Table 2.
RENEW treatment discontinuations
| |
Overall |
Type of MS |
||
|---|---|---|---|---|
| |
|
Worsening |
PRMS |
SPMS |
| RRMS | ||||
| Patients enrolleda |
509 |
81 |
33 |
395 |
| Discontinued treatment, n (%) |
486 (95.5) |
74 (91.4) |
32 (97.0) |
380 (96.2) |
| Deathb |
4 (0.8) |
1 (1.2) |
0 |
3 (0.8) |
| Other adverse event |
14 (2.8) |
2 (2.5) |
2 (6.1) |
10 (2.5) |
| Physician decision |
146 (28.7) |
28 (34.6) |
6 (18.2) |
112 (28.4) |
| Reached maximum cumulative dose (≥140 mg/m2)c |
23 (4.5) |
5 (6.2) |
1 (3.0) |
17 (4.3) |
| Lack of efficacy |
16 (3.1) |
0 |
2 (6.1) |
14 (3.5) |
| Lost to follow-up |
40 (7.9) |
3 (3.7) |
2 (6.1) |
35 (8.9) |
| LVEF <50% |
25 (4.9) |
0 |
1 (3.0) |
24 (6.1) |
| Clinically significant decrease in LVEF or occurrence of CHFd |
10 (2.0) |
2 (2.5) |
2 (6.1) |
6 (1.5) |
| Patient request |
132 (25.9) |
24 (29.6) |
11 (33.3) |
97 (24.6) |
| Other |
98 (19.3) |
16 (19.8) |
6 (18.2) |
76 (19.2) |
| Unknown | 1 (0.2) | 0 | 0 | 1 (0.3) |
CHF=congestive heart failure; LVEF=left ventricular ejection fraction; MS=multiple sclerosis; PRMS=progressive relapsing multiple sclerosis; RENEW=Registry to Evaluate Novantrone Effects in Worsening Multiple Sclerosis; RRMS=relapsing-remitting multiple sclerosis; SPMS=secondary progressive multiple sclerosis.
aPatients with validated data who have received at least one dose of Mitoxantrone.
bEight additional patients died following discontinuation; the reasons for discontinuation of Mitoxantrone treatment were: physician discretion (n = 4); patient request (n = 2); LVEF <50% (n = 1); and clinically significant reduction in LVEF/CHF (n = 1).
cIncludes patients who have reached a cumulative dose of at least 132 mg/m2.
dClinical significance determined by the study site investigator.