Title : Observational study post emergency use authorization of itolizumab in the treatment of COVID-19
Abstract:
COVID-19 continues to be a global health problem, it is a multifactorial disease characterized by a process of hyperinflammation. Itolizumab, a humanized anti-CD6 mAb, has the Emergency Use Authorization (UEA) for patients with this disease with signs of hyperinflammation. Methods. An observational study was conducted to evaluate the safety and efficacy of itolizumab. The study was approved by the MINSAP and the Ethics Committee of the IPK CEI-IPK 63-20(RPCEC00000402; https://rpcec.sld.cu/trials/RPCEC00000402-En). The dose was 1.6 mg/kg, every 72 hours, up to a maximum of four administrations, over a period of six hours, with antihistamine and glucocorticoid premedication to avoid infusion reactions. A retrospective cohort study was conducted using the propensity score. Results. 249 patients, treated in twelve hospitals from September 2020 to May 2021 were studied. The related SAEs were 0.8% of the total, immunosuppression in those patients was not reported. Lung functions improved 85.9% from the first 48 hours. The ROC curves showed that total leukocytes greater than 6.7, PLR ≥94.37 and NLR >2.21 predict the risk of death. The risk of death in those not treated with Itolizumab was 2.54 (1.18; 5.46) times higher (p=0.007). The Attributable Fraction in Untreated with MAb reveals that 60.7% IC95%: [15.3% ; 81.7%] of the deaths among those not treated could have been avoided had they received itolizumab. The risk of admission to therapy in those not treated was 2.2 (1.45; 3.33) times higher than the risk of admission to therapy in those treated with itolizumab (p =0.000). The population attributable fraction of 0.38 means that, in a prospective scenario, a 38.1% 95% CI: [17.4%; 53.7%] of the deaths in the severe or critical population could be avoided if they were treated with Mab. Conclusions. Itolizumab is recommended for use in moderate-stage COVID-19 pneumonia with signs of inflammation or severe with inflammatory indices less than the cut-off values of this study.
