Summary of AEs reported in the 52-week study period
| Week 16 | Week 52 | |||||||
| Abatacept+MTX (n=203, PY 62.7) | Placebo+MTX (n=202, PY 61.6) | Abatacept+MTX (n=203, PY 212.9) | Placebo+MTX (n=202, PY 108.7) | |||||
| n | IR | n | IR | n | IR | n | IR | |
| All AEs | 219 | 349.2 | 217 | 352.5 | 587 | 275.7 | 320 | 294.4 |
| Related AEs | 86 | 137.1 | 58 | 94.2 | 192 | 90.2 | 77 | 70.8 |
| SAEs | 4 | 6.4 | 6 | 9.7 | 17 | 8.0 | 9 | 8.3 |
| Related SAEs | 4 | 6.4 | 1 | 1.6 | 9 | 4.2 | 1 | 0.9 |
| AEs of special interest | ||||||||
| Infections | 59 | 94.1 | 65 | 105.6 | 167 | 78.4 | 104 | 95.7 |
| Malignancies | 1 | 1.6 | 0 | 0 | 2 | 0.9 | 0 | 0 |
| Autoimmune disorders | 0 | 0 | 0 | 0 | 1 | 0.5 | 0 | 0 |
| Peri-infusional AEs | 3 | 4.8 | 7 | 11.4 | 4 | 1.9 | 8 | 7.4 |
| Acute peri-infusional AEs | 1 | 1.6 | 0 | 0 | 1 | 0.5 | 0 | 0 |
| Other AEs within 24 hours of study drug | 35 | 55.8 | 45 | 73.1 | 99 | 46.5 | 57 | 52.4 |
IR per 100 PY. Includes events with an onset date up to 113 days post first dose or 56 days post last dose. AEs occurring after the initiation of rescue abatacept are excluded.
AE, adverse event; IR, incidence rate; MTX, methotrexate; PY, person-years; SAE, serious adverse event.