WHO strongly recommends baricitinib plus corticosteroids for severe, critical COVID-19
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The WHO has issued a “strong recommendation” for baricitinib, in combination with corticosteroids, in the treatment of patients with severe or critical COVID-19.
The new recommendation comes as part of the seventh update to the WHO’s Guideline on Drugs for COVID-19. The update also includes a conditional recommendation against ruxolitinib (Opzelura, Incyte) and tofacitinib (Xeljanz, Pfizer) for patients with severe or critical COVID-19, and a conditional recommendation for the monoclonal antibody sotrovimab (VIR-7831, GlaxoSmithKline) in patients with non-severe COVID-19 who are at highest risk for hospitalization.
According to the WHO, which published its guidelines in The BMJ, baricitinib (Olumiant, Eli Lilly & Co.) should be used as an alternative to interleukin-6 inhibitors in patients with severe or critical COVID-19.
“The strong recommendation for baricitinib in those with severe or critical illness reflects moderate certainty evidence for benefits on mortality, duration of mechanical ventilation, and hospital length of stay, with no observed increase in adverse events leading to drug discontinuation,” Arnav Agarwal, BHSc, MD, of McMaster University, in Hamilton, Canada, and colleagues in the WHO Guideline Development Group, wrote. “Baricitinib and IL-6 receptor blockers have similar effects; when both are available, choose one based on issues including cost and clinician experience.”
The FDA in July authorized emergency use of baricitinib alone for the treatment of patients aged 2 years and older who are hospitalized with COVID-19. That authorization applies to infected patients who require supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation.
Meanwhile, the WHO experts advised against the use of two other JAK inhibitors — ruxolitinib and tofacitinib — for patients with severe or critical COVID-19 due to low certainty of evidence from small trials, which failed to demonstrate benefit.
According to the updated guidelines, the evidence suggests a possible increase in serious side effects with tofacitinib.
Lastly, the new guidelines include a conditional recommendation for the sotrovimab in patients with non-severe COVID-19, but only in those at highest risk for hospitalization, as data suggest “trivial benefits in those at lower risk,” according to Agarwal and colleagues.
“A conditional recommendation for the monoclonal antibody sotrovimab in patients with non-severe illness reflects substantial reduction in risk of hospitalization in those at higher risk, and trivial benefits in those at lower risk,” Agarwal and colleagues wrote. “There were insufficient data to recommend one monoclonal antibody treatment over another, and evidence on their efficacy for emerging variants is likely to influence future recommendations.”
The FDA in June issued an emergency use authorization for sotrovimab to treat mild-to-moderate COVID-19 in patients at risk for progressing to severe disease. The authorization is specifically targeted to adults and children aged 12 years and older who weigh at least 40 kg, or approximately 88 pounds. It is not intended for patients who are hospitalized or require oxygen due to COVID-19.
The WHO based its new recommendations on evidence from seven trials with more 4,000 participants with non-severe, severe and critical COVID-19.
They add to previous WHO recommendations for the use of IL-6 receptor blockers and systemic corticosteroids for patients with severe or critical COVID-19; conditional recommendations for the use of the monoclonal antibody cocktail casirivimab-imdevimab (Regeneron Pharmaceuticals) in selected patients; and against the use of convalescent plasma, ivermectin and hydroxychloroquine in patients with COVID-19 regardless of disease severity.
“They are part of a living guideline, developed by the [WHO] with the methodological support of MAGIC Evidence Ecosystem Foundation, to provide trustworthy guidance on the management of COVID-19 and help doctors make better decisions with their patients,” read a WHO press release. “Living guidelines are useful in fast moving research areas like COVID-19 because they allow researchers to update previously vetted and peer reviewed evidence summaries as new information becomes available.”
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WHO press release.
WHO guidelines: Agarwal A, et al. BMJ. 2020;doi:10.1136/bmj.m3379.
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