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

Abstract

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