Variable | Statistics, Mixed Model Analysis | Timepoints, Mos | p, Mixed Model Analysis† | |||||
---|---|---|---|---|---|---|---|---|
3 | 6 | 12 | 15 | 18 | 24 | |||
IgG, g/l | Mean % compared with baseline | 99 | 94 | 82 | 90 | 87 | 99 | 0.010 |
95% CI* | 85–114 | 81–108 | 71–96 | 78–104 | 75–102 | 85–114 | ||
p# | 0.798 | 0.217 | 0.001 | 0.051 | 0.020 | 0.785 | ||
SSc-ANA IgG, U/ml | Mean % compared with baseline | 78 | 59 | 41 | 42 | 46 | 50 | 0.001‡ |
95% CI* | 45–134 | 34–101 | 23–72 | 24–74 | 25–85 | 28–88 | ||
p# | 0.200 | 0.009 | 0.000 | 0.000 | 0.001 | 0.002 | ||
SSc-ANA IgG corrected for total IgG, ratio | Mean % compared with baseline | 79 | 63 | 50 | 47 | 53 | 52 | 0.008‡ |
95% CI* | 45–138 | 36–109 | 28–89 | 26–85 | 29–99 | 28–91 | ||
p# | 0.243 | 0.025 | 0.002 | 0.001 | 0.007 | 0.003 | ||
EBV IgG, U/ml | Mean % compared with baseline | 94 | 80 | 84 | 84 | 85 | 103 | 0.031 |
95% CI* | 75–118 | 64–100 | 65–107 | 67–107 | 67–109 | 81–130 | ||
p# | 0.473 | 0.009 | 0.050 | 0.052 | 0.080 | 0.772 | ||
EBV IgG corrected for total IgG, ratio | Mean % compared with baseline | 96 | 85 | 101 | 94 | 98 | 104 | 0.114 |
95% CI* | 80–116 | 71–102 | 83–124 | 77–113 | 80–119 | 86–126 | ||
p# | 0.588 | 0.019 | 0.852 | 0.351 | 0.737 | 0.576 |
↵† Mixed model analysis performed on the ln transformed values, a statistical significance level of 0.05 was used;
↵‡ for patient 6 (2 SSc-ANA detected), only antitopoisomerase I levels were included in the mixed model analysis.
↵# Pairwise comparison versus baseline: p values in bold face are considered statistically significant (p < 0.0083, Bonferroni correction for multiple comparisons).
↵* Bonferroni corrected 95% CI. IgG: immunoglobulin G; SSc: systemic sclerosis; ANA: antinuclear antibodies; EBV: Epstein-Barr virus.