TY - JOUR
T1 - Sarilumab use in severe SARS-CoV-2 pneumonia
AU - Gremese, Elisa
AU - Cingolani, Antonella
AU - Bosello, Silvia Laura
AU - Alivernini, Stefano
AU - Tolusso, Barbara
AU - Perniola, Simone
AU - Landi, Francesco
AU - Pompili, Maurizio
AU - Murri, Rita
AU - Santoliquido, Angelo
AU - Garcovich, Matteo
AU - Sali, Michela
AU - De Pascale, Gennaro
AU - Gabrielli, Maurizio
AU - Biscetti, Federico
AU - Montalto, Massimo
AU - Tosoni, Alessio
AU - Gambassi, Giovanni
AU - Rapaccini, Gian Ludovico
AU - Iaconelli, Amerigo
AU - Zileri Del Verme, Lorenzo
AU - Petricca, Luca
AU - Fedele, Anna Laura
AU - Lizzio, Marco Maria
AU - Tamburrini, Enrica
AU - Natalello, Gerlando
AU - Gigante, Laura
AU - Bruno, Dario
AU - Verardi, Lucrezia
AU - Taddei, Eleonora
AU - Calabrese, Anna Chiara
AU - Lombardi, Francesca
AU - Bernabei, Roberto
AU - Cauda, Roberto
AU - Franceschi, Francesco
AU - Landolfi, Raffaele
AU - Richeldi, Luca
AU - Sanguinetti, Maurizio
AU - Fantoni, Massimo
AU - Antonelli, Massimo
AU - Gasbarrini, Antonio
PY - 2020
Y1 - 2020
N2 - Background: Interleukin-6 signal blockade showed preliminary beneficial effects in treating inflammatory response against SARS-CoV-2 leading to severe respiratory distress. Herein we describe the outcomes of off-label intravenous use of Sarilumab in severe SARS-CoV-2-related pneumonia. Methods: 53 patients with SARS-CoV-2 severe pneumonia received intravenous Sarilumab; pulmonary function improvement or Intensive Care Unit (ICU) admission rate in medical wards, live discharge rate in ICU treated patients and safety profile were recorded. Sarilumab 400 mg was administered intravenously on day 1, with eventual additional infusion based on clinical judgement, and patients were followed for at least 14 days, unless previously discharged or dead. Findings: Of the 53 SARS-CoV-2pos patients receiving Sarilumab, 39(73·6%) were treated in medical wards [66·7% with a single infusion; median PaO2/FiO2:146(IQR:120–212)] while 14(26·4%) in ICU [92·6% with a second infusion; median PaO2/FiO2: 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 h, 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%. 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 outcome and good safety.
AB - Background: Interleukin-6 signal blockade showed preliminary beneficial effects in treating inflammatory response against SARS-CoV-2 leading to severe respiratory distress. Herein we describe the outcomes of off-label intravenous use of Sarilumab in severe SARS-CoV-2-related pneumonia. Methods: 53 patients with SARS-CoV-2 severe pneumonia received intravenous Sarilumab; pulmonary function improvement or Intensive Care Unit (ICU) admission rate in medical wards, live discharge rate in ICU treated patients and safety profile were recorded. Sarilumab 400 mg was administered intravenously on day 1, with eventual additional infusion based on clinical judgement, and patients were followed for at least 14 days, unless previously discharged or dead. Findings: Of the 53 SARS-CoV-2pos patients receiving Sarilumab, 39(73·6%) were treated in medical wards [66·7% with a single infusion; median PaO2/FiO2:146(IQR:120–212)] while 14(26·4%) in ICU [92·6% with a second infusion; median PaO2/FiO2: 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 h, 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%. 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 outcome and good safety.
KW - Inflammation
KW - Sarilumab
KW - Severe sars-cov-2 pneumonia
KW - Inflammation
KW - Sarilumab
KW - Severe sars-cov-2 pneumonia
UR - http://hdl.handle.net/10807/165250
U2 - 10.1016/j.eclinm.2020.100553
DO - 10.1016/j.eclinm.2020.100553
M3 - Article
SN - 2589-5370
VL - 27
SP - 100553-N/A
JO - EClinicalMedicine
JF - EClinicalMedicine
ER -