Summary of safety over 48 weeks after treatment with biologic and nonbiologic disease-modifying antirheumatic drugs in combination with rituximab.
| Safety Population | No. Patients (%) Total = 176 | Events | Rate/100 Patient-yrs (95% CI) Total Patient-yrs = 147.2 |
|---|---|---|---|
| AE | 164 (93.2) | 921 | 625.7 (586.6–667.4) |
| SAE | 27 (15.3) | 33 | 22.4 (15.9–31.5) |
| IRR* | |||
| First infusion | 55 (31.3) | 103 | — |
| Second infusion | 29 (16.5) | 50 | — |
| Infections | 104 (59.1) | 217 | 147.4 (129.1–168.4) |
| Serious infections† | 4 (2.3) | 4 | 2.7 (1.0–7.2) |
| Retreatment Population | n = 147 | Total Patient-yrs = 61.7 | |
| AE | 105 (71.4) | 312 | 505.8 (452.7–565.1) |
| SAE | 9 (6.1) | 10 | 16.2 (8.7–30.1) |
| IRR | |||
| First infusion | 23 (15.6) | 40 | — |
| Second infusion | 16 (10.9) | 30 | — |
| Infections | 49 (33.3) | 72 | 116.7 (92.7–147.1) |
| Serious infections† | 1 (0.7) | 1 | 1.6 (0.2–11.5) |