Table 4.
Treatment-emergent adverse events by concomitant immunosuppressive therapy during the open-label extension (OLE) in patients using prednisone and related corticosteroids (PRED), azathioprine (AZA), or mycophenolate mofetil (MMF) at OLE baseline.
| PRED | AZA | MMF | All patients | |
|---|---|---|---|---|
| n = 90 | n = 39 | n = 30 | N = 117 | |
| Total patients with events, n (%) | 87 (96.7) | 38 (97.4) | 29 (96.7) | 114 (97.4) |
| Treatment-emergent adverse events occurring in >15% of all patients, n (%) | ||||
| Headache | 34 (37.8) | 17 (43.6) | 9 (30.0) | 47 (40.2) |
| Nasopharyngitis | 34 (37.8) | 8 (20.5) | 9 (30.0) | 42 (35.9) |
| Diarrhea | 17 (18.9) | 14 (35.9) | 7 (23.3) | 29 (24.8) |
| MGa | 23 (25.6) | 10 (25.6) | 12 (40.0) | 29 (24.8) |
| Upper respiratory tract infection | 21 (23.3) | 15 (38.5) | 6 (20.0) | 28 (23.9) |
| Arthralgia | 18 (20.0) | 10 (25.6) | 5 (16.7) | 23 (19.7) |
| Cough | 13 (14.4) | 8 (20.5) | 5 (16.7) | 22 (18.8) |
| Influenza | 15 (16.7) | 9 (23.1) | 6 (20.0) | 22 (18.8) |
| Nausea | 16 (17.8) | 9 (23.1) | 6 (20.0) | 22 (18.8) |
| Urinary tract infection | 9 (10.0) | 4 (10.3) | 6 (20.0) | 19 (16.2) |
| Pain in extremity | 14 (15.6) | 8 (20.5) | 3 (10.0) | 18 (15.4) |
The number (%) of patients who experienced treatment-emergent adverse events is provided for each group. A total of 90 patients were using PRED at OLE baseline, 39 were using AZA, and 30 were using MMF.
a
Worsening (increased frequency and/or intensity) of a pre-existing condition, including MG, is considered to be an adverse event.
MG, myasthenia gravis.