Table 1

Baseline demographics and disease characteristics

Placebo
(n=9)
E6742 100 mg
(n=8)
E6742 200 mg
(n=9)
Total
(n=26)
Age (years), mean (SD)38.9 (9.20)33.6 (12.97)40.4 (11.17)37.8 (11.07)
Female, n (%)8 (88.9)8 (100.0)8 (88.9)24 (92.3)
Ethnic origin (Asian), n (%)9 (100.0)8 (100.0)9 (100.0)26 (100.0)
Weight (kg), mean (SD)53.6 (13.74)53.2 (6.34)51.8 (8.26)52.9 (9.70)
BMI (kg/m2), mean (SD)21.1 (4.58)20.9 (2.55)21.1 (2.73)21.1 (3.31)
Disease duration of SLE (years), mean (SD)7.7 (6.10)4.5 (3.62)8.2 (6.96)6.9 (5.81)
SLEDAI-2K total score, mean (SD)7.8 (2.91)8.6 (4.69)6.7 (2.83)7.7 (3.47)
BILAG-2004 components, n (%)
Mucocutaneous, A/B/C0/6/0 (66.7)0/6/1 (87.5)1/4/3 (88.9)1/16/4 (80.8)
Musculoskeletal, A/B/C0/4/3 (77.8)0/5/1 (75.0)0/4/1 (55.6)0/13/5 (69.2)
Haematological, A/B/C0/0/5 (55.6)0/0/5 (62.5)0/0/5 (55.6)0/0/15 (57.7)
PGA (0–3) score, mean (SD)1.3 (0.50)1.0 (0.27)1.1 (0.40)1.2 (0.41)
CLASI activity score, mean (SD)3.7 (4.69)3.5 (3.30)3.7 (4.77)3.6 (4.17)
Tender joint count (68), mean (SD)9.6 (15.88)9.1 (12.38)5.4 (7.13)8.0 (11.98)
Swollen joint count (66), mean (SD)2.9 (5.30)3.8 (4.98)1.8 (2.33)2.8 (4.28)
Autoantibody titre, n (%)
 ANA positive (≥80 titre) at the time of study entry7 (77.8)7 (87.5)7 (77.8)21 (80.8)
 Anti-dsDNA positive
 (IgG 12 IU/mL or IgM ≥6 U/mL)
6 (66.7)5 (62.5)8 (88.9)19 (73.1)
 Anti-Sm positive (≥10 U/mL)3 (33.3)01 (11.1)4 (15.4)
Complement level, n (%)
 Low C3 (<0.65 g/L)4 (44.4)3 (37.5)2 (22.2)9 (34.6)
 Low C4 (<0.13 g/L)5 (55.6)4 (50.0)6 (66.7)15 (57.7)
Concomitant medication for SLE, n (%)
Oral glucocorticoids, n (%)8 (88.9)8 (100.0)9 (100.0)25 (96.2)
 Dose (mg/day)*, mean (SD)4.8 (3.45)5.6 (2.15)6.2 (2.99)5.6 (2.85)
 <=10 mg/day, n (%)7 (77.8)8 (100.0)9 (100.0)24 (92.3)
 >10 mg/day, n (%)1 (11.1)001 (3.8)
Hydroxychloroquine, n (%)8 (88.9)7 (87.5)6 (66.7)21 (80.8)
Immunosuppressants, n (%)4 (44.4)4 (50.0)4 (44.4)12 (46.2)
 Mycophenolate mofetil001 (11.1)1 (3.8)
 Methotrexate02 (25.0)1 (11.1)3 (11.5)
 Tacrolimus4 (44.4)2 (25.0)2 (22.2)8 (30.8)
  • Data expressed as n (%) or mean (SD).

  • *Prednisolone or equivalent.

  • ANA, antinuclear antibody; anti-dsDNA, anti-double-stranded DNA; anti-Sm, anti-Smith; BILAG, British Isles Lupus Assessment Group; BMI, body mass index; CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; PGA, Physician’s Global Assessment; SLE, systemic lupus erythematosus; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index.