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Table 25 (Abstract P71). See text for description

From: Proceedings of the 24th Paediatric Rheumatology European Society Congress: Part one

Clinical Outcomes

Mean (95% CI)

Safety Summary (to m72)

N (EP100PY) unless otherwise stated

 

BL1(n = 127)

m241(n = 109)

m482(n = 64)

m722(n = 47)

 

eoJIAEXP = 245.607 PY

ERAEXP = 158.888 PY

PsAEXP = 119.945 PY

TotalEXP = 524.441 PY

PtGA

4.96 (4.6,5.4)

0.97 (0.7,1.2)

1.32 (0.9,1.8)

1.29 (0.9,1.7)

TEAEs*

244 (99.35)

151 (95.04)

90 (75.03)

485 (92.48)

PGA

5.02 (4.7,5.3)

n = 108 0.62 (0.5,0.8)

n = 63 0.67 (0.5,0.9)

0.76 (0.5,1.0)

TE infections

351 (142.91)

93 (58.53)

117 (97.54)

561 (106.97)

CRP, mg/L

8.26 (5.7,10.8)

n = 103 2.76 (1.7,3.8)

2.85 (1.6,4.1)

n = 46 1.58 (1.2,2.0)

TEAEs* causing withdrawal, n (%)

5 (2.04)

8 (5.03)

0

13 (2.48)

JADAS 73 joints

n = 119 17.16 (15.9,18.4)

n = 102 2.28 (1.7,2.9)

n = 61 2.48 (1.8,3.1)

n = 29 3.12 (2.2,4.1)

TE infections causing withdrawal, n (%)

2 (0.81)

0

1 (0.83)

3 (0.57)

No. active joints

6.74 (5.9,7.6)

0.61 (0.2,1.0)

n = 63 0.49 (0.3,0.7)

n = 30 0.60 (0.2,1.0)

Serious TEAEs

11 (4.48)

17 (10.70)

4 (3.33)

32 (6.10)

No. active joints (LOM)

5.72 (5.0,6.5)

1.06 (0.5,1.6)

n = 63 1.02 (0.6,1.4)

n = 30 1.10 (0.5,1.8)

Serious TE infections

5 (2.04)

4 (2.52)

4 (3.33)

13 (2.48)

Opportunistic infections†

0

1 (0.63)

1 (0.83)

2 (0.38)

  1. Data from patients taking ETN (full analysis set)
  2. 1CLIPPER study
  3. 2CLIPPER2 study
  4. *Excluding infections/ISR
  5. †All herpes zoster
  6. CRP, C-reactive protein; EXP, exposure to ETN; LOM, limitation of motion; PGA, physician’s global assessment; PtGA, patient/parent global assessment; PY, pt-yr