Table 1.
Baseline demographics and disease characteristics in EVOLVE-MS-1.
| Characteristics | Overall population n = 1057 |
Newly diagnosed subgroup n = 109 |
De novo enrollment n = 593 |
EVOLVE-MS-2 rollover | |
|---|---|---|---|---|---|
| Prior DMF n = 225 |
Prior DRF n = 239 |
||||
| Age, years, mean (SD) | 42.5 (10.8) | 36.0 (10.8) | 41.5 (11.0) | 43.7 (9.8) | 44.0 (11.0) |
| Female, n (%) | 762 (72.1) | 78 (71.6) | 427 (72.0) | 170 (75.6) | 165 (69.0) |
| Race, n (%) | |||||
| White | 972 (92.0) | 104 (95.4) | 547 (92.2) | 205 (91.1) | 220 (92.1) |
| Black or African American | 72 (6.8) | 5 (4.6) | 37 (6.2) | 16 (7.1) | 19 (7.9) |
| Other | 13 (1.2) | 0 | 9 (1.5) | 4 (1.8) | 0 |
| BMI, kg/m2, mean (SD) | 26.6 (6.1) | 25.4 (6.2) | 26.2 (6.1) | 27.6 (6.2) | 27.0 (5.9) |
| Region, n (%) | |||||
| Non-US | 604 (57.1) | 78 (71.6) | 385 (64.9) | 104 (46.2) | 115 (48.1) |
| US | 453 (42.9) | 31 (28.4) | 208 (35.1) | 121 (53.8) | 124 (51.9) |
| Prior DMT a , n (%) | 681 (64.4) | 0 | 379 (63.9) | 143 (63.6) | 159 (66.5) |
| Interferon | 398 (37.7) | 0 | 232 (39.1) | 81 (36.0) | 85 (35.6) |
| Glatiramer acetate | 267 (25.3) | 0 | 145 (24.5) | 61 (27.1) | 61 (25.5) |
| Time since diagnosis, years, mean (SD) | 7.6 (7.3) b | 0.4 (0.5) | 7.6 (7.1) c | 7.8 (7.5) | 7.4 (7.8) |
| No. of relapses in the previous year, mean (SD) | 0.7 (0.8) | 1.2 (0.7) | 0.8 (0.8) | 0.6 (0.7) | 0.6 (0.7) |
| EDSS score, mean (SD) | 2.7 (1.5) | 2.0 (1.1) | 2.7 (1.5) | 2.7 (1.4) | 2.6 (1.5) |
| No. of Gd+ lesions, mean (SD) | 1.1 (3.5) d | 1.9 (5.1) | 1.3 (4.2) | 0.9 (2.6) | 0.8 (2.2) e |
| Gd+ lesion free, n (%) | 741 (70.1) | 61 (56.0) | 406 (68.5) | 159 (70.7) | 176 (73.6) |
| GI comorbidity, n (%) | 132 (12.5) | 17 (15.6) | 89 (15.0) | 26 (11.6) | 17 (7.1) |
BMI: body mass index; DMF: dimethyl fumarate; DRF: diroximel fumarate; DMT: disease-modifying therapy; EDSS: Expanded Disability Status Scale; Gd+: gadolinium-enhancing; GI: gastrointestinal.
a
Prior DMT includes immunomodulatory and immunosuppressant (investigational or approved).
b
n =1056.
c
n =592.
d
n =1053.
e
n =235.