[ad_1]
The results of the study published in Open JAMA Network show no difference between anakinra and standard care compared to standard care alone in reducing the risk of mortality or the need for mechanical ventilation in patients hospitalized with severe COVID-19-related pneumonia and hyperinflammation.
Spanish researchers conducted a decentralized, open-label, randomized phase 2/3 study in 12 hospitals from May 2020 to March 2021. The study included adult patients hospitalized with severe pneumonia and hyperinflammation related to COVID-19. Patients were randomized 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 endpoint was the percentage of patients who did not require invasive or noninvasive mechanical ventilation 15 days after treatment initiation.
Among 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.
“
[A]Nakinra may play an early treatment role in patients with less severe disease and inflammation.
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%; relative risk, 0.90; CI at 95%, 0.77-1.04; P =.16). Adding anakinra to standard care resulted in no significant difference between groups in time to mechanical ventilation (relative risk, 1.72; 95% CI, 0.82-3.62; P =.14).
On day 28, the cumulative survival rate was 92.9% in patients in the anakinra group and 92.6% in those in the control group.
No significant difference was 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 frequent of which was respiratory failure.
Limitations include open-label study design and small sample size.
According to the researchers, “[A]nakinra may play a role as an early treatment for patients with less severe disease and inflammation.
The references:
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 Phase 2/3 Randomized Clinical Trial. JAMA Netw Open. 2023;6(4):e237243. doi:10.1001/jamanetworkopen.2023.7243
|
Sources 2/ https://www.infectiousdiseaseadvisor.com/home/topics/covid19/anakinra-added-to-standard-care-does-not-improve-outcomes-in-covid-19-pneumonia/ The mention sources can contact us to remove/changing this article |
[ad_2]