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 rash38 (78)42 (82)32 (65)
 Discoid rash7 (14)6 (12)6 (12)
 Photosensitivity38 (78)37 (73)38 (78)
 Oral ulcers26 (53)30 (59)27 (55)
 Arthritis47 (96)49 (96)47 (96)
 Serositis11 (22)6 (12)13 (27)
 Renal disorder9 (18)12 (24)9 (18)
 Neurological disorder2 (4)3 (6)4 (8)
 Hematological disorder21 (43)22 (43)22 (45)
 Immunological disorder38 (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/ml13312075
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 (%)
 Corticosteroids43 (88)43 (84)35 (71)
 Antimalarial drugs30 (61)34 (67)43 (88)
 Corticosteroids alone7 (14)7 (14)3 (6)
 Corticosteroids and azathioprine12 (25)12 (24)8 (16)
 Corticosteroids and antimalarial drugs27 (55)26 (51)31 (63)
 Corticosteroids and methotrexate2 (4)2 (4)1 (2)
 Antimalarial drugs alone3 (6)8 (16)12 (25)
 Azathioprine alone1 (2)2 (4)3 (6)
 Methotrexate alone1 (2)2 (4)0 (0.0)
  • ACR, American College of Rheumatology; dsDNA, double-stranded DNA; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000.