Table 2.
Demographic and characteristics data of RA patients at baseline in FAS.
| Characteristics | MTX + HQT (n = 45) | MTX + LEF (n = 45) | P |
|---|---|---|---|
| Age (SD), years | 51.67 (9.92) | 47.56 (11.40) | 0.099 |
| Female, n (%) | 35.00 (77.80) | 31.00 (68.90) | 0.340 |
| Disease duration (SD), months | 41.82 (45.93) | 33.90 (36.53) | 0.783 |
| TJC (SD), n | 8.62 (5.09) | 9.20(6.15) | 0.948 |
| SJC (SD), n | 6.29 (4.19) | 4.67(3.02) | 0.053 |
| Patient's assessment of pain (SD), mm | 65.09 (16.40) | 59.78(20.17) | 0.183 |
| PhGADA† (SD), mm | 61.11 (14.81) | 56.33(18.84) | 0.246 |
| PaGADA† (SD), mm | 62.00 (18.17) | 57.56(20.47) | 0.295 |
| Morning stiffness (SD), min | 47.11 (32.80) | 53.89 (50.56) | 0.798 |
| HAQ, mean ± SD | 0.65 (0.56) | 0.92 (0.67) | 0.063 |
| hs-CRP (SD), mg/L | 17.72 (19.10) | 27.62 (35.15) | 0.161 |
| ESR (SD), mm/h | 60.09 (27.29) | 55.64 (31.39) | 0.368 |
| RF# (SD), U/ml | 216.15 (298.88) | 180.89 (194.82) | 0.812 |
| Anti-CCP#, positive rate | 86.05% (37/43) | 87.80% (36/41) | 0.811 |
| DAS28-CRP | 6.02 (1.81) | 5.97 (2.17) | 0.620 |
| cDAI (SD) | 27.22 (8.98) | 25.12 (10.06) | 0.284 |
| Concomitant treatments | |||
| NSAIDs, n (%) | 43 (95.6%) | 44 (97.8%) | 1.000 |
| Glucocorticoid oral, n (%) | 29 (64.4%) | 27 (60.0%) | 0.664 |
| Folic acid tablet, n (%) | 41 (91.1%) | 44 (97.8%) | 0.357 |
| Calcitriol/calcium carbonate, n (%) | 37 (82.2%) | 43 (95.6%) | 0.094 |
| Antacids, n (%) | 40 (88.9%) | 42 (93.3%) | 0.711 |
Data are presented as the mean (SD) or n (%).
FAS, full analysis set; TJC, tender joint count; SJC, swollen joint count; PhGADA, physician's global assessment of disease activity; PaGADA, patient's global assessment of disease activity; HAQ, Health Assessment Questionnaire; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; RF, rheumatoid factor; anti-CCP, anti-cyclic citrullinated peptide antibody; DAS28-CRP, 28-joint disease activity score- C-reactive protein; cDAI, clinical disease activity index; NSAIDs, non-steroidal anti-inflammatory drugs.
RF# was measured by immunonephelometric with a cutoff value of 20 U/ml. Anti-CCP# was measured using a commercially available second-generation ELISA kit (Abbott, USA) with a cutoff value of 25 U/ml.
Measured on a 100-mm visual analog scale; the upper limit of normal for CRP is 0–6 mg/L.