Outcome measure (n) | Baseline mean (SD) | Month 12 mean (SD) | Mean change (95% CI) | p Value |
---|---|---|---|---|
MRSS (24) | 29.4 (8.6) | 22.8 (10.2) | −6.6 (−4.5 to −8.7) | <0.001 |
PFT All (22) | ||||
FVC % predicted | 82.9 (21.1) | 89.3 (25.2) | 6.4 (1.9 to 10.9) | 0.008 |
DLCO Hb adj % predicted | 78.0 (22.9) | 83.5 (29.2) | 5.5 (−1.5 to 12.4) | 0.12 |
PFT ILD (11) | ||||
FVC % predicted | 73.3 (18.3) | 75.4 (20.7) | 2.1 (−2.8 to 7) | 0.36 |
DLCO Hb adj % predicted | 64.7 (14.0) | 65.7 (15.6) | 1.0 (−8.1 to 10.1) | 0.81 |
PFT not ILD (11) | ||||
FVC % predicted | 92.6 (19.8) | 103.2 (21.8) | 10.7 (3.3 to 18.2) | 0.01 |
DLCO Hb adj % predicted | 91.3 (22.8) | 101.2 (29.2) | 9.9 (−1.7 to 21.5) | 0.09 |
HRQoL (24) | ||||
VAS global | 46.7 (22.4) | 37.1 (28.2) | −9.6 (0.2 to 19.0) | 0.046 |
VAS SOB | 19.6 (24.2) | 12.8 (24.6) | −6.7 (2.0 to 11.5) | 0.008 |
VAS pain | 49.5 (27.4) | 30.8 (29.7) | −18.7 (9.7 to 27.8) | <0.001 |
VAS RP | 37.3 (28.7) | 30.0 (28.9) | −9.3 (−1.9 to 20.5) | 0.098 |
VAS digital ulcers | 33.6 (37.8) | 21.1 (28.5) | −12.5 (−0.9 to 25.9) | 0.066 |
SHAQ-DI | 1.1 (0.6) | 1.1 (0.7) | 0.02 (−0.15 to 0.18) | 0.85 |
SF-36 PC | 46.8 (17.3) | 53.5 (25.6) | 6.8 (1.7 to 15.3) | 0.11 |
SF-36 MC | 61.5 (15.8) | 68.1 (18.6) | −6.6 (−12.5 to −0.7) | 0.03 |
Other | ||||
PGA | 6.3 (1.6) | 4.1 (2.3) | −2.2 (−2.9 to −1.4) | <0.001 |
ESR | 25.6 (18.8) | 22.1 (15.5) | −3.5 (−4.0 to 11.0) | 0.35 |
DLCO, diffusion capacity of carbon monoxide; ESR, erythrocyte sedimentation rate; FVC, forced vital capacity; Hb, haemoglobin; HRQoL, health-related quality of life; MC, mental component; MRSS, modified Rodnan skin score; PC, physical component; PFT, pulmonary function test; PGA, physician global assessment; RP, Raynaud's phenomenon; SF-36, short form 36; SHAQ-DI, scleroderma health assessment questionnaire disability index; SOB, shortness of breath; VAS, visual analogue scale.