Table 2 Occurrence of SAEs in patients with RA treated with TCZ or TNFIs a
Types of SAEs | TCZ group, 224.68 PY | TNFI group, 231.01 PY | TCZ versus TNFI |
|---|---|---|---|
IR (/100PY) | IR (/100PY) | Crude IRR (95% CI) | |
Total SAEs | 21.36 (15.94 to 28.07) | 14.72 (10.37 to 20.32) | 1.45 (0.94 to 2.25) |
Serious infection (SI) | 10.68 (7.02 to 15.63) | 3.03 (1.35 to 5.95) | 3.53 (1.52 to 8.18) |
Pulmonary infection | 3.12 (1.39 to 6.12) | 1.30 (0.36 to 3.46) | 2.40 (0.62 to 9.28) |
Non-pulmonary infection | 7.57 (4.57 to 11.84) | 1.73 (0.58 to 4.12) | 4.37 (1.47 to 12.99) |
Skin infection | 1.78 (0.60 to 4.23) | 0.43 (0.04 to 2.02) | 4.11 (0.46 to 36.80) |
Urinary tract infection | 0.89 (0.18 to 2.85) | 0.43 (0.04 to 2.02) | 2.06 (0.19 to 22.68) |
Gastrointestinal infection | 0.89 (0.18 to 2.85) | 0.43 (0.04 to 2.02) | 2.06 (0.19 to 22.68) |
Bone and joint infections | 2.23 (0.84 to 4.88) | 0 | NA |
Sepsis | 1.34 (0.37 to 3.56) | 0 | NA |
Other infection | 0.45 (0.04 to 2.08) | 0.43 (0.04 to 2.02) | 1.03 (0.06 to 16.44) |
Pulmonary disease, except infection | 2.23 (0.84 to 4.88) | 2.16 (0.82 to 4.74) | 1.03 (0.30 to 3.55) |
Cardiovascular or cerebrovascular disease | 0.45 (0.04 to 2.08) | 2.16 (0.82 to 4.74) | 0.21 (0.02 to 1.76) |
Malignancy | 0.89 (0.18 to 2.85) | 1.30 (0.36 to 3.46) | 0.69 (0.11 to 4.10) |
Death | 1.78 (0.60 to 4.23) | 0.87 (0.17 to 2.78) | 2.06 (0.38 to 11.23) |
Others | 7.12 (4.24 to 11.29) | 6.06 (3.47 to 9.90) | 1.18 (0.57 to 2.41) |