Outcome of infection with omicron SARS-CoV-2 variant in patients with hematological malignancies: An EPICOVIDEHA survey report

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F22%3A00076618" target="_blank" >RIV/65269705:_____/22:00076618 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216224:14110/22:00127656

Výsledek na webu

<a href="https://onlinelibrary.wiley.com/doi/epdf/10.1002/ajh.26626" target="_blank" >https://onlinelibrary.wiley.com/doi/epdf/10.1002/ajh.26626</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1002/ajh.26626" target="_blank" >10.1002/ajh.26626</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Outcome of infection with omicron SARS-CoV-2 variant in patients with hematological malignancies: An EPICOVIDEHA survey report

Popis výsledku v původním jazyce

To the Editor:Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has caused high mortality in patients with hematological malignancies (HM).1 The newly emerged omicron variants of SARS-CoV-2 harbor multiple novel spike protein mutations that raise concerns about vaccine efficiency and antiviral efficacy of the available therapeutic monoclonal antibodies.2 The first published clinical data in immunocompetent patients have found that infection with omicron variants is associated with reduced vaccine efficiency compared to the delta variants, but decreased hospital admission and mortality.3,4 Preliminary, prepublished, data from a large case-control study have shown that the vaccine effect against omicron in immunocompromised patients, including HM patients, is even more reduced, but data regarding clinical outcomes are lacking.5 The aim of this study was todescribe risk factors, antiviral treatment and outcomes of SARSCoV-2 omicron variant infection in 593 HM patients included in the EPICOVIDEHA registry. EPICOVIDEHA is an international open web-based registry for patients with HM infected with SARS-CoV-2.1,6 Both hospitalized andnonhospitalized patients are eligible for inclusion. The questionnaire includes data on the HM, SARS-CoV-2 vaccination status, risk factors for severe COVID-19 infection, SARS-CoV-2 virus variant, antiviral treatment, and outcomes including mortality (eFigure 1 and eTable 4). Classification of attributable, contributable, or nonattributable death is made by the reporting physician. All included cases are validated by experts with previous experience in research studies of hematological malignancies and infectious diseases at the University Hospital Cologne, Cologne, Germany.Critical infection was defined as admittance to an intermediate and/or intensive care unit. Independent predictors for mortality were assed via a Cox proportional hazard model. Risk factors for critical SARS-CoV-2 infection were determined with a logistic regression. Variables with a p-value LESS-THAN OR EQUAL TO.1 in the univariable models were considered for multivariable analysis. Multivariable regression models (both Cox and logistic) were calculated with the Wald backward method, and only those variables that were statistically significant displayed. Log-rank test was used to compare the survival probability of the patients included in the different models. A priori sample size calculation was not applied in this exploratory study. SPSSv25.0 was employed for statistical analyses (SPSS, IBM Corp.). In total 593 HM patients infected with omicron were included, whereof 309 patients were admitted to hospital and 284 patients stayed home (eTable 1). Hospitalized patients were older than nonhospitalized patients, had more comorbidities, and had a higher proportion of patients with neutropenia, lymphocytopenia, active hematological malignancy, and treatment with anti-CD20 antibodies (eTable 1). At least one dose of vaccine had been administered to 83.1% of all patients, with a nonsignificant difference between nonhospitalized and hospitalized patients, 86.3% compared to 80.3% (p = .157) (eTable 1, eTable 2). Overall mortality among hospitalized patients was 16.5% (51/309), of which 61% was classified as attributable to omicron, 35.3% contributable, and 3.9% unrelated. Factors associated with attributable and contributable mortality in hospitalized patients were older age (analyzed as continuous variable, hazard ratio (HR) 1.05 (95% confidence interval (CI) 1.02-1.07, p &lt; .001]) and active malignancy (HR 2.5 [95% CI 1.3-4.8, p = .007]) (Table 1). Having received at least one dose of SARS-CoV-2 vaccine was protective in univariable analysis (HR 0.53 [95% CI 0.29-0.96, p = .036]), but did not reach statistical significance in multivariable analysis (HR 0.58 [95% CI 0.32-1.05, p = .074]) (eFigure 2a, Table 1). Progression to critical infection occurred in 53 (17.0%) of hospitalized patients. Risk factor for progression to critical COVID-19 was pre-existent chronic pulmonary disease (odds ratio (OR) 3.2 [95% CI 1.4-7.3, p = .005]) (eTable 3). Baseline lymphocytes of GREATER-THAN OR EQUAL TO500 cells/ mm3 were protective (OR 0.4 [95% CI 0.18-0.90, p = .027]) while a lymphocyte count between 200 and 499 cells/mm3 was protective in uni- but not multivariable analysis (OR 0.44 [95% CI 0.16-1.20, p = .108]). Three doses of vaccine were protective (OR 0.29 [95% CI 0.13-0.64, p = .003]), but not two doses (OR 0.73 [95% CI 0.33- 1.66, p = .457] (eTable 3). Mortality among patients with critical infection was 39.2% (20/53). Administration of antibody-based antiviral treatment with sotrovimab or tixagevimab/cilgavimab was ssociatedwith a lower risk for mortality in critical infection (HR 0.13, [95% CI 0.02-0.61, p = .010]) (eFigure 2b, Table 1), while administration of other SARS-CoV-2 directed monoclonal antibodies was not (data not shown).

