Subgroup analysis for risk of composite serious infections, propensity score-matched as-treated analyses
| Tocilizumab (n=16 074) | TNFi (n=33 109) | HR (95% CI) | Rate difference† | |||||||
| Subjects (n) | Events | Person-years | IR* (95% CI) | Subjects (n) | Events | Person-years | IR* (95% CI) | |||
| Age <65 | 9134 | 207 | 7543 | 2.74 (2.37 to 3.12) | 20 131 | 392 | 17 951 | 2.18 (1.97 to 2.40) | 1.18 (1.00 to 1.40) | 0.56 (0.13, 0.99) |
| Age ≥65 | 6803 | 382 | 5581 | 6.84 (6.16 to 7.53) | 12 720 | 745 | 10 718 | 6.95 (6.45 to 7.45) | 0.93 (0.82 to 1.06) | −0.11 (−0.96, 0.74) |
| Male | 2715 | 120 | 2332 | 5.15 (4.23 to 6.07) | 5733 | 221 | 5251 | 4.21 (3.65 to 4.76) | 1.08 (0.85 to 1.36) | 0.94 (−0.13, 2.01) |
| Female | 13 289 | 486 | 10 801 | 4.50 (4.10 to 4.90) | 27 139 | 927 | 23 509 | 3.94 (3.69 to 4.20) | 1.03 (0.92 to 1.15) | 0.56 (0.09, 1.03) |
| Baseline methotrexate use | 9867 | 393 | 8329 | 4.72 (4.25 to 5.18) | 20 577 | 756 | 18 292 | 4.13 (3.84 to 4.43) | 1.00 (0.88 to 1.13) | 0.59 (0.04, 1.14) |
| No baseline methotrexate use | 6053 | 210 | 4727 | 4.44 (3.84 to 5.04) | 11 936 | 397 | 10 147 | 3.91 (3.53 to 4.30) | 1.02 (0.86 to 1.21) | 0.53 (−0.18, 1.24) |
| Baseline oral steroid use | 12 200 | 497 | 9969 | 4.99 (4.55 to 5.42) | 24 729 | 999 | 21 458 | 4.66 (4.37 to 4.94) | 0.97 (0.87 to 1.08) | 0.33 (−0.19, 0.85) |
| No baseline oral steroid use | 3657 | 98 | 3033 | 3.23 (2.59 to 3.87) | 7819 | 163 | 7066 | 2.31 (1.95 to 2.66) | 1.30 (1.00 to 1.70) | 0.92 (0.19, 1.65) |
| Recent (prior 60 days) oral steroid use | 8874 | 401 | 7207 | 5.56 (5.02 to 6.11) | 17 494 | 781 | 15 151 | 5.15 (4.79 to 5.52) | 0.98 (0.86 to 1.11) | 0.41 (−0.24, 1.06) |
| No recent (prior 60 days) oral steroid use | 6988 | 191 | 5798 | 3.29 (2.83 to 3.76) | 14 957 | 385 | 13 298 | 2.90 (2.61 to 3.18) | 1.03 (0.86 to 1.23) | 0.39 (−0.16, 0.94) |
| Baseline antibiotic use | 8353 | 362 | 6637 | 5.45 (4.89 to 6.02) | 17 051 | 763 | 14 467 | 5.27 (4.90 to 5.65) | 0.93 (0.82 to 1.06) | 0.18 (−0.50, 0.86) |
| No baseline antibiotic use | 7543 | 234 | 6412 | 3.65 (3.18 to 4.12) | 15 613 | 398 | 13 917 | 2.86 (2.58 to 3.14) | 1.15 (0.97 to 1.37) | 0.79 (0.24, 1.34) |
*Incidence rate (IR) is per 100 person-years.
†Rate difference per 100 patients (tocilizumab-TNFi).
TNFi, tumour necrosis factor inhibitors.