Table 3 Rates of serious infections (overall and by baseline characteristics) in the all-control population
| Â | Exposure, PY | Control n= 1,555 | Exposure, PY | Tocilizumab 4 mg/kg + DMARDs n= 774 | Exposure, PY | Tocilizumab 8 mg/kg + DMARDs n= 1,870 |
|---|---|---|---|---|---|---|
Rate/100 PYa (number of eventsb) | ||||||
Overall | 824.6 | 3.5 (29) | 564.6 | 3.5 (20) | 1,194.1 | 4.9 (59) |
Rate/100 PYa (95% CIa), (number of eventsb) | ||||||
Age, years | ||||||
< 50 | 340.2 | 1.5 (0.5, 3.4), (5) | 244.2 | 1.6 (0.5, 4.2), (4) | 431.3 | 1.9 (0.8, 3.7), (8) |
≥ 50-64 | 354.2 | 3.7 (2.0, 6.3), (13) | 229.9 | 3.5 (1.5, 6.9), (8) | 572.8 | 5.9 (4.1, 8.3), (34) |
≥ 65 | 130.1 | 8.5 (4.2, 15.1), (10) | 90.6 | 8.8 (3.8, 17.4), (8) | 189.9 | 9.0 (5.2, 14.3), (17) |
BMI,c kg/m2 | ||||||
< 18.5 | 29.2 | -- | 9.6 | -- | 31.3 | 16.0 (5.2, 37.3), (5) |
18.5-24.9 | 282.1 | 2.8 (1.2, 5.6), (7) | 209.4 | 3.8 (1.7, 7.5), (8) | 414.4 | 2.7 (1.3, 4.8), (11) |
25-29.9 | 275.6 | 3.6 (1.7, 6.7), (10) | 187.2 | 3.2 (1.2, 7.0), (6) | 412.5 | 5.3 (3.3, 8.1), (22) |
≥ 30 | 234.2 | 4.7 (2.3, 8.4), (11) | 154.7 | 3.9 (1.4, 8.4), (6) | 327.8 | 6.1 (3.7, 9.4), (20) |
Background corticosteroid use | ||||||
Yes | 570.5 | 3.3 (2.0, 5.2), (18) | 426.6 | 4.7 (2.9, 7.2), (20) | 788.3 | 5.3 (3.8, 7.2), (42) |
No | 254.0 | 3.9 (1.9, 7.2), (10) | 138.0 | -- | 405.8 | 4.2 (2.4, 6.7), (17) |
Previous TNF-α inhibitor therapy | ||||||
Yes | 134.6 | 6.7 (3.1, 12.7), (9) | 114.4 | 5.3 (1.9, 11.4), (6) | 200.1 | 8.5 (5.0, 13.6), (17) |
No | 690.0 | 2.9 (1.8, 4.5), (19) | 450.2 | 3.1 (1.7, 5.2), (14) | 994.0 | 4.2 (3.1, 5.7), (42) |
Chronic pulmonary disease | ||||||
Yes | 38.9 | 10.3 (2.8, 26.3), (3) | 28.4 | 10.6 (2.2, 30.8), (3) | 54.1 | 7.4 (2.0, 18.9), (4) |
No | 785.6 | 3.2 (2.1, 4.7), (25) | 536.2 | 3.2 (1.9, 5.1), (17) | 1,140.0 | 4.8 (3.6, 6.3), (55) |
Serious infections | ||||||
Yes | -- | 10.3 (2.8, 26.3), (3) | -- | 10.6 (2.2, 30.8), (3) | -- | 7.4 (2.0, 18.9), (4) |
No | -- | 3.2 (2.1, 4.7), (25) | -- | 3.2 (1.9, 5.1), (17) | -- | 4.8 (3.6, 6.3), (55) |
Serious pneumonia | ||||||
Yes | -- | 7.7 (1.6, 22.5) | -- | 3.5 (0.1, 19.6) | -- | 5.6 (1.1, 16.2) |
No | -- | 0.4 (0.1, 1.1) | -- | 0.9 (0.3, 2.2) | -- | 0.9 (0.4, 1.6) |
Diabetes | ||||||
Yes | 66.6 | 7.5 (2.4, 17.5), (5) | 54.1 | 1.9 (0.1, 10.3), (1) | 99.4 | 12.1 (6.2, 21.1), (12) |
No | 758.0 | 3.2 (2.0, 4.7), (23) | 510.5 | 3.7 (2.2, 5.8), (19) | 1,094.7 | 4.3 (3.2, 5.7), (47) |