Sarilumab Use in Severe SARS-CoV-2 Pneumonia

Abstract

Background: Interleukin-6 signal blockade showed preliminary beneficial effects in treating aberrant host inflammatory response against SARS-CoV-2 leading to severe respiratory distress. Herein we describe the effect of off-label intravenous use of Sarilumab in patients with severe SARS-CoV-2-related pneumonia. Methods: 53 patients with SARS-CoV-2 severe pneumonia were treated with intravenous Sarilumab and pulmonary function improvement or Intensive Care Unit (ICU) admission rate in medical wards setting and live discharge rate in ICU treated patients and safety profile were recorded. Each patient received Sarilumab 400 mg intravenously on day 1, with eventual additional infusion based on clinical judgement, and was followed for at least 14 days, unless previously discharged or dead. Findings: Of the 53 SARS-CoV-2 pos patients receiving Sarilumab, 39(73·6%) were treated in medical wards [66·7% with a single infusion; median PaO 2 /FiO 2 :146(IQR:120-212)] while 14(26·4%) in ICU [92·6% with a second infusion; median PaO 2 /FiO 2 :112(IQR:100-141.5)]. Within the medical wards, 7(17·9%) required ICU admission, 4 of whom were re-admitted to the ward within 5-8 days. At 19 days median follow-up, 89·7% of medical inpatients significantly improved (46·1% after 24 hours, 61·5% after 3 days), 70·6% were discharged from the hospital and 85·7% no longer needed oxygen therapy. Within patients receiving Sarilumab in ICU, 64·2% were discharged from ICU to the ward and 35·8% were still alive at the last follow-up. Overall mortality rate was 5·7% after Sarilumab administration: 1(2·5%) patient died in the Medical Ward whilst 2(14·2%) patients died in ICU, respectively. Interpretation: IL-6R inhibition appears to be a potential treatment strategy for severe SARS-CoV-2 pneumonia and intravenous Sarilumab seems a promising treatment approach showing, in the short term, an important clinical benefit and good safety. Funding Statement: None. Declaration of Interests: All authors declare no conflict of interest with the submitted manuscript. Ethics Approval Statement: Sarilumab was administered according to a shared clinical-pharmacological protocol (Prot.n.926 approved by the Ethics Comittee of the Fondazione Policlinico Universitario A. Gemelli-IRCCS, Universita Cattolica del Sacro Cuore). Each patient or next of kin provided informed consent.