Název v anglickém jazyce

Outcome of infection with omicron SARS-CoV-2 variant in patients with hematological malignancies: An EPICOVIDEHA survey report

Popis výsledku anglicky

To the Editor:Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has caused high mortality in patients with hematological malignancies (HM).1 The newly emerged omicron variants of SARS-CoV-2 harbor multiple novel spike protein mutations that raise concerns about vaccine efficiency and antiviral efficacy of the available therapeutic monoclonal antibodies.2 The first published clinical data in immunocompetent patients have found that infection with omicron variants is associated with reduced vaccine efficiency compared to the delta variants, but decreased hospital admission and mortality.3,4 Preliminary, prepublished, data from a large case-control study have shown that the vaccine effect against omicron in immunocompromised patients, including HM patients, is even more reduced, but data regarding clinical outcomes are lacking.5 The aim of this study was todescribe risk factors, antiviral treatment and outcomes of SARSCoV-2 omicron variant infection in 593 HM patients included in the EPICOVIDEHA registry. EPICOVIDEHA is an international open web-based registry for patients with HM infected with SARS-CoV-2.1,6 Both hospitalized andnonhospitalized patients are eligible for inclusion. The questionnaire includes data on the HM, SARS-CoV-2 vaccination status, risk factors for severe COVID-19 infection, SARS-CoV-2 virus variant, antiviral treatment, and outcomes including mortality (eFigure 1 and eTable 4). Classification of attributable, contributable, or nonattributable death is made by the reporting physician. All included cases are validated by experts with previous experience in research studies of hematological malignancies and infectious diseases at the University Hospital Cologne, Cologne, Germany.Critical infection was defined as admittance to an intermediate and/or intensive care unit. Independent predictors for mortality were assed via a Cox proportional hazard model. Risk factors for critical SARS-CoV-2 infection were determined with a logistic regression. Variables with a p-value LESS-THAN OR EQUAL TO.1 in the univariable models were considered for multivariable analysis. Multivariable regression models (both Cox and logistic) were calculated with the Wald backward method, and only those variables that were statistically significant displayed. Log-rank test was used to compare the survival probability of the patients included in the different models. A priori sample size calculation was not applied in this exploratory study. SPSSv25.0 was employed for statistical analyses (SPSS, IBM Corp.). In total 593 HM patients infected with omicron were included, whereof 309 patients were admitted to hospital and 284 patients stayed home (eTable 1). Hospitalized patients were older than nonhospitalized patients, had more comorbidities, and had a higher proportion of patients with neutropenia, lymphocytopenia, active hematological malignancy, and treatment with anti-CD20 antibodies (eTable 1). At least one dose of vaccine had been administered to 83.1% of all patients, with a nonsignificant difference between nonhospitalized and hospitalized patients, 86.3% compared to 80.3% (p = .157) (eTable 1, eTable 2). Overall mortality among hospitalized patients was 16.5% (51/309), of which 61% was classified as attributable to omicron, 35.3% contributable, and 3.9% unrelated. Factors associated with attributable and contributable mortality in hospitalized patients were older age (analyzed as continuous variable, hazard ratio (HR) 1.05 (95% confidence interval (CI) 1.02-1.07, p &lt; .001]) and active malignancy (HR 2.5 [95% CI 1.3-4.8, p = .007]) (Table 1). Having received at least one dose of SARS-CoV-2 vaccine was protective in univariable analysis (HR 0.53 [95% CI 0.29-0.96, p = .036]), but did not reach statistical significance in multivariable analysis (HR 0.58 [95% CI 0.32-1.05, p = .074]) (eFigure 2a, Table 1). Progression to critical infection occurred in 53 (17.0%) of hospitalized patients. Risk factor for progression to critical COVID-19 was pre-existent chronic pulmonary disease (odds ratio (OR) 3.2 [95% CI 1.4-7.3, p = .005]) (eTable 3). Baseline lymphocytes of GREATER-THAN OR EQUAL TO500 cells/ mm3 were protective (OR 0.4 [95% CI 0.18-0.90, p = .027]) while a lymphocyte count between 200 and 499 cells/mm3 was protective in uni- but not multivariable analysis (OR 0.44 [95% CI 0.16-1.20, p = .108]). Three doses of vaccine were protective (OR 0.29 [95% CI 0.13-0.64, p = .003]), but not two doses (OR 0.73 [95% CI 0.33- 1.66, p = .457] (eTable 3). Mortality among patients with critical infection was 39.2% (20/53). Administration of antibody-based antiviral treatment with sotrovimab or tixagevimab/cilgavimab was ssociatedwith a lower risk for mortality in critical infection (HR 0.13, [95% CI 0.02-0.61, p = .010]) (eFigure 2b, Table 1), while administration of other SARS-CoV-2 directed monoclonal antibodies was not (data not shown).

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30205 - Hematology

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2022

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

American journal of hematology

ISSN

0361-8609

e-ISSN

1096-8652

Svazek periodika

97

Číslo periodika v rámci svazku

8

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

6

Strana od-do

"E312"-"E317"

Kód UT WoS článku

000816988100001

EID výsledku v databázi Scopus

2-s2.0-85132856048