Table 2.
Secondary outcomes in the SID and EID groups in the unadjusted, IPTW, and PSM models and sensitivity analysis by the shrinkage IPTW approach
| Outcomes | Raw data | IPTW | Matched | IPTW (shrinkage) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SID group (n = 156) | EID group (n = 147) | p valuea | SID group (wn = 161.0) | EID group (wn = 145.1) | p valueb | SID group (n = 102) | EID group (n = 102) | p valuec | SID group (wn = 129.9) | EID group (wn = 142.3) | p valueb | |
| ARR at 12 months, mean (SD) | 0.083 (0.300) | 0.041 (0.231) | 0.149 | 0.098 (0.320) | 0.043 (0.238) | 0.084 | 0.088 (0.318) | 0.059 (0.275) | 0.475 | 0.076 (0.270) | 0.044 (0.239) | 0.282 |
| EDSS score at 12 months, mean (SD) | 2.72 (1.85) | 2.43 (1.74) | 0.180 | 2.75 (1.79) | 2.56 (1.80) | 0.368 | 2.65 (1.87) | 2.54 (1.76) | 0.642 | 2.71 (1.75) | 2.51 (1.77) | 0.366 |
| Worsening of EDSS score from baseline to 12 months, n (%) | 20 (13) | 14 (11) | 0.610 | 26.5 (16) | 14.8 (11) | 0.172 | 13 (13) | 12 (12) | > 0.999 | 17.2 (13) | 14.8 (11) | 0.607 |
| Overall clinical disease activity at 12 months, n (%) | 126 (81) | 111 (86) | 0.236 | 121.2 (75) | 116.1 (86) | 0.022 | 82 (80) | 82 (84) | 0.690 | 105.3 (81) | 113.4 (86) | 0.314 |
Overall clinical disease activity: nondisease activity (no worsening of EDSS at 12 months and no relapse in the last 12 months)
ARR annualized relapse rate, EDSS Expanded Disability Status Scale, EID extended interval dosing, IPTW inverse probability treatment weighting, PSM propensity score matching, SD standard deviation, SID standard interval dosing, wn weighted number
ap value obtained by a univariate generalized linear model with a Poisson distribution for the ARR, by the Student t test for quantitative variables, and by the chi-square test for qualitative variables
bp value obtained by a univariate generalized linear model with a Poisson distribution for the ARR, by the Student t test for quantitative variables, and by the chi-square test for qualitative variables, weighted on stabilized weights
cp value obtained by a univariate generalized linear model with a Poisson distribution for the ARR taking into account matched data, the paired Student t test for quantitative variables, and the McNemar test for qualitative variables