Table 1.
Baseline characteristics of participants assigned to CYC in SLS I and SLS II.*
| SLS I-CYC | SLS II-CYC | P-value | |
|---|---|---|---|
| Characteristics | (N=79) | (N=69) | |
| Age (yr) | 0.040δ | ||
| Mean | 48.4±12.3 | 52.2±9.6 | |
| Range | 28–81 | 28–71 | |
| Female sex (%) | 76.0 | 74.6 | 0.853 σ |
| Duration of scleroderma (yr)† | 0.308 Ψ | ||
| Median (IQR) | 2.4 (1.3, 4.6) | 1.9 (1.2, 4.0) | |
| Limited/Diffuse (%) | 38.0/62.0 | 46.2/53.9 | 0.322 σ |
| Race | 0.220 σ | ||
| White (%) | 67.1 | 67.7 | |
| African American (%) | 15.2 | 23.1 | |
| Asian (%) | 3.8 | 4.6 | |
| Other (%) | 13.9 | 4.6 | |
| FVC (% of predicted) | 67.6±11.4 | 66.9±9.9 | 0.704δ |
| DLCO (% of predicted) | 47.2±13.7 | 54.5±14.6 | 0.002 δ |
| Mahler Dyspnea Index (Focal score) | 5.6±1.8 | 7.1±2.4 | 0.0002 δ |
| Skin-thickness score (MRSS) | |||
| All patients | 0.302 Ψ | ||
| Median (IQR) | 12 (7, 22) | 12 (5, 20) | |
| Range | 2–51 | 2–46 | |
| Patients with dcSSc | 0.545 Ψ | ||
| Median (IQR) | 21 (14, 25) | 19 (12, 26) | |
| Range | 7–51 | 6–46 | |
| Patients with lcSSc | 0.894 Ψ | ||
| Median (IQR) | 5 (3, 9) | 5 (2, 8) | |
| Range | 2, 16 | 2, 18 | |
| QLF-WL, Median (IQR) | 7.5 (2.8, 12.8) | 7.4 (3.1, 13.1) | 0.816 Ψ |
| QLF-ZM, Median (IQR) | 23.5 (6.8, 46.0) | 18.2 (6.3, 34.3) | 0.244 Ψ |
| QILD-WL | 35.8±17.1 | 30.6±14.2 | 0.066 δ |
| QILD-ZM | 58.1±22.3 | 51.1±20.0 | 0.055 δ |
| Positive anti-nuclear antibody | Not available | 65/70 (92.9%) | |
| Positive anti-centromere antibody | Not available | 2/70 (2.9%) | |
| Positive anti-Scl-70 antibody | Not available | 31/70 (44.3%) | |
| Positive RNA Polymerase III antibody | Not available | 9/70 (12.6%) |
Values are mean ± standard deviation, unless otherwise noted.
Disease duration based on the onset of the first non-Raynaud’s symptom attributable to SSc.
δ t-est
Chi-square test
Wilcoxon rank-sum test
Definitions of abbreviations: FVC = forced vital capacity; DLCO = diffusing capacity of the lung for carbon monoxide; QLF = quantitative extent of lung fibrosis on HRCT; QILD = quantitative extent of total interstitial lung disease (including fibrosis, honeycomb and ground glass opacity); WL = whole lung; ZM = zone of maximal involvement. Scores for the Mahler Baseline Dyspnea Index (BDI) can range from 0 to 12, with lower scores indicating worse dyspnea. Scores for skin thickening (Modified Rodnan Skin Scores, MRSS) can range from 0 to 51, with higher scores indicating more severe thickening. dcSSc = diffuse cutaneous systemic sclerosis; lcSSc = limited cutaneous systemic sclerosis.