Safety summary during the double-blind and cumulative study periods. Data are event/100 patient-years (95% CI) unless otherwise specified.
| Double-blind Study Periods* Abatacept 10 and 2 mg/kg Groups, 1 year | Cumulative Study Period† All Treatment Groups Combined, 5 years | |
|---|---|---|
| Deaths, n (%) | 1 (0.5) | 5 (1.7) |
| Discontinuations due to AE, n (%) | 18 (8.2) | 49 (17.1) |
| Discontinuations due to SAE, n (%) | 9 (4.1) | 32 (11.1) |
| AE events/100 pt-yrs | 489.7 (425.46, 561.03) | 374.9 (332.48, 421.20) |
| SAE events/100 pt-yrs | 20.0 (14.03, 27.74) | 18.9 (15.78, 22.37) |
| Infections/100 pt-yrs | 94.2 (78.06, 112.58) | 77.3 (67.58, 87.94) |
| Serious infections/100 pt-yrs | 2.1 (0.57, 5.38) | 3.0 (1.97, 4.35) |
| Malignancies/100 pt-yrs | 2.1 (0.57, 5.38) | 1.5 (1.07, 2.93) |
↵* All patients who received at least 1 dose of study medication during the double-blind period.
↵† All patients who were randomized to abatacept (10 and 2 mg/kg) and received 1 dose of study medication, plus all patients who were randomized to placebo and entered the open-label longterm extension period (and subsequently received 1 dose of study medication. AE: adverse event, SAE: serious adverse event.