95%CI 13.8, 16.3), Other Asian (13.7%; 95%CI 11.9, 15.8), white (13.4%; 95%CI 13.3, 13.6), and Bangladeshi (11.4%; 95%CI 8.8, 14.6); and lower amongst Black Caribbean individuals (6.4%; 95%CI 5.4, 7.5) and Black Africans (4.7%; 95%CI 4.1, 5.4). We find no increased risk of any of the suspected adverse outcomes in the period 2–28 days post-treatment. Conclusions We find no safety signals of concern for possible adverse outcomes in the period 2-28 days post treatment with Sotrovimab. However, there is evidence of unequal uptake of Sotrovimab treatment across ethnic groups. |
| format | Article |
| id | doaj-art-cb5456f73cb34d1daf6555c8e57fe306 |
| institution | Kabale University |
| issn | 2730-664X |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Nature Portfolio |
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| series | Communications Medicine |
| spelling | doaj-art-cb5456f73cb34d1daf6555c8e57fe3062025-01-19T12:36:53ZengNature PortfolioCommunications Medicine2730-664X2025-01-015111010.1038/s43856-024-00720-7Uptake and safety of Sotrovimab for prevention of severe COVID-19 in a cohort and self-controlled case series studyMartina Patone0Andrew JHL Snelling1Holly Tibble2Carol Coupland3Aziz Sheikh4Julia Hippisley-Cox5Nuffield Department of Primary Health Care Sciences, University of OxfordNuffield Department of Primary Health Care Sciences, University of OxfordUsher Institute, University of EdinburghNuffield Department of Primary Health Care Sciences, University of OxfordNuffield Department of Primary Health Care Sciences, University of OxfordNuffield Department of Primary Health Care Sciences, University of OxfordAbstract Background Sotrovimab is a neutralising monoclonal antibody (nMAB) currently available to treat extremely clinically vulnerable COVID-19 patients in England. Trials have shown it to have mild to moderate side effects, however, evidence regarding its safety in real-world settings remains insufficient. Methods Descriptive and multivariable logistic regression analyses were conducted to evaluate uptake, and a self-controlled case series analysis performed to measure the risk of hospital admission (hospitalisation) associated with 49 pre-specified suspected adverse outcomes in the period 2–28 days post-Sotrovimab treatment among eligible patients treated between December 11, 2021 and May 24, 2022. Results Here we show that among treated and untreated eligible individuals, the mean ages (54.6 years, SD: 16.1 vs 54.1, SD: 18.3) and sex distribution (women: 60.9% vs 58.1%; men: 38.9% vs 41.1%) are similar. There are marked variations in uptake between ethnic groups, which is higher amongst individuals categorised ethnically as Indian (15.0%; 95%CI 13.8, 16.3), Other Asian (13.7%; 95%CI 11.9, 15.8), white (13.4%; 95%CI 13.3, 13.6), and Bangladeshi (11.4%; 95%CI 8.8, 14.6); and lower amongst Black Caribbean individuals (6.4%; 95%CI 5.4, 7.5) and Black Africans (4.7%; 95%CI 4.1, 5.4). We find no increased risk of any of the suspected adverse outcomes in the period 2–28 days post-treatment. Conclusions We find no safety signals of concern for possible adverse outcomes in the period 2-28 days post treatment with Sotrovimab. However, there is evidence of unequal uptake of Sotrovimab treatment across ethnic groups.https://doi.org/10.1038/s43856-024-00720-7 |
| spellingShingle | Martina Patone Andrew JHL Snelling Holly Tibble Carol Coupland Aziz Sheikh Julia Hippisley-Cox Uptake and safety of Sotrovimab for prevention of severe COVID-19 in a cohort and self-controlled case series study Communications Medicine |
| title | Uptake and safety of Sotrovimab for prevention of severe COVID-19 in a cohort and self-controlled case series study |
| title_full | Uptake and safety of Sotrovimab for prevention of severe COVID-19 in a cohort and self-controlled case series study |
| title_fullStr | Uptake and safety of Sotrovimab for prevention of severe COVID-19 in a cohort and self-controlled case series study |
| title_full_unstemmed | Uptake and safety of Sotrovimab for prevention of severe COVID-19 in a cohort and self-controlled case series study |
| title_short | Uptake and safety of Sotrovimab for prevention of severe COVID-19 in a cohort and self-controlled case series study |
| title_sort | uptake and safety of sotrovimab for prevention of severe covid 19 in a cohort and self controlled case series study |
| url | https://doi.org/10.1038/s43856-024-00720-7 |
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