| Placebo-riociguat (N = 6) | Riociguat-riociguat (N = 6) | ||||
---|---|---|---|---|---|---|
Baseline* | Week 16 OLE | Change from baseline | Baseline* | Week 16 OLE | Change from baseline | |
Net ulcer burden | 2.7 (2.2) | 1.5 (1.1) | − 1.2 (2.3) | 1.67 (0.8) | 0 (0) | − 1.67 (0.8) |
Patient global assessment for overall disease | 4.3 (2.2) | 3.3 (1.9) | − 1.0 (2.3) | 4.2 (2.9) | 3.5 (1.6) | − 0.7 (2.6) |
Patient assessment | ||||||
 Severity of RP | 4.8 (2.5) | 3 (1.9) | − 1.8 (2.3) | 7.0 (1.7) | 3.0 (2.7) | − 4.0 (3.3) |
 Severity of DU | 6.3 (1.6) | 2.8 (1.5) | − 3.5 (2.6) | 8.3 (1.2) | 1.0 (0.9) | − 7.3 (1.9) |
Physician global assessment for overall disease | 4.8 (1.8) | 5.2 (1.7) | 0.6 (2.9) | 6 (1.7) | 3.2 (1.7) | − 1.8 (2.7) |
Physician assessment of severity of RP | 6.2 (2.2) | 4.7 (2.2) | − 1.4 (2.4) | 1.3 (5.5) | 3.0 (2.2) | − 3.0 (1.3) |
Physician assessment of severity of DU | 5.6 (2.5) | 2.8 (2.1) | − 2.2 (2.2) | 6.7 (2.2) | 0.5 (0.8) | − 6.2 (2.1) |
SHAQ-DI (VAS range 0–150) | ||||||
 VAS overall disease | 94.2 (20.1) | 65.5 (24.1) | − 28.7 (26.9) | 100.5 (24.4) | 42.8 (25.8) | − 57.7 (32.7) |
 VAS burden of DU | 64.3 (33.8) | 39.2 (35.2) | − 25.2 (42.1) | 107.2 (21.3) | 10.0 (6.3) | − 97.2 (24.2) |
 VAS Raynaud’s | 56.8 (36.7) | 37.8 (39.7) | − 19.0 (47.5) | 69.7 (38.3) | 36.7 (40.2) | − 33.0 (46.5) |
 VAS GI | 6.8 (7.5) | 46.2 (47.8) | 39.3 (47.7) | 44.5 (29.9) | 45.5 (33.6) | 1.0 (28.6) |
 VAS breathing | 18.5 (29.4) | 20.5 (27.5) | 2.0 (14.7) | 40.3 (22.6) | 33.7 (27.2) | − 6.7 (24.9) |
PROMIS-29 | ||||||
 Anxiety | 51.5 (9.8) | 51.9 (9.5) | 3.2 (9.4) | 61.4 (14.3) | 56.7 (9.4) | − 4.8 (11.4) |
 Depression | 51.2 (8.8) | 51.4 (8.7) | 0.2 (4.2) | 57.4 (7.1) | 55.7 (8.3) | − 1.7 (7.8) |
 Fatigue | 44.7 (8.7) | 54.0 (3.8) | 9.2 (6.4) | 57.6 (6.7) | 54.7 (7.0) | − 2.9 (9.5) |
 Physical function | 35.3 (5.4) | 33.8 (3.4) | − 1.5 (4.1) | 34.7 (3.3) | 32.0 (3.6) | − 2.7 (1.9) |
 Sleep disturbance | 51.1 (5.1) | 49.8 (4.3) | − 1.3 (7.9) | 52.3 (2.0) | 49.9 (1.9) | − 2.4 (3.2) |
 Pain interference | 60.3 (3.4) | 49.6 (9.0) | − 10.6 (8.3) | 63.8 (6.1) | 58.5 (3.1) | − 5.3 (7.5) |
 Pain intensity | 6.5 (1.5) | 3.7 (2.1) | − 2.8 (3.0) | 8.7 (0.8) | 5.0 (1.1) | − 3.7 (1.0) |
 Ability to participate in social activities | 41.1 (3.0) | 40.7 (5.0) | − 0.4 (7.2) | 45.7 (7.5) | 41.8 (3.6) | − 4.0 (5.7) |
HAQ-DI | 1.3 (0.7) | 1.5 (0.5) | 0.9 (0.5) | 1.2 (0.6) | 0.9 (0.5) | − 0.3 (0.5) |
HDISS-DU | 5.2 (1.7) | 5.5 (1.8) | 0.3 (1.0) | 4.8 (2.3) | 4.2 (1.9) | − 0.7 (2.0) |