Clinical characteristics at baseline and during 1 year follow-up of the total study group and separate for patients with and without radiological progression
| Radiological progression | ||||
|---|---|---|---|---|
| Total population | Yes | No | p Value | |
| Baseline | n=428 | n=28 | n=400 | |
| Age, years, mean±SD | 52±13 | 58±11 | 52±13 | 0.01 |
| Female, no (%) | 294 (69) | 22 (79) | 272 (68) | 0.2 |
| BMI, kg/m2, mean±SD | 26±4 | 25±4 | 26±4 | 0.6 |
| Current smoking, no (%) | 127 (30) | 11 (39) | 116 (29) | 0.3 |
| Current alcohol use, no (%) | 250 (58) | 17 (61) | 233 (58) | 0.9 |
| Postmenopausal status, no (%), n=294 | 156 (53) | 17 (89) | 139 (58) | 0.01 |
| Previous fractures, no (%) | 142 (33) | 8 (29) | 134 (34) | 0.7 |
| Familial osteoporosis, no (%) | 72 (17) | 6 (21) | 66 (17) | 0.5 |
| Calcium intake, mg/day, median (IQR) | 800 (600–1050) | 875 (725–1069) | 778 (600–1030) | 0.2 |
| 25 (OH) vitamin D, nmol/L, median (IQR) | 55 (38–75) | 46 (25–75) | 55 (39–75) | 0.3 |
| DAS (mean±SD) | 3.2±0.9 | 3.3±0.9 | 3.2±0.9 | 0.8 |
| RA (2010), no (%) | 344 (80) | 26 (93) | 318 (80) | 0.04 |
| Symptom duration, weeks, median (IQR) | 18 (9–33) | 20 (9–47) | 18 (9–32) | 0.5 |
| ACPA-positive, no (%) | 247 (58) | 23 (82) | 224 (56) | 0.008 |
| RF-positive, no (%) | 241 (56) | 18 (64) | 223 (56) | 0.2 |
| ACPA-positive and RF-positive, no (%) | 205 (48) | 19 (68) | 186 (47) | 0.04 |
| SHS total score | 0 (0–0) | 0.5 (0–4.5) | 0 (0–0) | <0.001 |
| Presence of erosions, no (%) | 62 (14) | 11 (39) | 51 (13) | <0.001 |
| 4 months | ||||
| DAS (mean±SD) | 1.5±0.9 | 1.5±0.8 | 1.5±0.9 | 0.9 |
| Remission no (%) | 275 (64) | 17 (61) | 258 (65) | 0.7 |
| Early remission group, no (%) | 281 (66) | 17 (61) | 264 (66) | 0.6 |
| Arm 1 MTX+SSZ+HCQ+pred, no (%) | 60 (14) | 4 (14) | 56 (14) | 0.97 |
| Arm 2 MTX+adalimumab, no (%) | 57 (13) | 5 (18) | 52 (13) | 0.5 |
| Outside of protocol group, no (%) | 30 (7) | 2 (7) | 28 (7) | 0.98 |
| 8 months | ||||
| DAS (mean±SD) | 1.5±0.8 | 1.8±1.0 | 1.5±0.8 | 0.05 |
| Remission no (%) | 246 (57) | 12 (43) | 234 (61) | 0.1 |
| 1 year | ||||
| Use of bisphosphonate, no (%) | 129 (30) | 9 (32) | 120 (30) | 0.8 |
| Use of calcium and/or vitamin D, no (%) | 204 (48) | 16 (57) | 180 (45) | 0.2 |
| DAS (mean±SD) | 1.6±0.9 | 1.6±0.9 | 1.6±0.9 | 0.7 |
| Remission, no (%) | 235 (55) | 16 (57) | 219 (55) | 0.8 |
| SHS progression | 0 (0–0) | 0.5 (0.5–1.4) | 0 (0–0) | <0.001 |
ACPA, anti-citrullinated protein antibodies; arm 1, patients not in early remission who were randomised to arm 1; arm 2, patients not in early remission who were randomised to arm 2; BMI, body mass index (kg/m2); DAS, disease activity score; early remission group, patients who were in remission after 4 months and started tapering medication; HCQ, hydroxychloroquine; pred, prednisone; MTX, methotrexate; Outside of protocol group, patients not in early remission but not randomised and treated outside the protocol; presence of erosions, defined as ≥1 erosions; RA (2010), rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria for RA; remission, defined as DAS<1.6; RF, rheumatoid factor; SHS, Sharp/van der Heijde Score; SSZ, sulfasalazine.