Double-blind Period* (Abatacept-treated Patients), n = 258 | Open-label Period† (Abatacept-treated Patients), n = 317 | |
---|---|---|
Mean (SD) total exposure | 162.6 (26.8)days, ∼5.8 (1.0) months†† | 39.5 (21.7) months |
Serious adverse events/100 patient-yrs | 25.98 (17.7, 37.6) | 19.18 (16.1, 22.7) |
Infection/100 patient-yrs | 107.75 (87.3, 131.6) | 81.80 (72.1, 92.5) |
Serious infections/100 patients-yrs | 5.28 (1.9, 11.5) | 3.50 (2.4, 4.9) |
Malignancies/100 patient-yrs | 2.63 (0.5, 7.7) | 2.11 (1.3, 3.2) |
Autoimmune disorders**/100 patient-yrs | 3.52 (1.0, 9.0) | 1.70 (1.0, 2.7) |
↵* Data are for patients randomized to abatacept during the double-blind period.
↵† Data are for all patients who received at least 1 dose of abatacept during the longterm extension period, regardless of treatment group during the double-blind period.
↵†† Based on mean (SD) total exposure of 162.6 (26.81) days, divided by 28 to provide months.
↵** Prespecified.