Clinical indicators of the efficacy of therapy with olokizumab in patients with COVID-19 infection

Introduction. A new form of coronavirus δ (SARS-CoV-2) caused the development of the global COVID-19 pandemic in 2019–2022, which claimed more than 7 million lives. COVID-19 infection is accompanied by a rapid deterioration in the health of patients with the development of a generalized systemic inflammatory response due to increased production of cytokines (IL-1β, IL-6, IL-18, IFN-γ) is a cytokine storm (CS). To relieve this condition, it is proposed to use monoclonal antibodies against IL-6 – tocilizumab, olokizumab.

The objective was to investigate the clinical efficacy of the inhibitor of IL-6 (olokizumab) against the background of standard (basic) therapy in patients with severe COVID-19 infection.

Materials and methods. A single-center clinical retrospective study included 266 patients (124 men and 142 women, aged 19–103, 70.7 ± 15.4 years) who had a positive PCR test result for the presence of SARS-CoV-2 RNA and were treated at the City Hospital No. 40 of the Kurortny District of St. Petersburg in 2020–2024. The main endpoints of the study were biological death or discharge from the intensive care unit (ICU). All patients received basic antibacterial and antiviral therapy with favipiravir or remdesivir. Olokizumab (n = 87) was used in 103 patients with CS.

Results. The use of olokizumab was accompanied by a decrease in the degree of respiratory failure (0.11 ± 0.05 points versus 1.94 ± 0.23 points, p < 0.000001), the number of points on the NEWS scale (0.59 ± 0.10 versus 6.41 ± 0.84 points, p < 0.000001), the form of the disease according to CT (1.79 ± 0.09 versus 3.27 ± 0.30 points, p < 0.000001), as well as the percentage of hydrothorax (26.4 ± 5.0% versus 64.7 ± 11.0%, p < 0.0026) and the comorbidity index (3.88 ± 0.31 versus 6.17 ± 0.66 points, p < 0.0018) in discharged patients compared to the fatal outcome group. In addition, olokizumab therapy was accompanied by a significant decrease in IL-6 levels by day 3 in both discharged (42.19 ± 6.29 pg/ml, p < 0.0001) and fatal (83.64 ± 22.769 pg/ml, p = 0.004658) patients compared to baseline values upon admission. There was a significant decrease in IL-6 levels in discharged patients compared to the fatal group (p = 0.002415). An increase in IL-6 levels above 50 pg/ml in COVID-19 patients treated with olokizumab was statistically significantly (p = 0.0002) associated with a 14.3 – fold increase in the risk of death. An increase in the respiratory failure degree over 1 point, NEWS morbidity level over 4–5 points, CT disease form over 2 points, and comorbidity index over 5 points increased the risk of death in patients receiving olokizumab by 7.4, 91.1, 6.2, and 12.6 times, respectively. Olokizumab administration resulted in a discharge rate of 80.5% (n = 70, p < 0.0001).

Conclusions. The use of olokizumab in patients with severe COVID-19 was effective in terms of clinical parameters: the degree of respiratory failure, the number of points on the NEWS scale, the form of the disease on CT, the percentage of hydrothorax and the comorbidity index, as well as the level of IL-6, which can be used as criteria for the effectiveness of therapy in patients with COVID-19.

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