Table 3.
Treatment response and discontinuation in MS patients receiving rituximab.
|
Subgroups |
Total (365) | |||
|---|---|---|---|---|
| RRMS (320) | SPMS (23) | PPMS (22) | ||
| Relapses during observation, n | 15 | 1 | 0 | 16 |
| – Relapses occuring after 6 months, n | 8 | 1 | 0 | 9 |
| Annual relapse rate (ARR) | 0.03 | 0.03 | 0 | 0.03 |
| – ARR calculated for observationtime and relapses occuring after 6 months | 0.02 | 0.04 | 0 | 0.02 |
| Patients with any new or enhanced MRI- lesions, n |
52 |
4 |
2 |
58 |
| – Patients with new or enhanced MRI- lesions ≥6 months |
13 |
3 |
1 |
17 |
| EDSS change, median (range) | 0 (−3.0 −2.5) | 0 (0.0 – 2.0) | 0 (−1,0 – 1.5) | 0 (--3.0 – 2.5) |
| – Improved EDSS, n (%) | 18 (5.7%) | 0 | 1 (4.5%) | 19 (5.4%) |
| – Stable EDSS, n, % | 282 (89.8%) | 16 (72.7%) | 18 (81.8%) | 316 (89.8%) |
| – Worsened EDSS, n, % | 10 (3.2%) | 6 (27.3%) | 1 (4.5%) | 17 (4.6%) |
| NEDA-3 at end of observation, n (%) | 80.3% | 57.1% | 81.0% | 79.0% |
|
Drug discontinuation, n (%) Annual drug discontinuation rate (ADDR) |
23 (7.2%) 0.04 |
7 (30.4%) 0.20 |
3 (13.6%) 0.10 |
33 (9%) 0.05 |
| Reason for discontinuation, n (% of total) | ||||
| – Treatment failure | 1 | 1 | 0 | 2 (0.5%) |
| – Adverse events | 13 | 3 | 2 | 18 (4.9%) |
| – Patient's request of HSCT | 4 | 2 | 0 | 6 (1.6%) |
| – Patient's request of discontinuation | 4 | 1 | 1 | 6 (1.6%) |
| – Other | 1 | 0 | 0 | 1 (0.3%) |