Table 2

Median and median percentage change from baseline to week 14 (GO-FORWARD) or week 24 (GO-BEFORE) in serum lipid and inflammatory markers of cardiovascular disease in patients with RA

 GO-FORWARD: RA patients with an inadequate response to MTX (week 14)GO-BEFORE: MTX-naïve RA patients (week 24)
Golimumab+MTXGolimumab+MTX
Placebo+MTXGolimumab 100 mg + Placebo50 mg100 mgCombinedPlacebo+MTXGolimumab 100 mg + Placebo50 mg100 mgCombined
Patients randomised,† n1331338989178160159159159318
Serum lipid markers
 Triglycerides (mg/dl)2.001.004.00*0.003.00−3.00−3.007.00−3.004.00
1.89%0.65%5.31%*0.16%3.68%*−2.04%−2.34%4.88%*−2.61%4.09%*
 Total cholesterol (mg/dl)2.008.00***16.00***15.50***16.00###/***6.50**9.00***10.50**8.00**8.00***
1.01%3.79%***8.51%***8.04%***8.44%***4.00%***4.74%***4.54%***3.94%**4.12%***
 LDL (mg/dl)4.008.00**8.00***9.00***8.00###/***7.50**8.00***3.003.00*3.00***
3.25%7.27%***11.67%***10.09%***11.64%***6.27%***7.89%***2.92%2.67%**2.68%***
 HDL (mg/dl)0.003.00*3.00**3.50**3.00##/***0.503.00**1.002.00*1.00*
0.00%5.08%**5.88%**5.05%**5.41%***0.63%4.26%**1.33%3.53%**2.50%***
 Total cholesterol/HDL0.070.030.11*0.040.09*0.16*0.030.05−0.010.03
1.90%0.99%3.26%*1.22%2.78%*4.77%**1.42%1.50%−0.52%0.79%
 LDL/HDL0.070.040.09*0.050.07*0.16**0.030.030.010.03
4.00%*2.66%4.81%*3.07%*3.41%***6.79%***1.49%1.80%1.28%1.29%
 Apolipoprotein B (mg/dl)0.005.00***4.50*3.00*3.50***1.001.000.001.000.00
0.00%6.10%***4.68%*3.75%**4.14%***0.93%1.61%0.00%1.25%0.00%
 Apolipoprotein A1 (mg/dl)4.5010.00***8.00***10.00**9.50***6.50**6.00**10.50***10.00***10.00***
2.68%7.37%***5.77%***6.71%**6.16%***5.14%**4.41%***6.72%***6.32%***6.67%***
 Apolipoprotein B/−0.01−0.01−0.02−0.02−0.02−0.01−0.02−0.02*−0.03−0.02***
 Apolipoprotein A1 (mg/dl)−1.08%−1.20%−3.34%−4.37%−3.78%−2.00%−3.76%−3.54%−4.00%−3.84%*
 LDL subfractions
 Total LDL particles (nmol/l)47.00**25.5033.0036.0033.00−7.00−51.00−20.50−67.00−47.00
4.79%**1.51%*2.94%2.39%2.62%*−0.72%−4.67%−1.89%−6.15%−5.51%
 Total small LDL (nmol/l)30.00−36.00−53.00−67.00−56.50###/**−71.00−62.00−79.50*−53.00**−72.00***
4.25%−5.96%−9.90%*−10.52%*−10.52%***−10.41%−10.94%−16.84%−16.90%−16.87%*
 Very small LDL (nmol/l)19.00−29.50−44.00−64.00−50.50##/*−41.00−43.00−70.00*−49.00*−63.00***
1.93%−5.25%−9.65%*−12.59%*−11.20%***−9.73%−12.18%−18.36%−11.73%−16.26%*
 Medium small LDL (nmol/l)6.00−9.50−11.50−13.00−12.50##/*−11.00*−14.00*−15.50*−16.00**−16.00***
4.88%−8.59%−11.21%−12.82%*−12.82%*−8.35%−9.23%−14.35%−16.67%*−15.03%*
 Large LDL(nmol/l)21.0054.50**106.50***69.00**90.50##/***43.00**32.0027.5054.00**38.00***
3.41%11.95%***27.73%***18.58%***21.45%***11.82%**7.05%*4.21%*13.16%***7.98%***
 Mean LDL size (nM)0.000.100.25***0.20**0.20###/***0.10**0.10*0.100.20***0.20***
0.00%0.46%1.16%***0.97%**0.98%***0.48%**0.46%*0.47%*0.95%***0.91%***
Inflammatory markers
 Serum amyloid A (µg/ml)−1.60**−2.00**−11.80***−8.70***−10.65###/***−15.95***−4.40***−14.55***−7.60***−10.10###/***
−20.07%−28.90%−72.07%***−57.95%***−65.59%***−66.39%***−41.84%***−68.65%***−72.37%***−70.90%***
 hsCRP (mg/dl)−0.63−2.74**−5.36***−3.40***−5.01###/***−5.40***−4.00***−4.79***−7.21***−6.05##/***
−10.42%−50.11%−71.83%***−69.54%***−70.68%***−49.58%**−57.20%***−70.38%***−72.66%***−71.74%***
 Fibrinogen (mg/dl)−2.00−38.50**−88.50***−79.00***−80.00###/***−38.50***−40.00***−83.00***−68.00***−74.00***
−0.58%−9.02%*−18.45%***−18.63%***−18.63%***−10.03%**−10.17%**−18.75%***−15.02%***−17.29%***
 ICAM-1 (ng/ml)0.00−20.00**−40.00***−36.00***−40.00###/***−2.00−40.00***−36.00***−40.00***−40.00###/***
0.00%−5.26%**−12.50%***−9.09%***−12.17%***−0.65%−12.50%***−10.33%***−13.33%***−12.50%***
 IL-6 (pg/ml)−1.20*−1.40**−4.10***−1.50***−3.60###/***−4.85***−2.90***−6.70***−8.20***−7.30###/***
−20.47%−42.86%*−70.37%***−44.44%**−60.13%***−60.97%***−57.14%***−76.09%***−77.78%***−76.92%***
 IL-8 (pg/ml)−1.75**−4.20***−6.30***−4.70***−5.30##/***−2.80***−6.00***−5.15***−5.00***−5.10##/***
−9.08%*−22.60%***−33.82%***−35.26%***−34.52%***−18.07%**−33.33%***−33.62%***−33.32%***−33.62%***
 MMP-3 (ng/ml)−4.27***−2.50**−13.40***−4.31***−9.71###/***−14.70***−4.30***−18.90***−21.00***−19.21#/***
−13.20%**−9.88%*−32.45%***−24.23%***−28.19%***−38.61%***−22.71%***−47.95%***−45.49%***−46.70%***
 VEGF (pg/ml)0.90−8.90***−20.40***−18.70***−19.80###/***−21.85***−23.10***−27.60***−30.30***−29.15##/***
1.50%−10.67%***−22.99%***−29.33%***−27.37%***−25.11%***−21.24%***−35.75%***−32.18%***−33.25%***
  • †Not all randomised patients had week 14/24 biomarker data.

  • *, **, ***Indicate p≤0.05, 0.01, 0.001, respectively, for change from baseline within group.

  • #, ##, ###Indicate p≤0.05, 0.01, 0.001, respectively, 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.