Table II.
Baseline | 6 months | 12 months | |
---|---|---|---|
Modified Rodnan skin score* | 20.6 ± 4.4 (9−31/19) | 20.2 ± 5.5 (5−45.5/17) | 21.1 ± 5.2 (8−45.5/17) |
Pulmonary Function testing | |||
Forced vital capacity (% predicted) | 89.2 ± 10.8 (62−119) | 92.7 ± 10.3 (53−120) | |
DLCO (% predicted) | 79.7 ± 8.3 (61−107) | 77.8 ± 7.5 (52−95) | |
Health Assessment Questionnaire | |||
Disability Index | 0.67 ± 0.32 (0−2.0) | 0.64 ± 0.36 (0−2.25) | 0.55 ± 0.33 (0−2.25) |
VAS | 0.73 ± 0.26 (0−1.875) | 0.53 ± 0.21 (0−1.5) | 0.56 ± 0.21 (0.03−1.5) |
Immunoglobulins | |||
IgM | 107 ± 25 (15−172) | 86 ± 24 (9−172) | 86 ± 24 (11−172) |
IgG | 1106 ± 197 (756−2210) | 1066 ± 173 (696−1970) | 1021 ± 181 (588−1970) |
IgA | 270 ± 100 (61−539) | 288 ± 105 (58−546) | 274 ± 94 (58−532) |
Sedimentation Rate | 27.9 ± 11.7 (2−69) | 20.5 ± 7.8 (6−40) | 17.0 ± 6.1 (6−38) |
Exploratory Outcomes | |||
B cell score | 10.4 ± 4.6 (0−23) | 3.4 ± 4.8 (0−30) | |
SMA score | 49.5 ± 16.6 (6−81.5) | 36.6 ± 16.6 (2−78) |
Values represent the average ± 95% confidence limit (range)