Table 2.
Biomarker | Fostamatinib (N = 11) vs. placebo (N = 10) at 6 weeks | Fostamatinib (N = 11) vs. adalimumab (N = 10) at 6 weeks | Fostamatinib (N = 6) vs. adalimumab (N = 5) at 24 weeks | |||
---|---|---|---|---|---|---|
Treatment ratio* (tr) or difference (td) (90% CI) | Two-sided p-value | Treatment ratio* (tr) or difference (td) (90% CI) | Two-sided p-value | Treatment ratio* (tr) or difference (td) (90% CI) | Two-sided p-value | |
K trans | tr = 0.95 (0.68–1.33) | 0.794 | tr = 1.92 (1.36–2.72) | 0.003 | tr = 1.59 (0.95–2.68) | 0.137 |
IRE | tr = 0.86 (0.62–1.18) | 0.417 | tr = 1.55 (1.12–2.15) | 0.031 | tr = 1.60 (1.06–2.42) | 0.064 |
IAUC 60 | tr = 0.91 (0.66–1.24) | 0.603 | tr = 1.67 (1.21–2.30) | 0.012 | tr = 1.57 (0.97–2.54) | 0.120 |
IAUC 120 | tr = 0.88 (0.65–1.19) | 0.478 | tr = 1.67 (1.22–2.28) | 0.010 | tr = 1.60 (0.98–2.61) | 0.116 |
VEP | tr = 0.85 (0.66–1.08) | 0.130 | tr = 0.77 (0.60–1.00) | 0.053 | tr = 1.23 (0.62–2.11) | 0.508 |
ME | tr = 0.95 (0.70–1.28) | 0.756 | tr = 1.64 (1.20–2.25) | 0.012 | tr = 1.57 (1.05–2.36) | 0.070 |
v e | n/a | n/a | n/a | n/a | n/a | n/a |
v p | tr = 0.90 (0.60–1.29) | 0.610 | tr = 1.75 (1.21–2.54) | 0.016 | tr = 1.75 (1.21–2.54) | 0.065 |
RAMRIS synovitis score | td = -2.00 (-3.25–-0.75) | 0.023 | td = -1.50 (-2.50–0.00) | 0.175 | td = 2.00 (-0.50–5.00) | 0.230 |
DAS-28 CRP | td = 0.65 (-0.11–1.41) | 0.155 | td = -0.13 (-0.89–0.64) | 0.780 | td = -1.48 (-3.43–0.47) | 0.200 |
Based on the response at 6 weeks in the adalimumab group, the standardised response mean for K trans was -0.64
DAS-28 CRP Disease Activity Score 28 based on C-reactive protein
*tr is used for VEP and the DCE-MRI endpoints as they are log-normally distributed but td for the RAMRIS synovitis score and DAS-28 CRP which are not:
tr <1 or td < 0 indicate an effect in favour of fostamatinib