Cell reports. Medicine · 2022
Toward personalized immunotherapy in sepsis: The PROVIDE randomized clinical trial.
Рандомизированное исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Leventogiannis Konstantinos, Kyriazopoulou Evdoxia, Antonakos Nikolaos, Kotsaki Antigone, Tsangaris Iraklis, Markopoulou Dimitra, Grondman Inge, Rovina Nikoleta, Theodorou Vassiliki, Antoniadou Eleni, Koutsodimitropoulos Ioannis, Dalekos George, Vlachogianni Glykeria, Akinosoglou Karolina, Koulouras Vassileios, Komnos Apostolos, Kontopoulou Theano, Prekates Athanassios, Koutsoukou Antonia, van der Meer Jos W M, Dimopoulos George, Kyprianou Miltiades, Netea Mihai G, Giamarellos-Bourboulis Evangelos J
Аннотация
The state of immune activation may guide targeted immunotherapy in sepsis. In a double-blind, double-dummy randomized clinical study, 240 patients with sepsis due to lung infection, bacteremia, or acute cholangitis were subjected to measurements of serum ferritin and HLA-DR/CD14. Patients with macrophage activation-like syndrome (MALS) or immunoparalysis were randomized to treatment with anakinra or recombinant interferon-gamma or placebo. Twenty-eight-day mortality was the primary endpoint; sepsis immune classification was the secondary endpoint. Using ferritin >4,420 ng/mL and <5,000 HLA-DR receptors/monocytes as biomarkers, patients were classified into MALS (20.0%), immunoparalysis (42.9%), and intermediate (37.1%). Mortality was 79.1%, 66.9%, and 41.6%, respectively. Survival after 7 days with SOFA score decrease was achieved in 42.9% of patients of the immunotherapy arm and 10.0% of the placebo arm (p = 0.042). Three independent immune classification strata are recognized in sepsis. MALS and immunoparalysis are proposed as stratification for personalized adjuvant immunotherapy. Clinicaltrials.gov registration NCT03332225.