JIA categories | Patients, n | Time point | JIA-ACR 30/50/70/90/100, % of patients | Exposure, PY | SAE, n | SAE/100PY |
---|---|---|---|---|---|---|
NCT00357903 (RCT with open-label wash-in, double-blind randomized treatment phase, and OLE) [13, 34,35,36] | ||||||
Multiple | ETN: 69 | 3Â months | 74/64/36/NR/NR | NR | NR | NR |
ETN: 69 | 1Â year | NR | 57 | 5 | 9.0 | |
ETN: 52 | 2Â years | 69/67/57/NR/NR | 50 | 8 | 16.0 | |
ETN: 48 | 3Â years | NR | 45 | 9 | 20.0 | |
ETN: 42 | 4Â years | NR | 40 | 5 | 13.0 | |
ETN: 37 | 5Â years | NR | 36 | 2 | 6.0 | |
ETN: 34 | 6Â years | NR | 33 | 0 | 0 | |
ETN: 31 | 7Â years | NR | 29 | 4 | 14.0 | |
ETN: 69 | LFU | 83/77/61/41/18 | 318 | 39 | 12.0 | |
PA onset | ETN: 30 | 24Â months OLE | 73/73/63/NR/NR | NR | NR | NR |
TREAT (Randomized treat-to-target concept trial with treatment switch from placebo to active if target not reached) [37] | ||||||
PA | ETN + MTX + pred: 42 | 16 weeks | NR/NR/71/NR/NR | NR | NR | NR |
PBO + MTX + PBO: 43 | 16 weeks | NR/NR/44/NR/NR | NR | NR | NR | |
ETN + MTX + pred: 30 | 24 weeks | NR/NR/40/NR/NR | NR | NR | NR | |
Multiple | ETN: 127 | 12Â weeks | 86/78/59/28/22 | NR | NR | NR |
 | 96 weeks | 84/84/79/55/46 | 215.1 | 16 | 7.4 | |
ExOA | ETN: 60 | 12Â weeks | 90/NR/NR/NR/NR | NR | NR | NR |
 | 96 weeks | 88/88/83/55/48 | 103.6 | 2 | 1.9 | |
ERA | ETN: 38 | 12Â weeks | 83/NR/NR/NR/NR | NR | NR | NR |
 | 96 weeks | 79/76/68/53/40 | 61.3 | 11 | 17.9 | |
CLIPPER2; NCT01421069 (Long-term OLE of CLIPPER) [44] | ||||||
Multiple | ETN: 109 | 6Â years | NR | 524.4 | 32* | 6.1* |
ExOA | ETN: 55 | 6Â years | NR | 245.6 | 11* | 4.5* |
ERA | ETN: 31 | 6Â years | NR | 158.9 | 17* | 10.7* |
REMINDER (24-week, open-label treatment phase following a 24-week withdrawal-design RCT) [41] | ||||||
ERA | ETN: 41 | 24Â weeks | 93/93/80/56/46 | 18.2 | 1 | 5.5 |
BeSt for Kids-study; NTR1574 (randomized, treat-to-target concept trial) [43] | ||||||
Multiple | MTX/SSZ: 32 | 3Â months | 50/31/25/NR/NR | NR | 2 | NR |
MTX + pred: 32 | 53/38/19/NR/NR | NR | 1 | NR | ||
ETN + MTX: 30 | 73/53/47/NR/NR | NR | 0 | NR | ||
EudraCT 2015–003,384–11 (RCT) [46] | ||||||
Multiple | ETN + MTX: 35 | 12 weeks | 94/NR/NR/NR/NR | NR | NR | NR |
PBO + MTX: 33 | 61/NR/NR/NR/NR | NR | NR | NR | ||
ETN + MTX: 35 | 48 weeks | NR | NR | NR | NR | |
 | PBO + MTX: 33 | NR | NR | 2 | NR |