Baseline characteristics of study patients
| Characteristic | RTX group | Placebo group | p-value |
| (n=8) | (n=8) | ||
| Demographic | |||
| Age, mean (year) | 44.5±5.6 | 36.6±4.3 | 0.21* |
| Female sex (% of patients, n) | 87.5 (7) | 87.5 (7) | 1† |
| Caucasians (% of patients, n) | 75 (6) | 62.5 (5) | 0.58† |
| Disease specific | |||
| dcSSc (% of patients, n) | 87.5 (7) | 62.5 (5) | 0.57† |
| Duration of scleroderma (year) | |||
| Since diagnosis (median, range) | 0.9 (0.7–3.5) | 1.3 (0.2–4.2) | 0.444* |
| Since onset first Raynaud symptom (median, range) | 2.3 (0.7–5.3) | 4.3 (0.7–16.1) | 0.13* |
| Since onset first non-Raynaud symptom (median, range) | 1.2 (0.6–3.5) | 2.4 (0.7–4.2) | 0.25* |
| Skin and musculoskeletal | |||
| Modified Rodnan skin score (mean±SE) | 16.4±4.4 | 14.0±3.8 | 0.88* |
| Heart and lungs | |||
| LVEF (mean±SE) | 61.1±4.2 | 62.0±4.6 | 0.96* |
| FVC (% of predicted) | 97.9±6.6 | 92.0±6.1 | 0.67* |
| DLCO (% of predicted) | 67.1±4.2 | 72.3±6.0 | 0.34* |
| Total extent of lung disease on HRCT¶ (mean %) | 9.5±11.0 | 6.9±10.8 | 0.65* |
| Extent ground glass (mean %) | 8.3±9.4 | 5.4±8.0 | 0.44* |
| Extent reticular pattern (mean %) | 4.0±8.7 | 3.9±7.1 | 1* |
| Function and quality of life | |||
| HAQ-DI (mean±SE) | 1.39±0.27 | 1.31±0.32 | 0.65* |
| Therapy | |||
| Previous immunosuppressive therapy‡ (% of patients) | 50.0 | 12.5 | 0.28† |
| months of use (median, range) | 1.5 (0.0–36.0) | 0.0 (0.0–9.0) | 0.20* |
| Immunosuppressive therapy§ (% of patients) | 87.5 | 62.5 | 0.57† |
| Months of use (median, range) | 8.1 (0.0–42.6) | 3.2 (0.0–26.3) | 0.33† |
| Laboratory findings | |||
| ANA-positive (% of patients) | 100 | 87.5 | 1.00† |
| Anti-topoisomerase I (% of patients) | 12.5 | 50.0 | 0.28† |
| Anti-RNA polymerase III (% of patients) | 25.0 | 0.0 | 0.47† |
*Mann-Whitney U test.
†Fisher's exact test.
‡Previous immunosuppressive therapy included high-dose (>15 mg/day) prednisone (RTX n=2, placebo n=1), methotrexate (RTX n=3, placebo n=0) and azathioprine (RTX n=2, placebo n=0).
§Current immunosuppressive treatment included high-dose (>15 mg/day) prednisone (RTX n=2, placebo n=0), methotrexate (RTX n=5, placebo n=3), plaquenil (RTX n=1, placebo n=1), mycophenolate mofetil (RTX=1, placebo n=1).
¶Extent of lung disease in HRCT was scored according to Goh criteria33; the extent was evaluated over five levels and averaged (origin of great vessels, main carina, pulmonary venous confluence, halfway between the third and fifth section, immediately above the right hemidiaphragm)
ANA, antinuclear antibody; dcSSc, diffuse cutaneous systemic sclerosis; DLCO, diffusing capacity of the lungs for carbon monoxide; FVC, forced vital capacity; HAQ-DI, Health Assessment Questionnaire Disability Index; HRCT, high-resolution CT; LVEF, left ventricular ejection fraction; RTX, rituximab.