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.
| Errataetall: |
CommentIn: Clin Microbiol Infect. 2021 Feb;27(2):158-159. - PMID 33007475 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:27 |
|---|---|
| Enthalten in: |
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases - 27(2021), 2 vom: 26. Feb., Seite 244-252 |
| Sprache: |
Englisch |
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| Links: |
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| Themen: |
Adrenal Cortex Hormones |
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| Anmerkungen: |
Date Completed 25.02.2021 Date Revised 07.12.2022 published: Print-Electronic CommentIn: Clin Microbiol Infect. 2021 Feb;27(2):158-159. - PMID 33007475 Citation Status MEDLINE |
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| doi: |
10.1016/j.cmi.2020.08.010 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM314341161 |
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| 245 | 1 | 0 | |a Treatment with tocilizumab or corticosteroids for COVID-19 patients with hyperinflammatory state |b a multicentre cohort study (SAM-COVID-19) |
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| 500 | |a Date Completed 25.02.2021 | ||
| 500 | |a Date Revised 07.12.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a CommentIn: Clin Microbiol Infect. 2021 Feb;27(2):158-159. - PMID 33007475 | ||
| 500 | |a Citation Status MEDLINE | ||
| 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a Cohort study | |
| 650 | 4 | |a Corticosteroids | |
| 650 | 4 | |a Hyperinflammatory state | |
| 650 | 4 | |a Mortality | |
| 650 | 4 | |a Tocilizumab | |
| 650 | 7 | |a Adrenal Cortex Hormones |2 NLM | |
| 650 | 7 | |a Antibodies, Monoclonal, Humanized |2 NLM | |
| 650 | 7 | |a tocilizumab |2 NLM | |
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| 700 | 0 | |a Hospital Clínico San Cecilio |e verfasserin |4 aut | |
| 700 | 0 | |a Parc Sanitari Sant Joan de Déu |e verfasserin |4 aut | |
| 700 | 0 | |a Hospital Josep Trueta |e verfasserin |4 aut | |
| 700 | 0 | |a Hospital Dos De Maig - Consorci Sanitari Integral |e verfasserin |4 aut | |
| 700 | 0 | |a Hospital Clínico Universitario de Valencia |e verfasserin |4 aut | |
| 700 | 0 | |a Complejo Asistencial de Ávila |e verfasserin |4 aut | |
| 700 | 0 | |a Hospital Universitario Marqués de Valdecilla |e verfasserin |4 aut | |
| 700 | 0 | |a Hospital de Barcelona SCIAS |e verfasserin |4 aut | |
| 700 | 0 | |a Hospital Álvaro Cunqueiro |e verfasserin |4 aut | |
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| 700 | 0 | |a Hospital CIMA-Sanitas |e verfasserin |4 aut | |
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| 700 | 0 | |a Hospital Comarcal de Blanes |e verfasserin |4 aut | |
| 700 | 0 | |a Hospital Universitario de Gran Canaria Dr Negrín |e verfasserin |4 aut | |
| 700 | 0 | |a Hospital Son Espases |e verfasserin |4 aut | |
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| 700 | 0 | |a Hospital Costa del Sol |e verfasserin |4 aut | |
| 700 | 0 | |a Hospital Clínico Universitario Lozano Blesa |e verfasserin |4 aut | |
| 700 | 0 | |a Hospital Mutua de Terrassa |e verfasserin |4 aut | |
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| 700 | 0 | |a Hospital Universitario de Jerez |e verfasserin |4 aut | |
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| 700 | 0 | |a Hospital Universitario de Jaén |e verfasserin |4 aut | |
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| 700 | 0 | |a Hospital Universitario Ramón y Cajal |e verfasserin |4 aut | |
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| 700 | 1 | |a Muñoz Aguirre, Clara |e investigator |4 oth | |
| 700 | 1 | |a Díaz Menéndez, Marta |e investigator |4 oth | |
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| 700 | 1 | |a Diaz Pollan, Beatriz |e investigator |4 oth | |
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| 700 | 1 | |a Loeches Yagüe, Belén |e investigator |4 oth | |
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| 700 | 1 | |a Aldámiz-Echevarría, Teresa |e investigator |4 oth | |
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| 700 | 1 | |a Pinilla, Blanca |e investigator |4 oth | |
| 700 | 1 | |a López, Juan Carlos |e investigator |4 oth | |
| 700 | 1 | |a Such Diaz, Ana |e investigator |4 oth | |
| 700 | 1 | |a Álvaro Alonso, Elena |e investigator |4 oth | |
| 700 | 1 | |a Torres Macho, Juan |e investigator |4 oth | |
