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Sarilumab use in severe SARS-CoV-2 pneumonia.
Gremese, Elisa; Cingolani, Antonella; Bosello, Silvia Laura; Alivernini, Stefano; Tolusso, Barbara; Perniola, Simone; Landi, Francesco; Pompili, Maurizio; Murri, Rita; Santoliquido, Angelo; Garcovich, Matteo; Sali, Michela; De Pascale, Gennaro; Gabrielli, Maurizio; Biscetti, Federico; Montalto, Massimo; Tosoni, Alberto; Gambassi, Giovanni; Rapaccini, Gian Ludovico; Iaconelli, Amerigo; Zileri Del Verme, Lorenzo; Petricca, Luca; Fedele, Anna Laura; Lizzio, Marco Maria; Tamburrini, Enrica; Natalello, Gerlando; Gigante, Laura; Bruno, Dario; Verardi, Lucrezia; Taddei, Eleonora; Calabrese, Angelo; Lombardi, Francesco; Bernabei, Roberto; Cauda, Roberto; Franceschi, Francesco; Landolfi, Raffaele; Richeldi, Luca; Sanguinetti, Maurizio; Fantoni, Massimo; Antonelli, Massimo; Gasbarrini, Antonio.
  • Gremese E; Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Reumatologia, Rome, Italy.
  • Cingolani A; Università Cattolica del Sacro Cuore, Divisione di Reumatologia, Rome, Italy.
  • Bosello SL; Fondazione Policlinico Universitario A. Gemelli IRCCS, Dipartimento di Scienze di Laboratorio e Infettivologiche, Rome, Italy.
  • Alivernini S; Università Cattolica del Sacro Cuore, Dipartimento di Sicurezza e Bioetica, Sez. Malattie Infettive, Rome, Italy.
  • Tolusso B; Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Reumatologia, Rome, Italy.
  • Perniola S; Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Reumatologia, Rome, Italy.
  • Landi F; Università Cattolica del Sacro Cuore, Divisione di Reumatologia, Rome, Italy.
  • Pompili M; Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Reumatologia, Rome, Italy.
  • Murri R; Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Reumatologia, Rome, Italy.
  • Santoliquido A; Fondazione Policlinico Universitario A. Gemelli IRCCS, Institute of Internal Medicine and Geriatrics, Rome, Italy.
  • Garcovich M; Università Cattolica del Sacro Cuore, Institute of Internal Medicine and Geriatrics, Rome, Italy.
  • Sali M; Fondazione Policlinico Universitario A. Gemelli IRCCS, Dipartimento di Scienze Mediche e Chirurgiche, Rome, Italy.
  • De Pascale G; Università Cattolica del Sacro Cuore, Dipartimento di Medicina e Chirurgia Traslazionale, Rome, Italy.
  • Gabrielli M; Fondazione Policlinico Universitario A. Gemelli IRCCS, Dipartimento di Scienze di Laboratorio e Infettivologiche, Rome, Italy.
  • Biscetti F; Università Cattolica del Sacro Cuore, Dipartimento di Sicurezza e Bioetica, Sez. Malattie Infettive, Rome, Italy.
  • Montalto M; Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Clinic Medica e Malattie Cardiovascolari, Rome, Italy.
  • Tosoni A; Fondazione Policlinico Universitario A. Gemelli IRCCS, Dipartimento di Scienze Mediche e Chirurgiche, Rome, Italy.
  • Gambassi G; Fondazione Policlinico Universitario A. Gemelli IRCCS, Dipartimento di Scienze di Laboratorio e Infettivologiche, Rome, Italy.
  • Rapaccini GL; Università Cattolica del Sacro Cuore, Dipartimento di Scienze Biotecnologiche di Base, Cliniche Intensivologiche e Perioperatorie - Sezione di Microbiologia, Rome, Italy.
  • Iaconelli A; Fondazione Policlinico Universitario A. Gemelli IRCCS, Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Rome, Italy.
  • Zileri Del Verme L; Università Cattolica del Sacro Cuore, Dipartimento di Scienze dell'Emergenza, Anestesiologiche e della Rianimazione, Rome, Italy.
  • Petricca L; Fondazione Policlinico Universitario A. Gemelli IRCCS, Emergency Medicine, Rome, Italy.
  • Fedele AL; Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Clinic Medica e Malattie Cardiovascolari, Rome, Italy.
