Summary of adverse events during the study
| DB period* | OLE† | ||
|---|---|---|---|
| Adverse events, number of patients (%) | Abatacept+MTX (n=27) | Placebo+MTX (n=23) | Abatacept+MTX (n=49) |
| Adverse events | 20 (74.1) | 14 (60.9) | 41 (83.7) |
| Related adverse events | 8 (29.6) | 6 (26.1) | 24 (49.0) |
| Serious adverse events | 0 | 2 (8.7) | 6 (12.2) |
| Infections | 10 (37.0) | 6 (26.1) | 26 (53.1) |
| Serious infections | 0 | 0 | 1 (2.0) |
| Malignancies | 0 | 0 | 0 |
| Autoimmune events | 0 | 0 | 1 (2.0) |
| Acute infusion events | 0 | 4 (17.4) | 2 (4.1) |
| Peri-infusional events | 4 (14.8) | 5 (21.7) | 6 (12.2) |
| Deaths | 0 | 0 | 0 |
*Includes data up to 56 days post the last study drug dose for patients who discontinued or up to the first dose of the OLE for patients who continued.
†Events for all patients who received at least one dose of abatacept in the 8-month OLE, up to 56 days post the last dose of open-label abatacept.
DB, double-blind; MTX, methotrexate; OLE, open-label extension.