Anakinra efficacy in COVID-19 pneumonia guided by soluble urokinase plasminogen activator receptor: Association with the inflammatory burden of the host.
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Kyriazopoulou Evdoxia, Akinosoglou Karolina, Florou Eleni, Kouriannidi Elli, Bogosian Artemis, Tsachouridou Olga, Syrigos Konstantinos N, Gatselis Nikolaos, Milionis Haralampos, Papanikolaou Ilias C, Sympardi Styliani, Dafni Maria, Alevizou Antonia, Amvrazi Alexia-Vasiliki, Alexandrou Errika, Archontoulis Kyprianos, Argyraki Katerina, Alexiou Zoi, Georgiou Yakinthi, Gkogka Dimitra, Kyrailidi Foteini, Kalyva Vassiliki, Nikolopoulou Triantafilli, Ioannou Sofia, Bakakos Petros, Karathanassiou Georgia, Koklanos Kyriakos, Miletis Dionysios-Nikolaos, Tili Anna-Maria, Vakkas Lampros, Vila Ioanna, Panagopoulos Periklis, Samarkos Michael, Chrysos George, Dalekos George N, Poulakou Garyphallia, Metallidis Symeon, Giamarellos-Bourboulis Evangelos J
Аннотация
METHODS: Patients with COVID-19 pneumonia and suPAR levels ≥ 6 ng/mL received subcutaneous anakinra 100 mg once daily for 10 days. The primary outcome was the incidence of SRF by day 14. Secondary outcomes were 30-day mortality, incidence of SRF according to time delay for start of treatment, safety, and associations with the inflammatory burden of the host.
RESULTS: From March 2020 to March 2022, a total of 992 patients were enrolled. The incidence of SRF was 18.8%, similar to the results of the phase III pivotal SAVE-MOREtrial. The overall 30-day mortality was 9.5%. Participants were divided into 4 subgroups according to time delay between symptoms onset and start of anakinra. The incidence of SRF was similar for all subgroups. Serious adverse events were reported in 15.4%; only 3 were possibly related to anakinra. The most common adverse event was increased liver function tests. A post hoc comparison with the pivotal phase III trial showed similar anakinra outcomes among patient subgroups by levels of inflammatory mediators and D-dimers.
CONCLUSIONS: Results support the efficacy of anakinra as being similar to that of the pivotal registrational trial for COVID-19 pneumonia. The lack of a comparator group is a limitation.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT04357366.