Table 1. Patient Characteristicsa.
| Characteristic | Development cohort (n = 327) | Validation cohort (n = 251) | Total (N = 578) |
|---|---|---|---|
| Sex | |||
| Female | 226 (69.1) | 184 (73.3) | 410 (70.9) |
| Male | 101 (30.9) | 67 (26.7) | 168 (29.1) |
| Age, median (IQR), y | |||
| At first symptom | 33.9 (27.1-42.4) | 33.2 (27.1-41.3) | 33.5 (27.1-42.1) |
| At sNfL analysis | 34.1 (27.2-42.7) | 33.3 (27.4-41.5) | 33.8 (27.3-42.2) |
| Time to analysis after first relapse, median (IQR), mo | 3.74 (1.21-6.36) | 2.26 (0.98-5.74) | 3.26 (1.12-6.03) |
| BMI, median (IQR) | 25 (22.4-26.0) | 24.3 (22.5-27.2) | 25 (22.5-26.7) |
| Topography of first relapse | |||
| Brain stem | 67 (20.5) | 60 (24.9) | 127 (22.4) |
| Optic nerve | 73 (22.3) | 49 (20.3) | 122 (21.5) |
| Spinal cord | 131 (40.1) | 76 (31.5) | 207 (36.4) |
| Multifocal | 9 (2.8) | 18 (7.5) | 27 (4.8) |
| Otherb | 47 (14.4) | 38 (15.8) | 85 (15) |
| Fulfillment of 2017 revised McDonald criteria at baseline11 | |||
| No | 45 (13.8) | 2 (0.8) | 47 (8.1) |
| Yes | 282 (86.2) | 249 (99.2) | 531 (91.9) |
| EDSS score at baseline, median (range) | 2 (0-6.5) | 1 (0-4) | 1.5 (0-6.5) |
| T2 lesions at baseline | |||
| 0-3 | 66 (17.1) | 25 (10.6) | 81 (13.4) |
| 4-9 | 92 (28.1) | 90 (38.1) | 182 (32.3) |
| 10-50 | 151 (46.2) | 118 (50) | 269 (47.8) |
| >50 | 28 (8.6) | 3 (1.3) | 31 (5.5) |
| Gadolinium-enhancing lesions, median (range) | 1 (0-36) | 0 (0-21) | 1 (0-36) |
| Patients with enhancing lesions, No. | 167/299 (55.9) | 97/212 (45.8) | 264/511 (51.7) |
| IgG oligoclonal bands | 267/327 (81.7) | 196/211 (92.9) | 460/538 (85.5) |
| DMT use during follow-up | |||
| None | 91 (27.8) | 32 (12.8) | 123 (21.3) |
| HE-DMTs exclusivelyc | 43 (13.1) | 18 (7.2) | 61 (10.6) |
| Other DMTs exclusivelyd | 160 (48.9) | 146 (58.2) | 306 (52.9) |
| Both HE-DMTs and other DMTs | 33 (10.1) | 55 (21.9) | 88 (15.2) |
| Time of follow-up, median (IQR), y | 5.43 (3.17-9.08) | 8.41 (5.83-10.85) | 7.10 (4.18-10.04) |
| Patients attaining 6-mo CDW during follow-upe | 72 (22.0) | 103 (41.0) | 175 (30.3) |
| Relapse-associated worsening | 34 (10.4) | 63 (25.1) | 97 (16.8) |
| Progression independent of relapse activity | 50 (15.3) | 69 (27.5) | 119 (20.6) |
| Patients reaching an EDSS score of 3 during follow-up | 61 (18.7) | 70 (27.9) | 131 (22.7) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CDW, confirmed disability worsening; DMT, disease-modifying treatment; EDSS, Expanded Disability Status Scale (scores range from 0 to 10 in 0.5-unit increments, with higher scores representing higher levels of disability); HE-DMT, highly effective DMT; IgG, immunoglobulin G; sNfL, serum neurofilament light chain.
Data are reported as number (percentage) of patients unless otherwise indicated.
Other topography of first relapse included cerebral hemisphere or paroxysmal symptoms.
HE-DMTs included natalizumab, alemtuzumab, ocrelizumab, rituximab, ofatumumab, and mitoxantrone.
Other DMTs included subcutaneous or intramuscular interferon-beta, glatiramer acetate, teriflunomide, dimethyl fumarate, fingolimod, oral cladribine, daclizumab, azathioprine, and tacrolimus.
Some patients may have experienced relapse-associated worsening, progression independent of relapse activity, or both events during their follow-up.