Table 1.
Baseline Characteristics
| All (n=158) | CYC (n=79) | Placebo (n=79) | P value† | |
|---|---|---|---|---|
| Age (yrs), mean (SD) | 48.5 (12.2) | 48.9 (12.2) | 48.2 (12.4) | 0.72 |
| Female, N (%) | 111 (70.3) | 60 (75.6) | 51 (64.6) | 0.15 |
| Duration (yrs), mean (SD) | 3.1 (2.1) | 3.05 (2.3) | 3.2 (1.9) | 0.69 |
| dcSSc, N (%) | 94 (59.5) | 49 (62) | 45 (57) | 0.70 |
| Digital Tip Ulcers, N (%) | 12 (7.6) | 5 (6.3) | 7 (8.9) | 0.55 |
| Non-digital Ulcers, N (%) | 17 (10.8) | 6 (7.6) | 11 (13.9) | 0.23 |
| Joint Swelling, N (%) | 37 (23.3) | 18 (22.8) | 19 (23.8) | 0.99 |
| Swollen Joint Count, median (IQR) a | 2 (2–3) | 2 (1.5–2) | 2 (2–4) | 0.16 |
| Joint Tenderness, N (%) | 47 (29.9) | 20 (25.6) | 27 (34.2) | 0.26 |
| Tender Joint Count, median (IQR) b | 3 (1–6) | 3 (1.5–6) | 6 (1–7) | 0.97 |
| Large Joint Contractures, N (%) | 74 (46.5) | 38 (47.5) | 36 (45.6) | 0.57 |
| Muscle Tenderness, N (%) | 26 (16.4) | 13 (16.5) | 13 (16.3) | 0.97 |
| Muscle Weakness, N (%) | 20 (12.7) | 9 (11.4) | 11 (13.9) | 0.68 |
| Oral Aperture (mm), mean (SD) | 45.1 (8.5) | 44.9 (8.6) | 45.4 (8.5) | 0.69 |
| Hand Extension (mm), mean (SD) | 175 (34.8) | 169.9 (37.6) | 180.3 (31) | 0.06 |
| Fist Closure (mm), mean (SD) | 12.1 (19.5) | 15 (24) | 9.1 (13.1) | 0.06 |
| CPK (U/L), mean (SD) | 135.3 (155.2) | 144.8 (191.2) | 125.7 (108.3) | 0.57 |
| Hemoglobin (g/dL), mean (SD) | 12.8 (1.6) | 12.9 (1.4) | 12.6 (1.8) | 0.15 |
| FVC (% predicted), mean (SD) | 68.1 (12.1) | 68.5 (12.9) | 67.8 (11.3) | 0.73 |
| DLCO (% predicted), mean (SD) | 47.4 (14.1) | 47.6 (14.3) | 47.2 (14) | 0.85 |
| MIP (cm, H2O), mean (SD) | 88.6 (30.8) | 85.7 (27.1) | 92.7 (34.3) | 0.22 |
| MEP (cm, H2O), mean (SD) | 91.8 (36.2) | 88.9 (35.2) | 95.6 (38.4) | 0.32 |
| Skin Score, mean (SD) | 14.7 (10.9) | 14 (10.5) | 15.4 (11.3) | 0.44 |
| HAQ-DI, mean (SD) | 0.83 (0.69) | 0.96 (0.67) | 0.69 (0.69) | 0.02 |
| SF-36 PCSa, mean (SD) | 33.5 (10.8) | 32.9 (10.9) | 34.4 (10.9) | 0.38 |
| SF-36 MCSb, mean (SD) | 49.8 (10.6) | 48.8 (10.4) | 50.7 (10.7) | 0.30 |
| NSAID usage, N (%) | 60 (38.0) | 32 (40.5) | 28 (35.4) | 0.512 |
| Pain medication usage, N (%) | 49 (31.0) | 29 (36.7) | 20 (25.3) | 0.122 |
| Glucocorticoid usage, N (%) | 42 (26.6) | 19 (24.1) | 23 (29.1) | 0.471 |
a
Patients with positive swollen joint count
b
Patients with positive tender joint count
c
PCS (Physical component score)
d
MCS (Mental component score)
†
CYC versus Placebo