Table 4 Observed and expected IRs of hospitalized infections, and pneumonia, in abatacept CDP and RA cohorts.
Data source | Counts | Hospitalized infections* IR**/100 py (95% CI) | Counts | Hospitalized pneumonia* IR**/100 py (95% CI) |
|---|---|---|---|---|
Observed (Double-blind trial data) | Â | Â | Â | Â |
Abatacept Population N = 1,955 | 51 | 3.05 (2.3, 4.0) | 12 | 0.71 (0.4, 1.3) |
Placebo Population N = 989 | 17 | 2.15 (1.26, 3.45) | 4 | 0.50 (0.14, 1.29) |
Observed (Long-term open-label trial data) | Â | Â | Â | Â |
Cumulative Abatacept Trial Population (DB + OL) N = 4,134 | 221 | 2.72 (2.37,3.10) | 54 | 0.65 (0.47, 0.82) |
Expected (Observational cohort data) | Â | Â | Â | Â |
   BC | 252 | 3.00 (2.65, 3.40) | 66 | 0.79 (0.62, 1.01) |
   NDB | NA | NA | 110 | 1.31 (1.09, 1.58) |
   PharMetrics | 296 | 3.53 (3.15, 3.96) | 106 | 1.26 (1.04, 1.53) |
   NOAR | 118 | 1.41 (1.18, 1.69) | 22 | 0.27 (0.18, 0.40) |
   Sweden ERA | 154 | 1.83 (1.57, 2.15) | 44 | 0.53 (0.39, 0.71) |
   Sweden INPT | 329 | 3.92 (3.52, 4.37) | 87 | 1.04 (0.84, 1.28) |