Table 2.
Baseline characteristics of pre-matched and post-matched populations for the FTY all-comer and FTY label comparison populations
| Baseline factor | DMF versus FTY all-comer | DMF versus FTY label | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-matched | Post-matched | Pre-matched | Post-matched | |||||||||||||
| DMF (n = 793) | FTY (n = 773) | d | p value | DMF (n = 457) | FTY (n = 457) | d | p value | DMF (n = 99) | FTY (n = 420) | d | p value | DMF (n = 99) | FTY (n = 99) | d | p value | |
| Female | 71.6% | 71.4% | 0.005 | 0.969 | 72.6% | 73.5% | 0.020 | 0.824 | 75.8% | 70.0% | 0.130 | 0.311 | 75.8% | 81.8% | 0.149 | 0.345 |
| Age in years (SD) | 40.3 (10.78) | 39.3 (10.05) | − 0.095 | 0.044 | 39.9 (10.95) | 40.2 (9.67) | 0.029 | 0.713 | 37.8 (9.6) | 39.1 (10.3) | 0.133 | 0.265 | 37.8 (9.6) | 37.1 (9.6) | − 0.065 | 0.624 |
| Median EDSS (Q25, Q75) | 1.5 (1, 2.5) | 2 (1.5, 3.5) | 0.406 | 0.000 | 2 (1, 3.5) | 2 (1, 3) | 0.03 | 0.689 | 2 (1, 3.25) | 2 (1.5, 3.5) | 0.266 | 0.035 | 2 (1, 3.25) | 2 (1.5, 3) | − 0.015 | 0.870 |
| Mean disease duration in months (SD) | 98.2 (93.3) | 106.6 (87.6) | 0.093 | 0.001 | 104.8 (93.4) | 108.1 (92.4) | 0.036 | 0.578 | 95.2 (81.9) | 109.6 (84.4) | 0.174 | 0.068 | 95.2 (81.9) | 93.9 (72.8) | − 0.016 | 0.955 |
| Prior number of DMT, % | ||||||||||||||||
| 0 | 41.5% | 13.8% | 23.0% | 22.1% | – | – | – | – | ||||||||
| 1 | 47.5% | 71.5% | 0.655 | 0.000 | 63.7% | 64.1% | 0.023 | 0.909 | 82.8% | 83.1% | 0.007 | 1.000 | 82.8% | 76.8% | 0.151 | 0.361 |
| 2 | 10.6% | 14.5% | 13.1% | 13.6% | 17.2% | 16.9% | 17.2% | 23.2% | ||||||||
| 3 | 0.4% | 0.1% | 0.2% | 0.2% | ‒ | ‒ | ‒ | ‒ | ||||||||
| Total number of relapses in the last 12 months, % | ||||||||||||||||
| 0 | 69.4% | 35.3% | 59.1% | 59.3% | 1.0% | 0.2% | 1.0% | 1.0% | ||||||||
| 1 | 24.8% | 38.8% | 31.1% | 30.6% | 72.7% | 58.3% | 72.7% | 66.7% | ||||||||
| 2 | 5.0% | 19.0% | 0.793 | 0.000 | 8.5% | 9.2% | 0.059 | 0.715 | 22.2% | 30.5% | 0.372 | 0.041 | 22.2% | 28.3% | 0.141 | 0.450 |
| 3 | 0.5% | 5.8% | 0.9% | 0.4% | 3.0% | 9.3% | 3.0% | 3.0% | ||||||||
| 4+ | 0.3% | 1.0% | 0.4% | 0.4% | 1.0% | 1.7% | 1.0% | 1.0% | ||||||||
| Total number of relapses in the last 24 months, % | ||||||||||||||||
| 0 | 59.3% | 29.5% | 50.5% | 49.5% | 48.5% | 34.8% | – | – | ||||||||
| 1 | 28.2% | 29.4% | 29.3% | 30.6% | 31.3% | 33.6% | 48.5% | 44.4% | ||||||||
| 2 | 8.8% | 22.0% | 0.776 | 0.000 | 14.2% | 13.3% | 0.045 | 0.967 | 13.1% | 19.8% | 0.317 | 0.051 | 31.3% | 31.3% | 0.106 | 0.219 |
| 3 | 2.5% | 12.3% | 3.9% | 4.4% | 7.1% | 11.9% | 13.1% | 16.2% | ||||||||
| 4+ | 1.1% | 6.9% | 2.0% | 2.2% | – | – | 7.1% | 8.1% | ||||||||
| C-statistic | 0.780 | 0.519 | 0.635 | 0.586 | ||||||||||||
d standardised difference, DMF delayed-release dimethyl fumarate, DMT disease-modifying therapy, EDSS Expanded Disability Status Scale, FTY fingolimod