Table 2.
Rates of all severe infections, according to agent, number of courses, and main autoimmune diseases
| Patients | Person-years | Number of infections | Rate of infections/ 1,000 person-years |
95% Confidence interval | |
|---|---|---|---|---|---|
| TOTAL | 344 | 495 | 45 | 90.90 | 66.31 to 121.64 |
| RITUXIMAB | |||||
| - Total | 264 | 328.83 | 37 | 112.52 | 79.20 to 155.10 |
| - First course | 211 | 252.17 | 30 | 119.00 | 88.03 to 169.80 |
| - Second course | 38 | 54.58 | 2 | 36.64 | 4.44 to 132.37 |
| - Third or subsequent courses | 15 | 22.08 | 5 | 226.40 | 73.50 to 528.50 |
| ANTI-TNF AGENTS | |||||
| - Total | 77 | 147.58 | 8 | 54.21 | 23.40 to 106.81 |
| - Infliximab | 37 | 52.00 | 4 | 76.92 | 20.96 to 196.95 |
| - Adalimumab | 19 | 29.91 | 2 | 66.85 | 8.10 to 241.55 |
| - Etanercept | 21 | 65.67 | 2 | 30.46 | 3.69 to 110.02 |
| DISEASES | |||||
| - SLE | 140 | 175.42 | 11 | 62.71 | 31.30 to 112.20 |
| - Systemic vasculitis | 50 | 74.75 | 11 | 147.16 | 73.50 to 263.30 |
| - Inflammatory myopathies | 38 | 60.42 | 7 | 115.86 | 46.60 to 238.70 |
| - Behçet disease | 31 | 61.25 | 2 | 32.65 | 3.95 to 117.95 |
| - Sjögren syndrome | 23 | 31.92 | 3 | 93.98 | 19.38 to 274.66 |
| DISEASE/AGENT | |||||
| - Behçet disease/IFX | 20 | 36.50 | 1 | 27.39 | 0.68 to 152.65 |
| - Cryoglobulinemia/RTX | 15 | 14.17 | 4 | 282.30 | 76.90 to 722.80 |
| - Wegener granulomatosis/RTX | 18 | 29.00 | 4 | 137.90 | 37.60 to 353.20 |
| - SLE/RTX | 139 | 171.08 | 11 | 64.30 | 32.09 to 115.04 |
| - Inflammatory myopathies/RTX | 27 | 32.17 | 2 | 62.18 | 7.53 to 224.61 |
| - Sjögren syndrome/RTX | 21 | 24.00 | 3 | 125.00 | 25.80 to 365.30 |
| INDICATION | |||||
| - Refractory disease | 296 | 421.17 | 38 | 90.22 | 63.85 to 123.84 |
| - Life-threatening situation | 48 | 73.83 | 7 | 94.81 | 38.12 to 195.35 |
IFX, infliximab; RTX, rituximab; SLE, systemic lupus erythematosus.