GO-FORWARD: RA patients with an inadequate response to MTX | GO-BEFORE: MTX-naïve RA patients | ||||||||
---|---|---|---|---|---|---|---|---|---|
Golimumab+MTX | Golimumab+MTX | ||||||||
Golimumab 100 mg + Placebo | 50 mg | 100 mg | Combined | Placebo+MTX | Golimumab 100 mg + Placebo | 50 mg | 100 mg | Combined | |
Patients randomised,† n | 133 | 89 | 89 | 178 | 160 | 159 | 159 | 159 | 318 |
Serum lipid markers | |||||||||
Triglycerides (mg/dl) | −1.00 | 2.00 | 3.50 | 3.00 | −4.00 | 2.00* | 6.00 | 0.00 | 3.00* |
−0.96% | 1.81% | 4.00% | 3.37%* | −3.41% | 2.41%* | 8.01%** | 0.00% | 3.82%*** | |
Total cholesterol (mg/dl) | 8.00** | 7.00** | 11.50*** | 9.00*** | 5.00 | 3.00** | 12.00** | 8.00*** | 10.00*** |
4.55%** | 4.02%*** | 5.45%*** | 4.58%*** | 1.90%* | 1.80%** | 6.41%*** | 3.56%*** | 4.91%*** | |
LDL (mg/dl) | 8.50*** | 7.00*** | 11.50*** | 8.00*** | 6.00* | 7.00** | 8.00*** | 6.00*** | 7.00*** |
8.48%*** | 6.19%*** | 9.50%*** | 7.09%*** | 6.08%** | 5.93%** | 7.80%*** | 6.04%*** | 6.56%*** | |
HDL (mg/dl) | −1.00 | 0.00 | 1.50 | 0.00 | −1.00 | 0.00 | −0.50 | 0.00 | 0.00 |
−2.49% | 0.00% | 1.78% | 0.00% | −1.28% | 0.00% | −0.85% | 0.00% | 0.00% | |
Total cholesterol/HDL | 0.20*** | 0.10** | 0.04 | 0.06*** | 0.12* | 0.13** | 0.23*** | 0.09* | 0.14*** |
6.37%*** | 3.31%** | 1.03%* | 1.87%*** | 2.91%* | 4.43%** | 7.51%*** | 2.76%** | 4.16%*** | |
LDL/HDL | 0.22*** | 0.09** | 0.09* | 0.09*** | 0.09* | 0.12** | 0.16*** | 0.15** | 0.15*** |
9.46%*** | 5.09%*** | 4.65%** | 5.03%*** | 4.52%** | 5.25%** | 8.64%*** | 7.98%*** | 8.19%*** | |
Apolipoprotein B (mg/dl) | 5.00** | 2.00* | 1.00 | 1.00* | 0.00 | 3.00 | 3.00** | 3.00* | 3.00*** |
5.43%*** | 2.35%** | 1.57% | 2.17%*** | 0.00% | 3.33% | 4.41%** | 3.85%** | 3.95%*** | |
Apolipoprotein A1 (mg/dl) | 5.00* | 10.00*** | 12.00*** | 11.00*** | 6.00** | 6.00** | 7.00** | 8.00*** | 8.00*** |
3.16%** | 6.88%*** | 8.30%*** | 7.51%*** | 4.55%*** | 4.55%** | 5.08%*** | 5.59%*** | 5.26%*** | |
Apolipoprotein B/ | 0.02 | −0.02 | −0.03* | −0.02*** | −0.01 | −0.01 | 0.00 | 0.00 | 0.00 |
Apolipoprotein A1 (mg/dl) | 3.99% | −4.44% | −5.48% | −4.68%* | −3.14% | −1.82% | −1.10% | −0.69% | −0.69% |
LDL subfractions | |||||||||
Total LDL particles (nmol/l) | 66.50* | −28.00 | −43.00 | −31.00 | −19.00 | −49.00 | −5.50 | −3.50 | −4.50 |
4.92%* | −2.33% | −3.82% | −3.25% | −1.58% | −3.88% | −0.42% | −0.34% | −0.42% | |
Total small LDL (nmol/l) | −1.00 | −98.00*** | −105.00* | −105.00*** | −53.00* | −104.00* | −28.50* | −72.50** | −46.50*** |
−0.39% | −17.87%** | −19.09%* | −18.93%*** | −7.41% | −17.43% | −6.72% | −14.80% | −10.60%* | |
Very small LDL (nmol/l) | 7.50 | −78.00*** | −85.00* | −78.00*** | −37.00* | −76.00* | −19.00 | −58.50* | −42.50*** |
0.62% | −19.17%** | −21.00%** | −19.81%*** | −8.29% | −18.06% | −6.50% | −14.22% | −11.90%* | |
Medium small LDL (nmol/l) | 2.50 | −18.00*** | −17.00* | −17.00*** | −11.50* | −16.00* | −10.50* | −17.50* | −16.00*** |
