Baseline demographics and disease characteristics
| Leuven observational cohort | |||||
|---|---|---|---|---|---|
| ICTS | IMT | Total | Leuven RCT | ASPIRE | |
| N | 37 | 43 | 80 | 20 | 1049 |
| Age | 49 (39–62) | 52 (39–70) | 50 (39–67) | 55 (38–63) | 51 (41–60) |
| Sex, female | 25 (67.6) | 27 (62.8) | 52 (65) | 12 (60) | 742 (71.1) |
| Disease duration (months) | 7.1 (3.5–12.3) | 6.2 (3–10) | 6.7 (3.4–11.9) | 6.9 (4.4–10.2) | 7.2 (4.8–13.2) |
| Health Assessment Questionnaire score (0–3) | 1 (0.66–1.75) | 1.125 (0.5–1.375) | 1.1 (0.5–1.6) | 1.25 (0.9–1.8) | 1.5 (1.0–1.9) |
| Tender joint count | 15 (9–24)* | 9 (5–14) | 12 (6–18) | 25 (7–36)† | 31 (22–44) |
| Swollen joint count | 15 (8–20.5)* | 9 (5–13) | 11 (6–17) | 15 (10–23)† | 19 (14–26) |
| C reactive protein (mg/dl) | 1.37 (0.73–4.92) | 1.66 (0.48–3.42) | 1.6 (0.6–4.2) | 2.6 (0.9–5.0) | 1.4 (0.4–4.1) |
| ESR (mm/h) | 38 (18.5–55.5) | 29 (12–48) | 32 (16–51) | 33 (23–44) | 40 (23–61) |
| DAS ESR | 5.82 (4.62–6.68)* | 4.86 (4.12–5.94) | 5.33 (4.29–6.37) | 6.15 (5.2–6.97)† | |
| RF (IU/ml) | 120 (21–396) | 87 (10–329) | 115 (12–369) | 65 (13–371) | 175 (30–357) |
| Presence of RF | 28 (75.7) | 28 (65.1) | 56 (70) | 13 (65) | No data |
| Presence of anti-CCP antibodies | 33 (89.2)* | 24 (57.1) | 57 (72.2) | 15 (75) | No data |
| Total modified Sharp/van der Heijde score | 4 (1.5–8) | 3 (1–10) | 3.5 (1.1–8.4) | 4.5 (1.7–9.9) | 5.0 (1.5–14.0) |
| Patients with joint erosion | 27 (73) | 26 (60.5) | 53 (66.3) | 17 (85) | 854 (82.0) |
| Patients with joint space narrowing | 36 (97.3) | 38 (88.4) | 74 (92.5) | 20 (100) | 687 (65.9) |
Data are presented as median (IQR1, IQR3) or as numbers (%).
↵* p<0.05 comparing ICTS with IMT patients.
↵† p<0.05 comparing total observational cohort (OC) with RCT cohort.
ASPIRE, Active-Controlled Study of Patients Receiving Infliximab for Treatment of Rheumatoid Arthritis of Early Onset; DAS, Disease Activity Score; ESR, erythrocyte sedimentation rate; ICTS, initial combination therapy with steroid; IMT, initial disease-modifying antirheumatic drug monotherapy; RCT, randomised controlled trial; RF, rheumatoid factor.