Table 1.
Patient demographics and disease status at baseline in ALLEVIATE-1 and -2 (SL0003 and SL0004) and at study entry into SL0006
| ALLEVIATE |
SL0006 |
|||||||
|---|---|---|---|---|---|---|---|---|
| Placebo (n = 37) | Epratuzumab 360 mg/m2 (n = 42) | Epratuzumab 720 mg/m2 (n = 11) | Epratuzumab 360 mg/m2 (n = 29) | |||||
| Age, years | ||||||||
| Median (range) | 38.0 (18–58) | 39.0 (20–59) | 38.0 (21–52) | 39.0 (22–61) | ||||
| Gender, n (%) | ||||||||
| Male | 3 (8.1) | 1 (2.4) | 1 (9.1) | 3 (10.3) | ||||
| Female | 34 (91.9) | 41 (97.6) | 10 (90.9) | 26 (89.7) | ||||
| Ethnicity, n (%) | ||||||||
| Caucasian | 25 (67.6) | 27 (64.3) | 7 (63.6) | 23 (79.3) | ||||
| Black | 8 (21.6) | 7 (16.7) | 3 (27.3) | 3 (10.3) | ||||
| Asian | 1 (2.7) | 4 (9.5) | 1 (9.1) | 2 (6.9) | ||||
| Other | 3 (8.1) | 4 (9.5) | 0 (0.0) | 1 (3.4) | ||||
| Weight, mean (s.d.), kg | 67.8 (16.4) | 68.4 (17.9) | 71.1 (21.8) | 70.4 (17.5) | ||||
| Immunosuppressive, antimalarial and steroid use | ||||||||
| Immunosuppressive use, n (%) | 24 (65) | 28 (67) | 5 (46) | 29 (100) | ||||
| Antimalarial use, n (%) | 24 (65) | 31 (74) | 9 (82) | N/A | ||||
| Prednisone dose >25 mg/day, n (%) | 13 (35) | 18 (43) | 8 (73) | N/A | ||||
| Disease activity and HRQOL, mean (s.d.) | ||||||||
| PGA | 2.6 (0.60) | 2.7 (0.54) | 2.2 (0.60) | N/A | ||||
| PtGA | 2.8 (0.73) | 2.6 (0.66) | 1.8 (0.87) | N/A | ||||
| SF-36 PCS | 34.6 (8.36) | 36.5 (9.17) | 29.0 (8.59) | 31.8 (8.80) | ||||
| SF-36 MCS | 41.8 (9.35) | 43.9 (9.42) | 37.8 (12.60) | 42.2 (10.00) | ||||
| Total BILAGa | 13.2 (4.85) | 12.4 (4.01) | 16.3 (6.57) | 12.6 (3.50) | ||||
| Number of patients with at least one BILAG A, n (%) | 13 (35) | 15 (35.7) | 11 (100) | 10 (34.5) | ||||
| BILAG scores for each body system, n (%) | A | B | A | B | A | B | A | B |
| General | 0 (0) | 11 (30) | 1 (2) | 16 (38) | 1 (9) | 3 (27) | 0 (0) | 14 (48) |
| Mucocutaneous | 5 (14) | 26 (70) | 10 (24) | 26 (62) | 3 (27) | 3 (27) | 5 (17) | 19 (66) |
| Neurological | 0 (0) | 1 (3) | 0 (0) | 2 (5) | 1 (9) | 0 (0) | 1 (3) | 3 (10) |
| Musculoskeletal | 5 (14) | 24 (65) | 4 (10) | 29 (69) | 6 (55) | 3 (27) | 2 (7) | 23 (79) |
| CV and respiratory | 1 (8) | 6 (16) | 2 (5) | 3 (7) | 1 (9) | 1 (9) | 2 (7) | 2 (7) |
| Vasculitis | 2 (5) | 7 (19) | 0 (0) | 5 (12) | 1 (9) | 1 (9) | 0 (0) | 4 (14) |
| Renal | 1 (3) | 5 (14) | 0 (0) | 4 (10) | 0 (0) | 1 (9) | 0 (0) | 1 (3) |
| Haematological | 1 (3) | 3 (8) | 0 (0) | 7 (17) | 0 (0) | 1 (9) | 0 (0) | 1 (3) |
aMean total BILAG, where BILAG A = 9, BILAG B = 3, BILAG C = 1 and BILAG D/E = 0 [39]. N/A: not measured; CV: cardiovascular; HRQOL: health-related quality of life; MCS: mental component summary; PCS: physical component summary; PGA: physician global assessment; PtGA: patient global assessment; SF-36: 36-item Medical Outcomes Survey Short Form questionnaire.