The efficacy of anakinra compared to standard care of treatment for COVID-19: a metaanalysis

MALIK, HAMNA; JABBAR, HIRA BINT ABDUL; LATIF, FARAH; SARFRAZ, AZZA; SARFRAZ, ZOUINA; SARFRAZ, MUZNA

doi:10.55730/1300-0144.5345

Cited by 3 publications

(4 citation statements)

References 17 publications

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“…Poprzez konkurencyjne hamowanie wiązania cytokin z antagonistami receptora interleukiny, anakinra ma potencjał, by kontrolować aktywny stan zapalny i przerwać pętlę autozapalną [30,39]. Dostępne dowody wskazują, że leczenie takie zmniejsza zarówno potrzebę inwazyjnej wentylacji mechanicznej, jak i ryzyko zgonu hospitalizowanych niezaintubowanych pacjentów z COVID-19 bez zwiększania ryzyka zdarzeń niepożądanych [35,36]. W innych próbach, biorących pod uwagę 1297 oraz 2032 badanych, zauważono, że średnie wartości ferrytyny jako parametru zapalnego w surowicy oraz D-dimery uległy obniżeniu.…”

Section: Rola Interleukinyunclassified

Is immunosuppressive therapy an effective treatment for COVID-19? – literature review

Ostrowska

Kacper

Justyna

et al. 2023

J Educ Health Sport

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Introduction: The disease caused by SARS-CoV-2 is associated with a dysregulated immune response and a generalized inflammatory response. Therefore, during the search for effective therapy, attention was paid to drugs affecting and stabilizing such a response - tocilizumab, sarilumab, siltuximab, anakinra, baricitinib.Purpose of the work: Evaluation of the impact of immunosuppressant therapy on the course of the disease caused by the SARS-CoV-2 virus.Material and methods: The work was based on a review of available medical publications about immunosuppressive therapy for COVID-19 treatment. The literature in the PubMed and Google Scholar databases was searched based on the following keywords: tocilizumab, sarilumab, siltuximab, baricitinib, COVID-19, SARS-CoV-2, immunosuppressive therapy.Conclusion: Based on the analysis of the literature, the most effective therapeutic option seems to be tocilizumab. Promising alternatives may be sarilumab and siltuximab as they have the same target point of action. However, it is necessary to conduct further tests on their operation. The use of baricitinib may be useful, but probably only in certain circumstances. Anakinra proved to be much less effective. It should therefore be used with great caution.

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Section: Rola Interleukinyunclassified

Is immunosuppressive therapy an effective treatment for COVID-19? – literature review

Ostrowska

Kacper

Justyna

et al. 2023

J Educ Health Sport

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“…However, such observational findings required extensive assessments in well-conducted randomized clinical trials to verify the reported outcomes ( Cavalli et al, 2020 ; Langer-Gould et al, 2020 ). Later, few small randomized trials and meta-analyses were conducted to assess the benefit of anakinra in COVID-19 patients with inconclusive outcomes ( Balkhair et al, 2021 ; Barkas et al, 2021 ; Declercq et al, 2021 ; Audemard-Verger et al, 2022 ; Kharazmi et al, 2022 ; Malık et al, 2022 ; Naveed et al, 2022 ). As in selected patients with severe COVID-19 pneumonia, anakinra has demonstrated beneficial outcomes, while it did not show a significant benefit in other patient groups ( Balkhair et al, 2021 ; Barkas et al, 2021 ; Declercq et al, 2021 ; Audemard-Verger et al, 2022 ; Kharazmi et al, 2022 ; Malık et al, 2022 ; Naveed et al, 2022 ).…”

Section: Introductionmentioning

confidence: 99%

“…Later, few small randomized trials and meta-analyses were conducted to assess the benefit of anakinra in COVID-19 patients with inconclusive outcomes ( Balkhair et al, 2021 ; Barkas et al, 2021 ; Declercq et al, 2021 ; Audemard-Verger et al, 2022 ; Kharazmi et al, 2022 ; Malık et al, 2022 ; Naveed et al, 2022 ). As in selected patients with severe COVID-19 pneumonia, anakinra has demonstrated beneficial outcomes, while it did not show a significant benefit in other patient groups ( Balkhair et al, 2021 ; Barkas et al, 2021 ; Declercq et al, 2021 ; Audemard-Verger et al, 2022 ; Kharazmi et al, 2022 ; Malık et al, 2022 ; Naveed et al, 2022 ). The presented open-label randomized clinical trial aimed to explore the safety and efficacy of anakinra in addition to standard of care (SOC) compared to SOC alone in patients with confirmed COVID-19 infection with respiratory distress and evidence of cytokine release syndrome.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of anakinra in the management of patients with COVID-19 infection: A randomized clinical trial

Elmekaty

Maklad²,

Abouelhassan³

et al. 2023

Front. Microbiol.

