Mean patient-reported outcome scores by treatment group and study visit. Data are adjusted mean (SD).
| Mixed-model Repeated-measures Analyses** | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Measure | n | Baseline | Week 12 | Week 26 | Week 52 | Week 76 | Week 104 | Treatment Effect, p | Treatment-by-week Interaction, p |
| HAQ-DI | |||||||||
| Adalimumab plus MTX | 266 | 1.5 (0.6) | 0.7 (0.5) | 0.6 (0.5) | 0.5 (0.5) | 0.4 (0.5) | 0.3 (0.5) | < 0.0001† | < 0.0001† |
| MTX | 256 | 1.5 (0.7) | 0.9 (0.6) | 0.9 (0.6) | 0.7 (0.6) | 0.6 (0.6) | 0.5 (0.6) | ||
| Adalimumab | 272 | 1.6 (0.6) | 1.0 (0.6) | 0.9 (0.6) | 0.8 (0.6) | 0.7 (0.6) | 0.6 (0.6) | 0.0704†† | < 0.0001†† |
| SF-36 PCS* | |||||||||
| Adalimumab plus MTX | 256 | 31.7 (7.8) | 44.8 (8.0) | 45.3 (8.2) | 46.6 (8.2) | 47.5 (8.8) | 48.8 (8.3) | < 0.0001† | |
| MTX | 247 | 32.2 (7.9) | 41.0 (8.1) | 42.2 (8.1) | 43.5 (8.1) | 44.7 (8.0) | 45.9 (7.8) | ||
| Adalimumab | 264 | 30.7 (7.4) | 39.9 (7.8) | 41.1 (8.0) | 42.5 (7.9) | 43.9 (7.8) | 44.7 (8.0) | 0.3912†† | |
| SF-36 MCS* | |||||||||
| Adalimumab plus MTX | 256 | 44.1 (12.5) | 49.7 (8.7) | 50.3 (8.6) | 50.7 (8.7) | 51.4 (8.7) | 51.8 (8.8) | 0.7609† | |
| MTX | 247 | 43.5 (12.4) | 50.1 (8.8) | 50.8 (8.5) | 51.3 (8.5) | 51.7 (8.4) | 52.4 (8.4) | ||
| Adalimumab | 264 | 42.6 (12.1) | 47.9 (8.2) | 48.6 (8.0) | 49.1 (8.2) | 49.3 (8.1) | 49.8 (8.1) | 0.0148†† | |
| VAS-PtGA | |||||||||
| Adalimumab plus MTX | 264 | 66.8 (22.1) | 25.0 (16.2) | 22.4 (16.3) | 17.8 (15.5) | 13.6 (15.1) | 9.4 (14.9) | < 0.0001† | < 0.0001† |
| MTX | 256 | 63.0 (25.0) | 35.3 (17.8) | 30.7 (21.8) | 24.5 (16.1) | 19.1 (16.1) | 12.9 (15.7) | ||
| Adalimumab | 273 | 67.8 (23.3) | 35.9 (17.7) | 32.2 (17.2) | 27.7 (17.0) | 23.9 (16.7) | 19.8 (16.5) | 0.2694†† | < 0.0001†† |
| VAS-pain assessment | |||||||||
| Adalimumab plus MTX | 265 | 62.5 (21.3) | 23.2 (16.5) | 20.9 (16.5) | 16.8 (15.7) | 13.1 (15.0) | 9.6 (14.9) | < 0.0001† | < 0.0001† |
| MTX | 256 | 59.6 (24.3) | 33.8 (17.9) | 29.4 (16.5) | 23.4 (16.1) | 18.4 (16.1) | 12.5 (15.8) | ||
| Adalimumab | 273 | 64.6 (23.6) | 34.2 (17.9) | 30.6 (17.2) | 26.6 (17.1) | 22.2 (16.9) | 19.6 (16.6) | 0.1571†† | < 0.0001†† |
| SF-36 domains* | |||||||||
| Physical function | |||||||||
