Treatment with anakinra reduces the need for invasive mechanical ventilation and mortality risk in hospitalized nonintubated patients with COVID-19, according to a meta-analysis published in Rheumatology.

Previous studies have suggested that interleukin (IL)-1 receptor antagonist anakinra, used for the treatment of autoinflammatory disorders, may improve hyperinflammatory symptoms in patients with COVID-19.

The objective of the current meta-analysis was to study the efficacy and safety of anakinra in hospitalized nonintubated patients with COVID-19.

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The analysis included 9 studies (n=1119), namely 6 retrospective studies, a prospective study, and an open-label Bayesian randomized clinical trial (CORIMUNO-ANA-1) nested with a cohort and an open label trial (SAVE) with propensity-matched comparators.

The majority of studies included patients with severe COVID-19, a high percentage of whom had comorbidities associated with increased mortality risk. Standard-of care-therapy included broad-spectrum antibiotics, azithromycin, and hydroxychloroquine; however, corticosteroid administration rates were high in 3 studies.

The primary outcomes were mortality and need for admission to the intensive care unit (ICU) with invasive mechanical ventilation. An increase in liver enzymes and bacteremia were the secondary outcomes of interest.

In pooled analyses, compared with standard-of-care therapy, treatment with anakinra reduced the need for invasive mechanical ventilation (odds ratio [OR], 0.38; 95% CI, 0.17-0.85, P =.02) and mortality risk (OR, 0.32; 95% CI, 0.23-0.45, P <.00001) in nonintubated patients with COVID-19.

There were no differences noted regarding the risk for adverse events; anakinra did not increase the risk for liver enzymes abnormalities (OR, 0.75; 95% CI, 0.48-1.16, P >.05) and bacteremia (OR, 1.07; 95% CI, 0.42-2.73, P >.05) in patients with severe COVID-19.

The study had several limitations, including those related to the design of the included studies, the sample size, and follow-up disparities, as well as the different dosage and route of anakinra administration.

“In the context of the current pandemic and the great shortage of ICUs beds, treatment with anakinra should be promptly tested by randomized placebo-controlled trials,” the researchers concluded.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures. 


Barkas F, Filippas Ntekouan S, Kosmidou M, Liberopoulos E, Liontos A, Milionis H. Anakinra in hospitalized non-intubated patients with coronavirus disease 2019: a systematic review and meta-analysis. Rheumatology (Oxford). Published online May 17, 2021. doi:10.1093/rheumatology/keab447