Baseline characteristics of patients
| Variables | Telitacicept 240 mg (N=62) | Telitacicept 160 mg (N=63) | Telitacicept 80 mg (N=62) | Placebo (N=62) |
| Age (years), mean (SD) | 33.5 (9.8) | 33.5 (10.3) | 33.8 (8.9) | 34.9 (9.6) |
| Women, n (%) | 59 (95.2) | 61 (96.8) | 57 (91.9) | 58 (93.5) |
| Ethnic origin (Asian), n (%) | 62 (100) | 63 (100) | 62 (100) | 62 (100) |
| Weight (kg), mean (SD) | 57.85 (11.86) | 54.37 (9.78) | 57.02 (9.28) | 57.07 (10.43) |
| BMI (kg/m2), mean (SD) | 22.54 (4.01) | 21.37 (3.20) | 22.17 (3.04) | 22.29 (4.26) |
| Disease duration of SLE (years), mean (SD) | 6.64 (5.36) | 6.67 (5.21) | 6.47 (5.46) | 8.79 (5.87) |
| SLEDAI score, mean (SD) | 11.7 (3.3) | 11.4 (3.2) | 12.0 (3.9) | 11.3 (2.9) |
| ≤9, n (%) | 12 (19.4) | 13 (20.6) | 12 (19.4) | 16 (25.8) |
| 10–14, n (%) | 43 (69.4) | 40 (63.5) | 38 (61.3) | 40 (64.5) |
| ≥15, n (%) | 7 (11.3) | 10 (15.9) | 12 (19.4) | 6 (9.7) |
| BILAG organ domain involvement | ||||
| At least 1A or 2B, n (%) | 38 (61.3) | 40 (63.5) | 37 (59.7) | 35 (56.5) |
| At least 1A, n (%) | 19 (30.6) | 7 (11.1) | 11 (17.7) | 11 (17.7) |
| At least 1A or 1B, n (%) | 58 (93.5) | 59 (93.7) | 55 (88.7) | 58 (93.5) |
| PGA (0–3) score, mean (SD) | 1.88 (0.48) | 1.87 (0.43) | 1.81 (0.46) | 1.80 (0.40) |
| Proteinuria level (g/24 hours), n | 56 | 59 | 56 | 57 |
| Mean (SD) | 1.65 (1.52) | 1.06 (1.22) | 1.36 (1.48) | 0.92 (1.07) |
| Proteinuria category, (g/24 hours) | ||||
| ≤0.5, n (%) | 17 (30.4) | 28 (47.5) | 21 (37.5) | 28 (49.1) |
| >0.5–<1, n (%) | 5 (8.9) | 10 (16.9) | 11 (19.6) | 11 (19.3) |
| ≥1–<2, n (%) | 14 (25.0) | 10 (16.9) | 10 (17.9) | 11 (19.3) |
| ≥2, n (%) | 20 (35.7) | 11 (18.6) | 14 (25.0) | 7 (12.3) |
| SLEDAI organ domain involvement | ||||
| Immunological, n (%) | 55 (88.7) | 52 (82.5) | 51 (82.3) | 56 (90.3) |
| Mucocutaneous, n (%) | 49 (79.0) | 50 (79.4) | 52 (83.9) | 54 (87.1) |
| Renal, n (%) | 41 (66.1) | 32 (50.8) | 37 (59.7) | 32 (51.6) |
| Musculoskeletal, n (%) | 24 (38.7) | 36 (57.1) | 30 (48.4) | 29 (46.8) |
| Haematological, n (%) | 5 (8.1) | 7 (11.1) | 3 (4.8) | 8 (12.9) |
| Vascular, n (%) | 5 (8.1) | 2 (3.2) | 4 (6.5) | 3 (4.8) |
| Serosal, n (%) | 1 (1.6) | 3 (4.8) | 3 (4.8) | 0 |
| CNS, n (%) | 0 | 1 (1.6) | 1 (1.6) | 0 |
| Organ systems with at least 1A or 1B BILAG score | ||||
| General, n (%) | ||||
| A | 0 | 0 | 0 | 0 |
| B | 2 (3.2) | 4 (6.3) | 0 | 5 (8.1) |
| Mucocutaneous, n (%) | ||||
| A | 0 | 0 | 1 (1.6) | 2 (3.2) |
| B | 29 (46.8) | 34 (54.0) | 27 (43.5) | 33 (53.2) |
| Musculoskeletal, n (%) | ||||
| A | 0 | 0 | 0 | 0 |
| B | 22 (35.5) | 33 (52.4) | 28 (45.2) | 28 (45.2) |
| Vasculitis, n (%) | ||||
| A | 5 (8.1) | 1 (1.6) | 1 (1.6) | 3 (4.8) |
| B | 2 (3.2) | 4 (6.3) | 5 (8.1) | 6 (9.7) |
| Renal, n (%) | ||||
| A | 14 (22.6) | 6 (9.5) | 9 (14.5) | 6 (9.7) |
| B | 22 (35.5) | 17 (27.0) | 19 (30.6) | 13 (21.0) |
| Haematology, n (%) | ||||
| A | 0 | 0 | 0 | 0 |
| B | 2 (3.2) | 4 (6.3) | 3 (4.8) | 2 (3.2) |
| Daily prednisone dose, mean (SD) | 18.59 (13.14) | 14.20 (9.42) | 18.71 (13.05) | 16.07 (11.61) |
| Prednisone dose at baseline | ||||
| 0 mg/day, n (%) | 0 | 0 | 1 (1.6) | 0 |
| >0~≤7.5 mg/day, n (%) | 8 (12.9) | 18 (28.6) | 10 (16.1) | 15 (24.2) |
| >7.5~≤20 mg/day, n (%) | 40 (64.5) | 34 (54.0) | 35 (56.5) | 33 (53.2) |
| >20 mg/day, n (%) | 14 (22.6) | 11 (17.5) | 16 (25.8) | 14 (22.6) |
| Biomarkers | ||||
| ANA positive, n (%) | 61 (98.4) | 61 (96.8) | 61 (98.4) | 60 (96.8) |
| Anti-dsDNA positive, n (%) | 38 (61.3) | 33 (52.4) | 32 (51.6) | 33 (53.2) |
| IgG (g/L), mean (SD) | 12.35 (4.25) | 13.65 (5.07) | 14.08 (5.93) | 12.66 (4.54) |
| IgA (g/L), mean (SD) | 2.60 (1.19) | 2.58 (1.22) | 3.03 (1.44) | 2.67 (1.28) |
| IgM (g/L), mean (SD) | 0.99 (0.69) | 0.98 (0.56) | 0.81 (0.47) | 0.91 (0.53) |
| C3 (g/L), mean (SD) | 0.71 (0.25) | 0.73 (0.25) | 0.72 (0.22) | 0.68 (0.19) |
| C4 (g/L), mean (SD) | 0.14 (0.08) | 0.14 (0.07) | 0.14 (0.07) | 0.13 (0.06) |
| Complement level | ||||
| Low C3 and/or C4, n (%) | 49 (79.0) | 48 (76.2) | 48 (77.4) | 49 (79.0) |
| CD19+ B cells (/μL), mean (SD) | 41.32 (110.42) | 38.69 (80.60) | 37.67 (52.03) | 42.78 (89.39) |
Data are listed either by n (%) or mean (SD).
ANA, antinuclear antibody; anti-dsDNA, anti-double-stranded DNA; BILAG, British Isles Lupus Assessment Group; BMI, body mass index; CNS, central nervous system; PGA, Physician’s Global Assessment; SLE, systemic lupus erythematosus; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index.