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Table 4 Incidence of adverse events recorded in patients with juvenile idiopathic arthritis

From: Persistence and adverse events of biological treatment in adult patients with juvenile idiopathic arthritis: results from BIOBADASER

  By age p Value Total
< 16 years ≥16 years
Total adverse events 457.6 (414.1–505.7) 346.9 (325.4–369.8) < 0.001 373.2 (353.6–393.8)
Serious adverse events 35.7 (24.9–51.0) 43.2 (36.1–51.8) 0.347 41.4 (35.2–48.7)
Fatal adverse events 1.2 (0.2–8.4) 0.999 0.3 (0.0–2.0)
By system/organ class
 Infections and infestations 253.2 (221.4–289.6) 136.0 (122.8–150.6) < 0.001 163.8 (151–177.6)
 Gastrointestinal disorders 30.9 (21.0–45.4) 18.1 (13.7–24.0) 0.028 21.1 (16.9–26.5)
 Skin and subcutaneous tissue disorders 17.8 (10.7–29.6) 21.1 (16.2–27.3) 0.797 20.3 (16.1–25.6)
 General disorders and administration site conditions 21.4 (13.5–34.0) 20.0 (15.3–26.0) 0.566 20.3 (16.1–25.6)
 Eye disorders 23.8 (15.3–36.8) 13.3 (9.6–18.4) 0.037 15.8 (12.1–20.5)
 Musculoskeletal and connective tissue disorders 11.9 (6.4–22.1) 11.8 (8.4–16.7) 0.988 11.8 (8.7–16)
 Surgical and medical procedures 3.6 (1.2–11.1) 13.7 (9.9–18.9) 0.025 11.3 (8.3–15.4)
 Nervous system disorders 10.7 (5.6–20.6) 11.5 (8.1–16.3) 0.857 11.3 (8.3–15.4)
 Blood and lymphatic system disorders 10.7 (5.6–20.6) 8.9 (5.9–13.2) 0.631 9.3 (6.6–13.1)
 Renal and urinary disorders 3.6 (1.2–11.1) 11.1 (7.7–15.9) 0.061 9.3 (6.6–13.1)
 Reproductive system and breast disorders 4.8 (1.8–12.7) 9.6 (6.5–14.1) 0.190 8.5 (5.9–12.1)
 Injury, poisoning, and procedural complications 8.3 (4.0–17.5) 8.1 (5.4–12.3) 0.957 8.2 (5.7–11.8)
 Respiratory, thoracic, and mediastinal disorders 11.9 (6.4–22.1) 5.9 (3.6–9.6) 0.083 7.3 (5–10.8)
 Neoplasms: benign, malignant, and unspecified (including cysts and polyps) 3.6 (1.2–11.1) 5.9 (3.6–9.6) 0.422 5.4 (3.4–8.4)
 Hepatobiliary disorders 2.4 (0.6–9.5) 5.9 (3.6–9.6) 0.225 5.1 (3.2–8.1)
 Metabolism and nutrition disorders 1.2 (0.2–8.4) 5.9 (3.6–9.6) 0.120 4.8 (3–7.7)
 Pregnancy, puerperium, and perinatal conditions 0.0 5.5 (3.3–9.2) 0.997 4.2 (2.5–7)
 Vascular disorders 1.2 (0.2–8.4) 4.8 (2.8–8.3) 0.178 3.9 (2.3–6.7)
 Psychiatric disorders 5.9 (2.5–14.3) 3.3 (1.7–6.4) 0.298 3.9 (2.3–6.7)
 Ear and labyrinth disorders 2.4 (0.6–9.5) 3.0 (1.5–5.9) 0.783 2.8 (1.5–5.2)
 Immune system disorders 2.4 (0.6–9.5) 2.6 (1.2–5.4) 0.916 2.5 (1.3–4.9)
 Cardiac disorders 3.6 (1.2–11.1) 1.8 (0.8–4.4) 0.368 2.3 (1.1–4.5)
 Endocrine disorders 2.4 (0.6–9.5) 1.5 (0.6–3.9) 0.583 1.7 (0.8–3.8)
 Congenital, familial, and genetic disorders 0.0 1.8 (0.8–4.4) 0.403 1.4 (0.6–3.4)
  1. Data represent the incidence (95% CI) × 1000 patients/yr