Table 2.
Summary of AEs during the long‐term extension phasea
| Double‐blind abatacept (n = 58) | Double‐blind placebo (n = 59) | Initial nonresponders (n = 36) | Total (n = 153) | |
|---|---|---|---|---|
| Overall AEs | 55 (94.8) | 54 (91.5) | 31 (86.1) | 140 (91.5) |
| Deaths | 0 | 1 (1.7) | 0 | 1 (1.7)b |
| Discontinuations due to AEs | 2 (3.4) | 3 (5.1) | 1 (2.8) | 6 (3.9) |
| Overall SAEs | 9 (15.5) | 12 (20.3) | 9 (25.0) | 30 (19.6) |
| Discontinuations due to SAEs | 1 (1.7) | 2 (3.4) | 0 | 3 (2.0) |
| Most common SAEsc | ||||
| Arthritis disease flare | 3 (5.2) | 0 | 3 (8.3) | 6 (3.9) |
| Arthralgia | 1 (1.7) | 1 (1.7) | 1 (2.8) | 3 (2.0) |
| Rheumatoid arthritisd | 0 | 1 (1.7) | 1 (2.8) | 2 (1.3) |
| Foot deformity | 1 (1.7) | 1 (1.7) | 0 | 2 (1.3) |
| Pyelonephritis | 1 (1.7) | 0 | 1 (2.8) | 2 (1.3) |
| Bacterial arthritis | 0 | 1 (1.7) | 1 (2.8) | 2 (1.3) |
| Appendicitis | 2 (3.4) | 0 | 0 | 2 (1.3) |
| Pyrexia | 1 (1.7) | 1 (1.7) | 0 | 2 (1.3) |
| Vomiting | 1 (1.7) | 1 (1.7) | 0 | 2 (1.3) |
a
The mean ± SD exposure to abatacept during the long‐term extension phase was 48.2 ± 24.6 months (53.2 ± 21.0 months, 50.0 ± 24.8 months, and 37.4 ± 27.0 months in the double‐blind abatacept, double‐blind placebo, and initial nonresponder groups, respectively). Values are the number (%). AEs = adverse events; SAEs = serious AEs.
b
Death attributable to motorcycle accident and considered unrelated to the study treatment.
c
Defined as those occurring in ≥1% of the total group.
d
As reported using the Medical Dictionary for Regulatory Activities (version 14.1).