Study findings published in JAMA Network Open show no difference between anakinra plus standard care vs standard care alone for reducing the risk of mortality or the need for mechanical ventilation among patients hospitalized with severe COVID-19 pneumonia and hyperinflammation.
Researchers in Spain conducted a decentralized, open-label, randomized, phase 2/3 study at 12 hospitals from May 2020 to March 2021. The study included adult patients hospitalized with severe COVID-19 pneumonia and hyperinflammation. Patients were randomly assigned 1:1 to receive either anakinra plus standard care (n=92) or standard care alone (controls; n=87). Standard care included hydroxychloroquine, lopinavir-ritonavir, and azithromycin. The primary efficacy outcome was the percentage patients who did not require invasive or noninvasive mechanical ventilation at 15 days following treatment initiation.
Of patients in the anakinra (n=83) and control (n=78) groups included in the intention-to-treat analysis, the mean (SD) age was 60.5 (11.5) years, and 69.9% were men.
At day 15, there was no difference in the percentage of patients in the anakinra vs control groups who did not require mechanical ventilation (77.1% vs 85.9%; risk ratio, 0.90; 95% CI, 0.77-1.04; P =.16). The addition of anakinra to standard care resulted in no significant between-group difference in time to mechanical ventilation (hazard ratio, 1.72; 95% CI, 0.82-3.62; P =.14).
At day 28, the cumulative survival rate was 92.9% among patients in the anakinra group and 92.6% among those in the control group.
No significant differences were observed for the occurrence of at least 1 severe adverse event between patients in the anakinra group (17.2%) and those in the control group (23.6%), the most common of which was respiratory failure.
Limitations include the open-label study design and the small sample size.
According to the researchers, “[A]nakinra may have a role as an early treatment for patients with less-severe disease and inflammation.”
Fanlo P, del Carmelo Gracia-Tello B, Aizpuru EF, et al; on behalf of the GEAS-SEMI group. Efficacy and safety of anakinra plus standard of care for patients with severe COVID-19: a randomized phase 2/3 clinical trial. JAMA Netw Open. 2023;6(4):e237243. doi:10.1001/jamanetworkopen.2023.7243