Dexamethasone Treatment for COVID-19 is Related with Increased Mortality in Haematological Malignancy Patients: Results from the EPICOVIDEHA Registry

Background: COVID-19 treatment strategies for haematological malignancy patients are adapted from immunocompetent population, without solid evidence. We aimed to describe the efficacy of dexamethasone in a large cohort of this population. Methods: Retrospective cohort study from the multicentre EPICOVIDEHA registry on COVID-19 haematological malignancy patients, diagnosed between May 2021 and January 2023. Patients receiving only dexamethasone were compared to those receiving dexamethasone plus antiviral strategies and those receiving only antiviral strategies. A Cox regression was modelled to detect factors associated with mortality. Findings: 500 COVID-19 patients with haematological malignancies treated with dexamethasone only were compared to 470 receiving dexamethasone plus antiviral strategies and to 1297 treated with only antiviral strategies. Day-90 mortality rate was 21% (n=464). Mortality rate in the dexamethasone only group was 28% (n=138), 18% (n=86) in the dexamethasone plus antiviral strategies and 4·2% (n=55) in the antiviral only strategy group. Similar findings were observed in Omicron-infected individuals. Cox regression analysis revealed that the use of dexamethasone is linked to higher mortality (adjusted hazard ratio (aHR) 0·562, 95% confidence interval (CI) 0·418-0·754 in the antiviral only strategy group; aHR 0·284, 95% CI 0·191-0·422 in the dexamethasone plus antiviral strategies group when compared to the dexamethasone only group). Interpretation: Dexamethasone treatment for SARS-COV-2 infection is related to increased mortality in haematological malignancy patients, even during the omicron wave with most patients being fully vaccinated.Trial Registration: EPICOVIDEHA (clinicaltrials.gov, NCT04733729).Funding: This study has been co-funded by the European Regional Development Fund (EDRD). CG-V [FIS PI21/01640] have received research grants from the Ministerio de Sanidad y Consumo, Instituto de Salud Carlos III. No funding bodies had any role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. This work was co-funded by a research grant (SGR 01324 Q5856414G) from the AGAUR (Agencia de Gestión de Ayudas Universitarias y de Investigación) of Catalunya.Declaration of Interest: Declaration of conflicts of interest: CGV has received honoraria for talks on behalf of Gilead Science, MSD, Novartis, Pfizer, Jannsen, GSK, and Lilly, as well as a grant from Gilead Science, Pfizer, and GSK.Ethical Approval: The corresponding local ethics committee of each participating institution has approved the EPICOVIDEHA study when applicable. The local Institutional Review Board and Ethics Committee of the Fondazione Policlinico Universitario Agostino Gemelli—IRCCS, Università Cattolica del Sacro Cuore of Rome, Italy, approved the multicentre, non-interventional EPICOVIDEHA study (Study ID: 3226).