Table 1.
Demographic and disease characteristics by concomitant immunosuppressive therapy (IST) in patients using prednisone and related corticosteroids (PRED), azathioprine (AZA), or mycophenolate mofetil (MMF) at open-label extension (OLE) baseline.
| Characteristic | PRED | AZA | MMF | All patients |
|---|---|---|---|---|
| n = 90 | n = 39 | n = 30 | N = 117 | |
| Agea, mean (SD), years | 48.3 (16.52) | 46.7 (16.87) | 49.4 (17.52) | 47.4 (16.70) |
| Sex, n (%) | ||||
| Male | 34 (37.8) | 14 (35.9) | 9 (30.0) | 38 (32.5) |
| Female | 56 (62.2) | 25 (64.1) | 21 (70.0) | 79 (67.5) |
| Race, n (%) | ||||
| Asian | 18 (20.0) | 2 (5.1) | 1 (3.3) | 19 (16.2) |
| Black/African American | 0 (0.0) | 0 (0.0) | 1 (3.3) | 2 (1.7) |
| White | 67 (74.4) | 34 (87.2) | 26 (86.7) | 88 (75.2) |
| Unknown | 1 (1.1) | 1 (2.6) | 0 (0.0) | 1 (0.9) |
| Multiple | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.9) |
| Other | 4 (4.4) | 2 (5.1) | 2 (6.7) | 6 (5.1) |
| Region, n (%) | ||||
| North America | 31 (34.4) | 16 (41.0) | 11 (36.7) | 43 (36.8) |
| South America | 9 (10.0) | 7 (17.9) | 1 (3.3) | 12 (10.3) |
| Europe | 34 (37.8) | 15 (38.5) | 18 (60.0) | 46 (39.3) |
| Asia Pacific | 5 (5.6) | 1 (2.6) | 0 (0.0) | 5 (4.3) |
| Japan | 11 (12.2) | 0 (0.0) | 0 (0.0) | 11 (9.4) |
| Duration of MGb, mean (SD), years | 9.87 (8.13) | 9.67 (8.17) | 10.31 (8.59) | 10.21 (8.23) |
| MGFA classification by randomization stratification at screening, n (%) | ||||
| IIa or IIIa | 47 (52.2) | 21 (53.8) | 18 (60.0) | 58 (49.6) |
| IVa | 3 (3.3) | 3 (7.7) | 1 (3.3) | 6 (5.1) |
| IIb or IIIb | 36 (40.0) | 13 (33.3) | 10 (33.3) | 47 (40.2) |
| IVb | 4 (4.4) | 2 (5.1) | 1 (3.3) | 6 (5.1) |
| Prior IST use, n (%) | ||||
| 2 ISTs only | 42 (46.7) | 32 (82.1) | 9 (30.0) | 52 (44.4) |
| 3 ISTs only | 27 (30.0) | 5 (12.8) | 14 (46.7) | 39 (33.3) |
| ≥4 ISTs | 20 (22.2) | 2 (5.1) | 6 (20.0) | 24 (20.5) |
| Prior IVIg use, n (%) | 70 (77.8) | 29 (74.4) | 24 (80.0) | 92 (78.6) |
| Prior plasma exchange use, n (%) | 39 (43.3) | 17 (43.6) | 17 (56.7) | 57 (48.7) |
A total of 90 patients were using PRED at OLE baseline, 39 were using AZA, and 30 were using MMF. PRED, AZA, and MMF could be used as monotherapies, in combination with each other, or with other ISTs.
a
On day 1 of OLE.
b
Time from MG diagnosis to first dose date in the OLE.
IVIg, intravenous immunoglobulin; MG, myasthenia gravis; MGFA, Myasthenia Gravis Foundation of America; SD, standard deviation.