| アブストラクト | Objectives: Tocilizumab (TCZ), an IL-6 receptor antagonist, is used in the treatment of severe COVID-19 caused by infection with SARS-CoV-2. However, unintended consequences of TCZ therapy include reactivation of tuberculosis (TB) or hepatitis B virus (HBV), and worsening of hepatitis C virus (HCV). We set out to assimilate existing data for these complications, in order to help inform evidence-based risk assessments for the use of TCZ, and thus to reduce the risk of serious but preventable complications. Methods: We searched the global WHO database of Individual Case Safety Reports (ICSRs) and adverse drug reactions (ADRs) ("VigiBase") and undertook a systematic literature review, in accordance with PRISMA guidelines. We generated mean cumulative incidence estimates for infection complications. Results: Mean cumulative incidence of HBV and TB were 3.3 and 4.3%, respectively, in patients receiving TCZ. Insufficient data were available to generate estimates for HCV. These estimates derive from heterogeneous studies pre-dating SARS-CoV-2, with differing epidemiology and varied approaches to screening and prophylaxis, so formal meta-analysis was not possible. Conclusions: We underline the need for careful individual risk assessment prior to TCZ prescription, and present an algorithm to guide clinical stratification. There is an urgent need for ongoing collation of safety data as TCZ therapy is used in COVID. |
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| ジャーナル名 | Frontiers in medicine |
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| 投稿日 | 2021/9/8 |
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| 投稿者 | Campbell, Cori; Andersson, Monique I; Ansari, M Azim; Moswela, Olivia; Misbah, Siraj A; Klenerman, Paul; Matthews, Philippa C |
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| 組織名 | Nuffield Department of Medicine, University of Oxford, Medawar Building for;Pathogen Research, Oxford, United Kingdom.;Department of Infectious Diseases and Microbiology, Oxford University Hospitals;NHS Foundation Trust, John Radcliffe Hospital, Oxford, United Kingdom.;Nuffield Department of Clinical Laboratory Sciences, University of Oxford,;Oxford, United Kingdom.;Wellcome Centre for Human Genetics, University of Oxford, Oxford, United Kingdom.;Pharmacy Department, Oxford University Hospitals NHS Foundation Trust, John;Radcliffe Hospital, Oxford, United Kingdom.;Department of Clinical Immunology, Oxford University Hospitals NHS Foundation;Trust, John Radcliffe Hospital, Oxford, United Kingdom. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/34490299/ |
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