Table 1

Baseline characteristics of SLS I and SLS II participants

MeasureSLS ISLS IIP values*
nMean±SDnMean±SD
(CYC; placebo)(CYC; MMF)(SLS I vs SLS II)
Age, years15848.5±12.3
(48.4±12.3; 47.7±12.5)
P=0.693
14252.3±9.7
(52.0±9.8; 52.6±9.7)
P=0.725
0.004
Gender (female/male) (%)15870/30
(76/24; 65/35)
P=0.117
14274/26
(78/22; 70/30)
P=0.248
0.477
Race (%)
 White15867 (67; 66)14268 (66; 71)
 African–American16 (15; 18)23 (26; 20)
 Asian4 (4; 5)6 (4; 9)
 Other12 (14; 10)1 (3; 0)
 Unknown1 (0; 1)0
P=0.776P=0.324
Diffuse %/Limited %15859/41
(62/38; 57/43)
P=0.512
14259/41
(55/45; 62/38)
P=0.363
0.855
Disease duration, years1583.2±2.1
(3.2±2.3; 3.1±1.8)
P=0.867
1392.6±1.8
(2.5±1.8; 2.6±1.7)
P=0.757
0.008
FVC, % predicted15868.1±12.1
(67.6±11.3; 68.6±13.0)
P=0.640
14266.5±9.1
(66.5±9.9; 66.5±8.3)
P=1.000
0.194
FEV1/FVC, %15582.8±8.0
(82.8±5.8; 82.8±7.4)
P=0.999
14282.6±5.6
(83.3±5.6; 81.8±5.5)
P=0.105
0.802
TLC, % reference15669.6±13.1
(69.8±12.9; 69.3±13.3)
P=0.845
14265.9±10.9
(65.5±12.0; 66.3±10.0)
P=0.668
0.008
DLCO, % reference15847.2±14.0
(47.1±13.7; 47.4±14.3)
P=0.881
14254.0±12.7
(54.1±14.1; 54.0±11.1)
P=0.963
<0.001
BDI (focal score, 0–12)†1565.7±1.8
(5.6±1.7; 5.7±2.0)
P=0.772
1347.1±2.2
(7.1±2.3; 7.3±2.1)
P=0.537
<0.001
HAQ-DI (score, 1–3)‡1570.83±0.7
(1.0±0.7; 0.7±0.7)
P=0.018
1420.72±0.7
(0.7±0.7; 0.7±0.6)
P=0.784
0.176
VAS – breathlessness (0–100)15628.4±26.1
(27.2±24.6; 29.5±27.6)
P=0.581
13924.5±28.1
(24.4±28.9; 24.5±27.4)
P=0.983
0.220
MRSS (0–51)15814.8±10.9
(15.6±11.4; 14.0±10.5)
P=0.361
14214.7±10.5
(14.0±10.6; 15.3±10.4)
P=0.471
0.936
Lung fibrosis (QLFib) score, whole lung (WL), %12510.2±10.4
(10.3±10.5; 10.1±10.4)
P=0.904
1378.6±6.9
(8.9±7.0; 8.3±6.8)
P=0.578
0.148
Lung fibrosis (QLFib) score, worst zone (ZM), %12526.5±21.9
(28.2±23.4; 25.0±20.5)
P=0.407
13722.8±19.6
(22.6±19.3; 23.0±20.2)
P=0.903
0.152
Quantitative ILD (QILD) score, % WL12535.5±16.9
(35.8±17.1; 35.3±16.9)
P=0.855
13729.5±14.0
(31.6±14.4; 27.2±13.2)
P=0.064
0.002
Quantitative ILD (QILD) score, % ZM12558.1±21.7
(58.1±22.3; 58.0±21.3)
P=0.977
13751.2±20.3
(52.3±19.9; 50.0±20.9)
P=0.517
0.009
  • BDI, Baseline Dyspnoea Index; CYC, cyclophosphamide; DLCO, single-breath diffusing capacity for carbon monoxide; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; HAQ-DI, Health Assessment Questionnaire for Scleroderma-Disability Index; HRCT, high-resolution CT; MMF, mycophenolate mofetil; MRSS, Modified Rodnan Skin Score; QLFib WL, %, quantitative extent of lung fibrosis (reticulations) in whole lung on high-resolution CT; QLFib ZM, %, quantitative extent of lung fibrosis in the zone of maximal involvement on HRCT; QILD WL, %, quantitative extent of interstitial lung disease (fibrosis+ground class opacity (GGO)+honeycombing) in whole lung on HRCT; QILD ZM, quantitative extent of interstitial lung disease (fibrosis+GGO+honeycombing) in the zone of maximal involvement on HRCT; SLS, Scleroderma Lung Studies; TLC, total lung capacity; VAS, Visual Analogue Scale.

  • *t-Tests were used for all comparisons with the exception of gender and diffuse vs limited disease (χ2 test).

  • †High score denotes worse dyspnoea.

  • ‡High score denotes worse function.