Table 1.
Participant characteristics and demographics in RDTN participants and in the overall population from the ASCLEPIOS I and II trials (FAS).
| Characteristic | RDTN participants from ASCLEPIOS I
and II
a
|
All participants from ASCLEPIOS I
and II |
||
|---|---|---|---|---|
| Ofatumumab (n = 314) | Teriflunomide (n = 301) | Ofatumumab (N = 946) | Teriflunomide (N = 936) | |
| Age, mean (SD) b , years | 36.8 (9.4) | 35.7 (9.0) | 38.4 (9.0) | 38.0 (9.2) |
| Women, n (%) | 217 (69.1) | 195 (64.8) | 637 (67.3) | 636 (67.9) |
| Type of MS, n (%) | ||||
| RRMS | 311 (99.0) | 296 (98.3) | 890 (94.1) | 884 (94.4) |
| SPMS | 3 (1.0) | 5 (1.7) | 56 (5.9) | 52 (5.6) |
| Time since diagnosis, mean (SD), years | 0.58 (0.63) | 0.53 (0.51) | 5.68 (6.21) | 5.56 (6.10) |
| Relapses in previous 12 months, mean (SD) | 1.3 (0.7) | 1.4 (0.7) | 1.2 (0.7) | 1.3 (0.7) |
| Relapses in previous 12–24 months, mean (SD) | 0.6 (0.8) | 0.5 (1.0) | 0.8 (1.0) | 0.9 (1.1) |
| EDSS score at baseline, mean (SD) c | 2.30 (1.20) | 2.28 (1.20) | 2.93 (1.35) | 2.90 (1.37) |
| Participants with Gd+T1 lesions, mean (SD) |
n = 306 1.8 (4.4) |
n = 298 1.4 (2.8) |
n = 923 1.7 (4.5) |
n = 922 1.3 (3.4) |
| Participants with Gd+T1 lesions, n (%) | 141 (44.9) | 130 (43.2) | 385 (40.7) | 352 (37.6) |
| Total volume of T2 lesions, mean (SD), cm3 |
n = 311 10.11 (12.23) |
n = 300 8.31 (8.83) |
n = 934 13.72 (13.80) |
n = 930 12.55 (13.81) |
| NfL concentration, mean (SD), pg/mL |
n = 297 15.19 (18.57) |
n = 279 13.66 (14.52) |
n = 893 13.98 (15.86) |
n = 853 12.54 (11.94) |
| Normalized brain volume, mean (SD), cm3 |
n = 310 1472.6 (72.3) |
n = 300 1472.9 (66.1) |
n = 929 1439.8 (78.9) |
n = 927 1444.0 (77.8) |
EDSS: Expanded Disability Status Scale; FAS: full analysis set; Gd+: gadolinium-enhancing; NfL: neurofilament light chain; RDTN, recently diagnosed, treatment-naive; RRMS: relapsing–remitting MS; SD: standard deviation; SPMS: secondary progressive MS.
Unless otherwise stated in individual rows, the number of participants with available data at baseline is indicated in the column header.
RDTN were those who had not received a prior MS disease-modifying therapy and who had received a diagnosis in the 36 months before screening.
Age at baseline was calculated from the date of the first administration of trial drug and the birth year (no exact birth date was captured for data privacy reasons). Eligibility for trial entry was assessed at the screening visit.
EDSS score at baseline was defined as the EDSS score at the last assessment before administration of the first dose of trial drug. EDSS scores range from 0 to 10.0, with higher scores indicating a higher degree of disability.