Outcomes and biomarker analyses among patients with COVID-19 treated with interleukin 6 (IL-6) receptor antagonist sarilumab at a single institution in Italy

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 i...

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Main Authors: Vincenzo Montesarchio, Paolo Antonio Ascierto, Antonio Maria Grimaldi, Marcello Curvietto, Domenico Mallardo, Marco Palla, Chiara Iommelli, Antonella Bianco, Elio Manzillo, Fiorentino Fraganza, Cristiana Palumbo, Gaetano Rea, Patrizia Murino, Rosanna De Rosa, Luigi Atripaldi, Maurizio D’Abbraccio, Egidio Celentano, Claudia Trojaniello, Maria Grazia Vitale, Samuel Lewis Million-Weaver, Roberto Parrella
Format: Article
Language:English
Published: BMJ Publishing Group 2020-10-01
Series:Journal for ImmunoTherapy of Cancer
Online Access:https://jitc.bmj.com/content/8/2/e001089.full
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author Vincenzo Montesarchio
Paolo Antonio Ascierto
Antonio Maria Grimaldi
Marcello Curvietto
Domenico Mallardo
Marco Palla
Chiara Iommelli
Antonella Bianco
Elio Manzillo
Fiorentino Fraganza
Cristiana Palumbo
Gaetano Rea
Patrizia Murino
Rosanna De Rosa
Luigi Atripaldi
Maurizio D’Abbraccio
Egidio Celentano
Claudia Trojaniello
Maria Grazia Vitale
Samuel Lewis Million-Weaver
Roberto Parrella
author_facet Vincenzo Montesarchio
Paolo Antonio Ascierto
Antonio Maria Grimaldi
Marcello Curvietto
Domenico Mallardo
Marco Palla
Chiara Iommelli
Antonella Bianco
Elio Manzillo
Fiorentino Fraganza
Cristiana Palumbo
Gaetano Rea
Patrizia Murino
Rosanna De Rosa
Luigi Atripaldi
Maurizio D’Abbraccio
Egidio Celentano
Claudia Trojaniello
Maria Grazia Vitale
Samuel Lewis Million-Weaver
Roberto Parrella
author_sort Vincenzo Montesarchio
collection DOAJ
description 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.
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spelling doaj-art-e73bdd141cc34cab8a9b7d641f45494b2024-11-11T03:05:08ZengBMJ Publishing GroupJournal for ImmunoTherapy of Cancer2051-14262020-10-018210.1136/jitc-2020-001089Outcomes and biomarker analyses among patients with COVID-19 treated with interleukin 6 (IL-6) receptor antagonist sarilumab at a single institution in ItalyVincenzo Montesarchio0Paolo Antonio Ascierto1Antonio Maria Grimaldi2Marcello Curvietto3Domenico Mallardo4Marco Palla5Chiara Iommelli6Antonella Bianco7Elio Manzillo8Fiorentino Fraganza9Cristiana Palumbo10Gaetano Rea11Patrizia Murino12Rosanna De Rosa13Luigi Atripaldi14Maurizio D’Abbraccio15Egidio Celentano16Claudia Trojaniello17Maria Grazia Vitale18Samuel Lewis Million-Weaver19Roberto Parrella2016 U.O.C. Oncologia, Azienda Ospedaliera dei Colli, Monaldi Hospital, Napoli, Campania, Italy8 Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, ItalyAff1 Cancer Immunotherapy and Innovative Therapies Istituto Nazionale Tumori di Napoli Fondazione “G. Pascale”O.U. Melanoma Napoli ItalyAff1 Istituto Tumori di Napoli, Fondazione Pascale Italy1Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, ItalyMelanoma, Cancer Immunotherapy and Innovative Therapy, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy1 Department of Medical Oncology, Azienda Ospedaliera dei Colli-Monaldi Hospital, Napoli, Italy1 Department of Medical Oncology, Azienda Ospedaliera dei Colli-Monaldi Hospital, Napoli, Italy2 Department of Infectious Diseases and Infectious Diseases Emergencies, Azienda Ospedaliera dei Colli-Cotugno Hospital, Napoli, Italy3 Critical Area Department, Azienda Ospedaliera dei Colli-Cotugno and Monaldi Hospital, Napoli, Italy4 Department of Health Services, Azienda Ospedaliera dei Colli-Cotugno and Monaldi Hospital, Napoli, Italy4 Department of Health Services, Azienda Ospedaliera dei Colli-Cotugno and Monaldi Hospital, Napoli, Italy3 Critical Area Department, Azienda Ospedaliera dei Colli-Cotugno and Monaldi Hospital, Napoli, Italy3 Critical Area Department, Azienda Ospedaliera dei Colli-Cotugno and Monaldi Hospital, Napoli, Italy4 Department of Health Services, Azienda Ospedaliera dei Colli-Cotugno and Monaldi Hospital, Napoli, Italy2 Department of Infectious Diseases and Infectious Diseases Emergencies, Azienda Ospedaliera dei Colli-Cotugno Hospital, Napoli, Italy6 Epidemiology and Biostatistics Unit, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy1Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy1Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy7 Independent Investigator, Madison, Wisconsin, USA2 Department of Infectious Diseases and Infectious Diseases Emergencies, Azienda Ospedaliera dei Colli-Cotugno Hospital, Napoli, ItalyBackground 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.https://jitc.bmj.com/content/8/2/e001089.full
spellingShingle Vincenzo Montesarchio
Paolo Antonio Ascierto
Antonio Maria Grimaldi
Marcello Curvietto
Domenico Mallardo
Marco Palla
Chiara Iommelli
Antonella Bianco
Elio Manzillo
Fiorentino Fraganza
Cristiana Palumbo
Gaetano Rea
Patrizia Murino
Rosanna De Rosa
Luigi Atripaldi
Maurizio D’Abbraccio
Egidio Celentano
Claudia Trojaniello
Maria Grazia Vitale
Samuel Lewis Million-Weaver
Roberto Parrella
Outcomes and biomarker analyses among patients with COVID-19 treated with interleukin 6 (IL-6) receptor antagonist sarilumab at a single institution in Italy
Journal for ImmunoTherapy of Cancer
title Outcomes and biomarker analyses among patients with COVID-19 treated with interleukin 6 (IL-6) receptor antagonist sarilumab at a single institution in Italy
title_full Outcomes and biomarker analyses among patients with COVID-19 treated with interleukin 6 (IL-6) receptor antagonist sarilumab at a single institution in Italy
title_fullStr Outcomes and biomarker analyses among patients with COVID-19 treated with interleukin 6 (IL-6) receptor antagonist sarilumab at a single institution in Italy
title_full_unstemmed Outcomes and biomarker analyses among patients with COVID-19 treated with interleukin 6 (IL-6) receptor antagonist sarilumab at a single institution in Italy
title_short Outcomes and biomarker analyses among patients with COVID-19 treated with interleukin 6 (IL-6) receptor antagonist sarilumab at a single institution in Italy
title_sort outcomes and biomarker analyses among patients with covid 19 treated with interleukin 6 il 6 receptor antagonist sarilumab at a single institution in italy
url https://jitc.bmj.com/content/8/2/e001089.full
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