Adalimumab: similar safety profile across pediatric indications

  • Horneff G & al.
  • J Pediatr
  • 25 Jul 2018

  • curated by Miriam Davis, PhD
  • Clinical Essentials
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Takeaway

  • The most common adverse events (AEs) associated with adalimumab use in children are upper respiratory tract infections, nasopharyngitis, and headache pooled across these indications: juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and pediatric enthesitis-related arthritis), psoriasis, and Crohn's disease.

Why this matters

  • Drug safety profile in pediatric patients, especially across indications, is rare.

Study design

  • Pooled analysis of safety data from 7 international, randomized, and open-label AbbVie-sponsored clinical trials (n=577) and their open-label extensions.
  • AEs occurring after the first dose and up to 70 days after the last dose were analyzed.
  • Funding: AbbVie.

Key results

  • The 577 patients had 1440.7 patient-years (PYs) of exposure.
  • The most commonly reported AEs across indications were upper respiratory tract infections (27% of all patients; 24.3 events/100 PYs), nasopharyngitis (24%; 17.3 events/100 PYs), and headache (24%; 19.9 events/100 PYs).
  • Serious infections were the most common serious AEs, occurring among 8% of all patients (4.0 events/100 PYs).
    • Pneumonia was the single most common serious infection (1%; 0.6 events/100 PYs).
  • Serious infection rates were 2.7 events/100 PYs in juvenile idiopathic arthritis, 0.8 events/100 PYs in psoriasis, and 6.6 events/100 PYs in Crohn's disease.
  • No new safety signals were found.
  • No malignancies were reported.

Limitations

  • More follow-up needed to assess malignancy risk.

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