Adverse events of biological agents in pediatric rheumatologic diseases

Polat M. C., MERTEK S., ÖZÇAKAR Z. B., Çelikel E., AYDIN F., Tekin Z. E., ...Daha Fazla

Postgraduate Medicine, cilt.136, sa.2, ss.198-207, 2024 (SCI-Expanded) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 136 Sayı: 2
  • Basım Tarihi: 2024
  • Doi Numarası: 10.1080/00325481.2024.2325333
  • Dergi Adı: Postgraduate Medicine
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, CAB Abstracts, CINAHL, EBSCO Education Source, Educational research abstracts (ERA), International Pharmaceutical Abstracts, Veterinary Science Database
  • Sayfa Sayıları: ss.198-207
  • Anahtar Kelimeler: Adverse events, biological agents, optic neuritis, pediatric rheumatologic disease, tuberculosis
  • Ankara Üniversitesi Adresli: Evet

Özet

Objectives: To evaluate adverse events (AEs) in pediatric patients with rheumatologic diseases being treated with approved or off-label biologic agents (BAs). Methods: This observational, retrospective, multicenter study was conducted from 2010 to 2022 in patients under 18 years of age with rheumatic diseases who were receiving interleukin-1 antibodies (Anti-IL1), interleukin-6 antibodies (Anti-IL6), and tumor necrosis factor alpha inhibitors (anti-TNF). Efficacy, AEs, and timing of AEs were collected from electronic medical records. Results: Three hundred and fifteen BAs were prescribed to 237 patients. Fifty AEs occurred in 44 patients (18.6%). Anti-TNF exposure was present in 8 (72.2%) of 11 patients with latent tuberculosis (TB) and in all 7 patients with herpes infections. Four of 6 patients (66.7%) with recurrent upper respiratory tract infections and 7 of 8 patients (87.5%) with local skin reactions were on Anti-IL1. The cutoff value for latent TB development was determined as 23.5 months by ROC analysis (AUC: 0.684 ± 0.072, p = 0.038, 95% CI: 0.54–0.82). In patients who used BA for 23.5 months or more, the risk of latent TB was 5.94-fold (p = 0.024, 95% CI: 1.26–27.97). Drug rash with eosinophilia and systemic symptoms (DRESS) occurred in 2 patients on anakinra, and anaphylaxis occurred in 1 patient on anti-IL6. There were no cases of malignancy or death in any patient. Conclusion: The physician should be vigilant for latent TB in patients exposed to BA for more than 2 years. While local skin reactions are more prevalent in patients receiving anti-IL1, severe skin reactions such as DRESS may also occur.