Table 1 Baseline demographic and disease characteristics for patients < 65 years and ≥ 65 years
Patients < 65 years | Patients ≥ 65 years | |||||
|---|---|---|---|---|---|---|
Placebo + MTX | Golimumab + MTX | Combined | Placebo + MTX | Golimumab + MTX | Combined | |
Patients, n | 179 | 336 | 515 | 18 | 59 | 77 |
Age, years | 49.5 ± 9.9 | 48.7 ± 10.7 | 49.0 ± 10.4 | 70.4 ± 3.4 | 70.1 ± 4.3 | 70.2 ± 4.1 |
Female | 141 (78.8) | 276 (82.1) | 417 (81.0) | 16 (88.9) | 50 (84.7) | 66 (85.7) |
Race | ||||||
Caucasian | 145 (81.0) | 272 (81.2) | 417 (81.1) | 15 (83.3) | 43 (72.9) | 58 (75.3) |
Asian | 10 (5.6) | 30 (9.0) | 40 (7.8) | 2 (11.1) | 1 (1.7) | 3 (3.9) |
Black | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.7) | 1 (1.3) |
Other | 24 (13.4) | 33 (9.8) | 57 (11.1) | 1 (5.6) | 14 (23.7) | 15 (19.5) |
Weight, kg | 71.7 ± 17.4 | 72.4 ± 16.2 | 72.2 ± 16.6 | 73.8 ± 15.3 | 66.3 ± 14.3 | 68.1 ± 14.7 |
BMI, kg/m2 | 26.9 ± 5.7 | 27.0 ± 5.6 | 27.0 ± 5.6 | 28.3 ± 5.5 | 25.8 ± 4.9 | 26.4 ± 5.1 |
RA disease duration | 6.6 ± 6.3 | 6.5 ± 6.3 | 6.5 ± 6.3 | 10.8 ± 13.1 | 9.3 ± 9.8 | 9.7 ± 10.6 |
ACR core components | ||||||
Number of swollen joints (0–68) | 14.7 ± 8.4 | 15.0 ± 8.5 | 14.9 ± 8.5 | 15.9 ± 9.8 | 14.6 ± 6.2 | 14.9 ± 7.2 |
Numbers of tender joints (0–68) | 25.9 ± 14.3 | 26.6 ± 13.7 | 26.3 ± 13.9 | 25.8 ± 12.8 | 25.5 ± 15.2 | 25.6 ± 14.6 |
CRP, mg/dL | 2.3 ± 1.9 | 2.8 ± 2.7 | 2.6 ± 2.5 | 1.5 ± 1.1 | 3.1 ± 3.7 | 2.7 ± 3.4 |
Physician’s global assessment (VAS, 0–10 cm) | 6.3 ± 1.5 | 6.3 ± 1.6 | 6.3 ± 1.6 | 5.9 ± 2.0 | 6.0 ± 1.7 | 5.9 ± 1.7 |
Patient’s global assessment (VAS, 0–10 cm) | 6.5 ± 1.9 | 6.5 ± 1.8 | 6.5 ± 1.9 | 6.2 ± 2.2 | 6.3 ± 1.8 | 6.3 ± 1.9 |
Patient’s assessment of pain (VAS, 0–10 cm) | 6.5 ± 2.0 | 6.5 ± 1.9 | 6.5 ± 1.9 | 6.6 ± 2.0 | 6.5 ± 1.6 | 6.5 ± 1.7 |
HAQ-DI | 1.60 ± 0.60 | 1.55 ± 0.66 | 1.56 ± 0.64 | 1.35 ± 0.72 | 1.61 ± 0.71 | 1.55 ± 0.72 |
Anti-CCP antibodies | 165/177 (93.2) | 307/335 (91.6) | 472/512 (92.2) | 16 (88.9) | 55 (93.2) | 71 (92.2) |
Rheumatoid factor | 164 (91.6) | 309 (92.0) | 473 (91.8) | 17 (94.4) | 56 (94.9) | 73 (94.8) |
SF-36 PCS | 30.8 ± 7.2 | 31.0 ± 6.6 | 30.9 ± 6.8 | 31.7 ± 8.9 | 30.0 ± 7.8 | 30.4 ± 8.0 |
SF-36 MCS | 38.3 ± 11.7 | 36.8 ± 11.1 | 37.3 ± 11.3 | 41.0 ± 10.4 | 38.9 ± 11.1 | 39.4 ± 10.9 |
Concomitant medications | ||||||
MTX dose at screening | 16.7 ± 2.8 | 16.9 ± 2.9 | 16.8 ± 2.9 | 16.4 ± 2.9 | 16.3 ± 2.8 | 16.3 ± 2.8 |
Duration of MTX use | ||||||
< 1 year | 44 (24.6) | 82 (24.4) | 126 (24.5) | 4 (22.2) | 20 (33.9) | 24 (31.2) |
1 to < 3 years | 53 (29.6) | 97 (28.9) | 150 (29.1) | 8 (44.4) | 17 (28.8) | 25 (32.5) |
≥ 3 years | 82 (45.8) | 154 (45.8) | 236 (45.8) | 6 (33.3) | 22 (37.3) | 28 (36.4) |
Unknown | 0 (0.0) | 3 (0.9) | 3 (0.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Oral corticosteroids | 121 (67.6) | 221 (65.8) | 342 (66.4) | 13 (72.2) | 30 (50.8) | 43 (55.8) |
Dose (prednisone or equivalent), mg/day | 7.0 ± 2.5 | 7.1 ± 2.5 | 7.0 ± 2.5 | 6.9 ± 2.7 | 6.6 ± 2.7 | 6.7 ± 2.6 |
NSAIDs | 145 (81.0) | 280 (83.3) | 425 (82.5) | 11 (61.1) | 43 (72.9) | 54 (70.1) |
Prior medications | ||||||
DMARDs* | 83 (46.4) | 182 (54.2) | 265 (51.5) | 9 (50.0) | 24 (40.7) | 33 (42.9) |