| Adalimumab plus MTX | 264 | 30.2 (10.0) | 42.7 (9.0) | 43.3 (9.2) | 44.7 (9.2) | 45.7 (9.2) | 46.9 (9.2) | < 0.0001† | |
| MTX | 256 | 31.5 (10.3) | 39.4 (9.6) | 40.6 (9.6) | 41.8 (9.7) | 43.3 (9.4) | 44.3 (9.3) | ||
| Adalimumab | 270 | 29.1 (9.5) | 38.0 (9.1) | 39.2 (9.1) | 40.5 (9.0) | 41.8 (9.0) | 43.0 (9.1) | 0.6364†† | |
| Bodily pain | |||||||||
| Adalimumab plus MTX | 265 | 32.5 (7.1) | 47.9 (7.1) | 48.5 (7.4) | 49.7 (7.3) | 50.7 (7.3) | 51.8 (7.2) | < 0.0001† | |
| MTX | 256 | 32.7 (7.7) | 44.3 (7.2) | 45.3 (7.3) | 46.5 (7.3) | 47.8 (7.3) | 48.8 (7.1) | ||
| Adalimumab | 271 | 31.6 (7.8) | 42.4 (7.0) | 43.6 (6.9) | 44.9 (6.9) | 46.0 (6.9) | 47.1 (6.9) | 0.0288†† | |
| Vitality | |||||||||
| Adalimumab plus MTX | 264 | 40.0 (10.0) | 51.4 (8.7) | 51.9 (8.9) | 52.9 (8.8) | 53.8 (8.9) | 54.7 (9.0) | 0.0139† | |
| MTX | 255 | 40.6 (9.7) | 49.8 (8.6) | 50.8 (8.6) | 51.8 (8.7) | 52.7 (8.7) | 53.7 (8.5) | ||
| Adalimumab | 271 | 39.2 (9.4) | 47.5 (8.0) | 48.5 (8.2) | 49.6 (8.3) | 50.4 (8.3) | 51.4 (8.4) | 0.0228†† | |
| Role limitations-physical | |||||||||
| Adalimumab plus MTX | 261 | 33.1 (8.8) | 44.7 (8.2) | 45.3 (8.3) | 46.6 (8.2) | 47.6 (8.3) | 48.8 (8.2) | 0.0005† | |
| MTX | 255 | 32.6 (8.4) | 41.7 (8.7) | 42.7 (8.8) | 44.1 (8.9) | 45.1 (8.7) | 46.5 (8.6) | ||
| Adalimumab | 268 | 32.5 (8.1) | 41.0 (7.8) | 42.0 (7.9) | 43.3 (8.0) | 44.6 (7.9) | 45.5 (8.0) | 0.2851†† | |
| Social function | |||||||||
| Adalimumab plus MTX | 265 | 38.3 (12.0) | 47.8 (7.2) | 48.1 (7.4) | 48.7 (7.4) | 49.3 (7.5) | 49.9 (7.4) | 0.1248† | |
| MTX | 256 | 38.1 (12.2) | 46.6 (7.9) | 47.3 (7.8) | 47.9 (7.8) | 48.8 (7.7) | 49.2 (7.6) | ||
| Adalimumab | 271 | 35.2 (12.2) | 43.8 (7.7) | 44.7 (7.6) | 45.9 (7.4) | 47.0 (7.4) | 48.0 (7.6) | 0.0031†† | 0.0250†† |
| General health | |||||||||
| Adalimumab plus MTX | 264 | 40.9 (10.0) | 46.9 (8.2) | 47.4 (8.3) | 48.2 (8.2) | 48.8 (8.2) | 49.5 (8.3) | 0.0870† | 0.0108† |
| MTX | 249 | 40.5 (9.1) | 45.2 (8.2) | 45.9 (8.1) | 46.4 (8.2) | 46.9 (8.2) | 47.2 (8.2) | ||
| Adalimumab | 268 | 39.8 (9.6) | 43.8 (7.8) | 44.5 (8.0) | 45.4 (7.9) | 46.2 (7.9) | 46.7 (8.1) | 0.0235†† | 0.0478†† |
| Role limitations-emotional | |||||||||
| Adalimumab plus MTX | 260 | 38.4 (14.1) | 45.8 (8.1) | 46.5 (8.1) | 47.3 (8.1) | 48.3 (7.9) | 49.1 (7.8) | 0.2283† | |
