Table 4.
Characteristic of study population | Central assessor 1 | Central assessor 2 | ||||
---|---|---|---|---|---|---|
β | 95% CI | p value | β | 95% CI | p value | |
Age (years) | −0.095 | −0.75 to 0.56 | 0.77 | 0.222 | −0.08 to 0.53 | 0.15 |
Male sex | −0.92 | −19.2 to 17.4 | 0.92 | −3.5 | −12.2 to 5.3 | 0.42 |
Smoking habit | ||||||
Never smoker | Reference | Reference | ||||
Ex-smoker | 3.61 | −18.7 to 25.9 | 0.74 | −1.4 | − 12.3 to 9.5 | 0.79 |
Current smoker | 11.54 | −6.2 to 29.3 | 0.20 | −3.9 | −12.7 to 4.8 | 0.36 |
Disease characteristics | ||||||
Time since RP onset (years) | −0.093 | −0.75 to 0.56 | 0.77 | 0.096 | −0.19 to 0.39 | 0.50 |
Time since first non-RP manifestation (years) | −1.16 | −2.9 to 0.6 | 0.18 | 0.91 | 0.1 to 1.7 | 0.025 |
Time since first DU (years) | −0.81 | −3.0 to 1.4 | 0.46 | 0.90 | 0.0 to 1.8 | 0.046 |
Previous major digital vascular complication | ||||||
None | Reference | Reference | ||||
Soft tissue infection | −5.62 | −25.9 to 14.6 | 0.58 | 3.15 | −6.4 to 12.7 | 0.51 |
Gangrene | 5.24 | −43.2 to 53.7 | 0.83 | 14.74 | −8.1 to 37.5 | 0.20 |
Cutaneous involvement | ||||||
Limited | Reference | Reference | ||||
Diffuse | 4.05 | −12.3 to 20.4 | 0.62 | −3.08 | −10.9 to 4.8 | 0.43 |
Erectile dysfunction | −7.99 | −14.2 to −1.8 | 0.019 | −7.28 | −21.1 to 6.5 | 0.25 |
RP condition score [20] at baseline | −0.51 | −2.4 to 1.4 | 0.59 | −0.11 | −1.0 to 0.8 | 0.81 |
mRSS at baseline | −0.04 | −0.9 to 0.9 | 0.93 | − 0.002 | −0.4 to 0.4 | 0.99 |
Number of DUs at baseline | 1.05 | −0.8 to 2.9 | 0.25 | 0.55 | −0.3 to 1.4 | 0.21 |
Laboratory parameters | ||||||
ACA positive | 6.08 | −10.4 to 22.5 | 0.46 | −0.02 | −8.1 to 8.0 | 0.99 |
Scl-70 positive | −16.5 | −34.8 to 1.8 | 0.075 | −2.73 | −12.1 to 6.7 | 0.56 |
ACA anticentromere autoantibodies, CI confidence interval, CSURI capillaroscopic skin ulcer risk index, DU digital ulcer, mRSS modified Rodnan skin score, RP Raynaud’s phenomenon, Scl-70 anti-topoisomerase autoantibodies