| Placebo (N = 8) | Riociguat (N = 7) | Treatment difference (95% CI) | p value |
---|---|---|---|---|
Net ulcer burden, LS mean†* | − 0.98 | − 1.22 | − 0.24 (− 1.46 to 0.99) | 0.706 |
Patient global assessment for overall disease, LS mean†| − 1.19 | 0.31 | 1.50 (− 1.30 to 4.30) | 0.27 |
Patient assessment, LS mean†| ||||
 Severity of RP | − 1.41 | − 3.47 | − 2.06 (− 4.63 to 0.51) | 0.11 |
 Severity of DU | − 4.00 | − 4.63 | − 0.63 (− 3.68 to 2.41) | 0.66 |
 Pain during RP attack (0–100) | − 7.01 | − 0.30 | 6.71 (− 14.01 to 27.43) | 0.49 |
 Numbness during RP attack (0–100) | − 15.44 | − 19.73 | − 4.28 (− 33.44 to 24.87) | 0.75 |
 Tingling during RP attack (0–100) | − 7.49 | 1.18 | 8.67 (− 13.75 to 31.09) | 0.41 |
Raynaud’s Condition Score, LS mean†| − 0.82 | − 1.15 | − 0.33 (− 2.60 to 1.94) | 0.76 |
Number of Raynaud’s attacks per day, LS mean†| − 0.96 | − 1.24 | − 0.28 (− 1.36 to 0.79) | 0.57 |
Duration of Raynaud’s attacks (minutes), LS mean†| 150.3 | − 44.8 | − 195.1 (− 683.7 to 293.5) | 0.40 |
Physician global assessment for overall disease, LS mean†| − 0.66 | − 1.17 | − 0.51 (− 2.27 to 1.25) | 0.54 |
Physician assessment of the severity of RP, LS mean†| − 1.86 | − 3.00 | − 1.15 (− 3.51 to 1.22) | 0.32 |
Physician assessment of severity of DU, LS mean†| − 3.81 | − 3.54 | 0.27 (− 2.55 to 3.10) | 0.84 |
SHAQ-DI (VAS range 0–150), LS mean†| ||||
 VAS overall disease | − 35.74 | − 50.35 | − 14.60 (− 45.48 to 16.27) | 0.32 |
 VAS burden of DU | − 53.47 | − 43.09 | 10.38 (− 58.03 to 78.79) | 0.75 |
 VAS Raynaud’s | − 25.40 | − 23.78 | 1.62 (− 54.56 to 57.80) | 0.95 |
 VAS GI | − 7.39 | 16.72 | 24.11 (− 25.22 to 73.44) | 0.31 |
 VAS breathing | − 12.69 | 8.35 | 21.04 (− 8.05 to 50.13) | 0.14 |
PROMIS-29, LS mean†| ||||
 Anxiety | − 1.50 | −3.11 | − 1.60 (− 9.77 to 6.56) | 0.68 |
 Depression | − 0.25 | − 3.35 | − 3.10 (− 8.65 to 2.45) | 0.25 |
 Fatigue | 0.46 | 0.64 | 0.19 (− 6.26 to 6.63) | 0.95 |
 Physical function | − 2.24 | − 2.46 | − 0.22 (− 3.96 to 3.53) | 0.90 |
 Sleep disturbance | 0.94 | − 0.47 | − 1.41 (− 4.76 to 1.95) | 0.38 |
 Pain interference | − 3.06 | − 3.69 | − 0.62 (− 6.54 to 5.30) | 0.82 |
 Pain intensity | − 1.63 | − 2.74 | − 1.11 (− 3.59 to 1.37) | 0.35 |
 Ability to participate in social activities | − 0.46 | − 1.68 | − 1.22 (− 4.80 to 2.36) | 0.47 |
HAQ-DI, LS mean†| ||||
 Overall | − 0.06 | − 0.01 | 0.04 (− 0.44 to 0.53) | 0.84 |
 Dressing and grooming | 0.05 | − 0.16 | − 0.21 (− 0.96 to 0.54) | 0.55 |
 Hygiene | − 0.27 | − 0.39 | − 0.11 (− 1.00 to 0.78) | 0.79 |
 Arising | 0.02 | 0.36 | 0.34 (− 0.41 to 1.09) | 0.34 |
 Reach | 0.01 | 0.37 | 0.36 (− 0.46 to 1.19) | 0.36 |
 Eating | 0.03 | − 0.53 | − 0.56 (− 1.08 to − 0.03) | 0.04 |
 Grip | − 0.18 | 0.16 | 0.34 (− 0.37 to 1.04) | 0.31 |
 Walking | − 0.12 | 0.35 | 0.47 (− 0.18 to 1.12) | 0.14 |
 Common daily activities | 0.04 | − 0.29 | − 0.33 (− 1.17 to 0.51) | 0.40 |
 HDISS-DU, LS mean†| − 0.32 | − 0.47 | − 0.14 (− 1.75 to 1.46) | 0.85 |