The safety of canakinumab in systemic juvenile idiopathic arthritis and autoinflammatory diseases in pediatric patients: a multicenter study

Coşkuner T., Çağlayan Ş., Akgün Ö., TORUN R., Yayla E. N. S., Bagrul İ., ...More

Expert Opinion on Biological Therapy, 2023 (SCI-Expanded) identifier identifier

  • Publication Type: Article / Article
  • Publication Date: 2023
  • Doi Number: 10.1080/14712598.2023.2282133
  • Journal Name: Expert Opinion on Biological Therapy
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Keywords: autoinflammatory diseases, Canakinumab, safety, systemic juvenile idiopathic arthritis
  • Dokuz Eylül University Affiliated: Yes


Objective: To evaluate the safety of canakinumab using real-world data in patients with systemic juvenile idiopathic arthritis (sJIA) and autoinflammatory diseases (AID). Research design and methods: This was a cross-sectional observational, multicenter study. Patients diagnosed with AID and sJIA treated with canakinumab were included in the study. The participating 13 centers retrospectively collected their patients’ data. Results: A total of 335 patients were involved in the study. Among these patients, 280 were in the AID group and 55 were in the sJIA group. Canakinumab was administered at a median dose of 3 (2.5–4) mg/kg. The median total exposure time to canakinumab was 1.9 (0.8–3.2) years, corresponding to 759.5 patient-years. Seven hundred and seventy-nine total adverse events (AE) were identified. The total incidence of AE, and serious adverse events (SAE) throughout the study period was 1.02 per patient-years. The upper respiratory tract infection rate was 0.7 per patient-years, while the other infection rate was 0.13 per patient-years. While no death was observed in any patient, SAE were observed in 8 patients. Interstitial lung disease, anaphylaxis, or anaphylactoid reactions were not observed in any patient. Conclusions: Real-life data from a large cohort of patients suggests that canakinumab is as safe as claimed in clinical trials.