Summary of safety in the treatment period*
| Abatacept plus MTX (n=119) | Abatacept monotherapy (n=116) | MTX (n=116) | |
|---|---|---|---|
| Deaths | 0 | 0 | 0† |
| Adverse events | 101 (84.9) | 93 (80.2) | 96 (82.8) |
| Serious adverse events | 8 (6.7) | 14 (12.1) | 9 (7.8) |
| Discontinuations due to serious adverse events | 2 (1.7) | 5 (4.3) | 3 (2.6) |
| Serious infections | 1 (0.8) | 4 (3.4) | 0 |
| Pneumonia | 1 (0.8) | 1 (0.9) | 0 |
| Limb abscess | 0 | 1 (0.9) | 0 |
| Herpes zoster | 0 | 1 (0.9) | 0 |
| Viral infection | 0 | 1 (0.9) | 0 |
| Malignancies | 1 (0.8) | 2 (1.7) | 1 (0.9) |
| Basal cell carcinoma | 1 (0.8) | 0 | 0 |
| Bowen's disease | 0 | 1 (0.9) | 0 |
| Pulmonary carcinoid tumour | 0 | 1 (0.9) | 0 |
| Invasive ductal breast carcinoma | 0 | 0 | 1 (0.9) |
Includes data up to 56 days after the last dose of study medication.
*All values are number (%).
†Two patients in the MTX arm died during the withdrawal period (uterine neoplasm, renal failure).
MTX, methotrexate.