Table 2.
Clinical and laboratory measures in the three groups over 2 years in intention-to-treat (ITT) analysis and per-protocol (PP) analysis
| Variables | Baseline | Year 2 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ITT | PP | ||||||||||
| MTX (n = 69) | TwFH (n = 69) | TwFH + MTX (n = 69) | MTX (n = 69) | TwFH (n = 69) | TwFH + MTX (n = 69) | P | MTX (n = 14) | TwFH (n = 11) | TwFH + MTX (n = 22) | P | |
| ESR (mm/h) | 54.0 (28.0) | 45.1 (24.6) | 51.6 (25.9) | 27.7 (22.6) | 21.9 (17.9) | 26.7 (27.3) | 20.6 (16.8) | 19.8 (19.0) | 22.7 (26.4) | ||
| mean (SD) | 54.0 (28.3, 77.0) | 38.0 (26.0, 67.0) | 48.2 (31.0, 72.0) | 23.0 (10.0, 34.8) | 15.0 (9.0, 31.0) | 17.5 (9.0, 34.8) | 0.760 | 17.0 (8.0, 27.3) | 12.0 (5.0, 28.0) | 15.5 (6.0, 28.5) | 0.868 |
| median (IQR) | |||||||||||
| CRP (mg/L) | |||||||||||
| mean (SD) | 37.5 (40.4) | 27.3 (25.0) | 30.1 (28.7) | 20.6 (34.6) | 11.3 (20.7) | 14.7 (28.6) | 9.0 (18.4) | 15.2 (37.7) | 9.8 (20.3) | ||
| median (IQR) | 21.7 (8.0, 53.8) | 17.9 (7.0, 38.4) | 24.8 (9.5, 42.6) | 5.9 (1.4, 20.0) | 3.5 (1.0, 12.7) | 4.0 (2.0, 19.4) | 0.803 | 1.7 (0.7, 9.4) | 2.4 (0.7, 5.6) | 3.7 (1.2, 9.1) | 0.375 |
| VAS (mm) | |||||||||||
| mean (SD) | 71.4 (22.4) | 68.5 (25.5) | 70.5 (21.3) | 36.8 (28.7) | 32.1 (27.5) | 36.7 (27.4) | 33.2 (31.0) | 29.1 (30.8) | 33.6 (25.5) | ||
| median (IQR) | 72.5 (50.0, 90.0) | 70.0 (50.0, 95.0) | 75.0 (50.0, 85.0) | 30.0 (10.0, 57.5) | 20.0 (10.0, 50.0) | 32.5 (15.0, 60.0) | 0.674 | 30.0 (7.5, 55.0) | 20.0 (0, 50.0) | 32.5 (7.5, 60.0) | 0.966 |
| PGA (mm) | |||||||||||
| mean (SD) | 68.0 (24.6) | 65.5 (23.6) | 65.8 (21.3) | 37.7 (27.5) | 32.7 (27.6) | 38.8 (25.9) | 33.6 (27.6) | 21.8 (24.4) | 35.7 (25.7) | ||
| median (IQR) | 70.0 (50.0, 87.5) | 60.0 (50.0, 87.5) | 62.5 (50.0, 80.0) | 30.0 (10.0, 57.5) | 25.0 (10.0, 50.0) | 40.0 (18.8, 60.0) | 0.959 | 30.0 (10.0, 50.0) | 20.0 (0, 30.0) | 37.5 (10.0, 60.0) | 0.373 |
| PhGA (mm) | |||||||||||
| mean (SD) | 62.8 (23.5) | 60.0 (23.7) | 60.7 (23.1) | 34.2 (27.7) | 31.0 (26.6) | 34.8 (26.1) | 31.4 (32.3) | 26.4 (26.9) | 34.5 (26.8) | ||
| median (IQR) | 65.0 (43.5, 80.0) | 60.0 (40.0, 80.0) | 60.0 (45.0, 80.0) | 30.0 (10.0, 60.0) | 20.0 (10.0, 50.0) | 30.0 (10.0, 51.3) | 0.826 | 30.0 (3.8, 55.0) | 20.0 (0, 50.0) | 32.5 (10.0, 60.0) | 0.701 |
