Table 1.
Demographics, baseline characteristics and concomitant drugs
| Lupuzor | |||
|---|---|---|---|
| Group 1 (200 μg every 4 weeks) (n=49) | Group 2 (200 μg every 2 weeks) (n=51) | Group 3 (placebo) (n=49) | |
| Age (years), mean (SD) | 39.2 (11.0) | 38.2 (12.6) | 35.3 (12.1) |
| Women, n (%) | 47 (96) | 50 (98) | 47 (96) |
| Disease duration (years), mean (SD) | 7.8 (7.9) | 8.0 (7.5) | 7.2 (7.3) |
| History of disease manifestations (ACR classification criteria), n (%) | |||
| Malar rash | 38 (78) | 42 (82) | 32 (65) |
| Discoid rash | 7 (14) | 6 (12) | 6 (12) |
| Photosensitivity | 38 (78) | 37 (73) | 38 (78) |
| Oral ulcers | 26 (53) | 30 (59) | 27 (55) |
| Arthritis | 47 (96) | 49 (96) | 47 (96) |
| Serositis | 11 (22) | 6 (12) | 13 (27) |
| Renal disorder | 9 (18) | 12 (24) | 9 (18) |
| Neurological disorder | 2 (4) | 3 (6) | 4 (8) |
| Hematological disorder | 21 (43) | 22 (43) | 22 (45) |
| Immunological disorder | 38 (78) | 43 (84) | 42 (86) |
| Antinuclear antibodies, with titre ≥1 : 160, n (%) | 49 (100) | 51 (100) | 48 (98) |
| Antibodies to dsDNA (Farr assay), mean IU/ml | 133 | 120 | 75 |
| SLEDAI-2K score, mean (SD) | 10.7 (2.5) | 11.1 (3.2) | 10.9 (3.3) |
| Patients with clinical SLEDAI-2K score ≥6, n (%) | 42 (86) | 48 (94) | 46 (94) |
| Physician's global assessment, mean (SD) | 1.2 (0.5) | 1.3 (0.5) | 1.2 (0.6) |
| Concomitant drugs, n (%) | |||
| Corticosteroids | 43 (88) | 43 (84) | 35 (71) |
| Antimalarial drugs | 30 (61) | 34 (67) | 43 (88) |
| Corticosteroids alone | 7 (14) | 7 (14) | 3 (6) |
| Corticosteroids and azathioprine | 12 (25) | 12 (24) | 8 (16) |
| Corticosteroids and antimalarial drugs | 27 (55) | 26 (51) | 31 (63) |
| Corticosteroids and methotrexate | 2 (4) | 2 (4) | 1 (2) |
| Antimalarial drugs alone | 3 (6) | 8 (16) | 12 (25) |
| Azathioprine alone | 1 (2) | 2 (4) | 3 (6) |
| Methotrexate alone | 1 (2) | 2 (4) | 0 (0.0) |
ACR, American College of Rheumatology; dsDNA, double-stranded DNA; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000.