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BackgroundThe global COVID-19 pandemic led to substantial clinical and economic outcomes with catastrophic consequences. While the majority of cases has mild to moderate disease, minority of patients progress into severe disease secondary to the stimulation of the immune response. The hyperinflammatory state contributes towards progression into multi-organ failure which necessitates suppressive therapy with variable outcomes. This study aims to explore the safety and efficacy of anakinra in COVID-19 patients with severe disease leading to cytokine release syndromes.MethodsIn this open-label, multi-center, randomized clinical trial, patients with confirmed COVID-19 infection with evidence of respiratory distress and signs of cytokine release syndrome were randomized in 1:1 ratio to receive either standard of care (SOC) or anakinra (100 mg subcutaneously every 12 h for 3 days then 100 mg subcutaneously once daily for 4 days) in addition to SOC. The primary outcome was treatment success at day 14 as defined by the WHO clinical progression score of ≤3. Primary analysis was based upon intention-to-treat population, with value of p of <0.05.ResultsOut 327 patients screened for eligibility, 80 patients were recruited for the study. The mean age was 49.9 years (SD = 11.7), with male predominance at 82.5% (n = 66). The primary outcome was not statistically different (87.5% (n = 35) in anakinra group vs. 92.5% (n = 37) in SOC group, p = 0.712; OR = 1.762 (95%CI: 0.39–7.93). The majority of reported adverse events were mild in severity and not related to the study treatment. Elevated aspartate aminotransferase was the only significant adverse event which was not associated with discontinuation of therapy.ConclusionIn patients with severe COVID-19 infection, the addition of anakinra to SOC treatment was safe but was not associated with significant improvement according to the WHO clinical progression scale. Further studies are warranted to explore patients’ subgroups characteristics that might benefit from administered therapy.Clinical Trial RegistrationTrial registration at ClinicalTrials.gov, identifier: NCT04643678.

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“…The first reported randomized control trial was terminated early for concerns that anakinra was not improving outcomes in patients with mild-to-moderate COVID-19 pneumonia [ 21 ]. Two meta-analyses suggested a COVID-19 survival benefit of anakinra, also among those patients with signs of hyperinflammation [ 22 ] and in the absence of glucocorticoid co-administration [ 22 , 23 ].…”

Section: Introductionmentioning

confidence: 99%

Prediction of Survival by IL-6 in a Randomized Placebo-Controlled Trial of Anakinra in COVID-19 Cytokine Storm

Jackson,

Khullar,

Beukelman

et al. 2023

Viruses

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(1) Background: Some severe COVID-19 patients develop hyperinflammatory cytokine storm syndrome (CSS). We assessed the efficacy of anakinra added to standard of care (SoC) in hospitalized COVID-19 CSS patients. (2) Methods: In this single-center, randomized, double-blind, placebo-controlled trial (NCT04362111), we recruited adult hospitalized patients with SARS-CoV-2 infection, evidence of pneumonia, new/increasing oxygen requirement, ferritin ≥ 700 ng/mL, and at least three of the following indicators: D-dimer ≥ 500 ng/mL, platelet count < 130,000/mm3, WBC < 3500/mm3 or lymphocyte count < 1000/mm3, AST or ALT > 2X the upper limit of normal (ULN), LDH > 2X ULN, C-reactive protein > 100 mg/L. Patients were randomized (1:1) to SoC plus anakinra (100 mg subcutaneously every 6 h for 10 days) or placebo. All received dexamethasone. The primary outcome was survival and hospital discharge without need for intubation/mechanical ventilation. The data were analyzed according to the modified intention-to-treat approach. (3) Results: Between August 2020 and January 2021, 32 patients were recruited, of which 15 were assigned to the anakinra group, and 17 to the placebo group. Two patients receiving the placebo withdrew within 48 h and were excluded. The mean age was 63 years (SD 10.3), 20 (67%) patients were men, and 20 (67%) were White. At Day 10, one (7%) patient receiving anakinra and two (13%) patients receiving the placebo had died (p = 1.0). At hospital discharge, four (27%) patients receiving anakinra and four (27%) patients receiving the placebo had died. The IL-6 level at enrollment was predictive of death (p < 0.01); anakinra use was associated with decreases in CXCL9 levels. (4) Conclusions: Anakinra added to dexamethasone did not significantly impact the survival of COVID-19 pneumonia patients with CSS. Additional studies are needed to assess patient selection and the efficacy, timing, and duration of anakinra treatment for COVID-19 CSS.

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The efficacy of anakinra compared to standard care of treatment for COVID-19: a metaanalysis

Cited by 3 publications

References 17 publications

Is immunosuppressive therapy an effective treatment for COVID-19? – literature review

Is immunosuppressive therapy an effective treatment for COVID-19? – literature review

Evaluation of anakinra in the management of patients with COVID-19 infection: A randomized clinical trial

Prediction of Survival by IL-6 in a Randomized Placebo-Controlled Trial of Anakinra in COVID-19 Cytokine Storm

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