Table 1

Baseline characteristics of study patients

CharacteristicRTX groupPlacebo groupp-value
 Age, mean (year)44.5±5.636.6±4.30.21*
 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±4.414.0±3.80.88*
Heart and lungs
 LVEF (mean±SE)61.1±4.262.0±4.60.96*
 FVC (% of predicted)97.9±6.692.0±6.10.67*
 DLCO (% of predicted)67.1±4.272.3±6.00.34*
 Total extent of lung disease on HRCT¶ (mean %)9.5±11.06.9±10.80.65*
 Extent ground glass (mean %)8.3±9.45.4±8.00.44*
 Extent reticular pattern (mean %)4.0±8.73.9±7.11*
Function and quality of life
 HAQ-DI (mean±SE)1.39±0.271.31±0.320.65*
 Previous immunosuppressive therapy‡ (% of patients)†
  months of use (median, range)1.5 (0.0–36.0)0.0 (0.0–9.0)0.20*
 Immunosuppressive therapy§ (% of patients)87.562.50.57†
  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)10087.51.00†
 Anti-topoisomerase I (% of patients)12.550.00.28†
 Anti-RNA polymerase III (% of patients)†
  • *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.