FDA Authorizes Emergency Use of Kineret for Certain Hospitalized COVID-19 Patients

The most common adverse reactions reported with anakinra were increased transaminases, neutropenia, rash, and injection site reactions.

The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Kineret (anakinra) for the treatment of COVID-19 in hospitalized patients with positive results of direct SARS-CoV-2 viral testing with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR).

Anakinra is an interleukin-1 (IL-1) receptor antagonist. IL-1 is involved in inflammatory diseases and has been linked to acute severe lung inflammation in COVID-19. The emergency authorization was supported by data from the phase 3 SAVE-MORE trial (ClinicalTrials.gov Identifier: NCT04680949), which evaluated the efficacy and safety of anakinra in adults with COVID-19 pneumonia who were at risk of developing severe respiratory failure. All enrolled patients were required to have a plasma suPAR level of at least 6ng/mL.

Patients were randomly assigned 2:1 to receive either anakinra 100mg subcutaneously once daily (n=405) or placebo (n=189) for 10 days, in addition to standard of care. The primary endpoint of the study was a comparison of the 2 treatment arms at day 28 using the 11-point WHO Clinical Progression ordinal Scale.

Results showed that treatment with anakinra was associated with lower odds of more severe disease at day 28 compared with placebo (odds ratio, 0.37; 95% CI, 0.26-0.50). There were 13 deaths (3.2%) in the anakinra arm and 13 deaths (6.9%) in the placebo arm (hazard ratio [HR], 0.48 [95% CI, 0.22-1.04]; risk difference, -3.7% [95% CI, -7.7, 0.3]). 

By day 28, there were 86 patients (21.2%) in the anakinra arm and 62 patients (32.8%) in the placebo arm who developed severe respiratory failure (HR, 0.66 [95% CI, 0.48-0.92]; risk difference, -11.6% [95% CI, -19.4, -3.8]).

By day 60, there were 21 deaths (5.3%) in the anakinra arm and 18 deaths (9.7%) in the placebo arm (HR, 0.56 [95% CI, 0.30-1.04]; risk difference, -4.4% [95% CI, -9.2, 0.4]).

The most common adverse reactions reported with anakinra were increased transaminases, neutropenia, rash, and injection site reactions.

For the treatment of adults with COVID-19, the recommended dose of Kineret is 100mg administered daily by subcutaneous injection for 10 days. Dosage adjustment should be considered in patients with severe renal insufficiency or end-stage renal disease.

Kineret is supplied in a single-use prefilled syringe.

This article originally appeared on MPR

References:

Fact Sheet for Healthcare Providers: Emergency Use Authorization for Kineret. Swedish Orphan Biovitrum AB. Accessed November 9, 2022. https://www.fda.gov/media/163075/download