AE occurring during the 6-month placebo-controlled period of nine studies18
| Placebo+MTX (n=570) | Rituximab+MTX (n=877) | |
|---|---|---|
| Total patients (%) with ≥1 AE infection | 223 (39.1) | 353 (40.3) |
| Infections occurring in ≥2% of patients | ||
| Nasopharyngitis | 43 (7.5) | 63 (7.2) |
| Upper respiratory tract infections* | 37 (6.5) | 64 (7.3) |
| Urinary tract infection* | 31 (5.4) | 31 (3.5) |
| Bronchitis* | 19 (3.3) | 27 (3.1) |
| Sinusitis | 20 (3.5) | 25 (2.9) |
| Gastroenteritis | 14 (2.5) | 12 (1.4) |
| Pharyngitis | 12 (2.1) | 11 (1.3) |
| Total patients (%) with a serious infection | 9 (1.6) | 15 (1.7) |
| Pneumonia | 2 (0.4) | 2 (0.2) |
| Gastroenteritis | 2 (0.4) | 1 (0.1) |
| Pyelonephritis | 0 | 3 (0.3) |
| Respiratory tract infection | 2 (0.4) | 0 |
| Abscess bacterial | 1 (0.2) | 0 |
| Abscess intestinal | 1 (0.2) | 0 |
| Bronchitis | 0 | 1 (0.1) |
| Bronchopneumonia | 1 (0.2) | 0 |
| Cellulitis | 0 | 1 (0.1) |
| Cellulitis gangrenous | 0 | 1 (0.1) |
Infusion-related reactions were the most common adverse event (AE) (25% infusion 1). Data for the placebo + methotrexate (MTX) group pooled from trials IIa, DANCER, REFLEX and SERENE. The overall rate (95% CI) of AE was 359.6 events per 100 patient-years (354.4 to 364.9) with highest rates during course 1; for serious AE, the rate (95% CI) was 17.85 events per 100 patient-years (16.72 to 19.06).
↵* Occurred in ≥10% patients.