Table 3 Changes in outcome measures over 12 months for limited and diffuse SSc patients by treatment group.
| Limited | Diffuse | Diffuse vs Limited | |||||
|---|---|---|---|---|---|---|---|
| CYC | Placebo | CYC | Placebo | CYC | |||
| n = 27 | n = 28 | p values* | n = 46 | n = 44 | p values* | p values** | |
| Pulmonary function | |||||||
| FVC (% predicted) | −0.17 (1.47) | −3.49 (0.95) | 0.03 | −0.35 (0.98) | −1.8 (1.20) | 0.39 | 0.26 |
| TLC (% predicted) | −1.08 (1.77) | −4.43 (1.48) | 0.13 | −0.08 (1.22) | −1.84 (1.25) | 0.40 | 0.30 |
| DLCO (% predicted) | −6.74 (1.59) | −1.47 (1.71) | 0.04 | −2.73 (1.03) | −3.25 (1.26) | 0.70 | 0.82 |
| FEV1 (% predicted) | −0.09 (1.69) | −4.16 (1.29) | 0.05 | −0.29 (0.91) | −2.25 (1.40) | 0.24 | 0.38 |
| TDI (units) | 1.76 (4.03) | −2.64 (3.01) | <0.001 | 1.18 (3.13) | −0.63 (3.28) | 0.02 | 0.03 |
| SF‐36 components | |||||||
| Vitality | 0.46 (3.82) | −7.57 (4.22) | 0.17 | 10.3 (2.41) | 0.44 (2.74) | 0.02 | 0.07 |
| Mental health | 2.76 (2.86) | −3.22 (3.79) | 0.31 | 7.57 (2.10) | 0.69 (2.25) | 0.03 | 0.24 |
| Physical function | 2.46 (4.97) | −7.83 (6.32) | 0.14 | 3.02 (2.72) | −4.80 (2.77) | 0.04 | 0.51 |
| Mental component | 0.83 (1.97) | 1.12 (1.69) | 0.69 | 6.23 (1.05) | 1.57 (1.20) | 0.05 | 0.39 |
| Health transition | −0.78 (0.25) | 0.01 (0.20) | 0.006 | −0.97 (0.2) | −0.36 (0.19) | 0.03 | 0.13 |
| Other outcomes | |||||||
| Skin score (units) | −2.92 (0.94) | −1.33 (1.02) | 0.16 | −5.18 (1.07) | −1.70 (1.42) | 0.03 | 0.001 |
| HAQ−DI | −0.21 (0.08) | 0.05 (0.07) | 0.13 | −0.09 (0.08) | 0.14 (0.08) | 0.04 | 0.646 |
*p values for change from baseline, comparing CYC to placebo patients within limited group and within the diffuse group analysed separately; **p values for comparison of placebo‐corrected change scores in the diffuse group compared to the placebo‐corrected changes scores in the limited group.