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 |