Baseline characteristics and clinical outcomes according to treatment group
| Characteristics and outcomes | Early DAS remission | Randomisation | Outside protocol treatment | |
|---|---|---|---|---|
| (n=387) | Arm 1(n=83) | Arm 2(n=78) | (n=50) | |
| Baseline characteristics | ||||
| DAS, mean±SD | 3.0±0.8 | 3.6±0.9 | 3.6±1.0 | 3.6±0.9 |
| HAQ, mean±SD | 1.0±0.7 | 1.4±0.6 | 1.4±0.6 | 1.3±0.7 |
| Swollen joint count, median (IQR) | 5 (2–9) | 6 (3–10) | 8 (4–12) | 7 (3–13) |
| Tender joint count, median (IQR) | 5 (3–8) | 8 (6–13) | 9 (6–13) | 8 (6–14) |
| Age (years), mean±SD | 52±14 | 49±14 | 51±14 | 54±14 |
| Female, n (%) | 240 (62) | 64 (77) | 58 (74) | 42 (84) |
| Symptom duration in weeks, median (IQR) | 17 (9–30) | 22 (9–41) | 21 (8–31) | 18 (9–42) |
| Symptom duration <12 weeks, n (%) | 247 (64) | 59 (71) | 49 (63) | 28 (56) |
| RF positive, n (%) | 224 (58) | 41 (49) | 43 (55) | 23 (46) |
| ACPA positive, n (%) | 225 (58) | 40 (48) | 37 (47) | 25 (50) |
| RA (2010), n (%) | 298 (77) | 66 (80) | 66 (85) | 40 (80) |
| Total SHS, median (IQR) | 0 (0–0.5) | 0 (0–0) | 0 (0–0) | 0 (0–0) |
| Erosive, n (%) | 63 (16) | 10 (12) | 13 (17) | 3 (6) |
| Follow-up—4 months | ||||
| DAS, mean±SD | 1.0±0.4 | 2.5±0.6 | 2.6±0.7 | 2.3±0.6 |
| HAQ, mean±SD | 0.2±0.3 | 0.9±0.6 | 0.9±0.6 | 0.8±0.7 |
| Swollen joint count, median (IQR) | 0 (0–0) | 1 (0–4) | 2 (1–5) | 0 (0–2) |
| Tender joint count, median (IQR) | 0 (0–1) | 4 (3–7) | 5 (3–9) | 4 (2–6) |
| ESR (mm/h), median (IQR) | 6 (3–12) | 13 (7–22) | 11 (6–19) | 15 (9–28) |
| VAS global health (mm), mean±SD | 14±14 | 37±21 | 38±21 | 30±21 |
| Follow up—1 year | ||||
| DAS, mean±SD | 1.3±0.8 | 2.1±0.9 | 1.8±0.9 | 2.1±0.8 |
| HAQ, mean±SD | 0.4±0.5 | 0.9±0.6 | 0.8±0.7 | 0.8±0.6 |
| Swollen joint count, median (IQR) | 0 (0–1) | 0 (0–3) | 0 (0–1) | 1 (0–2) |
| Tender joint count, median (IQR) | 0 (0–2) | 3 (1–7) | 3 (0–6) | 4 (1–8) |
| ESR (mm/h), median (IQR) | 8 (4–15) | 9 (5–18) | 9 (4–16) | 14 (7–31) |
| VAS global health (mm), mean±SD | 20±21 | 33±23 | 27±20 | 33±24 |
| Total SHS, median (IQR) | 0 (0–0.5) | 0 (0–0.5) | 0 (0–0) | 0 (0–0) |
| Erosive, n (%) | 65 (17) | 12 (15) | 12 (15) | 2 (4) |
| DAS remission, n (%) | 263 (68) | 21 (25) | 32 (41)* | 12 (24) |
| Drug-free remission, n (%) | 124 (32) | 1 (1) | 0 (0) | 5 (10) |
| ACR/EULAR remission, n (%) | 122 (32) | 9 (11) | 13 (17) | 4 (8) |
| SHS progression, median (IQR) | 0 (0–0) | 0 (0–0) | 0 (0–0) | 0 (0–0) |
*p Value <0.05 between arms 1 and 2.
ACPA, anti-citrullinated protein antibodies; DAS, disease activity score; ESR, erythrocyte sedimentation rate; HAQ, Health Assessment Questionnaire; RA (2010), rheumatoid arthritis according to the 2010 classification criteria; RF, rheumatoid factor; SHS, Sharp–van de Heijde Score, VAS, visual analogue scale.
Progression: increase in SHS ≥ 0.5 points; DAS remission: DAS < 1.613; ACR/EULAR remission: provisional Boolean-based remission definition published by the American College of Rheumatology and the European League Against Rheumatism based on a 44- joint count.11 Erosive denotes the presence of at least one erosion on radiographs of hands and feet.