Session Type: Poster Session A
Session Time: 8:30AM-10:30AM
Background/Purpose: Some patients with COVID-19 develop respiratory distress and cytokine storm syndrome (CSS) which is characterized by hyperinflammation and may progress to multi-organ failure. Anakinra is a recombinant interleukin-1 receptor antagonist used to treat some inflammatory disorders and has previously demonstrated mortality benefit in sepsis patients with CSS. Anakinra may play a role in certain patients with COVID-19 to reduce hyperinflammation and improve outcomes. The aim of this study was to assess the efficacy and safety of anakinra when added to standard of care in patients with COVID-19 infection and features of cytokine storm syndrome.
Methods: In this single center, randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov, NCT04362111), adult inpatients were recruited with molecular PCR RNA confirmed SARS-CoV-2 infection, radiographic evidence of COVID-19 pneumonia based on imaging, new or increasing oxygen requirement, ferritin ≥700 ng/ml, and any three of the following: D-dimer ≥500 ng/ml, platelet count < 130,000/mm3, white blood cell count < 3500/mm3 or lymphocyte count < 1000/mm3, AST or ALT >2X the upper limit of normal (ULN), LDH >2X the ULN, C-reactive protein >100 mg/L. Eligible patients were randomly assigned (1:1) to standard of care (SoC) plus anakinra (100 mg subcutaneous every 6 hours for 10 days) or SoC plus placebo. All received dexamethasone. Primary outcome was survival and discharge from the hospital without the need for intubation/mechanical ventilation at day 10. All analyses were done on a modified intention-to-treat basis.
Results: Between August 5, 2020 and January 2, 2021, 32 patients (235 screened) were recruited: 15 assigned to the anakinra group and 17 to placebo group. Two patients in the placebo group withdrew in the initial 48 hours and were excluded from analysis. Mean age was 63 (SD 10.3), 20 (66.7%) participants were men, and 20 (66.7%) were Caucasian. At day 10, 1 (6.7%) patient in the anakinra group had died and 2 (13.3%) patients in the placebo group had died (p=1.0). At hospital discharge, 4 (26.7%) patients in the anakinra group and 4 (26.7%) patients in the usual care group had died. Confirmed microbial infections occurred in 4 patients in the anakinra group and 2 in the placebo group (p=0.7).
Conclusion: Anakinra added to dexamethasone did not significantly impact outcomes in this study of patients with clinical laboratory features of early CSS and mild-to-moderate COVID-19 pneumonia. Additional studies are needed to assess the efficacy and optimal dosing duration of anakinra in patients with more severe COVID-19.
To cite this abstract in AMA style:Jackson L, Cron R, Khullar N, Chapleau C, Sun D, Chatham W. A Single Center, Double Blind, Randomized, Placebo-Controlled Trial of Anakinra in Adult Patients with Features of Cytokine Storm Syndrome in COVID-19 [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10). https://acrabstracts.org/abstract/a-single-center-double-blind-randomized-placebo-controlled-trial-of-anakinra-in-adult-patients-with-features-of-cytokine-storm-syndrome-in-covid-19/. Accessed May 16, 2022.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-single-center-double-blind-randomized-placebo-controlled-trial-of-anakinra-in-adult-patients-with-features-of-cytokine-storm-syndrome-in-covid-19/