Infectious Disease

WHO strongly recommends baricitinib plus corticosteroids for severe, critical COVID-19

January 13, 2022

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The WHO guideline development group does not report relevant financial disclosures. The relevant financial information of all other authors can be found in the study.

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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 is part of the seventh update of the WHO guidance on medicines 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 not severe COVID-19 with the highest risk of hospitalization.

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WHO has issued a “strong recommendation” for baricitinib in combination with corticosteroids in the treatment of patients with severe or critical COVID-19. Source: Adobe Stock.

According to the WHO, which published its guidance 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 patients with severe or critical illness reflects moderate-certainty evidence for benefits related to mortality, duration of mechanical ventilation, and length of hospital stay, with no observed increase in adverse events leading to drug discontinuation.” Arnav Agarwal, BHSc, MD, from McMaster University in Hamilton, Canada, and colleagues in the WHO Guideline Development Group. “Baricitinib and IL-6 receptor blockers have similar effects; If both are available, choose one based on aspects such as cost and the doctor’s experience.”

The FDA in July approved emergency use of baricitinib alone to treat patients ages 2 and older hospitalized with COVID-19. This approval applies to infected patients who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation.

Meanwhile, WHO experts advised against the use of two other JAK inhibitors – ruxolitinib and tofacitinib – for patients with severe or critical COVID-19 because of low-certainty evidence from small studies that failed to show benefit .

According to the updated guidelines, the evidence points to a possible increase in serious side effects with tofacitinib.

Finally, the new guidelines include a conditional recommendation for sotrovimab in patients with non-severe COVID-19, but only in patients at highest risk for hospitalization because the data suggest “trivial benefits in patients at lower risk,” according to Agarwal and colleagues.

“A conditional recommendation for the monoclonal antibody sotrovimab in patients with nonsevere disease reflects a significant reduction in risk of hospitalization in higher-risk patients and insignificant benefits in lower-risk patients,” Agarwal and colleagues wrote. “There were insufficient data to favor one monoclonal antibody treatment over another, and the evidence on their effectiveness in new variants is likely to inform future recommendations.”

The FDA in June granted emergency use authorization for sotrovimab to treat mild to moderate COVID-19 in patients who are at risk of progressing to severe disease. The permit is specifically for adults and children 12 years and older who weigh at least 40 kg or about 88 pounds. It is not intended for patients hospitalized or requiring oxygen due to COVID-19.

The WHO based its new recommendations on findings from seven studies involving more than 4,000 participants with non-severe, severe and critical COVID-19.

They complement previous WHO recommendations on the use of IL-6 receptor blockers and systemic corticosteroids in patients with severe or critical COVID-19; conditional recommendations for the use of the casirivimab-imdevimab monoclonal antibody cocktail (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 the MAGIC Evidence Ecosystem Foundation to provide trusted guidance for the management of COVID-19 and to help physicians make better decisions with their patients,” according to a WHO press release. “Living guidelines are useful in fast-paced research areas like COVID-19, as they allow researchers to update previously reviewed and peer-reviewed summaries of evidence as new information becomes available.”

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COVID-19 and Rheumatology

COVID-19 and Rheumatology

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