1.16% | −21.84%** | −19.51%* | −19.75%*** | −9.30% | −13.26% | −14.68% | −17.11% | −15.38%* | |
Large LDL(nmol/l) | 16.50 | 62.50*** | 71.00*** | 63.00*** | 38.50** | 17.00 | 74.00*** | 54.00*** | 60.00*** |
4.18% | 12.28%*** | 14.12%*** | 13.30%*** | 14.56%** | 4.28% | 14.33%*** | 14.40%*** | 14.40%*** | |
Mean LDL size (nM) | 0.00 | 0.30*** | 0.20** | 0.20*** | 0.20** | 0.20 | 0.10** | 0.20*** | 0.20*** |
0.00% | 1.42%*** | 0.96%** | 1.02%*** | 0.95%** | 0.93% | 0.48%** | 0.93%*** | 0.91%*** | |
Inflammatory markers | |||||||||
Serum amyloid A (µg/ml) | −1.70* | −8.80*** | −5.60*** | −8.00*** | −21.30*** | −7.30*** | −15.80*** | −11.90*** | −12.50*** |
−32.14%* | −59.75%*** | −57.76%*** | −58.82%*** | −76.57%*** | −51.39%*** | −72.58%*** | −70.87%*** | −72.50%*** | |
hsCRP (mg/dl) | −0.64 | −3.74*** | −5.20*** | −4.30*** | −8.35*** | −8.00*** | −4.14*** | −9.01*** | −6.27*** |
−18.60% | −56.73%*** | −64.78%*** | −56.93%*** | −75.29%*** | −61.54%*** | −66.60%*** | −71.73%*** | −69.59%*** | |
Fibrinogen (mg/dl) | −46.00* | −40.50*** | −71.00*** | −57.00*** | −41.00** | −44.00** | −59.00*** | −61.00*** | −60.50*** |
−11.75% | −10.73%*** | −15.63%*** | −12.00%*** | −9.33%* | −11.55%* | −13.90%** | −12.00%*** | −13.18%*** | |
ICAM-1 (ng/ml) | −69.50*** | −80.00*** | −96.50*** | −84.00*** | −59.50*** | −87.00*** | −86.00*** | −81.00*** | −81.00##/*** |
−22.59%*** | −25.00%*** | −25.53%*** | −25.17%*** | −17.48%*** | −26.32%*** | −27.78%*** | −24.23%*** | −25.81%*** | |
IL-6 (pg/ml) | 0.95 | −1.25** | −0.60** | −0.80*** | −4.55*** | −1.00* | −3.80*** | −5.30*** | −4.00##/*** |
16.92%*** | −24.76% | −10.71% | −22.92% | −49.82% | −10.38% | −50.70% | −50.00%* | −50.35%* | |
IL-8 (pg/ml) | −1.60 | −2.80*** | −1.15** | −2.30*** | −1.80 | −0.20 | −3.10*** | −3.00*** | −3.00*** |
−9.61% | −16.21% | −10.74% | −13.30%* | −10.43% | −1.74% | −22.12%** | −18.63%** | −20.00%*** | |
MMP-3 (ng/ml) | −10.54*** | −15.73*** | −16.82*** | −16.20*** | −24.43*** | −13.53*** | −25.76*** | −18.71*** | −22.21*** |
−32.72%*** | −41.05%*** | −44.74%*** | −42.56%*** | −56.46%*** | −37.53%*** | −61.74%*** | −49.52%*** | −57.34%*** | |
VEGF (pg/ml) | −17.80*** | −23.50*** | −28.80*** | −26.70*** | −37.45*** | −20.10*** | −23.70*** | −29.90*** | −28.60*** |
−22.47%*** | −27.60%*** | −34.20%*** | −31.78%*** | −40.17%*** | −25.74%*** | −33.56%*** | −35.11%*** | −34.15%*** |
†Not all randomised patients had week 52 biomarker data.
*, **, ***indicate p<0.05, 0.01, 0.001, respectively, for change from baseline within group.
# #indicates p<0.01, for the comparison of the combined golimumab+MTX and placebo+MTX groups.
HDL, high-density lipoprotein; hsCRP, high sensitivity C-reactive protein; ICAM-1, intracellular adhesion molecule-1; IL, interleukin; LDL, low-density lipoprotein; MMP-3, matrix metalloproteinase; MTX, methotrexate; RA, rheumatoid arthritis, VEGF, vascular endothelial growth factor.