Table 2.
Covariate summary statistics at baseline by study
| Variable (N) | OMS115102 (25) | MIRROR (231) | APLIOS (284) | ASCLEPIOS I (465) | ASCLEPIOS II (481) | All (1486) |
|---|---|---|---|---|---|---|
| Route of administration (IV, PFS [SC] or AI [SC]) |
AI = 0 PFS = 0 IV = 25 |
AI = 0 PFS = 231 IV = 0 |
AI = 141 PFS = 143 IV = 0 |
AI = 0 PFS = 465 IV = 0 |
AI = 0 PFS = 481 IV = 0 |
AI = 141 PFS = 1320 IV = 25 |
| Age (years) | 36.2 (7.5) | 37.1 (9.4) | 37.3 (8.9) | 38.9 (8.8) | 38.0 (9.3) | 37.9 (9.1) |
| 33 [26–52] | 38 [18–56] | 37 [18–55] | 40 [19–56] | 38 [18–56] | 38 [18–56] | |
| Weight (kg) | 73.6 (14.9) | 73.4 (17.0) | 73.7 (18.4) | 74.8 (19.9) | 73.6 (19.0) | 74.0 (18.8) |
| 76.0 [48.0–104.0] | 70.0 [42.0–136.0] | 70.0 [44.6–168.0] | 70.2 [41.2–171.5] | 70.0 [40.5–157.9] | 70.0 [40.5–171.6] | |
| Sex (% female) | 64.0 | 67.1 | 70.1 | 68.4 | 66.3 | 67.8 |
| Race (n) | ||||||
| White/Caucasian | 25 | 225 | 275 | 411 | 418 | 1354 |
| Black/African American | 0 | 2 | 6 | 15 | 13 | 36 |
| Asian | 0 | 1 | 0 | 15 | 21 | 37 |
| Unknown | 0 | 0 | 0 | 2 | 9 | 11 |
| Other/American Indian or Alaska Native | 0 | 3 | 3 | 22 | 20 | 48 |
| CD19+ B cell count (cells/µL) | 237.1 (125.4) | 245.2 (127.9) | 238.7 (126.9) | 223.0 (124.6) | 210.9 (129.0) | 225.8 (127.5) |
| 194 [69–534] | 220 [87–1091] | 218.5 [15–859] | 200 [0–1070] | 180 [0–1520] | 200.0 [0–1520] | |
| EDSSa |
2.9 (1.2) 3.0 [1.0–5.0] |
2.3 (1.2) 2.0 [0.0–5.5] |
3.0 (1.3) 2.5 [0.0–5.5] |
3.0 (1.4) 3.0 [0.0–6.0] |
2.9 (1.3) 3.0 [0.0–6.0] |
2.8 (1.3) 2.5 [0.0–6.0] |
| Number of relapses in the previous 2 years | 2.4 (1.5); 2 [1–6] | 1.8 (0.9); 2 [1–5] | 2.3 (1.9); 2 [0–22] | 2.1 (1.2); 2 [0–9] | 2.0 (1.3); 2 [0–8] | 2.1 (1.4); 2 [0–22] |
| Gd-enhancing T1 lesions count | ||||||
|
0.5 (0.8) 0 [0–2] |
3.2 (7.1) 1 [0–75] |
1.5 (5.0) 0 [0–60] |
1.7 (4.9) 0 [0–47] |
1.6 (4.1) 0 [0–58] |
1.9 (5.1) 0 [0–75] |
|
| Patients with at least 1 Gd-enhancing T1 lesion (%) | 32.0 | 51.1 | 37.7 | 37.4 | 43.9 | 41.6 |
| Volume of T2 lesions (cm3) |
10.2 (9.0) 9.3 [0.3–28.7] |
10.9 (12.6) 6.8 [0.0–111.3] |
13.6 (16.7) 7.1 [0.1–129.4] |
13.2 (13.3) 8.8 [0.1–85.9] |
14.3 (14.2) 9.0 [0.1–81.9] |
13.2 (14.2) 8.1 [0.0–129.3] |
Eligibility was assessed at the screening visit
For continuous covariates, mean (SD) and median [range] are reported
AI auto-injector, EDSS Expanded Disability Status Scale, Gd-enhancing gadolinium-enhancing, IV intravenous, N number of patients included in the PK–B cell analysis, n number of patients in each ethnic group, PFS prefilled syringe, SC subcutaneous, SD standard deviation,
aBaseline EDSS score was defined as the score at the last assessment before the first dose administration of trial drug