Patient characteristics at baseline (ITT analysis unless otherwise indicated)
| Placebo (n=38) | Epratuzumab | |||||
|---|---|---|---|---|---|---|
| 200 mg cd (100 mg EOW) (n=39) | 800 mg cd (400 mg EOW) (n=38) | 2400 mg cd (600 mg weekly) (n=37) | 2400 mg cd (1200 mg EOW) (n=37) | 3600 mg cd (1800 mg EOW) (n=38) | ||
| Age, mean (SD) | 41.1 (11.3) | 41.0 (9.8) | 38.6 (10.4) | 37.2 (11.4) | 37.2 (10.7) | 38.0 (12.2) |
| Female, n (%) | 33 (86.8) | 36 (92.3) | 35 (92.1) | 37 (100) | 37 (100) | 35 (92.1) |
| Ethnicity, n (%) | ||||||
| Hispanic or Latino | 2 (5.3) | 8 (20.5) | 5 (13.2) | 5 (13.5) | 5 (13.5) | 5 (13.2) |
| Race, n (%) | ||||||
| Caucasian | 30 (78.9) | 27 (69.2) | 32 (84.2) | 32 (86.6) | 25 (67.6) | 30 (78.0) |
| Black | 2 (5.3) | 8 (20.5) | 3 (7.9) | 3 (8.1) | 4 (10.8) | 3 (7.9) |
| Asian | 5 (13.2) | 4 (10.3) | 2 (5.3) | 2 (5.4) | 6 (16.2) | 4 (10.5) |
| American Indian/Alaskan Native | 0 | 0 | 0 | 0 | 0 | 1 (2.6) |
| Mixed race | 1 (2.6) | 0 | 1 (2.6) | 0 | 2 (5.4) | 0 |
| Severe (BILAG A) disease by organ/system, n (%)* | ||||||
| Mucocutaneous | 16 (42.1) | 14 (35.9) | 12 (31.6) | 12 (32.4) | 9 (24.3) | 11 (28.9) |
| Musculoskeletal | 10 (26.3) | 16 (41.0) | 9 (23.7) | 12 (32.4) | 13 (35.1) | 13 (31.6) |
| Cardiorespiratory | 9 (23.7) | 5 (12.8) | 8 (21.1) | 4 (10.8) | 6 (16.2) | 11 (28.9) |
| Neuropsychiatric | 1 (2.6) | 2 (5.1) | 5 (13.2) | 0 | 2 (5.4) | 7 (18.4) |
| Constitutional | 1 (2.6) | 2 (5.1) | 1 (2.6) | 1 (2.7) | 2 (5.4) | 0 |
| Renal | 0 | 0 | 1 (2.6) | 0 | 0 | 0 |
| Ophthalmic | 0 | 0 | 1 (2.6) | 1 (2.7) | 0 | 0 |
| Gastrointestinal | 1 (2.6) | 0 | 0 | 1 (2.7) | 0 | 1 (2.6) |
| Haematological | 0 | 0 | 1 (2.6) | 0 | 0 | 0 |
| At least one BILAG A | 29 (76.3) | 29 (74.4) | 29 (78.4) | 25 (67.6) | 27 (69.2) | 22 (62.9) |
| Total BILAG-2004 index score, median (range)*† | 15.0 (6, 28) | 13.0 (6, 28) | 13.0 (6, 33) | 12.0 (6, 33) | 14.0 (6, 37) | 15.5 (6, 34) |
| Total SLEDAI-2K score, median (range)* | 14.0 (6, 34) | 12.0 (8, 24) | 13.0 (8, 30) | 10.0 (6, 41) | 12.0 (6, 38) | 13.0 (6, 28) |
| Total SLICC ACR score, median (range)* | 1.0 (0, 5) | 1.0 (0, 5) | 1.0 (0, 5) | 1.0 (0, 8) | 0.0 (0, 7) | 1.0 (0, 9) |
| Immunosuppressives, n (%)* | 18 (47.4) | 16 (41.0) | 16 (43.2) | 13 (37.1) | 18 (48.6) | 18 (46.2) |
| Antimalarials, n (%)* | 18 (47.4) | 16 (41.0) | 16 (43.2) | 16 (45.7) | 18 (48.6) | 17 (43.6) |
| Corticosteroid use, mg/day prednisone equivalent | ||||||
| Mean (SD)* | 13.4 (10.6) | 14.6 (12.8) | 14.4 (10.5) | 13.2 (10.6) | 16.1 (9.9) | 11.3 (8.1) |
| No baseline dose (%) | 0 | 1 (2.6) | 1 (2.6) | 3 (8.1) | 0 | 1 (2.6) |
| Dosage >30 mg/day, n (%)* | 3 (7.9) | 5 (12.8) | 2 (5.4) | 3 (8.6) | 1 (2.7) | 1 (2.6) |
*Safety analysis.
†The total BILAG-2004 index score was based on the original convention of A=9; B=3; C=1; D=0; E=0;28 updated numerical scoring was proposed for the BILAG-2004 index after this study was initiated.29
BILAG, British Isles Lupus Assessment Group; cd, cumulative dose; EOW, every other week; ITT, intention-to-treat; PGA, Physician's Global Assessment; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000; SLICC ACR, Systemic Lupus International Collaborating Clinics American College of Rheumatology.