Abstract
BackgroundData on the safety and efficacy profile of tocilizumab in patients with severe COVID-19 needs to be enriched.MethodsIn this open label, prospective study, we evaluated clinical outcomes in consecutive patients with COVID-19 and PaO2/FiO2 < 200 receiving tocilizumab plus usual care versus usual care alone. Tocilizumab was administered at the time point that PaO2/FiO2 < 200 was observed. The primary outcome was 28-day mortality. Secondary outcomes included time to discharge, change in PaO2/FiO2 at day 5 and change in WHO progression scale at day 10.FindingsOverall, 114 patients were included in the analysis (tocilizumab plus usual care: 56, usual care: 58). Allocation to usual care was associated with significant increase in 28-day mortality compared to tocilizumab plus usual care [Cox proportional-hazards model: HR: 3.34, (95% CI: 1.21–9.30), (p = 0.02)]. There was not a statistically significant difference with regards to hospital discharge over the 28 day period for patients receiving tocilizumab compared to usual care [11.0 days (95% CI: 9.0 to 16.0) vs 14.0 days (95% CI: 10.0–24.0), HR: 1.32 (95% CI: 0.84–2.08), p = 0.21]. ΔPaO2/FiO2 at day 5 was significantly higher in the tocilizumab group compared to the usual care group [42.0 (95% CI: 23.0–84.7) vs 15.8 (95% CI: − 19.4–50.3), p = 0.03]. ΔWHO scale at day 10 was significantly lower in the tocilizumab group compared to the usual care group (-0.5 ± 2.1 vs 0.6 ± 2.6, p = 0.005).ConclusionAdministration of tocilizumab, at the time point that PaO2/FiO2 < 200 was observed, improved survival and other clinical outcomes in hospitalized patients with severe COVID-19 irrespective of systemic inflammatory markers levels.
Highlights
The spread of 2019 coronavirus disease (COVID-19) and the associated acute respiratory distress syndrome (ARDS) are responsible for the worst public health crisis of the latest century [1]
PCR analysis revealed that all cases included in our study were infected by alpha variant, which was the predominant variant in Greece by the time of the study
Median age was 66.0 years and 66.5 years for tocilizumab and usual care group, respectively
Summary
The spread of 2019 coronavirus disease (COVID-19) and the associated acute respiratory distress syndrome (ARDS) are responsible for the worst public health crisis of the latest century [1]. Despite major advances in the management of COVID-19, a considerable proportion of infected individuals experiences critical illness with hypoxic respiratory failure requiring prolonged. Hypoxic respiratory failure in patients with COVID-19 has been associated with release of pro-inflammatory cytokines including interleukin (IL)-6 [6]. Tocilizumab is a recombinant, humanized anti-IL-6 receptor monoclonal antibody initially launched as an intravenous treatment for rheumatoid arthritis, giant cell arteritis and chimeric antigen receptor T-cell-induced severe cytokine release syndrome [13,14,15]. Administration of tocilizumab in all hospitalized patients irrespective of disease severity may have diluted any potential therapeutic effects in specific subpopulations of patients, including critically-ill patients. Using arbitrary values of non-specific inflammatory markers such as CRP to tailor therapeutic approaches and prioritize patients for treatment has yielded poor results, so far. Data on the safety and efficacy profile of tocilizumab in patients with severe COVID-19 needs to be enriched
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