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Table 1 Baseline demographic and clinical characteristics of all of the randomized patients

From: A multicenter randomized, double-blind, placebo-controlled pilot study to assess the efficacy and safety of riociguat in systemic sclerosis-associated digital ulcers

Characteristics Double-blind phase Open-label extension
PBO (n = 8) RIO (n = 9) All patients (n = 17) PBO-RIO (n = 6) RIO-RIO (n = 6) All patients (n = 12)
Age in years, mean (SD) 61 (17) 43 (14) 51 (18) 61 (20) 44 (14) 52 (19)
Gender, n (%)
 Male 3 (38) 1 (11) 4 (24) 3 (50) 0 (0) 3 (25)
 Female 5 (63) 8 (89) 13 (76) 3 (50) 6 (100) 9 (75)
Race, n (%)
 Caucasian 7 (88) 6 (67) 13 (76) 5 (83) 5 (83) 10 (83)
 African-American 1 (13) 2 (22) 3 (18) 1 (17) 0 (0) 1 (8)
 Others 0 (0) 1 (11) 1 (6) 0 (0) 1 (17) 1 (8)
SSc subset, n (%)
 Limited cutaneous SSc 4 (50) 5 (56) 9 (53) 2 (33) 4 (67) 6 (50)
 Diffuse cutaneous SSc 4 (50) 4 (44) 8 (47) 4 (67) 2 (33) 6 (50)
Time since SSc diagnosis, in years, mean (SD) 15.0 (8.2) 6.2 (5.8) 10.4 (8.2) 14.3 (8.0) 5.2 (6.0) 9.7 (8.2)
Time since first non-RP symptom, in years, mean (SD)†† 17.5 (11.2) 7.1 (6.0) 12 (10.1) 16.9 (12.1) 5.7 (5.8) 11.3 (10.8)
Time since first RP symptom, in years, mean (SD)†† 14.5 (7.9) 7.5 (6.6) 11 (7.9) 13.2 (6.7) 6.9 (6.9) 10.1 (7.3)
Time since first DU,, in years 8.0 (6.8) 5.4 (4.6) 6.7 (5.7) 9.8 (7.0) 3.5 (3.1) 6.7 (6.1)
Number of DU, mean (SD)†† 2.5 (1.7) 2.7 (1.8) 2.6 (1.7) 2.7 (1.8) 1.7 (0.8) 2.2 (1.5)
 Number of active DU 1.4 (1.1) 1.1 (1.0) 1.2 (1.0) 1.2 (1.0) 0.5 (0.5) 0.8 (0.8)
 Number of indeterminate DU 1.1 (1.4) 1.6 (1.3) 1.3 (1.3) 1.5 (1.4) 1.2 (1.2) 1.3 (1.2)
 Net ulcer burden 2.5 (2.0) 2.4 (1.4) 2.5 (1.7) 2.7 (2.3) 1.7 (0.8) 2.2 (1.7)
Characteristics of Raynaud’s attacks
 Raynaud’s Condition Score (0–10 Likert scale), mean (SD) 3.4 (2.2) 5.4 (1.6) 4.5 (2.1) 4.0 (1.8) 5.1 (1.9) 4.6 (1.8)
 Number of Raynaud’s attacks per day, mean (SD) 2.2 (1.7) 4.3 (1.7) 3.3 (2.0) 2.4 (1.8) 3.6 (1.4) 3.0 (1.7)
 Pain during a RP attack (0–100 VAS scale), mean (SD) 37.2 (24.6) 54.9 (13.1) 46.6 (20.7) 41.7 (23.6) 53.4 (14.2) 47.5 (19.5)
 Numbness during a RP attack (0–100 VAS scale), mean (SD) 32.0 (30.2) 40.5 (15.9) 36.5 (23.2) 35.6 (31.4) 43.7 (16.3) 39.7 (24.2)
 Tingling during a RP attack (0–100 VAS scale), mean (SD) 26.9 (16.1) 34.8 (16.6) 31.1 (16.3) 29.7 (15.7) 37.7 (15.9) 33.7 (15.6)
 Duration of RP attacks, in minutes, mean (SD) 47.9 (51.6) 101.4 (117.3) 76.4 (93.8) 55.0 (52.6) 112.5 (136.4) 83.7 (103.0)
Patient assessment of RP (0–10 Likert scale)
 Severity of RP, mean (SD) 4.2 (2.7) 7.1 (1.4) 5.8 (2.5) 4.8 (2.5) 7.0 (1.7) 5.9 (2.3)
 Severity of DU, mean (SD) 6.7 (1.9) 8.0 (1.5) 7.4 (1.8) 6.3 (1.6) 8.3 (1.2) 7.3 (1.7)
SHAQ: DUs interfere with daily activities in past week (theoretical range, 0–150), median (IQR) 55 (36–102) 116 (98–125) 98 (62–124) 64.3 (33.8) 107.2 (21.3) 85.7 (35.0)
Physician assessment of RP (0–10 Likert scale)
 Severity of RP, mean (SD) 5.4 (3.0) 6.1 (1.0) 5.8 (2.1) 6.2 (2.2) 6.0 (1.3) 6.1 (1.7)
 Severity of DU, mean (SD) 6.3 (2.6) 6.4 (1.9) 6.4 (2.1) 5.6 (2.5) 6.7 (2.5) 6.2 (2.3)
SSc-related antibodies, n (%)
 Anti-centromere B 3 (38) 3 (33) 6 (35) 2 (33) 3 (50) 5 (42)
 Anti-topoisomerase I 3 (38) 2 (22) 5 (29) 3 (50) 0 (0) 3 (25)
 Anti-RNA polymerase III 0 (0) 1 (11) 1 (6) 0 (0) 1 (17) 1 (8)
 Not done 2 (25) 3 (33) 5 (29) 1 (17) 2 (33) 3 (25)
Baseline use of medications, n (%)
 Vasodilators 1 (13) 1 (11) 2 (12) 0 (0) 1 (17) 1 (8)
 Prednisone 1 (13) 0 (0) 1 (6) 1 (17) 0 (0) 1 (8)
 Immunosuppressive 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
  1. Mean (SD), unless otherwise mentioned
  2. SSc systemic sclerosis, DU digital ulcer, RP Raynaud’s phenomenon, SHAQ Scleroderma Health Assessment Questionnaire, IQR interquartile range, PAH pulmonary arterial hypertension, ILD interstitial lung disease, CCB calcium channel blocker
  3. Calculated from date of screening or at the screening
  4. Classes not mutually exclusive