Table 3

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 events20 (74.1)14 (60.9)41 (83.7)
Related adverse events8 (29.6)6 (26.1)24 (49.0)
Serious adverse events02 (8.7)6 (12.2)
Infections10 (37.0)6 (26.1)26 (53.1)
Serious infections001 (2.0)
Autoimmune events001 (2.0)
Acute infusion events04 (17.4)2 (4.1)
Peri-infusional events4 (14.8)5 (21.7)6 (12.2)
  • *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.