Baseline characteristics and clinical outcomes for the total population, SHS progression and no SHS progression
| Total population n=488 | SHS progression n=50 | No SHS progressionn=438 | p Value | |
|---|---|---|---|---|
| Baseline | ||||
| Age (years), mean±SD | 51±14 | 56±12 | 51±14 | 0.008 |
| Female, n (%) | 333 (68) | 33 (66) | 300 (68) | 0.720 |
| RA (2010), n (%) | 388 (80) | 41 (82) | 347 (79) | 0.777 |
| DAS, mean±SD | 3.19±0.91 | 3.25±1.08 | 3.19±0.89 | 0.649 |
| HAQ, mean±SD | 1.15±0.67 | 1.09±0.66 | 1.15±0.67 | 0.545 |
| Symptom duration (in weeks), median (IQR) | 18 (9–34) | 25 (16–39) | 17 (9–32) | 0.032 |
| RF positive, n (%) | 273 (56) | 31 (62) | 242 (55) | 0.242 |
| ACPA positive, n (%) | 274 (56) | 35 (70) | 239 (55) | 0.053 |
| Anti-CarP positive,n (%) | 139 (29) | 22 (44) | 117 (27) | 0.012 |
| ESR mm/h(median, IQR) | 24 (11–39) | 31 (19.5–43.5) | 24 (10.8–38.0) | 0.020 |
| SJC, median (IQR) | 5 (3–10) | 5 (2–12) | 5 (3–10) | 0.921 |
| TJC, median (IQR) | 6 (4–10) | 5 (4–9) | 6 (4–10) | 0.263 |
| SHS, median (IQR) | 0 (0–0) | 1.25 (0–4) | 0 (0–0) | <0.001 |
| DXR-BMD* g/cm2, median (IQR) | 0.591 (0.527–0.643) | 0.582 (0.479–0.632) | 0.593 (0.529–0.642) | 0.322 |
| 4 months | ||||
| DAS, mean±SD | 1.49±0.88 | 1.43±0.93 | 1.49±0.87 | 0.607 |
| ACR/EULAR remission, n (%) | 125 (26) | 16 (32) | 109 (25) | 0.264 |
| Early DAS remission, n (%) | 322 (66) | 33 (66) | 289 (66) | 0.998 |
| Arm 1 DMARD combination, n (%) | 69 (14) | 9 (18) | 60 (14) | 0.408 |
| Arm 2 adalimumab,n (%) | 65 (13) | 5 (10) | 60 (14) | 0.466 |
| Outside of Protocol,n (%) | 32 (7) | 3 (6) | 29 (7) | 0.867 |
| DXR-BMD* g/cm2, median (IQR) | 0.588 (0.522–0.631) | 0.579 (0.496–0.646) | 0.590 (0.522–0.631) | 0.747 |
| 2 years | ||||
| DAS, mean±SD | 1.47±0.83 | 1.52±0.85 | 1.47±0.83 | 0.670 |
| HAQ, mean±SD | 0.54±0.60 | 0.58±0.62 | 0.53±0.60 | 0.583 |
| Total SHS, median (IQR) | 0 (0–0.5) | 4 (1.0–6.6) | 0 (0–0) | <0.001 |
| SHS progression, median (IQR) | 0 (0–0) | 1 (0.5–3.0) | 0 (0–0) | <0.001 |
| JSN, n (%) | 111 (23) | 40 (80) | 71 (16) | <0.001 |
| JSN, median (IQR) | 0 (0–0) | 3 (0.9–6.0) | 0 (0–0) | <0.001 |
| JSN progression, n (%) | 38 (78) | 37 (74) | 1 (0.2) | <0.001 |
| JSN progression,median (IQR) | 1.8 (0.9–3.0) | 1.5 (0.8–3.0) | 2 (2–2) | <0.001 |
| Erosive, n (%) | 49 (10) | 26 (52) | 23 (5) | <0.001 |
| Erosion score,median (IQR) | 0 (0–0) | 0.5 (0–1) | 0 (0–0) | <0.001 |
| Erosion progression, n (%) | 20 (41) | 20 (40) | 0 (0) | <0.001 |
| Erosion progression, median (IQR) | 0.5 (0.5–3.0) | 0.5 (0.5–3.0) | 0 (0–0) | <0.001 |
| DAS-remission, n (%) | 285 (58) | 29 (58) | 256 (58) | 0.905 |
| Drug-free remission,n (%) | 123 (25) | 12 (24) | 111 (25) | 0.822 |
*DXR-BMD data imputed in 442 patients.
ACPA, anticitrullinated protein antibodies; anti-CarP, anticarbamylated protein antibodies; ACR, American College of Rheumatology; DAS, disease activity score; DXR-BMD, metacarpal bone mineral density measured by digital X-ray radiogrammetry; ESR, erythrocyte sedimentation rate; EULAR, European League Against Rheumatism; HAQ, health assessment questionnaire; JSN, joint space narrowing; RA, rheumatoid arthritis; RF, rheumatoid factor; SHS, Sharp/van der Heijde score; SJC, swollen joint count; TJC, tender joint count.