Table 1.
Baseline characteristics of study participants
| Characteristics | Overall (n=121) | Riociguat (n=60) | Placebo (n=61) |
| Mean age (SD), years | 50.7 (12.2) | 51.9 (11.5) | 49.5 (12.9) |
| Female, n (%) | 92 (76.0) | 47 (78.3) | 45 (73.8) |
| White, n (%) | 89 (73.6) | 43 (71.7) | 46 (75.4) |
| Black, n (%) | 5 (4.1) | 2 (3.3) | 3 (4.9) |
| Asian, n (%) | 24 (19.8) | 12 (20.0) | 12 (19.7) |
| Native Hawaiian or other Pacific Islander, n (%) | 1 (0.8) | 1 (1.7) | 0 |
| Not reported, n (%) | 2 (1.7) | 2 (3.3) | 0 |
| Mean disease duration (SD), months (from first non-RP manifestation) | 9.0 (6.4) | 9.5 (7.0) | 8.6 (5.8) |
| Mean mRSS (SD), units | 16.8 (3.7) | 16.9 (3.4) | 16.7 (4.1) |
| Mean % predicted FVC (SD), % | 92.8 (17.8) | 90.7 (18.5) | 94.8 (17.0) |
| Mean % predicted DLCO (Hb corr.) (SD), % | 76.4 (18.5) | 76.0 (19.9) | 76.8 (17.2) |
| Swollen joint count ≥1, n (%) | 38 (31.4) | 23 (38.3) | 15 (24.6) |
| Mean swollen joint count (SD), n | 2.0 (4.7) | 3.0 (6.1) | 1.1 (2.5) |
| Tender joint count ≥1, n (%) | 51 (42.1) | 30 (50.0) | 21 (34.4) |
| Mean tender joint count (SD), n | 3.0 (6.2) | 3.9 (7.3) | 2.1 (4.8) |
| Digital ulcer count ≥1, n (%) | 15 (12.4) | 9 (15.0) | 6 (9.8) |
| Mean digital ulcer count (SD), n | 0.3 (1.1) | 0.3 (0.7) | 0.4 (1.4) |
| Mean digital ulcer count in patients with ulcers (SD), n | 2.5 (2.3) | 1.7 (1.0) | 3.7 (3.2) |
| Tendon friction rubs ≥1, n (%) | 35 (28.9) | 15 (25.0) | 20 (32.8) |
| Mean tendon friction rubs (SD), n | 3.1 (2.2) | 2.4 (1.1) | 3.6 (2.7) |
| ILD by medical history, n (%) | 25 (20.7) | 12 (20.0) | 13 (21.3) |
| Mean HAQ-DI (SD), units | 0.79 (0.68) | 0.89 (0.67) | 0.69 (0.69) |
| Anti-RNA polymerase III positive, n (%) | 26 (21.5) | 10 (16.7) | 16 (26.2) |
| Anti-SCl-70 (anti-topoisomerase I) positive, n (%) | 49 (40.5) | 26 (43.3) | 23 (37.7) |
| Anti-centromere B positive, n (%) | 10 (8.3) | 4 (6.7) | 6 (9.8) |
DLCO, diffusing capacity of the lung for carbon monoxide; DLCO (Hb corr.), diffusing capacity of the lung for CO, corrected for haemoglobin; FVC, forced vital capacity; HAQ-DI, Health Assessment Questionnaire Disability Index; ILD, interstitial lung disease; mRSS, modified Rodnan skin score; RP, Raynaud’s phenomenon.