Table 2.
Disease characteristics at baseline and week 36, according to week-36 concordance category
| Week 36 (n = 763) | |||||
|---|---|---|---|---|---|
| Time frame | Positive discordance (n = 189) | Concordance (n = 556) | Negative discordance (n = 18) | P valuea | |
| DAS28 | BL | 4.4 (0.4) | 4.4 (0.4) | 4.5 (0.4) | 0.2356 |
| Week 36 | 2.8 (1.1) | 2.2 (0.9) | 3.1 (1.3) | <0.0001 | |
| Δ BL to wk 36 | −1.6 (1.0) | −2.2 (0.9) | −1.4 (1.3) | <0.0001 | |
| CRP, mg/L | BL | 9.9 (13.9) | 13.4 (17.7) | 8.1 (7.1) | 0.0256 |
| Week 36 | 6.4 (8.2) | 6.4 (7.9) | 7.6 (12.0) | 0.8036 | |
| Δ BL to wk 36 | −3.4 (14.7) | −7.0 (17.0) | −0.4 (9.8) | 0.0123 | |
| CRP, mg/L, median | BL | 4.6 | 5.9 | 4.0 | |
| Week 36 | 4.0 | 4.0 | 4.0 | ||
| Δ BL to wk 36 | 0 | −1 | 0 | ||
| ESR, mm/h | BL | 21.0 (13.9) | 22.9 (13.1) | 20.2 (10.5) | 0.1652 |
| Week 36 | 13.4 (13.1) | 11.8 (9.5) | 15.0 (10.5) | 0.1083 | |
| Δ BL to wk 36 | −7.6 (11.2) | −11.1 (12.6) | −5.2 (10.7) | 0.0006 | |
| TJC (0–28) | BL | 5.0 (2.6) | 5.0 (2.8) | 6.0 (3.5) | 0.3502 |
| Week 36 | 1.8 (2.5) | 1.1 (2.2) | 4.0 (5.6) | <0.0001 | |
| Δ BL to wk 36 | −3.3 (3.4) | −4.0 (3.2) | −2.0 (6.3) | 0.0039 | |
| SJC (0–28) | BL | 3.5 (2.3) | 4.0 (2.7) | 4.8 (3.3) | 0.0227 |
| Week 36 | 1.1 (1.9) | 0.9 (1.9) | 3.9 (4.3) | <0.0001 | |
| Δ BL to wk 36 | −2.3 (2.5) | −3.1 (2.6) | −0.9 (5.0) | <0.0001 | |
| Duration of morning joint stiffness, min | BL | 227 (384) | 158 (314) | 242 (472) | 0.0453 |
| Week 36 | 78 (164) | 39 (166) | 67 (144) | 0.0191 | |
| Δ BL to wk 36 | −148 (370) | −120 (324) | −175 (515) | 0.5315 | |
| BPI (0–10) | BL | 4.7 (2.1) | 3.7 (1.9) | 3.9 (2.1) | <0.0001 |
| Week 36 | 3.2 (2.2) | 1.1 (1.3) | 1.8 (1.6) | <0.0001 | |
| Δ BL to wk 36 | −1.5 (2.4) | −2.6 (2.1) | −2.1 (2.5) | <0.0001 | |
| HAQ-DI (0–3) | BL | 1.2 (0.6) | 1.1 (0.6) | 1.2 (0.7) | 0.1458 |
| Week 36 | 0.9 (0.6) | 0.5 (0.5) | 0.7 (0.6) | <0.0001 | |
| Δ BL to wk 36 | −0.3 (0.6) | −0.7 (0.5) | −0.5 (0.5) | <0.0001 | |
| FACIT-fatigueb (0–52) | BL | 30.8 (9.3) | 33.7 (9.4) | 29.7 (10.0) | 0.0006 |
| Week 36 | 35.7 (9.5) | 43.1 (8.0) | 39.1 (9.8) | <0.0001 | |
| Δ BL to wk 36 | 4.9 (9.4) | 9.4 (8.8) | 9.3 (11.4) | <0.0001 | |
| CDAI (0–76) | BL | 18.1 (4.5) | 17.6 (5.0) | 21.2 (6.3) | 0.0049 |
| Week 36 | 8.7 (5.8) | 4.7 (5.1) | 13.6 (10.1) | <0.0001 | |
| Δ BL to wk 36 | −9.5 (6.5) | −12.9 (6.4) | −7.6 (12.0) | <0.0001 | |
| SDAI (0–86) | BL | 19.2 (4.6) | 18.9 (5.2) | 22.0 (6.2) | 0.0382 |
| Week 36 | 9.4 (5.9) | 5.3 (5.3) | 14.4 (10.5) | <0.0001 | |
| Δ BL to wk 36 | −9.8 (6.4) | −13.6 (6.5) | −7.6 (12.2) | <0.0001 | |
| Patient global assessment (0–10) | BL | 5.5 (1.6) | 4.6 (1.7) | 5.2 (2.0) | <0.0001 |
| Week 36 | 4.5 (1.8) | 1.5 (1.2) | 1.4 (1.1) | <0.0001 | |
| Δ BL to wk 36 | −1.0 (2.2) | −3.1 (1.9) | −3.8 (2.2) | <0.0001 | |
| Physician global assessment (0–10) | BL | 4.2 (1.4) | 4.0 (1.3) | 5.2 (1.5) | 0.0002 |
| Week 36 | 1.4 (1.2) | 1.3 (1.1) | 4.3 (2.1) | <0.0001 | |
| Δ BL to wk 36 | −2.9 (1.6) | −2.7 (1.5) | −0.9 (2.9) | <0.0001 | |
| Patient general health VAS | BL | 47.8 (16.9) | 40.9 (15.9) | 45.7 (22.8) | <0.0001 |
| Week 36 | 36.9 (19.1) | 12.4 (13.3) | 14.7 (14.4) | <0.0001 | |
| Δ BL to wk 36 | −11.1 (22.4) | −28.5 (18.8) | −31.1 (22.6) | <0.0001 | |
Values are mean (SD). Positive discordance: patient global assessment – physician global assessment ≥2. Negative discordance: patient global assessment – physician global assessment ≤ –2. Concordance: patient global assessment – physician global assessment = 0 or 1. BL baseline, BPI brief pain inventory, CDAI clinical disease activity index, CRP C-reactive protein, DAS28 disease activity score based on 28 joint count, ESR erythrocyte sedimentation rate, FACIT-fatigue functional assessment of chronic illness therapy-fatigue, HAQ-DI health assessment questionnaire disability index, SDAI simplified disease activity index, SJC swollen joint count, TJC tender joint count, VAS visual analog scale, wk, week. a F-statistic (analysis of variance). bHigher scores indicate less fatigue