| TJC | |||||||||||
| mean (SD) | 16.2 (8.3) | 13.8 (7.2) | 15.5 (8.3) | 6.9 (7.1) | 4.5 (5.8) | 6.3 (7.5) | 6.1 (6.3) | 2.5 (3.4) | 0.9 (1.4) | ||
| median (IQR) | 16.0 (7.5, 23.5) | 13.0 (7.5, 17.0) | 14.0 (8.0, 22.3) | 5.0 (2.0, 10.0) | 2.0 (0, 7.0) | 3.0 (1.0, 9.0) | 0.287 | 3.0 (1.0, 10.5) | 2.0 (0, 5.0) | 0 (0, 2.3) | 0.368 |
| SJC | |||||||||||
| mean (SD) | 9.1(6.0) | 8.9 (6.1) | 8.9 (6.7) | 2.9 (4.4) | 2.5 (4.3) | 2.4 (4.6) | 3.1 (4.5) | 0.3 (0.6) | 2.2 (4.2) | ||
| median (IQR) | 7.0 (4.5, 13.0) | 7.0 (4.0, 12.0) | 7.0 (3.0, 11.3) | 2.0 (0, 4.0) | 0 (0, 4.0) | 0 (0, 3.0) | 0.836 | 1.0 (0, 5.0) | 0 (0, 0) | 0 (0, 2.3) | 0.191 |
| HAQ | |||||||||||
| mean (SD) | 1.5 (0.9) | 1.3 (0.9) | 1.4 (0.9) | 1.2 (3.6) | 0.5 (0.7) | 0.6 (0.7) | 2.6 (7.9) | 0.4 (0.6) | 0.6 (0.6) | ||
| median (IQR) | 1.5 (0.9, 2.3) | 1.3 (0.6, 2.0) | 1.5 (0.6, 2.1) | 0.5 (0, 1.3) | 0.1 (0, 0.9) | 0.4 (0, 1.0) | 0.162 | 0.1 (0, 0.9) | 0(0, 0.9) | 0.5 (0.1, 1.1) | 0.286 |
| SF36 | |||||||||||
| mean (SD) | 237.8 (127.0) | 292.6 (155.3) | 279.1 (153.4) | 388.8 (138.4) | 448.9 (152.8) | 417.2 (146.9) | 453.3 (78.3) | 469.7 (70.4) | 445.1 (74.6) | ||
| median (IQR) | 231.0 (143.8, 310.0) | 269.3 (181.2, 406.4) | 260.5 (163.5, 364.3) | 397.5 (305.5, 489.5) | 470.2 (351.3, 536.5) | 411.8 (329.8, 507.3) | 0.259 | 478.1 (373.6, 525.7) | 493.3 (426.8, 509.7) | 460.8 (397.8, 506.8) | 0.609 |
| DAS28 | |||||||||||
| mean (SD) | 6.62 (1.31) | 6.22 (1.28) | 6.38 (1.40) | 4.16 (1.70) | 3.54 (1.69) | 3.95 (1.77) | 3.82 (1.96) | 2.83 (1.72) | 3.58 (1.63) | ||
| median (IQR) | 6.66 (5.48, 7.60) | 6.16 (5.37, 7.06) | 6.26 (5.47, 7.37) | 3.70 (3.05, 5.12) | 3.49 (2.09, 4.86) | 3.89 (2.51, 5.13) | 0.298 | 3.45 (2.71, 5.52) | 2.40 (1.42, 4.49) | 3.53 (2.01, 4.63) | 0.613 |
ESR erythrocyte sedimentation rate, CRP C-reactive protein, PGA Patient’s global assessment of disease activity, PhGA Physician’s global assessment of disease activity, TJC tender joint count, SJC swollen joint count, HAQ Health Assessment Questionnaire, SF-36 36-item Short-Form Health Survey questionnaire, DAS28 28-joint count Disease Activity Score, MTX methotrexate, TwHF Tripterygium wilfordii Hook F
Data are presented as mean (standard deviation, SD) and median (interquartile range, IQR)
The p values were calculated using the χ2 test