Overall safety of placebo and rituximab 2×500 mg and 2×1000 mg (all with a stable dose of methotrexate (MTX) 10−25 mg/week) over 48 weeks (safety population)
| Baseline to week 24 | Baseline to week 48 | ||||
|---|---|---|---|---|---|
| Placebo + MTX (n=172) | Rituximab 2×500 mg + MTX (n=167) | Rituximab 2×1000 mg + MTX (n=170) | Rituximab 2×500 mg + MTX (n=167) | Rituximab 2×1000 mg + MTX (n=170) | |
| Treated (n) | 172 | 167 | 170 | 152 | 154 |
| Total patient-years of follow-up | 79.24 | 79.63 | 81.36 | 152.43 | 153.36 |
| Patients with AEs, n (%) | |||||
| Any AE | 128 (74) | 128 (77) | 130 (76) | 143 (86) | 138 (81) |
| Deaths | 0 | 0 | 0 | 2 (1) | 0 |
| Deaths after withdrawal | 1 (<1) | 0 | 0 | 1 (<1) | 1 (<1) |
| Serious AE | 15 (9) | 6 (4) | 15 (9) | 13 (8) | 17 (10) |
| AE leading to withdrawal (excluding RA flare) | 2 (1) | 2 (1) | 3 (2) | 3 (2) | 7 (4) |
| IRR (any)* | |||||
| Day 1 infusion | 24 (14) | 31 (19) | 42 (25) | 19 (13)† | 17 (11)† |
| Day 15 infusion | 14 (8) | 12 (7) | 10 (6) | 6 (4)† | 8 (5)† |
| IRR leading to withdrawal | 0 (0) | 0 (0) | 1 (1) | 0 (0) | 2 (1) |
| Infection | |||||
| Any | 74 (43) | 69 (41) | 61 (36) | 96 (57) | 85 (50) |
| Serious‡ | 4 (2) | 1 (<1) | 2 (1) | 3 (2) | 3 (2) |
| Lower gastrointestinal events | |||||
| Any | 20 (12) | 16 (10) | 16 (9) | 21 (13) | 24 (14) |
| Serious | 3 (2) | 1 (1) | 1 (<1) | 2 (1) | 1 (<1) |
| Cardiac disorder events | |||||
| Any | 4 (2) | 5 (3) | 7 (4) | 8 (5) | 8 (5) |
| Serious | 2 (1) | 2 (1) | 1 (<1) | 2 (1) | 1 (<1) |
| Vascular disorder events | |||||
| Any | 4 (2) | 6 (4) | 7 (4) | 11 (7) | 8 (5) |
| Serious | 0 | 0 | 0 | 0 | 0 |
| Malignancy | 1 (<1) | 1 (<1) | 2 (1) | 1 (<1) | 2 (1) |
| AE rates per 100 patient-years (95% CI) | |||||
| Overall infection rate | 159.00 (133.53 to 189.34) | 138.13 (114.59 to 166.52) | 120.45 (98.81 to 146.82) | 133.83 (116.67 to 153.52) | 106.94 (91.76 to 124.63) |
| Serious infection‡ rate | 8.83 (4.21 to 18.53) | 1.26 (0.18 to 8.92) | 2.46 (0.61 to 9.83) | 2.62 (0.98 to 6.99) | 1.96 (0.63 to 6.07) |
↵* AEs occurring during or within 24 h of an infusion and considered by the investigator to have at least a possible relation to treatment.
↵† Week 24 to week 48, based on number of patients receiving the infusion/day.
↵‡ Reported as serious and/or treated with intravenous antibiotics.
AE, adverse event; IRR, infusion-related reaction; RA, rheumatoid arthritis; SAE, serious adverse event.