High dose subcutaneous Anakinra to treat acute respiratory distress syndrome secondary to cytokine storm syndrome among severely ill COVID-19 patients
Open accessAbstract
Objective Severely ill COVID-19 patients may end in acute respiratory distress syndrome (ARDS) and multi-organ failure. Some of them develop a systemic hyperinflammatory state produced by the massive release of inflammatory agents, known as cytokine storm syndrome (CSS). Inhibition of IL-1 by Anakinra (ANK) is a potential life-saving therapy for severe CSS cases. We propose a rationale for the use of subcutaneous ANK and review our initial experience in a small cohort of severe COVID-19 CSS patients.Methods Retrospective cohort study of COVID-19 patients developing ARDS (PaO2/FiO2 <300) and exhibiting signs of hyperinflammation (ferritin >1000 ng/mL and/or d-dimers > 1.5 μg/mL, plus IL-6 < 40 mg/mL) that received ANK. For comparison, a propensity score matched historical cohort of patients treated with IL-6 inhibitor Tocilizumab (TCZ) was used. Patients had previously received combinations of azithromycin, hydroxy-chloroquine, and methyl-prednisolone. Laboratory findings, respiratory function and adverse effects were monitored. Resolution of ARDS within the first 7 days of treatment was considered a favorable outcome.Results Subcutaneous ANK (100 mg every 6 h) was given to 9 COVID-19 ARDS CSS patients (77.8% males). Median age was 62 years (range, 42 to 87). A TCZ cohort of 18 patients was selected by propensity score matching and treated with intravenous single dose of 600 mg for patients weighing >75 Kg, or 400 mg if < 75 Kg. Prior to treatment, median PaO2/FiO2 ratio of the ANK and TCZ cohorts were 193 and 249, respectively (p = 0.131). After 7 days of treatment, PaO2/FiO2 ratio improved in both groups to 279 (104-335) and 331 (140-476, p = 0.099) respectively. On day 7, there was significant reduction of ferritin (p = 0.046), CRP (p = 0.043), and IL-6 (p = 0.043) levels in the ANK cohort but only of CRP (p = 0.001) in the TCZ group. Favorable outcome was achieved in 55.6% and 88.9% of the ANK and TCZ cohorts, respectively (p = 0.281). Two patients that failed to respond to TCZ improved after ANK treatment. Aminotransferase levels significantly increased between day 1 and day 7 (p = 0.004) in the TCZ group. Mortality was the same in both groups (11%). There were not any opportunistic infection in the groups nor other adverse effects attributable to treatment.Conclusion Overall, 55.6% of COVID-19 ARDS CSS patients treated with ANK exhibited favorable outcome, not inferior to a TCZ treated matched cohort. ANK may be a potential alternative to TCZ for patients with elevated aminotransferases, and may be useful in non-responders to TCZ.
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Smaller studies have reported that anakinra, which targets IL-1, may be beneficial.
“This might be similarly true for targeting IL-1 with anakinra for which several smaller studies were reporting beneficial effects (Iglesias-Julián et al., 2020; Kooistra et al., 2020)”
From COVID-19 and the human innate immune system (2021) · cites this paper as Iglesias-Julián et al., 2020
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- Authors
- Iglesias-Julián, E., López-Veloso, M., de-la-Torre-Ferrera, N., Barraza-Vengoechea, J. C., Delgado-López, P. D., Colazo-Burlato, M., Ubeira-Iglesias, M., Montero-Baladía, M., Lorenzo-Martín, A., Minguito-de-la-Iglesia, J., García-Muñoz, J. P., Sanllorente-Sebastián, R., Vicente-González, B., Alemán-Alemán, A., & Buzón-Martín, L.
- Affiliations
- Hospital Universitario de Burgos (ES)
- Venue
- Journal of Autoimmunity
- Publisher
- Elsevier BV
- Published
- 2020-12
- Volume
- 115
- Pages
- 102537
- ISSN
- 0896-8411 (ISSN-L)
- PMC
- PMC7439828
- OpenAlex
- W3060557737
- Cited by
- 62
- References
- 37
- Citations by year
- 2026: 3 · 2025: 2 · 2024: 2 · 2023: 13 · 2022: 11 · 2021: 28 · 2020: 1 · 2015: 2
- FWCI
- 1.74
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Autoimmunity (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Respiratory Support and Mechanisms
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Keywords
- anakinra, COVID-19 pandemic, acute respiratory distress syndrome, cytokine storm, interleukin-1 inhibition, tocilizumab, IL-6 inhibition, hyperinflammation, ferritin, D-dimer, PaO2/FiO2 ratio, multiple organ failure, treatment safety, adverse events, interleukin-1 receptor antagonist
- MeSH terms
- Cytokine Release Syndrome, SARS-CoV-2, Interleukin-6 Inhibitors, COVID-19 Drug Treatment, Adult, Aged, Aged, 80 and over, Female, Humans, Injections, Subcutaneous, Interleukin-1, Male, Middle Aged, Respiratory Distress Syndrome, Spain, Cohort Studies, Interleukin-6, Disease Progression, Antirheumatic Agents, Interleukin 1 Receptor Antagonist Protein, Antibodies, Monoclonal, Humanized
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