Treatment with tocilizumab or corticosteroids for COVID-19 patients with hyperinflammatory state : a multicentre cohort study (SAM-COVID-19)
Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved..
OBJECTIVES: The objective of this study was to estimate the association between tocilizumab or corticosteroids and the risk of intubation or death in patients with coronavirus disease 19 (COVID-19) with a hyperinflammatory state according to clinical and laboratory parameters.
METHODS: A cohort study was performed in 60 Spanish hospitals including 778 patients with COVID-19 and clinical and laboratory data indicative of a hyperinflammatory state. Treatment was mainly with tocilizumab, an intermediate-high dose of corticosteroids (IHDC), a pulse dose of corticosteroids (PDC), combination therapy, or no treatment. Primary outcome was intubation or death; follow-up was 21 days. Propensity score-adjusted estimations using Cox regression (logistic regression if needed) were calculated. Propensity scores were used as confounders, matching variables and for the inverse probability of treatment weights (IPTWs).
RESULTS: In all, 88, 117, 78 and 151 patients treated with tocilizumab, IHDC, PDC, and combination therapy, respectively, were compared with 344 untreated patients. The primary endpoint occurred in 10 (11.4%), 27 (23.1%), 12 (15.4%), 40 (25.6%) and 69 (21.1%), respectively. The IPTW-based hazard ratios (odds ratio for combination therapy) for the primary endpoint were 0.32 (95%CI 0.22-0.47; p < 0.001) for tocilizumab, 0.82 (0.71-1.30; p 0.82) for IHDC, 0.61 (0.43-0.86; p 0.006) for PDC, and 1.17 (0.86-1.58; p 0.30) for combination therapy. Other applications of the propensity score provided similar results, but were not significant for PDC. Tocilizumab was also associated with lower hazard of death alone in IPTW analysis (0.07; 0.02-0.17; p < 0.001).
CONCLUSIONS: Tocilizumab might be useful in COVID-19 patients with a hyperinflammatory state and should be prioritized for randomized trials in this situation.
| Media Type: |
Electronic Article |
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| Year of Publication: |
2021 |
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| Contained In: |
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases - Vol. 27, No. 2 (2021), p. 244-252 |
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| Language: |
English |
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| Urls: |
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| Keywords: |
COVID-19 |
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| Notes: |
Date Revised 19.02.2021 published: Print-Electronic Citation Status In-Process Copyright: From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine |
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| Physical Description: |
Online-Ressource |
|---|
| doi: |
10.1016/j.cmi.2020.08.010 |
|---|---|
| PMID: |
32860964 |
| PPN (Catalogue-ID): |
NLM315284951 |
|---|
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| 100 | 1 | |a Rodríguez-Baño, Jesús | |
| 245 | 1 | 0 | |a Treatment with tocilizumab or corticosteroids for COVID-19 patients with hyperinflammatory state |h Elektronische Ressource |b a multicentre cohort study (SAM-COVID-19) |
| 300 | |a Online-Ressource | ||
| 500 | |a Date Revised 19.02.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status In-Process | ||
| 500 | |a Copyright: From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine | ||
| 520 | |a Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved. | ||
| 520 | |a OBJECTIVES: The objective of this study was to estimate the association between tocilizumab or corticosteroids and the risk of intubation or death in patients with coronavirus disease 19 (COVID-19) with a hyperinflammatory state according to clinical and laboratory parameters | ||
| 520 | |a METHODS: A cohort study was performed in 60 Spanish hospitals including 778 patients with COVID-19 and clinical and laboratory data indicative of a hyperinflammatory state. Treatment was mainly with tocilizumab, an intermediate-high dose of corticosteroids (IHDC), a pulse dose of corticosteroids (PDC), combination therapy, or no treatment. Primary outcome was intubation or death; follow-up was 21 days. Propensity score-adjusted estimations using Cox regression (logistic regression if needed) were calculated. Propensity scores were used as confounders, matching variables and for the inverse probability of treatment weights (IPTWs) | ||
