Table 3.
Differences among groups in baseline characteristics.
| NEDA-3 (n = 85) |
INFL (n = 20) |
PIRA (n = 10) |
p-Value NEDA-3 versus INFL | p-Value NEDA-3 versus PIRA | p-Value INFL versus PIRA | |
|---|---|---|---|---|---|---|
| Age (years) Median [range] |
42.4 [22.1–76.9] |
37.3 [25.2–61.4] |
44.9 [28.9–62.7] |
ns | ns | ns |
| BMI Median [range] |
23.1 [16.7–37.9] |
23.8 [18.5–28.8] |
21.3 [15.4–29.9] |
ns | ns | ns |
| Sex (F/M) | 51/34 | 18/2 | 7/3 | 0.02 | ns | ns |
| Current smoker N (%) |
9 (10.6%) | 3 (15.0%) | 0 (0.0%) | ns | ns | ns |
| Disease duration Median [range] |
7.4 [0.2–28.3] |
4.9 [0.1–18.0] |
10.7 [1.6–30.8] |
ns | ns | ns |
| EDSS score Median [range] |
2.5 [0.0–6.5] |
2.0 [1.5–6.0] |
3.3 [1.0–6.0] |
ns | ns | ns |
| sNfL Median [range] |
7.2 [1.6–120.7] |
16.0 [2.2–382.9] |
6.7 [2.5–16.7] |
0.0006 | ns | 0.01 |
| z-score sNfL Median [range] |
−0.1 [−3.4–3.5] |
2.5 [−3.0–4.0] |
−0.3 [−3.2–1.0] |
0.0003 | ns | 0.01 |
| sGFAP Median [range] |
126.4 [48.6–1,285.1] |
199.1 [85.3–1,105.8] |
154.5 [75.1–417.2] |
0.03 | ns | ns |
| Card. Comorbidities N (%) | ||||||
| High blood pressure Cardiomyopathy Ischemic heart disease |
5 (5.9%) 0 (0.0%) 0 (0.0%) |
2 (10.0%) 1 (5.0%) 0 (0.0%) |
0 (0.0%) 0 (0.0%) 0 (0.0%) |
ns | ns | ns |
| Previous treatment N (%) | ||||||
| Naïve Platform Orals Monoclonal Ab. |
19 (22.4%) 23 (27.1%) 26 (30.5%) 17 (20.0%) |
8 (40.0%) 4 (20.0%) 7 (35.0%) 1 (5.0%) |
0 (0%) 0 (0%) 10 (100%) 0 (0%) |
ns | 0.0004 | 0.009 |
| Reason for switching previous treatment N (%) | ||||||
| Effectiveness Safety |
58 (87.9%) 8 (12.1%) |
11 (91.6%) 1 (8.4%) |
9 (90%) 1 (10%) |
ns | ns | ns |
| T2 lesions on MRI N (%). | ||||||
| <10 lesions 10–50 lesions 50–100 lesions >100 lesions |
9 (10.6%) 59 (69.4%) 16 (18.8%) 1 (1.2%) |
3 (15.0%) 11 (55.0%) 4 (20.0%) 2 (10.0%) |
0 (0.0%) 7 (70.0%) 3 (30.0%) 0 (0.0%) |
ns | ns | ns |
| Gd-lesions on MR N (%). | ||||||
| At least one lesion | 35 (41.2%) | 12 (60.0%) | 2 (20.0%) | ns | ns | ns |
BMI, body mass index; F, female; M, male; Card, cardiovascular; EDSS, Expanded Disability Status Scale; sNfL, serum neurofilament light chains; sGFAP, serum glial fibrillary acidic protein; n, number of patients; NEDA-3, patients free of disease activity at 12 months of ocrelizumab initiation (n = 85); INFL, patients with new relapses and/or radiological activity during follow-up (n =2 0); PIRA, patients who had confirmed disability progression in the absence of relapses or new MRI activity at 12 months of ocrelizumab initiation (n = 10); ns, non-significant; N, number of patients; Ab, antibody; Naïve, no previous treatment; Gd, gadolinium-enhancing lesions.
Platform treatments included interferon beta and glatiramer acetate. Oral drugs included cladribine, dimethylfumarate, fingolimod, and teriflunomide. Monoclonal Ab. included alemtuzumab and natalizumab.