In a recent Phase II ESCAPE clinical trial in hospitals in Greece, the effects of anakinra and tocilizumab treatments in critically ill COVID-19 patients were studied. The study was conducted on patients screened with SOFA (Sequential Failure Organ Assessment score) ≥2 or ARDS, MAS (serum ferritin greater than 4,420ng/ml) and CID (serum ferritin ≤4,420ng/ml).
The Patients were treated with anakinra for MAS and with tocilizumab for CID. The primary endpoint of the study was minimum of 25% decrease in baseline SOFA score or 50% increase in ratio ofPaO2/FiO2 ratio by day 8 and Secondary endpoint of the study are 28-day mortality, SOFA score change by day 28 and changes in serum biomarkers and of cytokine production by PBMCs. Through stepwise forward logistic regression analysis, it was confirmed that the primary study endpoint was met in 58.3% of patients treated with Anakinra and 33.33% in patients with tocilizumab.
The secondary endpoint has no difference in 28-day mortality and SOFA score in Anakinra and Tocilizumab treatments. But the Anakinra treated patients had lower ferritin levels and increased mononuclear cells to produce IL-6 in comparison with tocilizumab treated patients. The incidence of secondary infections was greater with tocilizumab treatment and aminotransferases increase was also lower with anakinra treatment.
Through detailed investigations and analysis of cytokines production in PMBs; and with WHO clinical progression score, biomarkers might have favourable anakinra responses in critically ill patients with COVID-19.
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Reference: medRxiv preprint server. 2021. Karakike E. ESCAPE: An Open-Label Trial of Personalized Immunotherapy in Critically Ill COVID-19 Patients. doi: https://doi.org/10.1101/2021.01.20.21250182, https://www.medrxiv.org/content/10.1101/2021.01.20.21250182v1.