Summary of safety profile over 104 weeks (safety population)
| Placebo+MTX (n=249) | Rituximab 2×500 mg+MTX (n=249) | Rituximab 2×1000 mg+MTX (n=250) | |
|---|---|---|---|
| Patient-years of observation | 422.11 | 457.92 | 462.09 |
| AE incidence, n (%) | |||
| Any AE | 215 (86) | 206 (83) | 217 (87) |
| First course* | 183 (73) | 167 (67) | 188 (75) |
| Second course* | 135 (64) | 128 (60) | 140 (64) |
| Third course* | 107 (63) | 96 (57) | 111 (65) |
| Fourth course* | 52 (43) | 55 (52) | 55 (51) |
| Fifth course* | 5 (16) | 7 (29) | 8 (31) |
| Any serious AE (all courses) | 42 (17) | 37 (15) | 33 (13) |
| AE leading to withdrawal (all courses) | 17 (7) | 8 (3) | 7 (3) |
| All deaths† | 3 (1) | 2 (<1) | 1 (<1) |
| Infusion-related reaction, n (%) | |||
| First course* | 31 (12) | 35 (14) | 46 (18) |
| Second course* | 21‡(10) | 20 (9) | 21 (10) |
| Third course* | 10 (6) | 11 (7) | 12 (7) |
| Fourth course* | 10 (8) | 10 (9) | 8 (7) |
| Fifth course* | 2 (6) | 1 (4) | 3 (12) |
| Infection, n (%) | |||
| Any | 146 (59) | 162 (65) | 160 (64) |
| Serious§ | 19 (8) | 13 (5) | 12 (5) |
| Malignancy, n (%) | |||
| Any | 7 (3) | 6 (2) | 3 (1) |
| Serious | 6 (2) | 5 (2) | 2 (<1) |
| AE rates per 100 patient-years (95% CI) | |||
| Overall infection rate | 99.50 (90.42 to 109.49) | 92.37 (83.98 to 101.61) | 109.50 (100.36 to 119.47) |
| Serious infection§rate | 4.97 (3.24 to 7.63) | 4.15 (2.65 to 6.50) | 3.25 (1.96 to 5.38) |
↵* Percentage of incidence based on number receiving each treatment course (as described in the Results section).
↵† Includes patients who died during the safety follow-up period.
↵‡ One patient was randomised to placebo but received rituximab at the second course during which the patient experienced a mild infusion-related reaction. The patient did not experience any serious AEs during the study; this patient's data are summarised under placebo.
↵§ Reported as serious and/or treated with intravenous antibiotics.
AE, adverse event; MTX, methotrexate.