Table 2.
Demographic and clinical characteristics of MS-patients at initiation of rituximab therapy.
|
Subgroups |
|||||
|---|---|---|---|---|---|
| RRMS(n = 320, 87.7%) | SPMS(n = 23, 6.3%) | PPMS(n = 22, 6.0%) | Total(n = 365, 100%) | ||
| Female, n (% of subgroup) | 231 (72.1 %) | 14 (60.9 %) | 10 (45.5 %) | 255 (69.9 %) | |
| Age (years) at rituximab initiation, mean (SD) | 40.4 (±10.9) | 54.9 (±10.3) | 57.3 (±12.2) | 42.3 (±12.1) | |
| Disease duration (years since diagnosis), mean (SD) | 4.8 (±6.5) | 15.2 (±9.1) | 2.7 (±4.4) | 5.3 (±7.0) | |
| EDSS at rituximab initiation, median (range) | 1.5 (0–7.5) | 6 (3.0–7.5) | 4 (1.0-8.0) | 2.0 (0-8.0) | |
| Number of previous DMTs, median (range) | 1 (0–10) | 2 (0–4) | 0 (0–2) | 1 (0–10) | |
| Treatment naïve patients, n (%) | 104 (32.5 %) | 4 (17.4 %) | 18 (81.8 %) | 126 (34.5%) | |
| Reason for switch to rituximab, n (%) | |||||
| – Newly diagnosed | 104 (28.5%) | ||||
| – Adverse events on other DMT | 70 (19.2%) | ||||
| – Treatment failure on other DMT | 98 (26.8%) | ||||
| – JCV positive | 21 (5.8%) | ||||
| – Planned pregnancy | 9 (2.5%) | ||||
| – Disease progression in not treated patient | 38 (10.4%) | ||||
| – Other | 25 (6.8%) | ||||
| First dose of 2000 mg, n (%) | 35 (10.9 %) | 6 (26.1 %) | 3 (13.6 %) | 44 (12.1 %) | |
| Number of rituximab infusions, mean (SD) | 3.7 (±1.5) | 3.2 (±1.8) | 3.2 (±1.6) | 3.6 (±1.6) | |
| Patients with any prolonged dose interval, n (%) |
41 (12.8%) |
1 (4.3%) |
1 (4.5%) |
43 (11.8%) |
|
| Cause: | |||||
| • Pregnancy/planned pregnancy (n) | 19 | 0 | 0 | 19 | |
| • Adverse event (n) | 14 | 0 | 0 | 14 | |
| • Intercurrent disease (n) | 5 | 1 | 0 | 6 | |
| • Other reason (n) | 3 | 0 | 1 | 4 | |
| Observation time (days), mean (SD) | 620.0 (±274) | 560.0 (±312) | 516.5 (±271) | 610.0 (±277) | |
| Observation time (years), number of patients (n) | |||||
| <1 year | 61 | 5 | 8 | 74 | |
| ≥1 year | 259 | 17 | 15 | 291 | |
| ≥2 years | 120 | 5 | 8 | 133 | |
|
Baseline MRI before rituximab initiation, n (%) Any re-baseline or later MRI available, n (%) |
319 (99.6%) 313 (97.8%) |
23 (100%) 23 (100%) |
22 (100%) 22 (100%) |
364 (99.7%) 358 (98%) |
|
| Annualized relapse rate (ARR) last 2 years before study initiation | 0.52 | 0.34 | 0.12 | 0.55 | |