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/C | 0/6/0 (66.7) | 0/6/1 (87.5) | 1/4/3 (88.9) | 1/16/4 (80.8) |
Musculoskeletal, A/B/C | 0/4/3 (77.8) | 0/5/1 (75.0) | 0/4/1 (55.6) | 0/13/5 (69.2) |
Haematological, A/B/C | 0/0/5 (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 entry | 7 (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) | 0 | 1 (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) | 0 | 0 | 1 (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 mofetil | 0 | 0 | 1 (11.1) | 1 (3.8) |
Methotrexate | 0 | 2 (25.0) | 1 (11.1) | 3 (11.5) |
Tacrolimus | 4 (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.