Table 4.
| Pooled data for RAPID 1 and 2 Rate per 100 pt-yrs |
FAST4WARD Patients, n% |
||||
|---|---|---|---|---|---|
| Adverse events | Placebo + MTX (n = 324) | CZP 200 mg + MTX (n = 640) | CZP 400 mg + MTX (n = 635) | Placebo (n = 109) | CZP 400 mg (n = 111) |
| Exposure, n, pt-yrs | 132.0 | 406.7 | 419.5 | – | – |
| Any TEAE | 264.4 | 239.1 | 221.1 | 63 (57.8) | 84 (75.7) |
| Intensity | |||||
| Mild | 155.5 | 162.3 | 156.4 | 43 (39.4) | 62 (55.9) |
| Moderate | 96.7 | 79.0 | 75.6 | 40 (36.7) | 52 (46.8) |
| Severe | 14.2 | 12.5 | 12.9 | 11 (10.1) | 8 (7.2) |
| TEAE related to study drug | 66.9 | 78.1 | 74.4 | 24 (22.0) | 27 (24.3) |
| TEAE leading to withdrawal | 3.8 | 7.2 | 7.0 | 2 (1.8) | 5 (4.5) |
| Any TE infection | 73.2 | 80.9 | 76.7 | 16 (14.7) | 33 (29.7) |
| Serious TEAEs | 11.9 | 16.3 | 16.6 | 3 (2.8) | 8 (7.2) |
| TEAE leading to death | 0.8 | 0.7 | 1.2 | 0 | 0 |
| Serious infections | 1.5 | 6.0 | 7.1 | 0 | 2 (1.8) |
| Tuberculosis | 0 | 1.2 | 1.2 | 0 | 0 |
| Malignancy | 1.5 | 2.0 | 1.2 | 0 | 2 (1.8) |
| Cardiac disorders | 5.3 | 4.7 | 4.8 | 2 (1.8) | 0 |
aAll patients who received at least one dose of study medication. Reproduced from Mease [21] with permission of Future Medicine Ltd.