Biomarker Timepoint | Biomarker | Efficacy Measure | Placebo + MTX | Combined Golimumab ± MTX | ||||
---|---|---|---|---|---|---|---|---|
N | R | p | N | R | p | |||
Change at Week 28 in: | ||||||||
Baseline | α-2 macroglobulin | Erosion score | 23 | 0.480 | 0.021 | 71 | −0.057 | 0.635 |
BAP | JSN score | 36 | 0.447 | 0.006 | 109 | −0.016 | 0.870 | |
Haptoglobin | JSN score | 23 | 0.486 | 0.019 | 70 | −0.014 | 0.907 | |
IL-1ra | Erosion score | 23 | −0.311 | 0.149 | 69 | 0.246 | 0.042 | |
VEGF** | Erosion score | 34 | 0.522 | 0.002 | 105 | −0.017 | 0.863 | |
Change at Week 4 | CD40L | Total vdH-S score | 23 | 0.532 | 0.009 | 71 | −0.007 | 0.956 |
EGF | Erosion score | 23 | 0.479 | 0.021 | 70 | −0.045 | 0.714 | |
EGF | Total vdH-S score | 23 | 0.492 | 0.017 | 70 | −0.154 | 0.203 | |
MMP-3** | Total vdH-S score | 36 | 0.374 | 0.025 | 111 | −0.062 | 0.517 | |
Change at Week 52 in: | ||||||||
Baseline | COL 2–3/4C LN | Total vdH-S score | 35 | −0.448 | 0.007 | 103 | −0.051 | 0.607 |
Deoxypyridinoline | Erosion score | 33 | −0.483 | 0.004 | 102 | −0.063 | 0.532 | |
Deoxypyridinoline | Total vdH-S score | 33 | −0.354 | 0.043 | 102 | 0.054 | 0.592 | |
IL-1ra | Erosion score | 21 | −0.449 | 0.041 | 64 | 0.197 | 0.118 | |
IL-1ra | Total vdH-S score | 21 | −0.452 | 0.040 | 64 | 0.247 | 0.049 | |
Change at Week 4 | CD40L | Erosion score | 21 | 0.606 | 0.004 | 66 | 0.083 | 0.507 |
CD40L | JSN score | 21 | 0.541 | 0.011 | 66 | −0.143 | 0.252 | |
CD40L | Total vdH-S score | 21 | 0.656 | 0.001 | 66 | 0.030 | 0.810 | |
COL 2–3/4C LN | JSN score | 35 | −0.433 | 0.009 | 103 | 0.097 | 0.328 | |
COL 2–3/4C LN | Total vdH-S score | 35 | −0.367 | 0.030 | 103 | 0.107 | 0.282 | |
EGF | Erosion score | 21 | 0.460 | 0.036 | 65 | −0.119 | 0.344 | |
EGF | JSN score | 21 | 0.417 | 0.060 | 65 | −0.272 | 0.029 | |
EGF | Total vdH-S score | 21 | 0.471 | 0.031 | 65 | −0.224 | 0.072 | |
MIP1ß | Total vdH-S score | 21 | 0.470 | 0.032 | 65 | −0.045 | 0.721 | |
MMP-3** | JSN score | 21 | 0.460 | 0.036 | 66 | −0.050 | 0.688 |
↵* Defined as p < 0.05 and R ≥ 0.3 for either placebo + MTX or combined golimumab.
↵** Individual serum assays. BAP: bone alkaline phosphatase; CD40L: CD40 ligand; COL 2–3/4C LN: type 2 collagenase long neoepitope; EGF: epidermal growth factor; IL-1ra: interleukin 1 receptor antagonist; JSN: joint space narrowing; MIP1ß: macrophage inflammatory protein 1ß; MMP-3: matrix metalloproteinase-3; MTX: methotrexate; vdH-S: van der Heijde-Sharp score; VEGF: vascular endothelial growth factor.