Rheumatoid arthritis

Immunologists want tocilizumab for off-label use in COVID-19

Immunologists want IL-6 inhibitors such as tocilizumab (Actemra) to be made available for off-label use in treatment of severe COVID-19 disease.

While early clinical trials are still exploring the effects of the drug on severe inflammatory responses in COVID-19 disease, the Australasian Society for Clinical Immunology and Allergy (ASCIA) says its use should also be considered both in the prevention and treatment of acute respiratory distress syndrome (ARDS).

In a position statement on potential drug treatments for the inflammatory aspects of COVID-19 disease, ASCIA says there may be a role for tocilizumab based on its established role for the treatment of life-threatening cytokine release syndrome after CAR T-cell therapy, and also case series reports of success in managing patients with COVID-19.

“These data favour the use of IL-6 inhibitors, such as tocilizumab, as an intervention to prevent progression of COVID-19 pneumonia, which may prevent ICU admission and ventilation,” it says in a statement released on 20 April.

ASCIA says there is a rationale for IL-6 blockade to be beneficial in COVID-19 disease based on the possible contribution of cytokine storm syndrome to the increased mortality in COVID-19 related ARDS.

“Timing for administration of immunomodulatory therapies is likely to be critical to their potential effectiveness. Where tocilizumab is administered for COVID-19 related ARDS, it is recommended that treatment should be considered early in severe disease,” ASCIA says.

“ASCIA recommends that clinicians in all specialties involved in the care of COVID-19 patients consider the use of tocilizumab early in critically ill patients, in consultation with a clinical immunologist or other specialist with experience in use of immunomodulatory therapies for systemic inflammatory diseases.”

However the Society says it does not currently recommend the use of other anti-inflammatory agents such as corticosteroids or anakinra outside of clinical trials for COVID-19, and it actively recommends against the use of Intravenous Immunoglobulin G (IVIg)  therapy

The use of IL-6 inhibitors in COVID-19 has also been backed by other professional groups, such as the Society for Immunotherapy of Cancer (SITC).

In an article published in Journal for Immunotherapy in Cancer, representative of the Society noted that elevated interleukin-6 (IL-6) is a hallmark inflammatory signature seen in serum of patients with severe COVID-19 acute respiratory distress, and the ‘ground glass’ infiltrative appearance seen on CT scans from patients with COVID-19 with pneumonitis is reminiscent of imaging from patients with immune checkpoint inhibitor (ICI)-induced pneumonitis.

“Although randomised data definitively showing that IL-6 receptor blockade benefits patients with COVID-19-induced pneumonitis are currently lacking, we propose that an effort should be made to maximise the availability of anti-IL-6 agents, including tocilizumab and sarilumab for use on a compassionate basis to critically ill hospitalised SARS-CoV-2-infected patients during this extraordinary situation,” they write.

“Extraordinary times call for extraordinary measures, and SITC calls on all involved, including pharmaceutical sponsors, health authorities and IRBs, to continue to move swiftly and creatively to remove barriers and increase access to agents like anti-IL-6R drugs that may improve our care for COVID-19 pneumonitis.”

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