Table 2.
Recent Phase II/III RCTs for dcSSc
Therapeutic | Sample Size | Skin Outcome Measure | Result of skin outcome measure |
---|---|---|---|
Tocilizumab [21] | N=212 | Primary outcome: ΔmRSS at week 48 | Least squares mean ΔmRSS −6.1 in tocilizumab arm and −4.4 in placebo arm; P=0.10 |
Nintedanib [19] | N=576 | Secondary outcome: ΔmRSS at week 52 | Adjusted mean ΔmRSS −2.17 in the nintedanib arm and −1.96 in the placebo arm; P=0.58 |
Lenabasum [23] | N=363 | Secondary outcome: ΔmRSS at week 52 | Mean ΔmRSS −8.1 in the placebo arm and −6.7 in the lenabasum arm |
Abatacept [24] | N=88 | Primary outcome: ΔmRSS at week 52 | Adjusted mean ΔmRSS from baseline −6.24 in abatacept arm and −4.49 in placebo arm; P=0.28 |
Riociguat [25] | N=109 | Primary outcome: ΔmRSS at week 52 | Mean ΔmRSS −2.09 for riociguat arm and −0.77 for placebo arm; P=0.08 |