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The FDA has issued an injection for the treatment of COVID-19 in certain hospitalized adults.

These patients include those with pneumonia who require supplemental oxygen (low- or high-flow) and are at risk of progressing to severe respiratory failure and are likely to have an elevated plasma soluble urokinase plasminogen activator receptor.

Anakinra is an interleukin-1 (IL-1) receptor antagonist that is currently FDA approved for treatment of rheumatoid arthritis, cryopyrin-associated periodic syndromes, and deficiency of IL-1 receptor antagonist.

Results from the were used to support the efficacy and safety of anakinra in patients with COVID-19. That randomized, double-blind, placebo-controlled study involved 594 patients with COVID-19 pneumonia who were at risk of developing severe respiratory failure. At day 28, treatment with anakinra reduced the odds of having a worse score on the 11-point World Health Organization Clinical Progression Scale by 64% compared with placebo (OR 0.36, 95% CI 0.26-0.49, P<0.0001).

In addition, treatment with anakinra reduced the likelihood of severe disease or death at this time point by 54% versus placebo (OR 0.46, 95% CI 0.26-0.83, P=0.010), as well as the average time until hospital and intensive care unit discharge by 1 day and 4 days, respectively.

According to the EUA, the recommended dosage in adults with COVID-19 is 100 mg administered daily by subcutaneous injection for 10 days, while for COVID-19 patients who have severe renal insufficiency or end-stage renal disease (creatinine clearance <30 mL/min, estimated from serum creatinine levels) a dose of 100 mg administered every other day for five total doses over 10 days should be considered.

As for safety, anakinra has been associated with an increase of serious infections in patients with rheumatoid arthritis. The most common adverse reactions (incidence >1%) are increased transaminase levels, neutropenia, rash, and injection site reactions.

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