GO-FORWARD: RA patients with an inadequate response to MTX | GO-BEFORE: MTX-naïve RA patients | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Golimumab+MTX | Golimumab+MTX | |||||||||
Placebo+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 | 133 | 89 | 89 | 178 | 160 | 159 | 159 | 159 | 318 |
Female | 109 (82.0) | 105 (78.9) | 72 (80.9) | 72 (80.9) | 144 (80.9) | 134 (83.8) | 134 (84.3) | 135 (84.9) | 125 (78.6) | 260 (81.8) |
Age, years | 52.0 | 51.0 | 52.0 | 50.0 | 51.0 | 50.0 | 49.0 | 51.0 | 50.0 | 51.0 |
Body mass index | 25.6 | 26.3 | 26.3 | 25.6 | 25.9 | 26.4 | 25.7 | 27.1 | 25.9 | 26.4 |
Duration of RA, years | 6.5 | 5.9 | 4.5 | 6.7 | 5.3 | 1.2 | 1.8 | 1.0 | 1.3 | 1.1 |
Extra-articular manifestations | 37 (28.2) | 48 (36.4) | 35 (39.3) | 23 (25.8) | 58 (32.6) | 45 (28.1) | 42/156 (26.9) | 35 (22.0) | 30 (18.9) | 65 (20.4) |
Anti-CCP antibodies | 107 (80.5) | 106 (79.7) | 72 (80.9) | 68 (76.4) | 140 (78.7) | 121 (75.6) | 125 (78.6) | 106 (66.7) | 116 (73.0) | 222 (69.8) |
Rheumatoid factor | 108 (81.2) | 111 (83.5) | 77 (86.5) | 75 (84.3) | 152 (85.4) | 130/159 (81.8) | 129 (81.1) | 121 (76.1) | 127 (79.9) | 248 (78.0) |
Concomitant use of HMG-CoA reductase inhibitor | 9 (6.8) | 9 (6.8) | 4 (4.5) | 8 (9.0) | 12 (6.7) | 7 (4.4) | 10 (6.3) | 8 (5.0) | 12 (7.5) | 20 (6.3) |
Patients with a history of: | ||||||||||
Hyperlipidaemia | 17 (12.8) | 19 (14.3) | 10 (11.2) | 16 (18.0) | 26 (14.6) | 19 (11.9) | 18 (11.4) | 29 (18.2) | 23 (14.5) | 52 (16.4) |
Required therapy | 10 (7.5) | 13 (9.8) | 5 (5.6) | 8 (9.0) | 13 (7.3) | 11 (6.9) | 10 (6.3) | 12 (7.5) | 12 (7.5) | 24 (7.5) |
Systemic corticosteroid use | 120 (90.2) | 113 (85.0) | 79 (88.8) | 79 (88.8) | 158 (88.8) | 109 (68.1) | 101 (63.5) | 111 (69.8) | 104 (65.4) | 215 (67.6) |
Serum lipid markers | ||||||||||
Triglycerides (mg/dl) | 103.5 | 116.5 | 102.5 | 117.0 | 108.0 | 114.0 | 105.0 | 114.0 | 104.0 | 107.0 |
Total cholesterol (mg/dl) | 194.0 | 192.0 | 190.5 | 206.0 | 198.5 | 193.0 | 190.0 | 195.5 | 190.0 | 191.0 |
LDL (mg/dl) | 107.5 | 108.0 | 107.0 | 117.0 | 112.0 | 109.0 | 106.0 | 108.5 | 108.0 | 108.0 |
HDL (mg/dl) | 61.0 | 58.0 | 61.0 | 60.0 | 60.5 | 58.0 | 58.0 | 56.5 | 57.0 | 57.0 |
Total cholesterol/HDL | 3.2 | 3.3 | 3.3 | 3.4 | 3.3 | 3.3 | 3.3 | 3.5 | 3.3 | 3.4 |
LDL/HDL | 1.8 | 1.8 | 1.8 | 2.0 | 1.9 | 1.9 | 1.9 | 2.0 | 1.9 | 2.0 |
Apolipoprotein B (mg/dl) | 78.0 | 79.0 | 83.0 | 88.5 | 85.0 | 79.0 | 80.5 | 84.0 | 81.0 | 82.0 |
Apolipoprotein A1 (mg/dl) | 147.0 | 146.0 | 148.0 | 147.0 | 148.0 | 140.0 | 144.0 | 143.0 | 139.0 | 142.0 |
Apolipoprotein B/A1 Apolipoprotein A1 (mg/dl) | 0.5 | 0.6 | 0.5 | 0.6 | 0.6 | 0.6 | 0.6 | 0.6 | 0.6 | 0.6 |
LDL subfractions | ||||||||||
Total LDL particles (nmol/l) | 1089.0 | 1136.0 | 1074.0 | 1192.5 | 1133.0 | 1188.0 | 1131.0 | 1157.0 | 1120.5 | 1149.0 |
Total small LDL (nmol/l) | 543.0 | 600.0 | 578.0 | 660.5 | 648.0 | 679.0 | 623.0 | 681.0 | 612.5 | 644.5 |
Very small LDL (nmol/l) | 433.0 | 488.0 | 456.0 | 531.0 | 509.0 | 537.0 | 493.0 | 544.5 | 488.0 | 513.5 |
Medium small LDL (nmol/l) | 114.0 | 124.0 | 119.5 | 141.0 | 130.5 | 140.0 | 136.0 | 136.5 | 127.0 | 130.0 |
Large LDL (nmol/l) | 465.5 | 451.0 | 434.5 | 485.5 | 457.0 | 406.0 | 420.0 | 464.5 | 461.0 | 464.5 |
Mean LDL size (nM) | 21.3 | 21.3 | 21.2 | 21.2 | 21.2 | 21.2 | 21.1 | 21.1 | 21.2 | 21.2 |
Inflammatory markers | ||||||||||
Serum amyloid A (µg/ml) | 14.1 | 15.6 | 17.0 | 19.4 | 18.3 | 30.0 | 19.5 | 22.3 | 19.5 | 21.8 |
hsCRP (mg/dl) | 7.0 | 9.1 | 9.7 | 10.1 | 9.7 | 13.3 | 13.4 | 12.4 | 13.0 | 12.5 |
Fibrinogen (mg/dl) | 420.0 | 413.0 | 419.0 | 420.0 | 419.0 | 433.0 | 416.0 | 439.5 | 439.0 | 439.0 |
ICAM-1 (ng/ml) | 340.0 | 344.0 | 324.0 | 344.0 | 340.0 | 338.0 | 354.0 | 348.0 | 343.0 | 345.0 |
IL-6 (pg/ml) | 7.3 | 6.0 | 6.9 | 6.6 | 6.9 | 10.7 | 10.1 | 10.5 | 11.8 | 11.2 |
IL-8 (pg/ml) | 19.1 | 19.2 | 19.7 | 17.3 | 18.9 | 17.6 | 16.7 | 16.6 | 17.4 | 16.7 |
MMP-3 (ng/ml) | 39.4 | 35.2 | 43.9 | 46.4 | 44.7 | 51.1 | 44.8 | 45.4 | 42.8 | 43.7 |
VEGF (pg/ml) | 84.0 | 94.9 | 85.4 | 89.6 | 86.3 | 104.9 | 100.1 | 99.1 | 101.5 | 99.9 |
Data shown are median value or number (%) of patients unless otherwise noted.
Anti-CCP, anti-cyclic citrullinated peptide; 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.