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Outcomes and biomarker analyses among patients with COVID-19 treated with interleukin 6 (IL-6) receptor antagonist sarilumab at a single institution in Italy.
Montesarchio, Vincenzo; Parrela, Roberto; Iommelli, Chiara; Bianco, Antonella; Manzillo, Elio; Fraganza, Fiorentino; Palumbo, Cristiana; Rea, Gaetano; Murino, Patrizia; De Rosa, Rosanna; Atripaldi, Luigi; D'Abbraccio, Maurizio; Curvietto, Marcello; Mallardo, Domenico; Celentano, Egidio; Grimaldi, Antonio Maria; Palla, Marco; Trojaniello, Claudia; Vitale, Maria Grazia; Million-Weaver, Samuel Lewis; Ascierto, Paolo Antonio.
  • Montesarchio V; Department of Medical Oncology, Azienda Ospedaliera dei Colli-Monaldi Hospital, Napoli, Italy.
  • Parrela R; Department of Infectious Diseases and Infectious Diseases Emergencies, Azienda Ospedaliera dei Colli-Cotugno Hospital, Napoli, Italy.
  • Iommelli C; Department of Medical Oncology, Azienda Ospedaliera dei Colli-Monaldi Hospital, Napoli, Italy.
  • Bianco A; Department of Medical Oncology, Azienda Ospedaliera dei Colli-Monaldi Hospital, Napoli, Italy.
  • Manzillo E; Department of Infectious Diseases and Infectious Diseases Emergencies, Azienda Ospedaliera dei Colli-Cotugno Hospital, Napoli, Italy.
  • Fraganza F; Critical Area Department, Azienda Ospedaliera dei Colli-Cotugno and Monaldi Hospital, Napoli, Italy.
  • Palumbo C; Department of Health Services, Azienda Ospedaliera dei Colli-Cotugno and Monaldi Hospital, Napoli, Italy.
  • Rea G; Department of Health Services, Azienda Ospedaliera dei Colli-Cotugno and Monaldi Hospital, Napoli, Italy.
  • Murino P; Critical Area Department, Azienda Ospedaliera dei Colli-Cotugno and Monaldi Hospital, Napoli, Italy.
  • De Rosa R; Critical Area Department, Azienda Ospedaliera dei Colli-Cotugno and Monaldi Hospital, Napoli, Italy.
  • Atripaldi L; Department of Health Services, Azienda Ospedaliera dei Colli-Cotugno and Monaldi Hospital, Napoli, Italy.
  • D'Abbraccio M; Department of Infectious Diseases and Infectious Diseases Emergencies, Azienda Ospedaliera dei Colli-Cotugno Hospital, Napoli, Italy.
  • Curvietto M; Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy.
  • Mallardo D; Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy.
  • Celentano E; Epidemiology and Biostatistics Unit, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy.
  • Grimaldi AM; Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy.
  • Palla M; Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy.
  • Trojaniello C; Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy.
  • Vitale MG; Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy.
  • Million-Weaver SL; Independent Investigator, Madison, Wisconsin, USA.
  • Ascierto PA; Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy paolo.ascierto@gmail.com.
J Immunother Cancer ; 8(2)2020 08.
Article in English | MEDLINE | ID: covidwho-713881
Semantic information from SemMedBD (by NLM)
1. COVID-19 PROCESS_OF Patients
Subject
COVID-19
Predicate
PROCESS_OF
Object
Patients
2. sarilumab TREATS Symptoms
Subject
sarilumab
Predicate
TREATS
Object
Symptoms
3. sarilumab AFFECTS Disease
Subject
sarilumab
Predicate
AFFECTS
Object
Disease
4. interleukin-6 ASSOCIATED_WITH Disease
Subject
interleukin-6
Predicate
ASSOCIATED_WITH
Object
Disease
5. early/brief intervention/therapy (treatment) TREATS COVID-19
Subject
early/brief intervention/therapy (treatment)
Predicate
TREATS
Object
COVID-19
6. COVID-19 PROCESS_OF Patients
Subject
COVID-19
Predicate
PROCESS_OF
Object
Patients
7. sarilumab TREATS Symptoms
Subject
sarilumab
Predicate
TREATS
Object
Symptoms
8. sarilumab AFFECTS Disease
Subject
sarilumab
Predicate
AFFECTS
Object
Disease
9. interleukin-6 ASSOCIATED_WITH Disease
Subject
interleukin-6
Predicate
ASSOCIATED_WITH
Object
Disease
10. early/brief intervention/therapy (treatment) TREATS COVID-19
Subject
early/brief intervention/therapy (treatment)
Predicate
TREATS
Object
COVID-19
ABSTRACT

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.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Interleukin-6 / Coronavirus Infections / Biomarkers, Pharmacological / Antibodies, Monoclonal, Humanized Type of study: Observational study / Risk factors Limits: Aged / Female / Humans / Male / Middle aged Country/Region as subject: Europa Language: English Year: 2020 Document Type: Article Affiliation country: Jitc-2020-001089

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Interleukin-6 / Coronavirus Infections / Biomarkers, Pharmacological / Antibodies, Monoclonal, Humanized Type of study: Observational study / Risk factors Limits: Aged / Female / Humans / Male / Middle aged Country/Region as subject: Europa Language: English Year: 2020 Document Type: Article Affiliation country: Jitc-2020-001089