Table 1.
Demographic, clinical, and treatment characteristics of patients with multiple sclerosis and demographic characteristics of healthy controls.
| pwMS under anti-CD20 therapy at latest sampling | pwMS before anti-CD20 therapy at latest sampling | Controls (hospital employees) | p value a | |
|---|---|---|---|---|
| Number | 181 | 41 | 19 | – |
| Age, median (range), years | 40 (17–81) | 37 (18–67) | 31 (22–44) | 0.003 b |
| Female/male (%female) | 110/71 (61%) | 18/23 (44%) | 14/5 (74%) | 0.06 |
| RRMS/PPMS (%PPMS) | 141/40 (22%) | 36/5 (12%) | – | 0.15 |
| EDSS, median (range) | 2 (0–7.5) | 2 (0–7) | – | 0.08 |
| Any previous immunotherapy, n/total n (%) | 108/181 (60%) | 20/41 (49%) | – | 0.2 |
| At least two previous immunotherapies, n/total n (%) | 62/108 (57%) | 12/20 (60%) | – | 0.82 |
| Cumulative dose c ocrelizumab per patient, median (range), mg | 2400 (600–11,400) | 600 (300–600) | – | – |
| Treatment with rituximab before ocrelizumab, n/total n (%) | 39/181 (22%) | 1/41 (2%) d | – | – |
| Cumulative dose c rituximab per patient, median (range), mg | 4000 (2000–9000) | d | – | – |
| Time from MS diagnosis to first sample collection within this study, median (range), months | 60 (1–540) | 12 (0–288) | – | < 0.0001 |
pwMS: patients with multiple sclerosis; RRMS: relapsing remitting multiple sclerosis; PPMS: primary progressive multiple sclerosis; EDSS: Expanded Disability Status Scale; n: number; MS: multiple sclerosis.
Statistical significance of differences in the age of the three groups was assessed by Kruskal–Wallis test; statistical significance of differences in the distribution of women/men, MS type, any previous immunotherapy, and at least two previous immunotherapies were assessed by Chi-square test; statistical significance of differences in disease duration and EDSS were assessed by Mann–Whitney U test.
In pairwise comparison with Mann–Whitney U tests, age did not differ between patients with MS (pwMS) under anti-CD20 therapy and pwMS before anti-CD20 therapy (p = 0.08), as well as between pwMS before anti-CD20 therapy and hospital employees (HE, p = 0.09), but HE were younger than pwMS under anti-CD20 therapy (p = 0.0014).
Cumulative lifetime dose of anti-CD20 therapy until 6 August 2021.
One patient had previously been treated with a cumulative lifetime dose of 8000 mg rituximab followed by an anti-CD20 treatment free interval of >18 months before anti-CD20 therapy was re-initiated with ocrelizumab during the course of this study.