Analysis of the effectiveness of the administration of tocilizumab in patients admitted to an intermediate respiratory care unit with a diagnosis of severe coronavirus disease 2019 pneumonia: a prospective observational study with propensity score matching

Analysis of the effectiveness of the administration of tocilizumab in patients admitted to an intermediate respiratory care unit with a diagnosis of severe coronavirus disease 2019 pneumonia: a prospective observational study with propensity score matching

Miguel Lorente-González 1, Fernando Neria-Serrano 2, José R. Terán-Tinedo 1, Clotilde Funes-Moreno 3, Daniel Laorden 4, Annette Zevallos-Villegas 1, Pablo Mariscal-Aguilar 1, Miguel Suárez-Ortiz 1, Eduardo Cano-Sanz 5, Ma. Ángeles Ortega-Fraile 5, Joaquín Hernández-Núñez 5, Adalgisa E. Falcone 6, Elena M. Saiz-Lou 7, Ma. Cristina Plaza-Moreno 1, Christian García-Fadul 1, Manuel Valle-Falcones 1, Isabel De-La-Calle-Gil 3, Rosalía Navarro-Casado 3, Daniel Carballo-López 3, Soraya Gholamian-Ovejero 3, Berta Gallego-Rodríguez 3, Aylaf Latif-Essa 1, Carmen Rodríguez-Calle 1, Juan Martín-Torres 7, Marta D. Espuelas-Borderia 5, Cristian Rosas-Espinoza 8, Antonio Martín-Alonso 8, Tomás Villén-Villegas 5, Pedro Landete 9

1 Department of Pneumology, Intermediate Respiratory Care Unit, Hospital de Emergencias Enfermera Isabel Zendal, Madrid, Spain; 2 Research Support Unit, Faculty of Medicine, Universidad Francisco de Vitoria, Pozuelo de Alarcón, Madrid, Spain; 3 Department of Anaesthesiology and Resuscitation, Intermediate Respiratory Care Unit, Hospital de Emergencias Enfermera Isabel Zendal, Madrid, Spain; 4 Servicio de Neumología, Unidad de Cuidados Respiratorios Intermedios, Hospital de Emergencias Enfermera Isabel Zendal, Madrid, España; 5 Department of Emergency Medicine, Intermediate Respiratory Care Unit, Hospital de Emergencias Enfermera Isabel Zendal, Madrid, Spain; 6 Servicio de Neumología, Hospital Clínico San Carlos, Madrid, España; 7 Department of Internal Medicine, Intermediate Respiratory Care Unit, Hospital de Emergencias Enfermera Isabel Zendal, Madrid, Spain; 8 Department of Hospital Pharmacy, Hospital de Emergencias Enfermera Isabel Zendal, Madrid, Spain; 9 Department of Pneumology, Intermediate Respiratory Care Unit, Hospital de Emergencias Enfermera Isabel Zendal; Department of Medicine, Faculty of Medicine, Universidad Autónoma de Madrid. Madrid, Spain

Miguel Lorente-González, Fernando Neria-Serrano, José R. Terán-Tinedo, Clotilde Funes-Moreno, Daniel Laorden, Annette Zevallos-Villegas, Pablo Mariscal-Aguilar, Miguel Suárez-Ortiz, Eduardo Cano-Sanz, Ma. Ángeles Ortega-Fraile, Joaquín Hernández-Núñez, Adalgisa E. Falcone, Elena M. Saiz-Lou, Ma. Cristina Plaza-Moreno, Christian García-Fadul, Manuel Valle-Falcones, Isabel De-La-Calle-Gil, Rosalía Navarro-Casado, Daniel Carballo-López, Soraya Gholamian-Ovejero, Berta Gallego-Rodríguez, Aylaf Latif-Essa, Carmen Rodríguez-Calle, Juan Martín-Torres, Marta D. Espuelas-Borderia, Cristian Rosas-Espinoza, Antonio Martín-Alonso, Tomás Villén-Villegas, Pedro Landete

La información completa de afiliaciones y autor de correspondencia está disponible en la versión original en PDF.

*Correspondence: Adalgisa E. Falcone, Email not available

Summary

Background: The use of tocilizumab might counteract the inflammatory hyperresponsiveness associated with the most severe cases of coronavirus disease 2019 (COVID-19) and thus improve the vital prognosis, although this fact is controversial in the scientific literature. Objectives: We evaluated the effects of tocilizumab therapy in semi-critical patients with severe COVID-19 pneumonia. Material and method: We conducted a prospective observational study in patients admitted to an intermediate respiratory care unit (IRCU) for severe COVID-19 pneumonia requiring non-invasive respiratory support (NIRS). We established two groups of patients according to whether or not they had received tocilizumab, respectively. In order to reduce the derived selection bias, we used the propensity score matching. The most important outcomes were death, receipt of invasive mechanical ventilation (IMV), and the composite of receipt of IMV or death (clinical failure). Results: We included 1306 patients: 532 (40.7%) received tocilizumab and 774 (59.3%) did not receive tocilizumab. We matched 321 patients in each group. After matching, we did not detect any statistically significant differences between the two groups in mortality within 30 days (36/321 vs. 35/321; 11.2% vs. 10.9%) (hazard ratio [HR] = 1.03; HR 95% confidence interval [CI] = 0.65-1.64; p = 0.896) (odds ratio [OR] = 1.03; OR 95% CI = 0.63-1.69; p = 0.900), nor in the probability of receipt of IMV within 30 days (89/301 vs. 76/302; 29.6% vs. 25.2%) (HR = 1.22; HR 95% CI = 0.90-1.66; p = 0.194) (OR = 1.25; OR 95% CI = 0.87-1.79; p = 0.225), nor in the probability of clinical failure within 30 days (104/321 vs. 89/321; 32.4% vs. 27.7%) (HR = 1.22; HR 95% CI = 0.92-1.62; p = 0.167) (OR = 1.25; OR 95% CI = 0.89-1.75; p = 0.197). We also did not observe any statistically significant difference in in-hospital mortality (59/321 vs. 49/321; 18.4% vs. 15.3%) (OR = 1.25; OR 95% CI = 0.83-1.89; p = 0.291). Conclusion: In our sample of patients admitted to the IRCU for severe COVID-19 pneumonia under NIRS, tocilizumab therapy did not demonstrate any effectiveness in terms of reducing the probabilities of death, receipt of IMV, and clinical failure.

Keywords:  Tocilizumab. COVID-19 pneumonia. Intermediate respiratory care unit. Non-invasive respiratory support. Mortality. Invasive mechanical ventilation. Clinical failure.

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