Demographic data, clinical characteristics, and radiographic findings at baseline in patients randomized to receive initial infliximab (FIN-RACo+IFX) or initial placebo infusions (FIN-RACo+PLA) for 6 months in addition to a combination of 3 DMARD and low-dose prednisolone.
| Characteristics at Baseline | Initial Randomization Group | |
|---|---|---|
| FIN-RACo+IFX, n = 38 | FIN-RACo+PLA, n = 47 | |
| Demographic data | ||
| Female, n (%) | 28 (74) | 29 (62) |
| Age, yrs, mean (SD) | 48 (9) | 47 (11) |
| Duration of symptoms (mos), median (IQR) | 4 (2–6) | 4 (2–6) |
| RF present, n (%) | 30 (79) | 34 (72) |
| Measures of disease activity, mean (SD) | ||
| No. swollen joints (0–66) | 15 (5) | 16 (8) |
| No. tender joints (0–68) | 19 (9) | 21 (11) |
| ESR, mm/h | 32 (22) | 33 (22) |
| PtGA (0–100 VAS, mm) | 51 (25) | 48 (27) |
| Pain (0–100 VAS, mm) | 54 (28) | 53 (27) |
| PGA (0–100, VAS, mm) | 49 (22) | 55 (20) |
| DAS28 | 5.53 (0.94) | 5.60 (1.39) |
| Physical function (HAQ) | 1.08 (0.59) | 0.91 (0.71) |
| Radiography at baseline | ||
| Erosion score, mean (SD)* | 2.9 (7.6) | 1.3 (2.9) |
| Narrowing score, mean (SD)* | 0.6 (1.7) | 0.3 (0.6) |
| Total score, mean (SD)* | 3.4 (8.9) | 1.6 (3.2) |
| Erosions in hand or foot radiographs, n (%) | 18 (47) | 14 (30) |
↵* Radiologic score by modified Sharp/van der Heijde method. DAS28: 28-joint count Disease Activity Score; DMARD: disease-modifying antirheumatic drug; ESR: erythrocyte sedimentation rate; HAQ: Health Assessment Questionnaire; IQR: interquartile range; PGA: physician’s global assessment; PLA: placebo; PtGA: patient’s global assessment; RF: rheumatoid factor; VAS: visual analog scale.