BACKGROUND: Interleukin-1 plays a pivotal role in the inflammatory response during cytokine storm syndromes .

OBJECTIVE: To analyse the efficacy and safety of early anti-inflammatory treatment (AIT) with i.v anakinra with or without glucocorticoids (GC) in COVID19 pneumonia .

METHODS: We performed a retrospective single-centre cohort study on patients admitted for COVID19 pneumonia from February 26th to April 29th, 2020 to assess the efficacy of early AIT with i.v . Anakinra (100mg every 8 hours for 3 days, with tapering) alone or in combination with GC (i.v . methylprednisolone, 1-2 mg/kg daily, with tapering). Standard of care (SOC) treatment was: hydroxychloroquine and/or azithromycin with or without antivirals and anticoagulants . Late rescue AIT with anakinra or tocilizumab was also evaluated . Treatment effect on Overall Survival (OS) was assessed by a Propensity Score adjusted Cox model .

RESULTS: 128 patients were analyzed; 63 received early AIT (30 anakinra, 33 anakinra and CG) at admission; 65 patients (44 with SOC , 21 SOC plus late rescue AIT) did not and were used as controls . After adjusting for all the unbalanced baseline covariates, early AIT reduced the hazard of mortality by 74% (adjusted HR=0.26, p <0.001). The effect was similar in patients receiving anakinra alone (adjusted HR=0.28, p=0.04) and anakinra plus GC (adjusted HR=0.33, p=0.07). Late rescue treatment did not show a significant advantage over SOC alone (adjusted HR=0.82, p=0.70).

CONCLUSIONS: This study suggests, on a larger series of patients with COVID-19 pneumonia, the potential efficacy and safety of the early use of high doses of i.v . anakinra with or without GC.