Table 3.
Clinical and laboratory measures of the two groups at each visit in the ITT analysis.
| Measures | MTX + HQT | MTX + LEF | ||||||
|---|---|---|---|---|---|---|---|---|
| 0W | 4W | 12W | 24W | 0W | 4W | 12W | 24W | |
| TJC, n | 8.40 (5.10) | 6.47 (4.86) | 4.72 (3.53) | 3.56 (4.04) | 8.98 (5.92) | 6.36 (5.19) | 4.77 (5.02) | 3.32 (5.01) |
| SJC, n | 6.33 (4.28) | 4.05 (3.37) | 2.00 (2.40) | 1.81 (3.81) | 4.61 (3.03) | 2.91 (2.87) | 1.89 (2.53) | 1.07 (1.89) |
| Patient's assessment of pain, mm† | 65.09 (16.75) | 45.81 (17.89) | 30.35 (20.66) | 23.44 (18.20) | 60.00 (20.35) | 42.45 (22.35) | 29.91 (21.30) | 21.48 (19.55) |
| PaGADA, mm† | 61.86 (18.55) | 39.70 (20.52) | 29.53 (19.75) | 19.95 (17.47) | 58.18 (20.26) | 44.32 (22.45) | 29.32 (20.95) | 20.80 (20.17) |
| PhGADA, mm† | 61.16 (15.15) | 40.81 (20.18) | 28.60 (18.85) | 20.70 (16.53) | 56.25 (19.05) | 43.18 (20.88) | 30.57 (21.41) | 21.25 (19.68) |
| Morning stiffness, min | 47.91 (33.35) | 26.98 (28.10) | 17.84 (32.62) | 19.30 (49.07) | 54.20 (51.01) | 35.00 (41.81) | 14.55 (18.48) | 11.50 (22.49) |
| CRP, mg/L | 18.42 (19.25) | 14.36 (19.21) | 12.50 (15.38) | 11.52 (18.39) | 27.16 (35.78) | 15.07 (25.27) | 18.12 (55.57) | 10.13 (16.96) |
| ESR, mm/h | 60.70 (26.44) | 55.05 (27.41) | 51.81 (31.30) | 46.91 (27.69) | 54.43 (30.79) | 51.95 (32.14) | 44.12 (29.49) | 42.09 (28.45) |
| RF, U/ml | 204.14 (283.21) | 157.91 (222.86) | 153.38 (224.95) | 222.09 (437.13) | 182.05 (196.06) | 182.21 (246.89) | 123.59 (202.98) | 113.37 (149.13) |
| HAQ | 0.64 (0.57) | 0.43 (0.45) | 0.38 (0.53) | 0.26 (0.46) | 0.91 (0.68) | 0.59 (0.63) | 0.44 (0.56) | 0.31 (0.57) |
| DAS28-CRP | 5.98 (1.85) | 4.73 (2.08) | 3.69 (1.60) | 3.21 (1.77) | 5.90 (2.09) | 4.47 (2.04) | 3.64 (2.09) | 2.98 (2.05) |
*
Values are the mean (SD).
TJC, tender joint count; SJC, swollen joint count; PaGADA, patient's global assessment of disease activity; PhGADA, physician's global assessment of disease activity; HAQ, Health Assessment Questionnaire; ESR, erythrocyte sedimentation rate; CRP, C-reactive protein; RF, rheumatoid factor; DAS28, 28-joint disease activity score.
†
Measured on a 100-mm visual analog scale.