Safety Data for Baricitinib Use in Children With Severe SARS-CoV-2 Infection.

Area of Science:

• Pediatric critical care medicine
• Infectious diseases
• Pharmacology

Background:

• The Food and Drug Administration authorized baricitinib (a Janus Kinase inhibitor) for severe COVID-19 in hospitalized children and adults.
• Limited safety data exists for baricitinib's pediatric use in severe COVID-19 cases.

Purpose of the Study:

• To evaluate the safety and clinical outcomes of baricitinib in pediatric patients with severe COVID-19.
• To identify adverse events and reasons for early discontinuation of baricitinib in this population.

Main Methods:

• A retrospective case series was conducted on 37 patients younger than 21 years treated with baricitinib for severe COVID-19 between 2021 and 2022.
• Data collected included patient characteristics, treatments, adverse events, discontinuation reasons, and hospitalization outcomes.

Main Results:

• Baricitinib was administered for a median of 6 days, with most patients receiving remdesivir and corticosteroids.
• Adverse events included elevated liver enzymes and thrombocytosis, all of which resolved. One patient experienced deep vein thrombosis.
• No deaths occurred. Median hospitalization was 7 days, with two patients discharged on supplemental oxygen.

Conclusions:

• Baricitinib demonstrates a favorable safety profile in children hospitalized with severe COVID-19.
• Early discontinuation of baricitinib was often due to laboratory abnormalities attributed to provider caution rather than severe adverse events.