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

Hosp Pediatr. 2025 May 1;15(5):e203-e208. doi: 10.1542/hpeds.2024-008245.

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.

MeSH terms

  • Adolescent
  • Antiviral Agents / therapeutic use
  • Azetidines* / adverse effects
  • Azetidines* / therapeutic use
  • COVID-19 Drug Treatment*
  • COVID-19* / therapy
  • Child
  • Child, Preschool
  • Female
  • Humans
  • Infant
  • Janus Kinase Inhibitors* / adverse effects
  • Janus Kinase Inhibitors* / therapeutic use
  • Male
  • Purines* / adverse effects
  • Purines* / therapeutic use
  • Pyrazoles* / adverse effects
  • Pyrazoles* / therapeutic use
  • Retrospective Studies
  • SARS-CoV-2
  • Sulfonamides* / adverse effects
  • Sulfonamides* / therapeutic use
  • Young Adult

Substances

  • baricitinib
  • Purines
  • Pyrazoles
  • Azetidines
  • Sulfonamides
  • Antiviral Agents
  • Janus Kinase Inhibitors