| MTX | 254 | 36.7 (13.8) | 44.5 (8.6) | 45.3 (8.6) | 46.2 (8.6) | 47.2 (8.3) | 48.1 (8.0) | ||
| Adalimumab | 269 | 37.5 (13.9) | 42.9 (7.9) | 43.5 (7.9) | 44.5 (7.9) | 45.0 (7.9) | 45.8 (7.9) | 0.0281†† | |
| Mental health | |||||||||
| Adalimumab plus MTX | 264 | 42.1 (12.2) | 48.8 (8.7) | 49.2 (8.8) | 49.9 (8.8) | 50.5 (8.7) | 51.1 (8.7) | 0.3895† | |
| MTX | 255 | 42.6 (12.1) | 48.5 (9.3) | 49.5 (8.9) | 50.0 (9.0) | 50.5 (9.2) | 51.1 (9.3) | ||
| Adalimumab | 270 | 41.4 (11.9) | 46.8 (8.6) | 47.4 (8.6) | 48.0 (8.7) | 48.6 (8.6) | 49.2 (8.7) | 0.0503†† | |
| SF-6D | |||||||||
| Adalimumab plus MTX | 256 | 0.55 (0.11) | 0.70 (0.13) | 0.70 (0.13) | 0.75 (0.13) | 0.75 (0.14) | 0.76 (0.14) | 0.0152† | < 0.0001† |
| MTX | 256 | 0.56 (0.11) | 0.66 (0.12) | 0.70 (0.14) | 0.72 (0.14) | 0.72 (0.15) | 0.73 (0.14) | ||
| Adalimumab | 272 | 0.54 (0.11) | 0.64 (0.12) | 0.67 (0.13) | 0.70 (0.14) | 0.69 (0.13) | 0.70 (0.13) | 0.0480†† | < 0.0001†† |
| FACIT-F | |||||||||
| Adalimumab plus MTX | 265 | 28.4 (11.7) | 39.2 (8.3) | 40.0 (8.2) | 41.1 (8.2) | 42.1 (8.0) | 43.0 (8.1) | < 0.0001† | 0.0010† |
| MTX | 254 | 29.0 (11.1) | 37.5 (8.7) | 38.7 (8.2) | 40.0 (8.1) | 41.4 (8.1) | 42.5 (8.1) | ||
| Adalimumab | 272 | 26.2 (11.3) | 35.8 (8.4) | 37.0 (8.2) | 38.6 (8.0) | 39.7 (8.0) | 40.8 (8.1) | 0.8844†† | |
| HUI-3 | |||||||||
| Adalimumab plus MTX | 239 | 0.39 (0.29) | 0.69 (0.20) | 0.72 (0.20) | 0.73 (0.20) | 0.76 (0.20) | 0.79 (0.19) | 0.0034† | |
| MTX | 234 | 0.39 (0.27) | 0.64 (0.20) | 0.67 (0.20) | 0.69 (0.20) | 0.72 (0.19) | 0.74 (0.19) | ||
| Adalimumab | 243 | 0.33 (0.28) | 0.60 (0.21) | 0.62 (0.21) | 0.65 (0.20) | 0.67 (0.20) | 0.70 (0.21) | 0.0975†† | |
↵* Normative scores (mean 50.0, SD 10.0), with greater scores indicating better health status.
↵** Two-tailed p values from repeated-measures random-intercept model, including treatment, week, treatment-by-week interaction, and baseline score as independent variables. The interaction term was retained in the model when the p value for the interaction was < 0.10. Otherwise, the interaction term was removed.
↵† Adalimumab plus MTX monotherapy vs MTX monotherapy.
↵†† Adalimumab monotherapy vs MTX monotherapy. 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.