Table 1.
Baseline demographics and disease characteristics for subjects receiving ADA or PBO with or without concomitant MTX
| Characteristica | Treatment group | |||||
|---|---|---|---|---|---|---|
| ADA (n = 151) | PBO (n = 162) | |||||
| +MTX (n = 77) | No MTX (n = 74) | Overall (n = 151) | +MTX (n = 81) | No MTX (n = 81) | Overall (n = 162) | |
| Age, mean (s.d.) (range), years | 48.0 (12.1) (20.0–76.0) | 49.3 (13.0) (24.0–88.0) | 48.6 (12.5) (20.0–88.0) | 50.9 (11.0) (24.0–73.0) | 47.6 (11.1) (21.0–79.0) | 49.2 (11.1) (21.0–79.0) |
| Sex male, n (%) | 42 (54.5) | 43 (58.1) | 85 (56.3) | 44 (54.3) | 45 (55.6) | 89 (54.9) |
| Baseline psoriasis BSA ≥3%, n (%) | 29 (37.7) | 41 (55.4) | 70 (46.4) | 28 (34.6) | 42 (51.9) | 70 (43.2) |
| TJC78 | 22.2 (16.8) | 25.7 (17.8) | 23.9 (17.3) | 25.7 (17.1) | 25.9 (19.0) | 25.8 (18.0) |
| SJC76 | 12.4 (9.7) | 16.3 (14.1) | 14.3 (12.2) | 12.9 (9.7) | 15.8 (12.3) | 14.3 (11.1) |
| Oligoarthritis, n (%)b | 2 (2.6) | 3 (4.1) | 5 (3.3) | 1 (1.2) | 1 (1.2) | 2 (1.2) |
| Polyarthritis, n (%)c | 75 (97.4) | 71 (95.9) | 146 (96.7) | 80 (98.8) | 80 (98.8) | 160 (98.8) |
| PhGA (VAS 0–100) | 53.8 (16.7) | 53.8 (14.7)** | 53.8 (15.7)** | 54.0 (15.0) | 53.0 (16.5)* | 53.5 (15.7)* |
| PtGA (VAS 0–100) | 44.9 (22.9) | 49.3 (23.4) | 47.1 (23.2) | 48.3 (19.4)* | 47.9 (22.9) | 48.1 (21.2)* |
| Pain (VAS 0–100) | 50.6 (22.7) | 51.5 (20.1) | 51.1 (21.4) | 47.4 (20.4)* | 50.1 (23.0) | 48.8 (21.7)* |
| CRP, mg/l | 1.5 (2.2) | 1.2 (2.0) | 1.4 (2.1) | 1.3 (1.6) | 1.5 (1.8) | 1.4 (1.7) |
| HAQ-DI | 1.0 (0.6) | 1.0 (0.6) | 1.0 (0.6) | 1.0 (0.6) | 1.0 (0.7) | 1.0 (0.7) |
| SF-36 PCS | 32.7 (10.3)* | 33.8 (9.5)** | 33.2 (9.9)*** | 32.5 (9.1) | 34.1 (10.4) | 33.3 (9.8) |
| Dactylitis | 1.9 (4.1)* | 2.7 (5.3)* | 2.3 (4.7)** | 2.1 (6.8)* | 2.0 (4.4) | 2.1 (5.7)* |
| Enthesitis | 0.9 (1.3)* | 0.6 (1.1)* | 0.8 (1.2)** | 1.0 (1.3)* | 0.8 (1.3)* | 0.9 (1.3)** |
a
Values are mean (s.d.) unless otherwise stated.
b
≤4 involved joints.
c
≥5 involved joints. Data missing for: *1 subject, **2 subjects, ***3 subjects. ADA: adalimumab; BSA: body surface area; HAQ-DI: HAQ-disability index; PCS: physical component summary; PhGA: physician global assessment; PBO: placebo; PtGA: patient global assessment; SF-36: Medical Outcomes Study Short-Form (36-item) Health Survey; SJC: swollen joint count; TJC: tender joint count; VAS: visual analogue scale.