Table 1.
Demographics and baseline characteristics by ALC count (safety population)
| Characteristics | Without lymphopenia (always ALC ≥ LLN) n = 593 |
With lymphopenia (at least one ALC < LLN) n = 452 |
SMD in absolute value | All patients N = 1045 |
|---|---|---|---|---|
| Age, years, mean (SD) | 41.0 (10.6) | 44.4 (10.6) | 0.32* | 42.5 (10.8) |
| Female, n (%) | 404 (68.1) | 349 (77.2) | 0.20* | 753 (72.1) |
| Race, n (%) | ||||
| White | 530 (89.4) | 432 (95.6) | 0.26* | 962 (92.1) |
| Black or African American | 56 (9.4) | 14 (3.1) | 70 (6.7) | |
| Othera | 7 (1.2) | 6 (1.3) | 13 (1.2) | |
| Ethnicity, n (%) | ||||
| Hispanic or Latino | 19 (3.2) | 19 (4.2) | 0.05 | 38 (3.6) |
| Not Hispanic or Latino | 574 (96.8) | 433 (95.8) | 1007 (96.4) | |
| BMI, kg/m2, mean (SD) | 26.7 (6.4) | 26.6 (5.8) | 0.02 | 26.6 (6.1) |
| US region, n (%) | 255 (43.0) | 189 (41.8) | 0.02 | 444 (42.5) |
| Prior DMT, n (%) | 373 (62.9) | 299 (66.2) | 0.07 | 672 (64.3) |
| Time since diagnosis, years, mean (SD) | 7.1 (7.2)b | 8.2 (7.4) | 0.15* | 7.6 (7.3)c |
| No. of relapses in previous year, mean (SD) | 0.7 (0.8) | 0.7 (0.8) | < 0.01 | 0.7 (0.8) |
| EDSS score, mean (SD) | 2.7 (1.5) | 2.7 (1.4) | < 0.01 | 2.7 (1.5) |
| No. of Gd+ lesions, mean (SD) | 1.1 (3.0)b | 1.2 (4.1)d | 0.03 | 1.1 (3.5)e |
| Gd+ lesion free, n (%) | 410 (69.1) | 320 (70.8) | 0.04 | 730 (69.9) |
ALC absolute lymphocyte count, BMI body mass index, DMT disease-modifying therapy, EDSS expanded disability status score, Gd+ gadolinium-enhancing, LLN lower limit of normal, SMD standardized mean difference
*p < 0.05
a“Other” race includes Asian, American Indian, Alaska Native, Native Hawaiian, or other Pacific Islander, and multiple races; subjects who reported multiple races including White were included in White subgroup
bn = 592
cn = 1044
dn = 450
en = 1042