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A meta analysis on the utility of Anakinra in severe COVID-19 disease
Aliae A R Mohamed Hussein1, Reem Sayad2, Abdelrahman Abdelshafi2
1Pulmonology, Chest Department, Assiut Faculty of Medicine, Assiut, Egypt; Assiut Research Team (ART), Assiut 71515, Egypt.
Insights
Anakinra, an Interleukin-1 inhibitor, significantly reduced mortality and the need for invasive mechanical ventilation in severe COVID-19 patients. This cytokine storm treatment shows promise but requires cautious use, especially in immunocompromised individuals.
Area of Science:
- Immunology
- Infectious Diseases
- Critical Care Medicine
Background:
- COVID-19 presents with hyper-inflammatory conditions and cytokine storms driven by elevated pro-inflammatory mediators like IL-6 and TNF-α.
- Anakinra, an Interleukin-1 (IL-1) inhibitor, is explored as an adjuvant therapy for severe COVID-19 by targeting IL-1's role in the cytokine storm pathway.
Purpose of the Study:
- To systematically review and meta-analyze studies evaluating the safety and efficacy of Anakinra in COVID-19 patients.
- To assess Anakinra's impact on key clinical outcomes in severe COVID-19.
Main Methods:
- A comprehensive search of PubMed, Cochrane Library, Scopus, and Web of Science databases was conducted.
- Included randomized and non-randomized clinical trials, cohort studies, and case series involving COVID-19 patients treated with Anakinra.
- A meta-analysis was performed using Review Manager 5.4 on data from 23 studies with 3179 patients.
Main Results:
- Anakinra significantly reduced Intensive Care Unit (ICU) stays (MD = -0.65, p = 0.04) and the need for invasive mechanical ventilation (RR = 0.57, p = 0.004).
- A statistically significant reduction in mortality was observed (RR = 0.80, p = 0.04), along with a significant decrease in D-dimer levels.
- No significant differences were found in hospital stay duration, oxygen-free days, or the need for non-invasive mechanical ventilation.
Conclusions:
- Anakinra demonstrates significant benefits in reducing mortality and the requirement for invasive mechanical ventilation in severe COVID-19.
- The drug is considered safe at doses below 100 mg and may be more beneficial in severe cases than mild or moderate ones.
- Cautious use is advised, particularly in immunocompromised patients, despite promising results and observed D-dimer level reduction.
Background And Objective:
The most important presentation of COVID-19 is hyper inflammatory condition and cytokine storm that occurs due to excessive increase of the inflammatory mediators specially, pro-inflammatory interleukins such as IL-1β, IL-6 and tumor necrosis factor-α which have an important role in the cytokine storm pathway. Up till now there is not a definitive treatment for COVID-19 disease, but according to the pathophysiology of the disease, Anakinra (Interleukin- 1 inhibitor) is an adjuvant treatment option in patients with severe COVID-19 by blocking the effect of IL-1. So, we aimed to summarize the studies that evaluated the safety and efficacy of Anakinra in patients diagnosed with COVID-19.
Methods:
We performed a search in PubMed, Cochrane Library, Scopus, and Web of Science (WOS) databases from inception till 7 Jan 2022. Additionally, we searched randomized and non-randomized clinical trials, cohort, case series, case control, case report more than 3 patients which contain confirmed cases of COVID-19 who received Anakinra (Interleukin- 1 inhibitor) for the management of hyper-inflammatory condition associated with COVID-19 disease. A meta-analysis was conducted using review manager 5.4.
Results:
We included 44 articles in the systematic review. Ultimately, 23 studies were incorporated in the meta-analysis with a total number of 3179 patients. Our analysis showed statistically significant difference in the following outcomes: duration of ICU stays [MD = -0.65, 95% CI (-1.09, -0.03), p = 0.04], the number of patients who needed invasive mechanical ventilation [RR = 0.57, 95% CI (0.39, 0.84), p = 0.004], and number of deaths [RR = 0.80, 95% CI (0.66, 0.99), p = 0.04]. Our analysis showed no statistically significant difference in the following outcomes: length of hospital stays [MD = -0.16, 95% CI (-0.42, 0.11), p = 0.26], oxygen-free days [MD = -0.81, 95% CI (-3.81, 2.20), p = 0.60], and the number of patients who needed non-invasive mechanical ventilation [RR = 1.09, 95% CI (0.47, 2.52), p = 0.84].
Conclusion:
Anakinra showed some promising results in important outcomes related to COVID-19 as it significantly reduced the rate of mortality and the need of invasive mechanical ventilation. It should be used in severe cases more than mild and moderate cases to avoid possible immunosuppression complications. Anakinra use is safe in cases of COVID-19 at dose less than 100 mg. Another important outcome was significant reduction is the D-dimer level. Anakinra may be effective in the treatment of specific immunocompromised cases, but it should be used cautiously.
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