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Systematic Review and Meta-Analysis of Case-Control Studies from 7,000 COVID-19 Pneumonia Patients Suggests a Beneficial Impact of Tocilizumab with Benefit Most Evident in Non-Corticosteroid Exposed Subjects.

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Document pages: 47 pages

Abstract: Background. Tocilizumab is an anti-IL-6 therapy widely adopted in the management of the so-called “cytokine storm” related to SARS-CoV-2 virus infection, but its effectiveness, use in relationship to concomitant corticosteroid therapy and safety remain unproven.Methods: We performed a systematic review and meta-analysis of case-control studies utilising tocilizumab in COVID-19 on different databases (PubMed MEDLINE Scopus) and preprint servers (medRxiv and SSRN) from inception until July 1st 2020 (PROSPERO CRD42020195690). The impact of tocilizumab and concomitant corticosteroid therapy and tocilizumab alone on death rate, need for mechanical ventilation, ICU admission, and bacterial infections were assessed. Subgroup analyses and meta-regressions were performed. Findings: Nineteen studies comprising 7,298 patients (2,377 cases versus 4,921 controls) were included. Therapy including hydroxychloroquine, antivirals, antibiotics and steroids were generally balanced across groups. Tocilizumab use was associated with mortality rate reduction (HR 0.41 ([95 CI 0.25-0.66], p<0.001). Stratifying according to concomitant steroid use which could mask the true effect of tocilizumab, the protective effect was even more highly significant (HR 0.04 [95 CI 0.004-0.35], p<0.001). Reduction in ICU admission (OR 0.16 ([95 CI 0.06-0.43], p<0.001) and in the need for mechanical ventilation (HR 0.49 [95 CI 0.30-0.81], p<0.01; estimate based on 1 study) were significant. Risk of infections was increased (OR 3.11 [95 CI 1.15-8.44], p=0.026; based on unadjusted estimates).Interpretation: Our findings suggest that tocilizumab use can reduce COVID-19 related mortality especially in corticosteroid naïve cases but also exerts benefits with concomitant corticosteroid therapy. These findings are immediately relevant for therapy consideration for severe COVID-19 cytokine storm and needs confirmatory future randomized trials.

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