Effectiveness of Tocilizumab with and without Dexamethasone in Patients with Severe COVID-19: A Retrospective Study

Abstract

The pathogenesis of coronavirus disease 2019 (COVID-19) is complicated, and in addition to antiviral therapy and combating coagulopathy, treatment should also include inhibition of the proinflammatory cytokines overproduction. The purpose of this study is to compare the effectiveness of tocilizumab (TCZ) and dexamethasone (DEX) administered alone or in combination in patients with severe COVID-19. Patients and Methods: Patients were selected from the SARSTer database, containing 3330 individuals with COVID-19 treated between 1 March 2020 and 10 March 2021. The current study included adult patients with baseline oxygen saturation (SpO 2 ) ≤90%, requiring regular or non-invasive high-flow oxygen supplementation. Results: Among included 460 patients, 59 were treated with TCZ, 125 with TCZ and DEX, 169 with DEX, and 107 did not receive TCZ nor DEX. The groups were balanced regarding demographics, coexisting diseases, baseline SpO 2 , and comedications with remdesivir or low-molecular-weight heparin. The death rate of 6.8% was significantly lower in patients receiving TCZ alone than each arm (19.6%-23.1%), particularly in patients with interleukin-6 concentration exceeding 100pg/mL (5% vs 22.9%-51.7%, respectively). Analysis of clinical improvement demonstrated doubled, significantly higher rate after 21 and 28 days in patients treated with TCZ alone (60% and 75%, respectively) compared to DEX (27.6% and 37.9%, respectively). The need for mechanical ventilation was similar in all arms. Conclusion:In patients with severe course of COVID-19, particularly those developing cytokine storm, administration of TCZ provides a significantly better effect than DEX regarding survival, clinical improvement, and hospital discharge rate. The combination of TCZ and DEX does not improve therapy effectiveness in patients with severe COVID-19 compared to the administration of TCZ alone.

Real-world experience with molnupiravir during the period of SARS-CoV-2 Omicron variant dominance

“…Moreover, clinical improvement was analyzed with ordinal scale categories at consecutive time points on day 7, 14, 21, or 28 depending on baseline oxygen saturation (SpO 2 ), patient's age and molnupiravir administration within 5 days of symptom onset. This scale is based on WHO recommendations modified to fit the specificity of the national health care system as applied previously [ 13 , 14 ]. The ordinal scale was scored as follows: (1) unhospitalized, no activity restrictions; (2) unhospitalized, with limited activity; (3) hospitalized, does not require oxygen supplementation or medical care; (4) hospitalized, requiring no oxygen supplementation, but requiring medical care; 5) hospitalized, requiring normal oxygen supplementation; (6) hospitalized, on non-invasive ventilation with high-flow oxygen equipment; (7) hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (8) death.…”

“…Moreover, clinical improvement was analyzed with ordinal scale categories at consecutive time points on day 7, 14, 21, or 28 depending on baseline oxygen saturation (SpO 2 ), patient's age and molnupiravir administration within 5 days of symptom onset. This scale is based on WHO recommendations modified to fit the specificity of the national health care system as applied previously [13,14]. The ordinal scale was scored as follows: (1) unhospitalized, no activity restrictions;…”

Variability in the Clinical Course of COVID-19 in a Retrospective Analysis of a Large Real-World Database

“…Additionally, the clinical course of the disease was assessed on admission to the hospital, and then after 7, 14, 21, and 28 days using an ordinal scale based on WHO recommendations, it was modified to the 8-point version to match the specificity of the Polish healthcare system and used in previous SARSTer research [ 11 , 22 , 23 ]. The score was defined as follows: (1) not hospitalized, no activity restrictions; (2) not hospitalized, no activity restrictions and/or not requiring oxygen supplementation at home; (3) hospitalized, and not requiring oxygen supplementation and not requiring medical care; (4) hospitalized, not requiring oxygen supplementation, but requiring medical care; (5) hospitalized, requiring normal oxygen supplementation; (6) hospitalized, requiring non-invasive ventilation with high-flow oxygen equipment; (7) hospitalized, for invasive mechanical ventilation or extracorporeal membrane oxygenation; (8) death.…”

Real-world experience with molnupiravir during the period of SARS-CoV-2 Omicron variant dominance

“…Moreover, clinical improvement was analyzed with ordinal scale categories at consecutive time points on day 7, 14, 21, or 28 depending on baseline oxygen saturation (SpO2), patient's age and molnupiravir administration within 5 days of symptom onset. This scale is based on WHO recommendations modified to fit the specificity of the national health care system as applied previously [12,13]. The ordinal scale was scored as follows: 1) unhospitalized, no activity restrictions; 2) unhospitalized, with limited activity; 3) hospitalized, does not require oxygen supplementation or medical care; 4) hospitalized, requiring no oxygen supplementation, but requiring medical care; 5) hospitalized, requiring normal oxygen supplementation; 6) hospitalized, on non-invasive ventilation with high-flow oxygen equipment; 7) hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) death.…”