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

In November 2020, the Food and Drug Administration issued an Emergency Use Authorization for baricitinib, a Janus Kinase protein inhibitor, for hospitalized children and adults with COVID-19 requiring supplemental oxygen, but safety data for this pediatric indication is lacking.

This retrospective case series describes patients aged younger than 21 years treated with baricitinib for severe COVID-19 between 2021 and 2022. Patient characteristics, treatments, adverse events, reasons for early discontinuation of baricitinib, durations of oxygen supplementation and hospitalization, and complications were recorded.

There were 37 patients who received baricitinib. Median age was 16 years (range 1-20). All had a comorbidity (59% obesity, 5% malignancy), and 76% were cared for in the intensive care unit. All received remdesivir (median 5 days; range: 2-11), and 34 (92%) received corticosteroids (median 6 days; range: 1-10). Median duration of baricitinib was 6 days (range 3-14). Baricitinib was discontinued early for clinical improvement (2), and adverse events (7; 6 elevated liver enzymes [only 1 meeting discontinuation criteria), 1 thrombocytosis]). One patient had deep vein thrombosis without pulmonary embolism, 5 patients had concurrent infections (4 bacterial, 1 fungal, 2 herpes simplex virus reactivation). All adverse events were resolved. There were no deaths. Median hospitalization was 7 days (range 2-108) and mechanical ventilation was 4.5 days (range 1-86 days). Two patients (5%) were discharged with supplemental oxygen and one with a tracheostomy.

Baricitinib appears safe in children hospitalized for severe COVID-19. Most early baricitinib discontinuation for abnormal laboratory studies was secondary to provider caution.