Adverse events
| Double-blind period | |||
|---|---|---|---|
| Incidence rate (95% CI) | Abatacept*, n=156 | Infliximab*, n=165 | Cumulative 2-year study period† Abatacept, n=399 |
| Mean (range) months of exposure | 11.7 (2.4 – 13.3) | 11.6 (1.9 – 13.1) | 17.2 (1.9 – 26.5) |
| Deaths | 0.7 (0.0 to 3.7) | 1.3 (0.2 to 4.6) | 0.7 (0.2 to 1.8) |
| AE | 326.0 (274.1 to 384.9) | 448.6 (380.6 to 525.3) | 257.5 (231.8 to 285.3) |
| SAE | 11.8 (6.9 to 18.9) | 21.1 (14.2 to 30.1) | 15.2 (12.0 to 19.0) |
| Infections | 99.8 (80.4 to 122.4) | 134.1 (110.6 to 161.1) | 86.2 (76.2 to 97.3) |
| Serious infectious events | 2.0 (0.4 to 5.9) | 9.2 (5.0 to 15.5) | 1.6 (0.7 to 3.1) |
| Opportunistic infections | 0 | 2.6 (0.7 to 6.6) | 0.2 (0.0 to 1.0) |
| Neoplasms‡ | 2.7 (0.7 to 6.9) | 3.2 (1.0 to 7.5) | 2.7 (1.5 to 4.5) |
| Malignant neoplasms | 0.7 (0.0 to 3.7) | 1.3 (0.2 to 4.6) | 0.4 (0.0 to 1.3) |
| Autoimmune symptoms or events | 1.3 (0.2 to 4.8) | 0.6 (0.0 to 3.6) | 1.4 (0.6 to 2.8) |
| Acute infusional AE | 7.7 (3.8 to 13.8) | 32.3 (23.3 to 43.6) | 6.4 (4.5 to 9.0) |
↵* Represents original randomisation group and events experienced in the double-blind period (updated database lock relative to previously published double-blind findings).6
↵† Patients who received at least one infusion of abatacept in the cumulative study period (double-blind or long-term extension), regardless of original randomisation group.
↵‡ Benign, malignant and unspecified.
incidence rates (IR) are calculated as the number of patients with the event of interest, divided by total exposure (patient-years) during the specified treatment period, multiplied by 100 to provide incidence/100 patient-years of exposure. A patient's contribution to exposure ended at the time of first occurrence of the specific AE.
AE, adverse event; SAE, serious adverse event.