Table 2.
Adverse events (AEs) in the safety analysis
| No. (%) patients | Placebo (n=38) | Epratuzumab | ||||
|---|---|---|---|---|---|---|
| 200 mg cd (100 mg EOW) (n=39) | 800 mg cd (400 mg EOW) (n=37) | 2400 mg cd (600 mg weekly) (n=35) | 2400 mg cd (1200 mg EOW) (n=37) | 3600 mg cd (1800 mg EOW) (n=39) | ||
| At least one AE | 27 (71.7) | 28 (71.8) | 20 (54.1) | 27 (77.1) | 29 (78.4) | 26 (66.7) |
| At least one drug-related AE | 8 (21.1) | 12 (30.8) | 10 (27.0) | 13 (37.1) | 16 (43.2) | 12 (30.8) |
| AEs leading to discontinuation | 2 (5.3) | 0 | 1 (2.7) | 1 (2.9) | 1 (2.7) | 0 |
| Serious AEs* | 3 (7.9) | 2 (5.1) | 2 (5.4) | 3 (8.6) | 4 (10.8) | 2 (5.1) |
| Infusion reactions | 4 (10.5) | 3 (7.7) | 5 (13.5) | 5 (14.3) | 6 (16.2) | 5 (12.8) |
| AEs possibly indicative of infection | 15 (39.5) | 15 (38.5) | 9 (24.3) | 16 (45.7) | 16 (43.2) | 20 (51.3) |
| Most common AEs† | ||||||
| Headache | 5 (13.2) | 4 (10.3) | 4 (10.8) | 4 (11.4) | 7 (18.9) | 2 (5.1) |
| Nausea | 2 (5.3) | 3 (7.7) | 2 (5.4) | 3 (8.6) | 3 (8.1) | 5 (12.8) |
| Upper respiratory Tract infection | 2 (5.3) | 2 (5.1) | 0 | 1 (2.9) | 3 (8.1) | 6 (15.4) |
| Dizziness | 0 | 1 (2.6) | 2 (5.4) | 1 (2.9) | 3 (8.1) | 3 (7.7) |
| Urinary tract infection | 2 (5.3) | 2 (5.1) | 1 (2.7) | 1 (2.9) | 2 (5.4) | 1 (2.6) |
| Pyrexia | 2 (5.3) | 2 (5.1) | 1 (2.7) | 0 | 1 (2.7) | 1 (2.6) |
| Cough | 3 (7.9) | 0 | 0 | 1 (2.9) | 0 | 1 (2.6) |
| Viral infection | 2 (5.3) | 0 | 0 | 1 (2.9) | 1 (2.7) | 0 |
| Pneumonia | 2 (5.3) | 0 | 0 | 0 | 0 | 0 |
*Placebo: 1 case each of small intestinal obstruction, SLE and venous thrombosis; epratuzumab 100 mg EOW: 1 each of angina pectoris and rib fracture; epratuzumab 400 mg EOW: 1 each of haemorrhagic diarrhoea and anaphylactic reaction; epratuzumab 600 mg weekly: 1 each of non-cardiac chest pain, cholestasis and cervical carcinoma (diagnosed by biopsy before screening: the patient discontinued the study); epratuzumab 1200 mg EOW: 1 each of abdominal pain, abdominal abscess, urinary tract infection, loss of consciousness and lupus encephalitis; epratuzumab 1800 mg EOW: 1 each of headache and arterial thrombosis.
†Only AEs occurring in ≥5% of patients in the placebo or combined epratuzumab arms are shown. EOW, every other week; SLE, systemic lupus erythematosus.