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. Author manuscript; available in PMC: 2022 Sep 12.
Published in final edited form as: Curr Opin Pharmacol. 2022 Apr 18;64:102211. doi: 10.1016/j.coph.2022.102211

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