Overview of infections in the short-term and cumulative periods from the 8 integrated trials. Data show incidence rates (IR) per 100 patient-years (95% Poisson CI).
| Short-term Period | Cumulative Period, n = 4149 | |||
|---|---|---|---|---|
| Placebo, n = 1099 | IV Abatacept, n = 3173 | |||
| Infections | Patients with event, n | 537 | 1559 | 2998 |
| IR (95% CI) | 92.46 (84.81, 100.62) | 98.00 (93.20, 102.99) | 75.68 (73.00, 78.44) | |
| Serious infections | Patients with event, n | 22 | 85 | 332 |
| IR (95% CI) | 2.60 (1.63, 3.94) | 3.68 (2.94, 4.55) | 2.87 (2.57, 3.19) | |
| Hospitalized infections | Patients with event, n | 20 | 77 | 307 |
| IR (95% CI) | 2.36 (1.44, 3.65) | 3.33 (2.63, 4.16) | 2.64 (2.35, 2.95) | |
| Most frequently reported infections (IR ≥ 6.0/100 patient-yrs for patients receiving abatacept at any time) | ||||
| Upper respiratory tract infection | Patients with event, n | 133 | 346 | 990 |
| IR (95% CI) | 16.78 (14.05, 19.88) | 15.82 (14.19, 17.57) | 10.18 (9.56, 10.84) | |
| Nasopharyngitis | Patients with event, n | 98 | 280 | 819 |
| IR (95% CI) | 12.17 (9.88, 14.83) | 12.71 (11.27, 14.29) | 8.38 (7.82, 8.97) | |
| Bronchitis | Patients with event, n | 60 | 193 | 673 |
| IR (95% CI) | 7.26 (5.54, 9.35) | 8.57 (7.40, 9.86) | 6.38 (5.91, 6.88) | |
| Urinary tract infection | Patients with event, n | 56 | 170 | 658 |
| IR (95% CI) | 6.75 (5.10, 8.76) | 7.50 (6.41, 8.71) | 6.23 (5.77, 6.73) | |
| Sinusitis | Patients with event, n | 73 | 199 | 587 |
| IR (95% CI) | 8.87 (6.95, 11.15) | 8.82 (7.64, 10.13) | 5.41 (4.98, 5.86) | |
| Most frequency reported serious infections (IR ≥ 0.25/100 patient-yrs for patients receiving abatacept at any time) | ||||
| Pneumonia | Patients with event, n | 5 | 15 | 55 |
| IR (95% CI) | 0.59 (0.19, 1.37) | 0.64 (0.36, 1.06) | 0.46 (0.34, 0.59) | |
| Bronchitis | Patients with event, n | 0 | 7 | 19 |
| IR (95% CI) | 0 | 0.30 (0.12, 0.62) | 0.16 (0.09, 0.25) | |
| Cellulitis | Pateints with event, n | 2 | 5 | 22 |
| IR (95% CI) | 0.23 (0.03, 0.85) | 0.21 (0.07, 0.50) | 0.18 (0.11, 0.28) | |
| Urinary tract infection | Patients with event, n | 1 | 5 | 24 |
| IR (95% CI) | 0.12 (0, 0.65) | 0.21 (0.07, 0.50) | 0.20 (0.13, 0.30) | |