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Table 1 (abstract A8). Safety Summary

From: Proceedings of the 2019 Childhood Arthritis and Rheumatology Research Alliance (CARRA) Annual Scientific Meeting

  pJIA sJIA
TCZ SC Q3W
(<30 kg)
n = 24
TCZ SC Q2W
(≥30 kg)
n = 20
All
TCZ SC
N = 44
TCZ SC Q10D
or Q2W (<30 kg)
n = 19
TCZ SC QW
(≥30 kg)
n = 19
All
TCZ SC
N = 38
Duration in study, PY 52.3 48.8 101.1 23.4 44.0 67.3
AEs
 Pts, n (%) 24 (100) 20 (100) 44 (100) 17 (89.5) 17 (89.5) 34 (89.5)
 n 269 249 518 136 222 358
 rate/100 PY (95% CI) 514.0 (454.5, 579.3) 510.7 (449.2, 578.2) 512.4 (469.2, 558.5) 582.2 (488.5, 688.7) 504.8 (440.6, 575.7) 531.6 (478.0, 589.7)
SAEs
 Pts, n (%) 2 (8.3) 3 (15.0) 5 (11.4) 1 (5.3) 1 (5.3) 2 (5.3)
 n 2 4 6 1 1 2
 rate/100 PY (95% CI) 3.8 (0.5, 13.8) 8.2 (2.2, 21.0) 5.9 (2.2, 12.9) 4.3 (0.1, 23.9) 2.3 (0.1, 12.7) 3.0 (0.4, 10.7)
AEs leading to withdrawal
 Pts, n (%) 2 (8.3) 1 (5.0) 3 (6.8) 0 0 0
 n 2 1 3 0 0 0
 rate/100 PY (95% CI) 3.8 (0.5, 13.8) 2.1 (0.1, 11.4) 3.0 (0.6, 8.7)    
AEs leading to dose interruption
 Pts, n (%) 11 (45.8) 2 (10.0) 13 (29.5) 4 (21.1) 6 (31.6) 10 (26.3)
 n 21 3 24 7 14 21
 rate/100 PY (95% CI) 40.1 (24.8, 61.3) 6.2 (1.3, 18.0) 23.7 (15.2, 35.3) 30.0 (12.0, 61.7) 31.8 (17.4, 53.4) 31.2 (19.3, 47.7)
  1. AEs, adverse events; pJIA, polyarticular juvenile idiopathic arthritis; Pts, patients; PY, patient-years; Q2W, every 2 weeks; Q3W, every 3 weeks; Q10D, every 10 days; QW, weekly; SAEs, serious adverse events; SC, subcutaneous; sJIA, systemic juvenile idiopathic arthritis; TCZ, tocilizumab