| 700 | 1 | |a Cuevas Tascon, Guillermo |e investigator |4 oth | |
| 700 | 1 | |a Jiménez González de Buitrago, Eva |e investigator |4 oth | |
| 700 | 1 | |a Brañas Baztán, Fátima |e investigator |4 oth | |
| 700 | 1 | |a Valencia de la Rosa, Jorge |e investigator |4 oth | |
| 700 | 1 | |a Pérez Butragueño, Mario |e investigator |4 oth | |
| 700 | 1 | |a Fernández Jiménez, Inés |e investigator |4 oth | |
| 700 | 1 | |a Muñiz Nicolás, Gemma |e investigator |4 oth | |
| 700 | 1 | |a Sepúlveda Berrocal, Antonia |e investigator |4 oth | |
| 700 | 1 | |a Gato Díez, Alberto |e investigator |4 oth | |
| 700 | 1 | |a Toledano Sierra, María Pilar |e investigator |4 oth | |
| 700 | 1 | |a García Butenegro, María Paz |e investigator |4 oth | |
| 700 | 1 | |a Peláez Ballesta, Ana Isabel |e investigator |4 oth | |
| 700 | 1 | |a Morcillo Rodríguez, Elena |e investigator |4 oth | |
| 700 | 1 | |a Fernández Romero, Isidoro |e investigator |4 oth | |
| 700 | 1 | |a Peláez Ballesta, Cristina |e investigator |4 oth | |
| 700 | 1 | |a Guirado Torrecillas, María Isabel |e investigator |4 oth | |
| 700 | 1 | |a Goikoetxea Agirre, Josune |e investigator |4 oth | |
| 700 | 1 | |a Bereciartua Bastarrica, Elena |e investigator |4 oth | |
| 700 | 1 | |a Guio Carrión, Laura |e investigator |4 oth | |
| 700 | 1 | |a Rodríguez Álvarez, Regino |e investigator |4 oth | |
| 700 | 1 | |a Ibarrola Hierro, Marta |e investigator |4 oth | |
| 700 | 1 | |a Pérez Hernández, Isabel A |e investigator |4 oth | |
| 700 | 1 | |a Pérez Zapata, Inés |e investigator |4 oth | |
| 700 | 1 | |a Román Soto, Sergio |e investigator |4 oth | |
| 700 | 1 | |a Kallouchi, Mohamed |e investigator |4 oth | |
| 700 | 1 | |a Domínguez Vicent, Juan Ramón |e investigator |4 oth | |
| 700 | 1 | |a Silvariño Fernández, Rafae |e investigator |4 oth | |
| 700 | 1 | |a Ugalde Espiñeira, Jon |e investigator |4 oth | |
| 700 | 1 | |a Sanjuan López, Ainhoa |e investigator |4 oth | |
| 700 | 1 | |a García Martínez, Silvia |e investigator |4 oth | |
| 700 | 1 | |a Temprano Gogenola, Mikel |e investigator |4 oth | |
| 700 | 1 | |a Asensi, Víctor |e investigator |4 oth | |
| 700 | 1 | |a Suárez, Silvia |e investigator |4 oth | |
| 700 | 1 | |a Suárez, Lucia |e investigator |4 oth | |
| 700 | 1 | |a Yllera, Carmen |e investigator |4 oth | |
| 700 | 1 | |a Rivas-Carmenado, María |e investigator |4 oth | |
| 700 | 1 | |a Romero-Palacios, Alberto |e investigator |4 oth | |
| 700 | 1 | |a Ruiz Aragón, Jesús |e investigator |4 oth | |
| 700 | 1 | |a Jiménez Aguilar, Patricia |e investigator |4 oth | |
| 700 | 1 | |a Fernández Ávila, Ma Luisa |e investigator |4 oth | |
| 700 | 1 | |a Castilla Ortiz, Rosario |e investigator |4 oth | |
| 700 | 1 | |a Alende Castro, Vanesa |e investigator |4 oth | |
| 700 | 1 | |a Pérez García, Cristina |e investigator |4 oth | |
| 700 | 1 | |a Fernández Morales, Marta |e investigator |4 oth | |
| 700 | 1 | |a Valle Feijoo Begoña Rodríguez Ferreira, María Lorena María |e investigator |4 oth | |
| 700 | 1 | |a Gómez-Junyent, Joan |e investigator |4 oth | |
| 700 | 1 | |a Villar-García, Judit |e investigator |4 oth | |
| 700 | 1 | |a López-Montesinos, Inmaculada |e investigator |4 oth | |
| 700 | 1 | |a Arrieta-Aldea, Itziar |e investigator |4 oth | |
| 700 | 1 | |a Rial-Villavecchia, Abora |e investigator |4 oth | |
| 700 | 1 | |a García Vázquez, Elisa |e investigator |4 oth | |
| 700 | 1 | |a Roura Piloto, Aychel Elena |e investigator |4 oth | |
| 700 | 1 | |a Moral Escudero, Encarnación |e investigator |4 oth | |
| 700 | 1 | |a Hernández Torres, Alicia |e investigator |4 oth | |
| 700 | 1 | |a Albendín Iglesias, Helena |e investigator |4 oth | |
| 700 | 1 | |a Vinuesa García, David |e investigator |4 oth | |
| 700 | 1 | |a Martínez Montes, Clara |e investigator |4 oth | |
| 700 | 1 | |a De la Hera Fernández, Francisco Javier |e investigator |4 oth | |
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| 700 | 1 | |a Ruiz Sancho, Andrés |e investigator |4 oth | |
| 700 | 1 | |a Díaz de Brito Fernández, Vicens |e investigator |4 oth | |
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| 700 | 1 | |a Chara Cervantes, Joel Elías |e investigator |4 oth | |
| 700 | 1 | |a Policarpo Torres, Guillem |e investigator |4 oth | |
| 700 | 1 | |a Ortega Montoliu, Meritxell |e investigator |4 oth | |
| 700 | 1 | |a Angerri Nadal, Mònica |e investigator |4 oth | |
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