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Table 3 Safety

From: Comparison of treatment response, remission rate and drug adherence in polyarticular juvenile idiopathic arthritis patients treated with etanercept, adalimumab or tocilizumab

  ADA ETA TOC ETA vs ADA ADA vs TOC ETA vs TOC
Patients, n 236; 236.4 419 74    
Patient years, n 236.4 524,096 72,47364819    
Exposure, years mean ± SD 1.00 ± 0.86 1.25 ± 1.05 0.98 ± 0.60    
Adverse events, n; n/patient 386; 1.63 996; 2.37 102: 1.38 p = 0.011   p = 0.004
Rate/100 PY (95% CI) 163.3 (148.8; 180.4) 190.0 (178.6; 202.2) 140,7 (113.5; 167.4) RR 1.16 (1.03–1.31) ns RR 1.35 (1.1–1.66)
Serious adverse events, n; n/patient 26; 0.11 119; 0.28 3; 0.04 p = 0.0008   p = 0.004
Rate/100 PY (95% CI) 11.0 (7.5; 16.2) 22.07 (19.0; 27.2) 4.1 (1.3; 12.8) RR 2.06 (1.35–3.16) ns RR 5.48 (1.74–17.25)
Autoimmunopathy, n; n/patient 3; 0.012 2; 0.004 1; 0.014    
Rate/100 PY (95% CI) 1.27 (0.41; 3.39) 0.38 (0.09; 1.53) 1.38 (0.19; 9.59) ns ns ns
Bleeding disorder, n; n/patient 2; 0.008 3; 0.007 0    
Rate/100 PY (95% CI) 0.85 (0.21; 3.38) 0.57 (0.18; 1.17)   ns ns ns
CED, n; n/patient 1; 0.004 13; 0.031 0 p = 0.09   
Rate/100 PY (95% CI) 0.42 (0.06; 3.0) 2.48 (1.44; 4.27)   RR 5.86 (0.77–44.83) ns ns
Demyelinisation 0 1; 0.002 0    
Rate/100 PY (95% CI)   0.19 (0.03-1.35)   ns ns ns
Hepatitis 6; 0.025 10; 0.024 3; 0.041    
Rate/100 PY (95% CI) 2.54 (1.14; 5.65) 1.91 (1.03; 3.55) 4.14 (1.31; 12.57) ns ns ns
Hyperlipidemia 0 3; 0.007 1; 0.014    
Rate/100 PY (95% CI)   0.57 (0.18; 1.17) 1.38 (0.19; 9.59) ns ns ns
Infection. serious or medically important; n; n/patient 13; 0.055 50; 0.119 3; 0.041 p = 0.076   
Rate/100 PY (95% CI) 5.5 (3.19; 9.47) 9.54 (7.23; 12.59) 4.14 (1.31; 12.57) RR 1.73 (0.94–3.19) ns ns
Intolerance, n; n/patient 2; 0.008 3; 0.007 2; 0.027    
Rate/100 PY (95% CI) 0.85 (0.21; 3.38) 0.57 (0.18; 1.17) 2.76 (0.68; 10.81) ns ns ns
Malignancy, n; n/patient 0 1; 0.002 0    
Rate/100 PY (95% CI)   0.19 (0.03; 1.35)   ns ns ns
  1. ADA adalimumab, ETA etanercept, TOC tocilimuzab, PY person years, ns not significant, RR relative risk