Table 1.
Baseline patient characteristics, stratified by disease duration
| Variable | All patients (n = 93) | Placebo (n = 48) | CYC (n = 45) | p Value |
|---|---|---|---|---|
| Age, yr, mean (SD) | 47.19 (11.72) | 47.43 (13.24) | 46.93 (10.00) | 0.8388 |
| Female sex, n (%) | 68 (73.12) | 34 (70.83) | 34 (75.56) | 0.6077 |
| White race, n (%) | 71 (76.34) | 38 (79.17) | 33 (73.33) | 0.6764 |
| Type of SSc, n (%) | ||||
| Limited | 37 (39.78) | 19 (39.58) | 18 (40.00) | 0.9673 |
| Diffuse | 56 (60.22) | 29 (60.42) | 27 (60.00) | |
| Disease duration, yr, mean (SD) | 3.27 (2.24) | 3.30 (1.97) | 3.24 (2.52) | 0.8895 |
| Antibodies (n = 55), n (%)a | ||||
| Scl-70 | 22 (32.84) | 13 (35.14) | 9 (30.00) | 0.6563 |
| Anti-centromere/anti-RNA polymerase III | 14 (20.90) | 5 (13.51) | 9 (30.00) | 0.0988 |
| FVC, % predicted, mean (SD) | 67.73 (11.90) | 68.86 (11.91) | 66.53 (11.90) | 0.3497 |
| DLCO, % predicted, mean (SD) | 46.32 (12.75) | 46.04 (12.41) | 46.61 (13.24) | 0.8303 |
| MRSS, mean (SD) | 15.22 (11.02) | 14.56 (10.52) | 15.91 (11.60) | 0.5580 |
| Mahler’s BDI focal score (0–12), mean (SD) | 5.67 (1.76) | 5.48 (1.99) | 5.90 (1.45) | 0.2613 |
| HAQ-DI (0–3), mean (SD) | 0.82 (0.67) | 0.70 (0.67) | 0.96 (0.64) | 0.0629 |
| SF-36 PCS (0–100), mean (SD) | 33.70 (11.29) | 34.63 (10.98) | 32.68 (11.66) | 0.4099 |
| SF-36 MCS (0–100), mean (SD) | 49.15 (10.94) | 49.23 (11.17) | 49.06 (10.82) | 0.9413 |
| HRCT-determined disease extent, mean (SD) | ||||
| Maximum fibrosis score (0–4) | 1.99 (1.05) | 1.96 (1.07) | 2.02 (1.03) | 0.7700 |
| Maximum honeycombing (0–4) | 0.40 (0.58) | 0.42 (0.54) | 0.37 (0.62) | 0.9592 |
| Maximum ground-glass opacity (0–4) | 0.73 (0.76) | 0.73 (0.71) | 0.72 (0.83) | 0.7101 |
| Visual maximum fibrosis score, n (%) | 0.2007 | |||
| 0 % | 7 (7.69) | 4 (8.33) | 3 (6.98) | |
| 1–25 % | 25 (27.47) | 15 (31.25) | 10 (23.26) | |
| 26–50 % | 25 (27.47) | 9 (18.75) | 16 (37.21) | |
| 51–75 % | 30 (32.97) | 19 (39.58) | 11 (25.58) | |
| 76–100 % | 4 (4.40) | 1 (2.08) | 3 (6.98) | |
| Goh and Wells unadjusted stratification for lung involvement (consensus of 3 readers), n (%) | 0.5298 | |||
| <20 % | 38 (44.71) | 22 (47.83) | 16 (41.03) | |
| >20 % | 47 (55.29) | 24 (52.17) | 23 (58.97) | |
| Goh’s adjusted minimal disease, n (%) | 20 (21.98) | 8 (17.02) | 12 (27.27) | 0.3540 |
| Goh’s adjusted extensive disease, n (%) | 71 (78.02) | 39 (82.98) | 32 (72.73) | |
| CAD scores | ||||
| QILD WL, mean (SD) | 34.71 (15.67) | 34.96 (16.95) | 34.44 (14.35) | 0.8771 |
| QILD ZM, mean (SD) | 58.84 (20.94) | 58.53 (21.33) | 59.19 (20.75) | 0.8833 |
| QLF WL, mean (SD) | 9.80 (9.83) | 10.11 (10.60) | 9.47 (9.02) | 0.7591 |
| QLF ZM, mean (SD) | 26.44 (21.82) | 25.23 (21.44) | 27.77 (22.40) | 0.5851 |
FVC forced vital capacity, DLCO diffusing capacity for carbon monoxide, MRSS modified Rodnan skin thickness score, BDI Baseline Dyspnea Index, HAQ-DI Health Assessment Questionnaire Disability Index, PCS Physical Component Score, SF-36 36-item Short Form Health Survey, MCS Mental Component Score, HRCT high-resolution computed tomography, CAD computer-aided diagnosis, QILD quantitative assessment of total extent of interstitial lung disease, QLF quantitative percentage of lung fibrosis, ZM zone of maximal involvement, WL whole lung, SD standard deviation, SSc systemic sclerosis, CYC cyclophosphamide
a p < 0.05