Uptake and safety of Sotrovimab for prevention of severe COVID-19 in a cohort and self-controlled case series study

Patone, Martina; Snelling, Andrew J.H.L.; Tibble, Holly; Coupland, Carol; Sheikh, Aziz; Hippisley-Cox, Julia

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.

Citation

Patone, M., Snelling, A. J., Tibble, H., Coupland, C., Sheikh, A., & Hippisley-Cox, J. (2025). Uptake and safety of Sotrovimab for prevention of severe COVID-19 in a cohort and self-controlled case series study. Communications Medicine, 5(1), Article 20. https://doi.org/10.1038/s43856-024-00720-7

• Journal Article Type: Article
• Acceptance Date: Dec 17, 2024
• Online Publication Date: Jan 16, 2025
• Publication Date: Jan 16, 2025
• Deposit Date: Jan 23, 2025
• Publicly Available Date: Jan 23, 2025
• Journal: Communications Medicine
• Electronic ISSN: 2730-664X
• Publisher: Springer Nature
• Peer Reviewed: Peer Reviewed
• Volume: 5
• Issue: 1
• Article Number: 20
• DOI: https://doi.org/10.1038/s43856-024-00720-7
• Keywords: Drug development; Epidemiology
• Public URL: https://nottingham-repository.worktribe.com/output/44426724
• Publisher URL: https://www.nature.com/articles/s43856-024-00720-7