Table 1:
Baseline demographics and disease characteristics
| Double-blind phase |
Open-label extension |
|||
|---|---|---|---|---|
| Placebo (n=44) | Abatacept (n=44) | Placebo–abatacept (n=34) | Abatacept– abatacept (n=33) | |
| Age, years | 51 (47–58) | 52 (42–56) | 53 (47–59) | 50 (42–56) |
| Sex | ||||
| Female | 35 (80%) | 31 (70%) | 27 (79%) | 27 (82%) |
| Male | 9 (20%) | 13 (30%) | 7 (21%) | 6 (18%) |
| Ethnic origin | ||||
| White | 37 (84%) | 35 (80%) | 30 (88%) | 27 (82%) |
| Not Hispanic or Latino | 36 (82%) | 40 (91%) | 29 (85%) | 32 (97%) |
| Disease duration, years* | 1·3 (1·0–2·2) | 1·5 (0·9–2·5) | 1·3 (1·0–2·1) | 1·7 (0·9–2·4) |
| Disease duration ≤18 months | 27 (61%) | 26 (59%) | 22 (65%) | 18 (55%) |
| Modified Rodnan Skin Score | 21·6 (7·3) | 23·3 (7·9) | 21·1 (6·6) | 23·4 (8·5) |
| Forced vital capacity, % predicted | 86·5% (16·6) | 84·2% (13·5) | 88·5% (16·5) | 85·9% (11·3) |
| Diffusion capacity of carbon monoxide, % predicted† | 76·4% (18·4) | 79·6% (18·1) | 78·7% (19·2)‡ | 84·3% (16·0) |
| Patient global assessment§ | 4·3 (2·6)¶ | 3·9 (2·2)‡ | 4·1 (2·6) | 3·4 (2·0) |
| Health Assessment Questionnaire disability index|| | 1·0 (0·7) | 1·1 (0·7) | 0·9 (0·7) | 1·0 (0·7) |
| Physician global assessment§ | 4·8 (1·7)¶ | 4·8 (1·7) | 4·7 (1·7)¶ | 4·6 (1·7) |
| Tender joint count | 5·4 (7·1) | 3·6 (5·7) | 4·1 (6·1) | 4·2 (6·4) |
| Any tender joint | 28 (64%) | 21 (48%) | 19 (56%) | 15 (45%) |
| Swollen joint count | 3·9 (5·8) | 3·6 (5·6) | 3·9 (6·5) | 3·0 (4·9) |
| Any swollen joint | 21 (48%) | 21 (48%) | 13 (38%) | 14 (42%) |
| Large joint contractures | 32 (74%)‡ | 31 (70%) | 26 (76%) | 24 (73%) |
| Friction rub | 13 (30%) | 19 (43%) | 12 (35%) | 14 (42%) |
| Erythrocyte sedimentation rate, mm/h |
17·6 (15·8) | 17·9 (15·2)‡ | 17·2 (16·5) | 15·1 (11·2)‡ |
| High-sensitivity C-reactive protein, mg/dL | 1·0 (1·4) | 1·1 (1·2) | 0·9 (1·5) | 0·9 (0·9) |
| Anti-centromere positive | 1 (2%)¶ | 3 (7%)‡ | 1 (3%)¶ | 2 (6%)‡ |
| Anti-RNA polymerase 3 positive | 17 (40%)¶ | 22 (51%)‡ | 13 (41%)¶ | 19 (59%)‡ |
| Anti-topoisomerase positive | 7 (17%)¶ | 9 (21%)‡ | 4 (13%)¶ | 6 (19%)‡ |
| Use of prednisone | 5 (11%) | 7 (16%) | 2 (6%) | 7 (21%) |
Data are median (IQR), mean (SD), or n (%).
*
Disease onset was defined as first non-Raynaud’s sign or symptoms.
†
Corrected for haemoglobin.
‡
Data missing for one patient.
§
Theoretical range 0–10.
¶
Data missing for two patients.
||
Theoretical range 0–3.