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Baricitinib leads to small mortality reduction in COVID-19 according to RECOVERY trial

Baricitinib administered for 10 days to hospitalised COVID-19 patients reduces mortality by 13% compared with those receiving standard care

Giving baricitinib for 10 days to patients hospitalised with severe COVID-19 led to a 13% reduced risk of death compared with those in receipt of standard care. This was the main finding of the RECOVERY trial group at Oxford University, UK.

During the pandemic, several studies identified that a hyper-inflammatory response induced by the virus is a major cause of disease severity and death. Furthermore, data also indicates that glucocorticoids such as dexamethasone, can modulate this inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death.

Another factor which mediates inflammation in COVID-19 is interleukin-6, a cytokine produced by macrophages that induces a pro-inflammatory response and is often found to be elevated infected patients.

Baricitinib is a Janus Kinase (JAK) inhibitor and licensed for the treatment of both rheumatoid arthritis and atopic eczema. The Janus kinase/signal transduction and activator of transcription (JAK-STAT) signalling pathway has been implicated in the pathogenesis of inflammatory and autoimmune diseases.

Consequently, inhibition of this pathway with drugs such as baricitinib, represent a potentially useful therapeutic option for patients with COVID-19. In fact, there is already some evidence that while baricitinib does not reduce disease progression in COVID-19, it is associated with a mortality benefit.

For the current trial, which is available as a preprint, the RECOVERY team evaluated the effectiveness of baricitinib in a large number of patients, to further strengthen the evidence base for the drug. Patients were eligible for inclusion to the study if they had either confirmed or suspected COVID-19 and where their attending physician believed that inclusion did not pose a risk to the patient, e.g., because of their medical history.

Eligible patients were randomised 1:1 to either usual care plus baricitinib (10 mg daily for 10 days or until discharged if this was sooner) or usual care only. The primary outcome was 28-day all-cause mortality and secondary outcomes included time to discharge from hospital and a composite outcome of invasive mechanical ventilation or death among those not mechanically ventilated at the point of randomisation.

Baricitinib and mortality

A total of 8156 patients were included with 4148 (mean age 58.5 years, 66% male) randomised to baricitinib. Upon entry to the study, 95% of participants were receiving corticosteroids and 23% tocilizumab.

Among those allocated to baricitinib, the primary outcome occurred in 12% compared to 14% in the usual care group (adjusted rate ratio, RR = 0.87, 95% CI 0.77 – 0.98, p = 0.026). This reduction was similar (although non-significant) when adjusted for those with a confirmed positive PCR test (RR = 0.90, 95% CI 0.79 – 1.02).

In the baricitinib group, there was a lower risk of progression to the composite secondary outcome (RR = 0.90, 95% CI 0.81 – 0.99).

The authors concluded that their large randomised trial provided further and more robust evidence for the beneficial effects of baricitinib and support the use of the drug for patients hospitalised with COVID-19.

RECOVERY Collaborative Group. Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis. MedRxiv 2022