Demographic data at baseline as well as clinical characteristics and radiographic findings at baseline and at 5 years in patients randomised to receive initial infliximab (FIN-RACo+INFL) or initial placebo infusions (FIN-RACo+PLA) for 6 months in addition to a combination of three DMARDs and small-dose prednisolone
| Characteristic | The initial randomisation group | p Value | |
|---|---|---|---|
| FIN-RACo+Infliximab (n=47) | FIN-RACo+Placebo (n=46) | ||
| Demographic data at baseline | |||
| Female, no. (%) | 34 (72) | 29 (63) | 0.34 |
| Age (years), mean±SD years | 47±10 | 45±11 | 0.45 |
| Duration of symptoms (months), median (IQR) | 4 (2, 4) | 4 (3, 4) | 0.59 |
| Rheumatoid factor present (%) | 36 (77) | 33 (72) | 0.59 |
| Measures of disease activity at baseline | |||
| Number of swollen joints, median (IQR) | 14 (11, 19) | 13 (9, 21) | 0.99 |
| Number of tender joints, median (IQR) | 16 (12, 24) | 19 (12, 28) | 0.50 |
| Erythrocyte sedimentation rate (mm/h), median (IQR) | 31 (18, 44) | 27 (14, 48) | 0.84 |
| Patient's global assessment (VAS, mm), mean±SD | 50±24 | 48±26 | 0.63 |
| Pain (VAS, mm), mean±SD | 55±27 | 52±27 | 0.67 |
| Physician's global assessment (VAS, mm), mean±SD | 49±21 | 54±19 | 0.17 |
| DAS28, mean±SD | 5.5±1.0 | 5.6±1.4 | 0.91 |
| Physical function (HAQ), median (IQR) | 0.9 (0.6, 1.8) | 0.9 (0.4, 1.5) | 0.18 |
| Radiography at baseline | |||
| Erosion score, mean±SD | 2.3±6.9 | 1.4±2.9 | 0.44 |
| Narrowing score, mean±SD | 0.4±1.5 | 0.3±0.6 | 0.57 |
| Total score, mean±SD | 2.6±8.0 | 1.6±3.2 | 0.47 |
| Erosions in hand or foot radiographs (%) | 20 (43) | 15 (33) | 0.32 |
| Measures of disease activity at 5 years | |||
| Number of swollen joints, median (IQR) | 0 (0, 0) | 0 (0, 0) | 0.84 |
| Number of tender joints, median (IQR) | 0 (0, 1) | 0 (0, 2) | 0.51 |
| Erythrocyte sedimentation rate (mm/h), median (IQR) | 11 (6, 14) | 7 (4, 13) | 0.14 |
| Patient's global assessment (VAS, mm), mean±SD | 12±20 | 9±15 | 0.40 |
| Pain (VAS, mm), mean±SD | 12±20 | 11±19 | 0.87 |
| Physician's global assessment (VAS, mm), mean±SD | 8±16 | 5±14 | 0.44 |
| DAS28, mean±SD | 2.0±1.2 | 1.7±0.9 | 0.33 |
| Proportion of patients in DAS28 remission (%) (95% CI) | 84 (71 to 94) | 89 (76 to 96) | 0.51 |
| Proportion of patients in strict ACR remission (%) (95% CI) | 60 (44 to 74) | 61 (45 to 75) | 0.93 |
| Physical function (HAQ), median (IQR) | 0 (0, 0.1) | 0 (0, 0) | 0.39 |
| Radiography at 5 years | |||
| Erosion score, mean±SD | 3.7±6.2 | 4.0±5.2 | 0.80 |
| Narrowing score, mean±SD | 0.8±1.8 | 1.1±2.2 | 0.40 |
| Total score, mean±SD | 4.3±7.6 | 5.3±7.3 | 0.54 |
| Erosions in hand or foot radiographs (%) | 26 (58) | 30 (65) | 0.47 |
DAS, disease activity score; HAQ, Health Assessment Questionnaire; VAS, visual analogue scale.