Table 1

Baseline characteristics of study participants

CharacteristicsOverall (n=121)Riociguat (n=60)Placebo (n=61)
Mean age (SD), years50.7 (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), units16.8 (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), n2.0 (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), n3.0 (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), n0.3 (1.1)0.3 (0.7)0.4 (1.4)
Mean digital ulcer count in patients with ulcers (SD), n2.5 (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), n3.1 (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), units0.79 (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.