| 520 | |a RESULTS: In all, 88, 117, 78 and 151 patients treated with tocilizumab, IHDC, PDC, and combination therapy, respectively, were compared with 344 untreated patients. The primary endpoint occurred in 10 (11.4%), 27 (23.1%), 12 (15.4%), 40 (25.6%) and 69 (21.1%), respectively. The IPTW-based hazard ratios (odds ratio for combination therapy) for the primary endpoint were 0.32 (95%CI 0.22-0.47; p < 0.001) for tocilizumab, 0.82 (0.71-1.30; p 0.82) for IHDC, 0.61 (0.43-0.86; p 0.006) for PDC, and 1.17 (0.86-1.58; p 0.30) for combination therapy. Other applications of the propensity score provided similar results, but were not significant for PDC. Tocilizumab was also associated with lower hazard of death alone in IPTW analysis (0.07; 0.02-0.17; p < 0.001) | ||
| 520 | |a CONCLUSIONS: Tocilizumab might be useful in COVID-19 patients with a hyperinflammatory state and should be prioritized for randomized trials in this situation | ||
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| 655 | 7 | |a Mortality |2 gnd | |
| 655 | 7 | |a Tocilizumab |2 gnd | |
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| 700 | 1 | |a Aguayo Jiménez, Carmen | |
| 700 | 1 | |a Ruíz Campuzano, María | |
| 700 | 1 | |a Naranjo Velasco, Virginia | |
| 700 | 1 | |a Santos Peña, Marta | |
| 700 | 1 | |a Mora Delgado, Juan | |
| 700 | 1 | |a Sevilla Moreno, Israel | |
| 700 | 1 | |a Lojo Cruz, Cristina | |
| 700 | 1 | |a Kortajarena Urkola, Xabier | |
| 700 | 1 | |a Iribarren Loyarte, José Antonio | |
| 700 | 1 | |a Bustinduy Odriozola, María Jesús | |
| 700 | 1 | |a Ibarguren Pinilla, Maialen | |
| 700 | 1 | |a Álvarez Rodríguez, Ignacio | |
| 700 | 1 | |a Martínez Marcos, Francisco Javier | |
| 700 | 1 | |a Rodríguez Gómez, Francisco Javier | |
| 700 | 1 | |a Asschert Agüero, Isabel | |
| 700 | 1 | |a Muñoz Beamud, Francisco | |
| 700 | 1 | |a Ruiz Reina, Antonio José | |
| 700 | 1 | |a Llenas-García, Jara | |
| 700 | 1 | |a González-Cuello, Inmaculada | |
| 700 | 1 | |a Hellín-Valiente, Elena | |
| 700 | 1 | |a Martínez Birlanga, Esther | |
| 700 | 1 | |a Tafalla Torres, José Manuel | |
| 700 | 1 | |a Calderón Parra, Jorge | |
| 700 | 1 | |a Escudero López, Gabriela | |
| 700 | 1 | |a Gutiérrez Martín, Isabel | |
| 700 | 1 | |a Andrés Eisenhofer, Ane | |
| 700 | 1 | |a García Prieto, Sonia | |
| 700 | 1 | |a Álvarez Franco, Raquel | |
| 700 | 1 | |a Roger Zapata, Daniel | |
| 700 | 1 | |a Martínez Cifre, Blanca | |
| 700 | 1 | |a Aranda Rife, Elena | |
| 700 | 1 | |a Martín Rubio, Irene | |
| 700 | 1 | |a Barbosa Ventura, André | |
| 700 | 1 | |a Garrido, Javier | |
| 700 | 1 | |a Gonzalo, Concepción | |
| 700 | 1 | |a Piñero, Iván | |
| 700 | 1 | |a de la Cruz Felipe, Nieves | |
| 700 | 1 | |a Talavera García, Eva | |
| 700 | 1 | |a Lamata Subero, Marta | |
| 700 | 1 | |a Mendoza Roy, Paula | |
| 700 | 1 | |a García de Carlos, María Soledad | |
| 700 | 1 | |a Lajusticia Aisa, Justo | |
| 700 | 1 | |a Arteche Eguizabal, Lorea | |
| 700 | 1 | |a Urrutia Losada, Ainhoa | |
| 700 | 1 | |a Domingo Echaburu, Saioa | |
| 700 | 1 | |a Cuadros Tito, Pedro Ángel | |
| 700 | 1 | |a Orbe Narváez, Gurutz | |
| 700 | 1 | |a Liébana Martos, Ma Del Carmen | |
| 700 | 1 | |a Roldán Fontana, Carolina | |
| 700 | 1 | |a Herrero Rodríguez, Carmen | |
| 700 | 1 | |a Duro Ruiz, Gaspar | |
| 700 | 1 | |a Pérez Parra, Santiago | |
| 700 | 1 | |a Mera Fidalgo, Arantzazu | |
| 700 | 1 | |a Hortos Alsina, Miquel | |
| 700 | 1 | |a Alberich Conesa, Ana | |
| 700 | 1 | |a Bladé Vidal, Lourdes | |
| 700 | 1 | |a Merchante Gutiérrez, Nicolás | |
| 700 | 1 | |a León Jiménez, Eva | |
| 700 | 1 | |a Espíndola Gómez, Reinaldo | |
| 700 | 1 | |a Erostarbe Gallardo, María | |
| 700 | 1 | |a Martínez Pérez-Crespo, Pedro | |
| 700 | 1 | |a Cisneros, José Miguel | |
| 700 | 1 | |a Aguilar-Guisado, Manuela | |
| 700 | 1 | |a Aldabó, Teresa | |
| 700 | 1 | |a Bueno, Claudio | |
| 700 | 1 | |a Cordero-Matía, Elisa | |
| 700 | 1 | |a Escoresca, Ana | |
| 700 | 1 | |a Infante, Carmen | |
| 700 | 1 | |a Guillermo, Martín | |
| 700 | 1 | |a Salto, Sonsoles | |
| 700 | 1 | |a Gioia, Francesca | |
| 700 | 1 | |a Vizcarra, Pilar | |
| 700 | 1 | |a Fortún Abete, Jesús | |
| 700 | 1 | |a Martín Dávila, Pilar | |
| 700 | 1 | |a Moreno Guillén, Santiago | |
| 700 | 1 | |a Oteo Revuelta, José A | |
| 700 | 1 | |a García-García, Concepción | |
| 700 | 1 | |a Santibañez Sáenz, Paula | |
| 700 | 1 | |a Cervera Acedo, Cristina | |
| 700 | 1 | |a Azcona Gutiérrez, José M | |
| 700 | 1 | |a Reguera Iglesias, José María | |
| 700 | 1 | |a Plata Ciezar, Antonio | |
| 700 | 1 | |a Valiente de Santis, Lucia | |
| 700 | 1 | |a Sobrino Diaz, Beatriz | |
| 700 | 1 | |a Ruiz Mesa, Juan Diego | |
| 773 | 0 | 8 | |i in |t Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases |g Vol. 27, No. 2 (2021), p. 244-252 |q 27:2<244-252 |w (DE-601)NLM094582645 |x 1469-0691 |
| 856 | 4 | 1 | |u http://dx.doi.org/10.1016/j.cmi.2020.08.010 |3 Volltext |
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 27 |j 2021 |e 2 |b 27 |c 02 |h 244-252 | ||