Overall
|
Patients
|
n = 82
|
n = 42
| | |
Patients with TMA, n (%)
|
2 (2)
|
10 (24)
| | |
Manifestations
|
3
|
14
| | |
Total patient-years
|
292.5
|
103.8
| | |
Rate per 100 patient-years
|
1.0
|
13.5
|
13.5
|
93%
|
Patients who never discontinued
|
Patients
|
n = 51
|
N/A
| | |
Patients with TMA, n (%)
|
2 (4)
|
N/A
| | |
Manifestations
|
3
|
N/A
| | |
Total patient-years
|
218.2
|
N/A
| | |
Rate per 100 patient-years
|
1.4
|
N/A
|
N/A
|
N/A
|
Patients who discontinued eculizumab
|
Patients
|
n = 31
|
n = 42
| | |
Patients with TMA, n (%)
|
0 (0)
|
10 (24)
| | |
Manifestations
|
0
|
14
| | |
Total patient-years
|
74.2
|
103.8
| | |
Rate per 100 patient-years
|
0.0
|
13.5
|
N/A
|
100%
|
Genetic or autoimmune complement abnormality status
|
Patients with complement abnormality
|
n = 51
|
n = 24
| | |
Patients with TMA, n (%)
|
1 (2)
|
7 (29)
| | |
Manifestations
|
2
|
9
| | |
Total patient-years
|
188.3
|
50.1
| | |
Rate per 100 patient-years
|
1.1
|
18.0
|
16.4
|
94%
|
Patients without identified complement abnormality
|
n = 31
|
n = 18
| | |
Patients with TMA, n (%)
|
1 (3)
|
3 (17)
| | |
Manifestations
|
1
|
5
| | |
Total patient-years
|
104.1
|
53.7
| | |
Rate per 100 patient-years
|
1.0
|
9.3
|
9.3
|
89%
|
Age at diagnosis
|
Adult patients
|
n = 41
|
n = 22
| | |
Patients with TMA, n (%)
|
0 (0)
|
3 (14)
| | |
Manifestations
|
0
|
5
| | |
Total patient-years
|
140.5
|
56.2
| | |
Rate per 100 patient-years
|
0.0
|
8.9
|
N/A
|
100%
|
Pediatric patientsb
|
n = 41
|
n = 20
| | |
Patients with TMA, n (%)
|
2 (5)
|
7 (35)
| | |
Manifestations
|
3
|
9
| | |
Total patient-years
|
152.0
|
47.6
| | |
Rate per 100 patient-years
|
2.0
|
18.9
|
9.5
|
89%
|
History of TMA events
|
Single TMA
|
n = 51
|
n = 29
| | |
Patients with TMA, n (%)
|
2 (4)
|
6 (21)
| | |
Manifestations
|
3
|
8
| | |
Total patient-years
|
192.7
|
70.4
| | |
Rate per 100 patient-years
|
1.6
|
11.4
|
7.1
|
86%
|
Multiple TMA prior to initiation of eculizumab
|
n = 31
|
n = 13
| | |
Patients with TMA, n (%)
|
1 (3)
|
4 (31)
| | |
Manifestations
|
1
|
6
| | |
Total patient-years
|
99.8
|
33.4
| | |
Rate per 100 patient-years
|
1.0
|
18.0
|
18.0
|
94%
|
Transplant status
|
Transplanted kidney
|
n = 21
|
n = 9
| | |
Patients with TMA, n (%)
|
0 (0)
|
0 (0)
| | |
Manifestations
|
0
|
0
| | |
Total patient-years
|
76.0
|
24.3
| | |
Rate per 100 patient-years
|
0.0
|
0.0
|
N/A
|
N/A
|
Native kidney
|
n = 61
|
n = 33
| | |
Patients with TMA, n (%)
|
2 (3)
|
10 (30)
| | |
Manifestations
|
3
|
14
| | |
Total patient-years
|
216.5
|
79.5
| | |
Rate per 100 patient-years
|
1.4
|
17.6
|
12.6
|
92%
|