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expert reaction to study looking at the IL-1 receptor antagonist, anakinra, and outcomes in 22 patients with advanced-stage COVID-19-associated pneumonia

Research, published in PNAS, looked at the IL-1 receptor antagonist, anakinra, and outcomes in 22 patients with advanced-stage COVID-19-associated pneumonia.

 

Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:

“This drug is licensed in an injectable form in rheumatoid arthritis and is theoretically capable of reducing severe responses in Covid-19- preventing a cytokine storm.  It has been suggested as a treatment in the past but this study adds very little to knowledge.  It has only 12 patients treated with the drug intravenously and retrospectively compared with 10 patients who did not receive it.  It is not a randomised trial and the conclusions must be treated with great caution.

“The RECOVERY trial has demonstrated that the corticosteroid dexamethasone is effective in treating similar patients in the context of a properly randomised trial which is a dramatically cheaper drug and for which there is good evidence that it reduces mortality.  That trial compared over 2000 patients on dexamethasone with 4000 given standard treatment.  A study with only 12 patients treated and that is not randomised is a very poor standard for evidence of efficacy and saying that no adverse effects were seen is not real reassurance of safety.”

 

Prof A. V. Ramanan, Consultant Paediatric Rheumatologist, and Professor of Paediatric Rheumatology, University of Bristol, said:

“This is a small retrospective study.  The role of uncontrolled inflammation, the ‘cytokine storm’ is thought to play a key role in mortality of COVID-19.  This study suggests a role for an agent, anakinra which blocks the cytokine IL-1.  The fact it is a small study and retrospective in nature means we cannot draw any firm conclusions from this.  Large studies which address role of cytokine blockers like RECOVERY study are needed to address these questions conclusively.”

 

Prof Martin Landray, Professor of Medicine & Epidemiology, Nuffield Department of Population Health, University of Oxford, said:

“This is yet another small, retrospective study from which it is not possible to draw reliable conclusions about efficacy or safety.  We have seen many such studies over the past few months.  As with other re-purposed drugs, there are mechanistic reasons to think that anakinra might be effective in patients with more severe COVID.  However, hope and hypothesis are not enough – what is needed is robust evidence from sufficiently large randomized controlled trials.”

 

‘Early IL-1 receptor blockade in severe inflammatory respiratory failure complicating COVID-19’ by Raphaël Cauchois et al. was published in PNAS on Wednesday 22 July 2020.

DOI: 10.1073/pnas.2009017117

https://www.pnas.org/content/early/2020/07/21/2009017117

 

All our previous output on this subject can be seen at this weblink:

www.sciencemediacentre.org/tag/covid-19

 

Declared interests

Prof Stephen Evans: “No conflicts of interest.  I am funded (1 day/week) by LSHTM.  They get funding from various companies, including Astra Zeneca and GSK but I am not funded by them, I have no involvement in obtaining funding from them and I am not an investigator or any grants obtained from them.  I am the statistician to the “meta-Data Safety and Monitoring Board” for CEPI.  I will probably be paid for my attendance at meetings and expenses for travel.”

Prof A. V. Ramanan: “I have recieved Speaker fees/Honoraria from SOBI. I have also been involved in multiple studies of anakinra in rheumatic diseases and widely published on this.”

Prof Martin Landray: “Co-chief investigator of the RECOVERY trial of potential treatments for COVID-19 (funded by UKRI and NIHR).

Research funding to University of Oxford received from Novartis, Boehringer Ingelheim, and Merck Sharp & Dohme.

Infrastructure and core funding received from Health Data Research UK, NIHR Oxford Biomedical Research Centre, UK Biobank Ltd, MRC Population Health Research Unit, and British Heart Foundation Centre for Research Excellence.

Employee of University of Oxford with salary supported by Li Ka Shing Foundation, Health Data Research UK, NIHR Oxford Biomedical Research Centre, Wellcome Trust, and National Health Service.”

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