TY - JOUR
T1 - Outcomes and biomarker analyses among patients with COVID-19 treated with interleukin 6 (IL-6) receptor antagonist sarilumab at a single institution in Italy
AU - Montesarchio, Vincenzo
AU - Parrela, Roberto
AU - Iommelli, Chiara
AU - Bianco, Antonella
AU - Manzillo, Elio
AU - Fraganza, Fiorentino
AU - Palumbo, Cristiana
AU - Rea, Gaetano
AU - Murino, Patrizia
AU - De Rosa, Rosanna
AU - Atripaldi, Luigi
AU - D'Abbraccio, Maurizio
AU - Curvietto, Marcello
AU - Mallardo, Domenico
AU - Celentano, Egidio
AU - Grimaldi, Antonio Maria
AU - Palla, Marco
AU - Trojaniello, Claudia
AU - Vitale, Maria Grazia
AU - Million-Weaver, Samuel Lewis
AU - Ascierto, Paolo Antonio
N1 - © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2020/8
Y1 - 2020/8
N2 - BACKGROUND: The inflammatory pathology observed in severe COVID-19 disease caused by the 2019 novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is characterized by elevated serum levels of C reactive protein (CRP) and cytokines, including interferon gamma, interleukin 8 (IL-8), and interleukin 6 (IL-6). Initial reports from the outbreak in Italy, China and the USA have provided anecdotal evidence of improved outcomes with the administration of anti-IL-6 agents, and large-scale trials evaluating these therapies are ongoing.STUDY DESCRIPTION: In this retrospective case series, clinical outcomes and correlates of response to treatment with the IL-6 receptor antagonist sarilumab are described for 15 patients with COVID-19 from a single institution in Southern Italy. Among 10 patients whose symptoms improved after sarilumab treatment, rapid decreases in CRP levels corresponded with clinical improvement. Lower levels of IL-6 at baseline as well as lower neutrophil to lymphocyte ratio as compared with patients whose COVID-19 did not improve with treatment were associated with sarilumab-responsive disease.CONCLUSIONS: This observation may reflect a possible clinical benefit regarding early intervention with IL-6-modulatory therapies for COVID-19 and that CRP could be a potential biomarker of response to treatment.
AB - BACKGROUND: The inflammatory pathology observed in severe COVID-19 disease caused by the 2019 novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is characterized by elevated serum levels of C reactive protein (CRP) and cytokines, including interferon gamma, interleukin 8 (IL-8), and interleukin 6 (IL-6). Initial reports from the outbreak in Italy, China and the USA have provided anecdotal evidence of improved outcomes with the administration of anti-IL-6 agents, and large-scale trials evaluating these therapies are ongoing.STUDY DESCRIPTION: In this retrospective case series, clinical outcomes and correlates of response to treatment with the IL-6 receptor antagonist sarilumab are described for 15 patients with COVID-19 from a single institution in Southern Italy. Among 10 patients whose symptoms improved after sarilumab treatment, rapid decreases in CRP levels corresponded with clinical improvement. Lower levels of IL-6 at baseline as well as lower neutrophil to lymphocyte ratio as compared with patients whose COVID-19 did not improve with treatment were associated with sarilumab-responsive disease.CONCLUSIONS: This observation may reflect a possible clinical benefit regarding early intervention with IL-6-modulatory therapies for COVID-19 and that CRP could be a potential biomarker of response to treatment.
KW - Aged
KW - Antibodies, Monoclonal, Humanized/therapeutic use
KW - Antiviral Agents/therapeutic use
KW - Biomarkers, Pharmacological/blood
KW - COVID-19
KW - Coronavirus Infections/complications
KW - Female
KW - Humans
KW - Interleukin-6/blood
KW - Italy
KW - Lymphocyte Count
KW - Male
KW - Middle Aged
KW - Neutrophils
KW - Pandemics
KW - Pneumonia, Viral/complications
KW - Receptors, Interleukin-6/antagonists & inhibitors
KW - Retrospective Studies
KW - Treatment Outcome
U2 - 10.1136/jitc-2020-001089
DO - 10.1136/jitc-2020-001089
M3 - Article
C2 - 32784217
VL - 8
JO - Journal for ImmunoTherapy of Cancer
JF - Journal for ImmunoTherapy of Cancer
SN - 2051-1426
IS - 2
ER -