Table 4.
Safety profile of mavrilimumab (100 and 150 mg) versus placebo in EARTH and Japanese studies
| Mavrilimumab
|
Placebo (n=75) | ||
|---|---|---|---|
| 100 mg (n=39) | 150 mg (n=0) | ||
| EARTH (NCT01050998)56 | |||
| Safety data at 12 weeks n (%) | |||
| Total subjects reporting ≥1 AE | 23 (57.5) | – | 36 (45.6) |
| Total subjects reporting ≥1 treatment-related AE | 7 (17.5) | – | 11 (13.9) |
| Total subjects reporting ≥1 related SAE | 0 | – | 1 (1.2) |
|
| |||
| 100 mg (n=8) | 150 mg (n=0) | Placebo (n=17) | |
|
| |||
| EARTH (Japan) (NCT01050998)57 | |||
| Safety data at 12 weeks n (%) | |||
| Total subjects reporting ≥1 AE | 5 (62.5) | 10 (58.8) | |
| Total subjects reporting ≥1 treatment-related AE | 4 (50.0) | 6 (35.3) | |
| Total subjects reporting ≥1 related SAE | 0 | 0 | |
|
| |||
| 100 mg (n=85) | 150 mg (n=79) | Placebo (n=81) | |
|
| |||
| EARTH EXPLORER 1 (NCT01706926)61 | |||
| Safety data at 24 weeks n (%) | |||
| Total subjects reporting ≥1 AE | NA | NA | NA |
| Total subjects reporting ≥1 treatment-related AE | NA | NA | NA |
| Total subjects reporting ≥1 related SAE | 0 | 0 | NA |
|
| |||
|
Golimumab
|
|||
| 100 mg (n=70) | 150 mg (n=0) | 50 mg (n=68) | |
|
| |||
| EARTH EXPLORER 2 (NCT01715896)62 | |||
| Safety data at 24 weeks n (%) | |||
| Total subjects reporting ≥1 AE | NA | NA | |
| Total subjects reporting ≥1 treatment-related AE | NA | NA | |
| Total subjects reporting ≥1 related SAE | NA | 2 (3.0) | |
|
| |||
| 100 mg (n=442) | |||
|
| |||
| Open-label extension* (NCT01712399)64 | |||
| Safety data at 158 weeks n (%) | |||
| Total subjects reporting ≥1 AE | NA | – | |
| Total subjects reporting ≥1 treatment-related AE | 114 (25.8) | – | |
| Total subjects reporting ≥1 related SAE | 60 (13.6) | – | |
Note:
*
Open-label extension study enrolled RA patients who had completed the EARTH EXPLORER 1 and 2.
Abbreviations: AE, adverse events; NA, data not available; SAE, serious adverse events.