Safety Data for Baricitinib Use in Children with Severe SARS-CoV-2 Infection
Elspeth Bittle, Sandra Arnold, Diego R Hijano, Melissa HinesAbstract
Background
In November 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for baricitinib, a JAK protein inhibitor, for hospitalized children and adults with COVID-19 requiring supplemental oxygen, but safety data for this indication in children is lacking.
Methods
This retrospective study describes patients <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.
Results
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 (ICU). 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 (one meeting EUA discontinuation criteria), 1 thrombocytosis)]. One patient had deep vein thrombosis without pulmonary embolism, 5 patients developed infection (4 bacterial, 1 fungal, 2 herpes simplex virus (HSV) reactivation). All adverse events 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.
Conclusions
Baricitinib appears safe in children hospitalized for severe COVID-19. Most early baricitinib discontinuation for abnormal lab studies was secondary to provider caution.