Patient demographics, disease characteristics, and patient-reported outcome scores at baseline. Data are mean (SD) unless otherwise noted.
| Characteristics | Adalimumab Plus MTX, n = 268 | MTX Monotherapy, n = 257 | Adalimumab Monotherapy, n = 274 |
|---|---|---|---|
| Age, yrs | 51.9 (14.0) | 52.0 (13.1) | 52.1 (13.5) |
| Women, n (%) | 193 (72.0) | 190 (73.9) | 212 (77.4) |
| Disease duration, yrs | 0.7 (0.8) | 0.8 (0.9) | 0.7 (0.8) |
| Prior DMARD use, n (%) | 87 (32.5) | 81 (31.5) | 91 (33.2) |
| Concomitant corticosteroid use, n (%) | 96 (35.8) | 91 (35.4) | 100 (36.5) |
| Tender joint count, 0–68 | 30.7 (14.2) | 32.3 (14.3) | 31.8 (13.6) |
| Swollen joint count, 0–66 | 21.1 (11.2) | 22.1 (11.7) | 21.8 (10.5) |
| Patient’s global assessment of disease activity, 100-mm VAS | 66.8 (22.1) | 63.0 (25.0) | 67.8 (23.3) |
| Patient’s assessment of pain, 100-mm VAS | 62.5 (21.3) | 59.6 (24.3) | 64.6 (23.6) |
| DAS28 | 6.3 (0.9) | 6.3 (0.9) | 6.4 (0.9) |
| HAQ-DI* | 1.5 (0.6) [p = 0.8719†] | 1.5 (0.7) | 1.6 (0.6) [p = 0.0132††] |
| SF-36 component summary scores* | |||
| PCS | 31.7 (7.8) [p = 0.4373†] | 32.2 (7.9) | 30.7 (7.4) [p = 0.0272††] |
| MCS | 44.1 (12.5) [p = 0.5816†] | 43.5 (12.4) | 42.6 (12.1) [p = 0.4107††] |
| SF-36 domains* | |||
| Physical function | 30.2 (10.0) [p = 0.1486†] | 31.5 (10.3) | 29.1 (9.5) [p = 0.0061††] |
| Role limitations-physical | 33.1 (8.8) [p = 0.4714†] | 32.6 (8.4) | 32.5 (8.1) [p = 0.9268††] |
| Social function | 38.3 (12.0) [p = 08682†] | 38.1 (12.2) | 35.2 (12.2) [p = 0.0076††] |
| General health | 40.9 (10.0) [p = 0.5918†] | 40.5 (9.1) | 39.8 (9.6) [p = 0.4400††] |
| Bodily pain | 32.5 (7.1) [p = 0.7854†] | 32.7 (7.7) | 31.6 (7.8) [p = 0.0823††] |
| Vitality | 40.0 (10.0) [p = 0.5239†] | 40.6 (9.7) | 39.2 (9.4) [p = 0.0954††] |
| Role limitations-emotional | 38.4 (14.1) [p = 0.1617†] | 36.7 (13.8) | 37.5 (13.9) [p = 0.5280††] |
| Mental health | 42.1 (12.2) [p = 0.6366†] | 42.6 (12.1) | 41.4 (11.9) [p = 0.2851††] |
| SF-6D* | 0.55 (0.11) [p = 0.3534†] | 0.56 (0.11) | 0.54 (0.11) [p = 0.0362††] |
| FACIT-F* | 28.4 (11.7) [p = 0.5770†] | 29.0 (11.1) | 26.2 (11.3) [p = 0.0045††] |
| HUI-3* | 0.39 (0.27) [p = 0.9200†] | 0.39 (0.29) | 0.33 (0.28) [p = 0.0236††] |
↵* Unadjusted mean (SD).
↵† p values from Student t tests between MTX monotherapy and adalimumab plus MTX combination therapy.
↵†† p values from Student t tests between MTX and adalimumab monotherapy groups. DAS28: 28-joint Disease Activity Score; DMARD: disease-modifying antirheumatic drug; FACIT-F: Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI: Health Assessment Questionnaire Disability Index; HUI-3: Health Utility Index Mark 3; MCS: mental component summary; MTX: methotrexate; PCS: physical component summary; SF-6D: Short-Form 6 Dimension; SF-36: Short-Form 36 Health Survey; VAS: visual analog scale.