Summary of safety profile over 52 weeks (safety population)
| Placebo + MTX (n=250) | Rituximab (2×500 mg) + MTX (n=249) | Rituximab (2×1000 mg) + MTX (n=249) | |
|---|---|---|---|
| Treated first course | 250 | 249 | 249 |
| Patient-years of observation | 229.75 | 238.77 | 241.06 |
| AE incidence: no. of patients (%) | |||
| Any AE | 203 (81%) | 189 (76%) | 197 (79%) |
| Any serious AE | 26 (10%) | 23 (9%) | 24 (10%) |
| Serious AE in >1 patients | |||
| Pneumonia | 3 (1%) | 1 (<1%) | 2 (<1%) |
| Urinary tract infection | 2 (<1%) | 1 (<1%) | – |
| Appendicitis | – | 2 (<1%) | – |
| RA flare | 1 (<1%) | – | 2 (<1%) |
| AE leading to withdrawal | 12 (5%) | 4 (2%) | 5 (2%) |
| Death | 3 (1%) | 0 | 0 |
| Infusion-related reaction | |||
| First course* | 31 (12%) | 35 (14%) | 46 (18%) |
| Second course* | 20 (10%) | 19 (9%) | 22† (10%) |
| Third course* | 7 (6%) | 2 (2%) | 9 (10%) |
| Serious infusion-related reactions | – | – | 1 (<1%)‡ |
| Infection | |||
| Any | 124 (50%) | 127 (51%) | 129 (52%) |
| Serious§ | 13 (5%) | 6 (2%) | 8 (3%) |
| Cardiac event | |||
| Any | 3 (1%) | 3 (1%) | 8 (3%) |
| Serious | – | 2 (<1%) | 3 (1%) |
| Vascular event | |||
| Any | 17 (7%) | 19 (8%) | 21 (8%) |
| Serious | 2 (<1%) | 2 (<1%) | 1 (<1%) |
| Malignancy | |||
| Any | 5 (2%) | 2 (<1%) | 1 (<1%) |
| Serious | 4 (2%) | 2 (<1%) | 1 (<1%) |
| AE rates per 100 patient-years (95% CI) | |||
| Overall infection rate | 115 (101.85 to 129.6) | 103.87 (91.71 to 117.6) | 126.52 (113.09 to 141.5) |
| Serious infection§ rate | 6.09 (3.61 to 10.29) | 4.61 (2.55 to 8.32) | 3.73 (1.94 to 7.18) |
↵* Percentage incidence based on number receiving each treatment course.
↵† One of these infusion-related reactions was reported as serious.
↵‡ Anaphylactic reaction during the second infusion of the second course.
↵§ Reported as serious and/or treated with intravenous antibiotics.
AE, adverse event; MTX, methotrexate; RA, rheumatoid arthritis.