Patient demographics and disease characteristics at baseline
| Placebo (n=45) | 10 mg (n=45) | 50 mg (n=47) | 200 mg (n=46) | |
|---|---|---|---|---|
| Mean age, years (SD) | 42.3 (13.0) | 39.9 (11.5) | 38.3 (10.5) | 41.3 (11.3) |
| Female, n (%) | 38 (84.4) | 43 (95.6) | 43 (93.6) | 43 (93.5) |
| Race, n (%) | ||||
| White | 33 (73.3) | 37 (82.2) | 36 (76.6) | 33 (71.7) |
| Black | 4 (8.9) | 3 (6.7) | 8 (17.0) | 9 (19.6) |
| Asian | 1 (2.2) | 1 (2.2) | 0 (0.0) | 0 (0.0) |
| Other | 7 (15.6) | 4 (8.9) | 3 (6.4) | 4 (8.7) |
| Mean BMI, kg/m2 (SD) | 29.6 (7.1) | 28.6 (6.9) | 27.4 (6.9) | 29.9 (8.1) |
| Mean SLE duration, years (SD) | 9.1 (6.9) | 7.9 (8.1) | 7.5 (6.0) | 8.6 (6.1) |
| Mean SLEDAI-2K score (SD) | 9.5 (2.2) | 9.6 (2.7) | 9.0 (2.7) | 10.1 (3.9) |
| SLEDAI-2K ≥10, n (%) | 22 (48.9) | 22 (48.9) | 19 (40.4) | 22 (47.8) |
| BILAG 2004 | ||||
| BILAG A in ≥1 organ system, n (%) | 20 (44.4) | 19 (42.2) | 16 (34.0) | 25 (54.3) |
| BILAG B in ≥2 organ systems, n (%) | 25 (55.6) | 27 (60.0) | 33 (70.2) | 26 (56.5) |
| Mean BILAG numerical score (SD) | 18.4 (3.3) | 18.5 (4.1) | 18.3 (4.1) | 20.0 (5.2) |
| BILAG A or B in organ domain, n (%) | ||||
| Cardiorespiratory | 0 (0.0) | 2 (4.4) | 4 (8.5) | 6 (13.0) |
| Constitutional | 3 (6.7) | 3 (6.7) | 2 (4.3) | 1 (2.2) |
| Gastrointestinal | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Haematological | 1 (2.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Mucocutaneous | 39 (86.7) | 39 (86.7) | 41 (87.2) | 37 (80.4) |
| Musculoskeletal | 44 (97.8) | 45 (100.0) | 46 (97.9) | 45 (97.8) |
| Neuropsychiatric | 0 (0.0) | 0 (0.0) | 0 (0.0) | 5 (10.9) |
| Ophthalmic | 1 (2.2) | 0 (0.0) | 1 (2.1) | 0 (0.0) |
| Renal | 1 (2.2) | 1 (2.2) | 2 (4.3) | 3 (6.5) |
| Mean PhGA score (SD) | 1.6 (0.4) | 1.7 (0.4) | 1.6 (0.4) | 1.8 (0.3) |
| Serologically positive (ANA ≥1:80 and/or anti-dsDNA >120 IU/mL), n (%) | 36 (80.0) | 35 (77.8) | 38 (80.9) | 32 (71.1) |
| Anti-dsDNA >ULN (120 IU/mL), n (%) | 13 (28.9) | 7 (15.6) | 10 (21.3) | 11 (23.9) |
| Detectable anti-dsDNA (≥28 IU/mL), n (%) | 27 (60.0) | 28 (62.2) | 28 (59.6) | 21 (45.7) |
| Low C3 (<90 mg/dL), n (%) | 13 (28.9) | 12 (26.7) | 11 (23.4) | 12 (26.7)* |
| Low C4 (<16 mg/dL), n (%) | 10 (22.2) | 9 (20.0) | 5 (10.6) | 7 (15.6)* |
| Corticosteroid use, n (%) | 31 (68.9) | 32 (71.1) | 36 (76.6) | 34 (73.9) |
| Corticosteroids >7.5 mg/day, n (%) | 23 (51.1) | 14 (31.1) | 24 (51.1) | 18 (39.1) |
| Immunosuppressive use, n (%) | 20 (44.4) | 18 (40.0) | 21 (44.7) | 23 (50.0) |
| Antimalarial use, n (%) | 34 (75.6) | 35 (77.8) | 34 (72.3) | 26 (56.5) |
| Mean SF-36 score (SD) | ||||
| PCS score | 34.6 (10.2) | 34.0 (8.0) | 34.5 (8.4) | 33.9 (9.6) |
| MCS score | 39.9 (9.7) | 39.6 (11.8) | 42.7 (9.9) | 39.2 (12.2) |
| Physical functioning | 51.4 (27.8) | 48.6 (25.2) | 51.3 (24.3) | 45.0 (24.3) |
| Role physical | 43.8 (26.8) | 38.5 (24.8) | 47.1 (21.7) | 42.4 (25.9) |
| Body pain | 39.5 (22.5) | 37.8 (20.3) | 39.9 (20.8) | 36.3 (19.6) |
| General health | 34.4 (18.7) | 34.6 (19.0) | 33.9 (11.9) | 36.8 (18.7) |
| Vitality | 35.0 (22.1) | 38.9 (21.4) | 41.2 (17.8) | 37.2 (18.6) |
| Social functioning | 51.7 (25.2) | 54.4 (24.5) | 57.7 (22.1) | 49.7 (24.8) |
| Role emotional | 61.3 (24.6) | 56.5 (30.0) | 61.2 (27.1) | 53.6 (27.9) |
| Mental health | 57.7 (18.7) | 55.0 (20.6) | 63.2 (16.2) | 57.6 (21.4) |
| Mean EQ-5D VAS score (SD) | 56.7 (22.9) | 55.2 (21.5) | 57.6 (18.5) | 49.8 (20.4) |
| Mean FACIT-Fatigue score (SD) | 26.0 (11.8) | 25.9 (11.4) | 29.4 (10.3) | 24.7 (11.6) |
*n=45 for the 200 mg group.
ANA, antinuclear antibody; BILAG, British Isles Lupus Assessment Group; BMI, body mass index; dsDNA, double-stranded DNA; EQ-5D, European Quality of Life 5 Dimensions; FACIT, Functional Assessment of Chronic Illness Therapy; MCS, mental component summary; PCS, physical component summary; PhGA, Physician's Global Assessment; SF-36, 36-item Short Form Health Survey; SLE, systemic lupus erythematosus; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index; ULN, upper limit of normal; VAS, visual analogue scale.