  • Lizzio MM; Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Clinic Medica e Malattie Cardiovascolari, Rome, Italy.
  • Tamburrini E; Università Cattolica del Sacro Cuore, Division of Internal Medicine, Rome, Italy.
  • Natalello G; Fondazione Policlinico Universitario A. Gemelli IRCCS, Dipartimento di Scienze Mediche e Chirurgiche, Rome, Italy.
  • Gigante L; Università Cattolica del Sacro Cuore, Division of Internal Medicine, Rome, Italy.
  • Bruno D; Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Medicina Generale, Rome, Italy.
  • Verardi L; Fondazione Policlinico Universitario A. Gemelli IRCCS, Dipartimento di Scienze Mediche e Chirurgiche, Rome, Italy.
  • Taddei E; Università Cattolica del Sacro Cuore, Dipartimento di Medicina e Chirurgia Traslazionale, Rome, Italy.
  • Calabrese A; Fondazione Policlinico Universitario A. Gemelli IRCCS, Dipartimento di Scienze Mediche e Chirurgiche, Rome, Italy.
  • Lombardi F; Fondazione Policlinico Universitario A. Gemelli IRCCS, Dipartimento di Scienze Mediche e Chirurgiche, Rome, Italy.
  • Bernabei R; Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Reumatologia, Rome, Italy.
  • Cauda R; Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Reumatologia, Rome, Italy.
  • Franceschi F; Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Reumatologia, Rome, Italy.
  • Landolfi R; Fondazione Policlinico Universitario A. Gemelli IRCCS, Dipartimento di Scienze di Laboratorio e Infettivologiche, Rome, Italy.
  • Richeldi L; Università Cattolica del Sacro Cuore, Dipartimento di Sicurezza e Bioetica, Sez. Malattie Infettive, Rome, Italy.
  • Sanguinetti M; Università Cattolica del Sacro Cuore, Divisione di Reumatologia, Rome, Italy.
  • Fantoni M; Università Cattolica del Sacro Cuore, Divisione di Reumatologia, Rome, Italy.
  • Antonelli M; Università Cattolica del Sacro Cuore, Divisione di Reumatologia, Rome, Italy.
  • Gasbarrini A; Università Cattolica del Sacro Cuore, Divisione di Reumatologia, Rome, Italy.
EClinicalMedicine ; 27: 100553, 2020 Oct.
Article in English | MEDLINE | ID: covidwho-1385448
Preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
See preprint
Semantic information from SemMedBD (by NLM)
1. sarilumab ASSOCIATED_WITH Pneumonia
Subject
sarilumab
Predicate
ASSOCIATED_WITH
Object
Pneumonia
2. sarilumab ADMINISTERED_TO Patients
Subject
sarilumab
Predicate
ADMINISTERED_TO
Object
Patients
3. Pneumonia PROCESS_OF Patients
Subject
Pneumonia
Predicate
PROCESS_OF
Object
Patients
4. Body position PROCESS_OF Patients
Subject
Body position
Predicate
PROCESS_OF
Object
Patients
5. sarilumab DISRUPTS interleukin-6 receptor activity
Subject
sarilumab
Predicate
DISRUPTS
Object
interleukin-6 receptor activity
6. sarilumab ASSOCIATED_WITH Pneumonia
Subject
sarilumab
Predicate
ASSOCIATED_WITH
Object
Pneumonia
7. sarilumab ADMINISTERED_TO Patients
Subject
sarilumab
Predicate
ADMINISTERED_TO
Object
Patients
8. Pneumonia PROCESS_OF Patients
Subject
Pneumonia
Predicate
PROCESS_OF
Object
Patients
9. Body position PROCESS_OF Patients
Subject
Body position
Predicate
PROCESS_OF
Object
Patients
10. sarilumab DISRUPTS interleukin-6 receptor activity
Subject
sarilumab
Predicate
DISRUPTS
Object
interleukin-6 receptor activity
ABSTRACT

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/FiO2146(IQR120-212)] while 14(26·4%) in ICU [92·6% with a second infusion; median PaO2/FiO2 112(IQR100-141.5)].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.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Language: English Journal: EClinicalMedicine Year: 2020 Document Type: Article Affiliation country: J.ECLINM.2020.100553

Full text: Available Collection: International databases Database: MEDLINE Language: English Journal: EClinicalMedicine Year: 2020 Document Type: Article Affiliation country: J.ECLINM.2020.100553