Table 4.
Safety and adverse events in MS-patients receiving rituximab therapy.
|
Subgroups |
||||
|---|---|---|---|---|
| RRMS (320) | SPMS (23) | PPMS (22) | Total (365) | |
| Patients who experienced any adverse event, n (%) | 105 (32.8%) | 8 (34.8%) | 5 (22.7%) | 118 (32.3%) |
| Number of adverse events, n | 142 | 6 | 8 | 156 |
| Patients who experienced any infusion-related adverse event (CTCAE grade 1-5), n (%) | 56 (17.5%) | 2 (8.7%) | 3 (13.6%) | 61 (16.7%) |
| – Serious infusion-related events (CTCAE grade 3–4), n (%) | 2 (0.6%) | 0 | 0 | 2 (0.5%) |
| Patients who experienced any serious non-infusion-related adverse events (CTCAE grade 3–4), n (%) | 13 (4.1%) | 4 (17.0%) | 1 (4.5%) | 18 (4.9%) |
| – Serious infections | 11 (3.4%) |
4 (17.0%) |
1 (4.5% | 16 (4.4%) |
| – Other serious non-infusion related adverse events (ventricular extrasystoles, tinnitus) | 2 (0.5%) | 0 | 0 | 2 (0.5%) |
| Patients registered with any infection (CTCAE grade 2–5), n (%) | 28 (8.7%) | 4 (17.4%) | 2 (9.1%) | 34 (9.3%) |
| Deaths (CTCAE grade 5), n | 0 | 1a | 0 | 1a |
| PML cases, n | 0 | 0 | 0 | 0 |
| Patients receiving cancer diagnosis during observation period, n | 0 | 0 | 2b | 2b |
|
Patients with neutropenia, n (%) |
14 (4.4%) |
0 |
2 (9.1%) |
16 (4.4%) |
| • Neutrophil count 0,5 – 1.0 × 109/L (CTCAE grade 3) | 2 (0.6%) | 0 | 0 | 2 (0.5%) |
| • Neutrophil count <0.5 × 109/L (CTCAE grade 4) | 3 (0.9%) | 0 | 1 (4.5%) | 4 (1.1%) |
|
Other laboratory parameters: Patients with hypogammaglobulinemia (IgG) of any grade , n (%) |
16 (5%) |
2 (8.7%) |
1 (4.5%) |
19 (5.2%) |
aSuicide.
bCancer coli, melanoma.