| General |
|
|
|
|
| Weight (kg) |
72 (7) |
70 (17) |
73 (16) |
0.23 |
| Lung |
|
|
|
|
| Forced vital capacity (% predicted) |
66.1 (12.1) |
69.3 (12.8) |
67.3 (11.7) |
0.32 |
| Forced expiratory volume‐1 s (% predicted) |
68.9 (12.8) |
70.8 (14.5) |
67.6 (11.4) |
0.13 |
| FEV/FVC ratio (% predicted) |
82.8 (8.0) |
83.6 (6.0) |
82.2 (9.1) |
0.27 |
| Total lung capacity (% predicted) |
69.6 (13.0) |
70.0 (13.4) |
69.5 (12.9) |
0.96 |
| Diffusing capacity (% predicted) |
47.2 (14.0) |
45.7 (13.5) |
48.3 (14.2) |
0.25 |
| Mahler Baseline Dyspnoea Index (0–12) |
5.7 (1.9) |
5.7 (1.5) |
5. 7 (2.1) |
0.89 |
| Breathing VAS (0–100 mm) |
28.4 (26.2) |
25.2 (21.0) |
30.5 (29.0) |
0.22 |
| Cough index (0–4) |
1.9 (0.9) |
2.2 (0.8) |
1.9 (0.8) |
0.06 |
| HRCT and BAL |
|
|
|
|
| Fibrosis score (worst) |
1.98 (1.04) |
2.09 (0.57) |
1.77 (1.05) |
0.08 |
| Fibrosis score (total) |
7.08 (4.04) |
7.74 (4.07) |
6.31 (3.93) |
0.046 |
| BAL neutrophils (% of total cells) |
6.29 (7.31) |
7.23 (8.11) |
5.62 (6.66) |
0.20 |
| BAL eosinophils (% of total cells) |
2.87 (4.35) |
3.19 (4.69) |
2.65 (4.12) |
0.47 |
| Questionnaires |
|
|
|
|
| SF‐36, Physical component scale (0–100) |
33.5 (10.8) |
36.0 (10.2) |
31.8 (10.9) |
0.016 |
| SF‐36, Mental component scale (0–100) |
49.5 (10.6) |
51.6 (9.8) |
48.5 (11.0) |
0.08 |
| Disability Index of HAQ (0–3) |
0.8 (0.7) |
0.5 (0.5) |
1.1 (0.7) |
0.0001 |
| Patient global assessment VAS (0–100 mm) |
40.8 (26.6) |
31.6 (24.2) |
47.1 (26.4) |
0.0002 |
| Raynaud's VAS (0–100 mm) |
25.7 (29.0) |
21.2 (26.3) |
28.8 (30.4) |
0.10 |
| GI VAS (0–100 mm) |
13.1 (20.2) |
12.9 (21.3) |
13.3 (19.5) |
0.90 |
| Digital ulcer VAS (0–100 mm) |
13.6 (25.4) |
6.3 (15.1) |
18.5 (29.6) |
0.003 |
| Skin |
|
|
|
|
| Modified Rodnan skin score (0–51) |
14.6 (10.8) |
5.6 (3.3) |
20.8 (9.8) |
0.0001 |
| Handspread (mm): right |
176.6 (33) |
188.6 (26.4) |
168.3 (34.6) |
0.0003 |
| Musculoskeletal |
|
|
|
|
| CPK (ratio of observed/upper limit normal) |
1.43 (1.7) |
1.3 (1.8) |
1.5 (1.7) |
0.49 |
| Joint tenderness count (0–8) |
1.0 (2.0) |
0.7 (1.8) |
1.2 (2.2) |
0.18 |
| Joint swelling count (0–8) |
0.6 (1.5) |
0.3 (1.3) |
0.9 (1.6) |
0.06 |
| Proximal muscle weakness (% of subjects) |
11 |
3.7 |
15.9 |
0.03 |
| Tendon friction rubs (% of subjects) |
12 |
0 |
23.2 |
0.0001 |
| Renal |
|
|
|
|
| Serum creatinine (mg/dl) |
0.75 (0.24) |
0.71 (0.16) |
0.78 (0.27) |
0.11 |
| 24‐h urine protein (mg/24 h) |
0.15 (0.12) |
0.13 (0.13) |
0.15 (0.12) |
0.50 |
