TY - JOUR
T1 - Interleukin-6 blockade with sarilumab in severe COVID-19 pneumonia with systemic hyperinflammation
T2 - An open-label cohort study
AU - SARI-RAF Study Group members
AU - Della-Torre, Emanuel
AU - Campochiaro, Corrado
AU - Cavalli, Giulio
AU - De Luca, Giacomo
AU - Napolitano, Angela
AU - La Marca, Salvatore
AU - Boffini, Nicola
AU - Da Prat, Valentina
AU - di Terlizzi, Gaetano
AU - Lanzillotta, Marco
AU - Rovere-Querini, Patrizia
AU - Ruggeri, Annalisa
AU - Landoni, Giovanni
AU - Tresoldi, Moreno
AU - Ciceri, Fabio
AU - Zangrillo, ALberto
AU - De Cobelli, Francesco
AU - Dagna, Lorenzo
AU - Angelillo, Piera
AU - Assanelli, Andrea
AU - Baldissera, Elena
AU - Bozzolo, Enrica Paola
AU - Calvisi, Stefania
AU - Canetti, Diana
AU - Cariddi, Adriana
AU - Castagna, Antonella
AU - Cicalese, Maria Pia
AU - Di Lucca, Giuseppe
AU - Farina, Nicola
AU - Fazio, Maria
AU - Mancuso, Gaia
AU - Monti, Giacomo
AU - Moroni, Luca
AU - Oltolini, Chiara
AU - Palumbo, Diego
AU - Ripa, Marco
AU - Rovere-Querini, Patrizia
AU - Sartorelli, Silvia
AU - Scarpellini, Paolo
AU - Spessot, Marzia
AU - Tomelleri, Alessandro
N1 - Funding Information:
This study was supported by institutional funding.
Publisher Copyright:
©
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/10/1
Y1 - 2020/10/1
N2 - Objectives To assess the safety and efficacy of interleukin (IL)-6 blockade with sarilumab in patients with severe COVID-19 pneumonia and systemic hyperinflammation. Methods We conducted an open-label study of sarilumab in severe COVID-19 pneumonia (PaO 2 /FiO 2 <300 mm Hg) with hyperinflammation (elevated inflammatory markers and serum IL-6 levels). Sarilumab 400 mg was administered intravenously in addition to standard of care and results were compared with contemporary matched patients treated with standard of care alone. Clinical improvement, mortality, safety and predictors of response were assessed at 28 days. Results Twenty-eight patients were treated with sarilumab and 28 contemporary patients receiving standard of care alone were used as controls. At day 28 of follow-up, 61% of patients treated with sarilumab experienced clinical improvement and 7% died. These findings were not significantly different from the comparison group (clinical improvement 64%, mortality 18%; p=NS). Baseline PaO 2 /FiO 2 ratio >100 mm Hg and lung consolidation <17% at CT scan predicted clinical improvement in patients treated with sarilumab. Median time to clinical improvement in patients with lung consolidation <17% was shorter after sarilumab (10 days) than after standard treatment (24 days; p=0.01). The rate of infection and pulmonary thrombosis was similar between the two groups. Conclusions At day 28, overall clinical improvement and mortality in patients with severe COVID-19 were not significantly different between sarilumab and standard of care. Sarilumab was associated with faster recovery in a subset of patients showing minor lung consolidation at baseline.
AB - Objectives To assess the safety and efficacy of interleukin (IL)-6 blockade with sarilumab in patients with severe COVID-19 pneumonia and systemic hyperinflammation. Methods We conducted an open-label study of sarilumab in severe COVID-19 pneumonia (PaO 2 /FiO 2 <300 mm Hg) with hyperinflammation (elevated inflammatory markers and serum IL-6 levels). Sarilumab 400 mg was administered intravenously in addition to standard of care and results were compared with contemporary matched patients treated with standard of care alone. Clinical improvement, mortality, safety and predictors of response were assessed at 28 days. Results Twenty-eight patients were treated with sarilumab and 28 contemporary patients receiving standard of care alone were used as controls. At day 28 of follow-up, 61% of patients treated with sarilumab experienced clinical improvement and 7% died. These findings were not significantly different from the comparison group (clinical improvement 64%, mortality 18%; p=NS). Baseline PaO 2 /FiO 2 ratio >100 mm Hg and lung consolidation <17% at CT scan predicted clinical improvement in patients treated with sarilumab. Median time to clinical improvement in patients with lung consolidation <17% was shorter after sarilumab (10 days) than after standard treatment (24 days; p=0.01). The rate of infection and pulmonary thrombosis was similar between the two groups. Conclusions At day 28, overall clinical improvement and mortality in patients with severe COVID-19 were not significantly different between sarilumab and standard of care. Sarilumab was associated with faster recovery in a subset of patients showing minor lung consolidation at baseline.
KW - anti-inflammatory agents
KW - inflammation
KW - non-steroidal
KW - therapeutics
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U2 - 10.1136/annrheumdis-2020-218122
DO - 10.1136/annrheumdis-2020-218122
M3 - Article
C2 - 32620597
AN - SCOPUS:85088384484
VL - 79
SP - 1277
EP - 1285
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
SN - 0003-4967
IS - 10
ER -