Clinical outcomes at week 48 (full analysis set)
| Outcomes | Telitacicept 240 mg (N=62) | Difference vs placebo (95% CI) | P value | Telitacicept 160 mg (N=63) | Difference vs placebo (95% CI) | P value | Telitacicept 80 mg (N=62) | Difference vs placebo (95% CI) | P value | Placebo (N=62) |
| SRI-4 response, n (%) | 47/62 (75.8)* | 41.9 (26.0, 57.8) | <0.001 | 43/63 (68.3)* | 34.4 (17.9, 50.8) | <0.001 | 44/62 (71.0)* | 37.1 (20.8, 53.4) | <0.001 | 21/62 (33.9) |
| Reduction ≥4 points in SLEDAI, n (%) | 49/62 (79.0)* | 29.0 (13.0, 45.1) | <0.001 | 49/63 (77.8)† | 27.8 (11.6, 43.9) | 0.001 | 47/62 (75.8)† | 25.8 (9.4, 42.2) | 0.003 | 31/62 (50.0) |
| Per cent of patients with improvement in SLEDAI by organ domain involvement | ||||||||||
| Mucocutaneous, n (%) | 24/49 (49.0)† | 30.5 (13, 47.9) | 0.001 | 20/50 (40.0)‡ | 21.5 (4.4, 38.6) | 0.016 | 21/52 (40.4)‡ | 21.9 (5, 38.8) | 0.013 | 10/54 (18.5) |
| Musculoskeletal, n (%) | 17/24 (70.8)† | 36.4 (11.3, 61.4) | 0.008 | 27/36 (75.0)† | 40.5 (18.2, 62.9) | 0.001 | 24/30 (80.0)* | 45.5 (23.1, 68) | <0.001 | 10/29 (34.5) |
| Immunological, n (%) | 15/55 (27.3)‡ | 16.6 (2.3, 30.8) | 0.026 | 9/52 (17.3) | 6.6 (−6.5, 19.7) | 0.322 | 9/51 (17.6) | 6.9 (−6.3, 20.2) | 0.302 | 6/56 (10.7) |
| Renal, n (%) | 28/41 (68.3) | 21.4 (−1, 43.8) | 0.065 | 18/32 (56.3) | 9.4 (−15, 33.8) | 0.453 | 18/37 (48.6) | 1.8 (−21.9, 25.4) | 0.883 | 15/32 (46.9) |
| Vascular, n (%) | 3/5 (60.0) | 60.0 (17.1, 100.0) | 0.196 | 2/2 (100.0) | 100.0 (100.0, 100.0) | 0.100 | 3/4 (75.0) | 75.0 (32.6, 100.0) | 0.143 | 0/3 |
| Haematological, n (%) | 4/5 (80.0) | 42.5 (−6.0, 91.0) | 0.266 | 6/7 (85.7) | 48.2 (5.8, 90.6) | 0.119 | 2/3 (66.7) | 29.2 (−33.8, 92.2) | 0.545 | 3/8 (37.5) |
| Serosal, n (%) | 1/1 (100.0) | NA | NA | 2/3 (66.7) | NA | NA | 3/3 (100.0) | NA | NA | 0/0 |
| CNS, n (%) | 0/0 | NA | NA | 0/1 | NA | NA | 0/1 | NA | NA | 0/0 |
| General, n (%) | 0/0 | NA | NA | 0/0 | NA | NA | 0/0 | NA | NA | 0/0 |
| No worsening in BILAG, n (%) | 60/62 (96.8) | 3.2 (−4.3, 10.8) | 0.680 | 62/63 (98.4) | 4.9 (−2.0, 11.7) | 0.207 | 61/62 (98.4) | 4.8 (−2.0, 11.7) | 0.365 | 58/62 (93.5) |
| Per cent of patients with improvement in BILAG by organ domain involvement | ||||||||||
| General, n (%) | 2/2 (100.0) | 20.0 (−15.1, 55.1) | >0.999 | 4/4 (100.0) | 20.0 (−15.1, 55.1) | >0.999 | 0/0 | NA | NA | 4/5 (80.0) |
| Mucocutaneous, n (%) | 21/29 (72.4)‡ | 26.7 (3.5, 49.9) | 0.031 | 24/34 (70.6)‡ | 24.9 (2.4, 47.4) | 0.036 | 15/28 (53.6) | 7.9 (−16.9, 32.6) | 0.535 | 16/35 (45.7) |
| Musculoskeletal, n (%) | 18/22 (81.8)† | 39.0 (14.6, 63.4) | 0.005 | 26/33 (78.8)† | 35.9 (12.9, 59.0) | 0.004 | 25/28 (89.3)* | 46.4 (24.8, 68.0) | <0.001 | 12/28 (42.9) |
| Vasculitis, n (%) | 6/7 (85.7) | 41.3 (−0.3, 82.8) | 0.145 | 4/5 (80.0) | 35.6 (−12.2, 83.3) | 0.301 | 5/6 (83.3) | 38.9 (−5.2, 83.0) | 0.287 | 4/9 (44.4) |
| Renal, n (%) | 25/36 (69.4) | 6.3 (−20.1, 32.7) | 0.637 | 12/23 (52.2) | −11.0 (−40.8, 18.8) | 0.474 | 15/28 (53.6) | −9.6 (−38.1, 18.9) | 0.514 | 12/19 (63.2) |
| Haematological, n (%) | 2/2 (100.0) | 50.0 (−19.3, 100.0) | >0.999 | 4/4 (100.0) | 50.0 (−19.3, 100.0) | 0.333 | 2/3 (66.7) | 16.7 (−70.8, 100.0) | >0.999 | 1/2 (50.0) |
| No worsening in PGA, n (%) | 60/62 (96.8)* | 21.0 (9.4, 32.5) | <0.001 | 58/63 (92.1)‡ | 16.3 (3.7, 28.8) | 0.013 | 60/62 (96.8)* | 21.0 (9.4, 32.5) | <0.001 | 47/62 (75.8) |
| Prednisone dose reduced by ≥25% or to ≤7.5 mg/day during weeks 44–48, n (%) | 21/54 (38.9) | 17.6 (0.1, 35.1) | 0.056 | 10/45 (22.2) | 0.9 (-15.9, 17.8) | 0.912 | 17/51 (33.3) | 12.1 (−5.4, 29.5) | 0.182 | 10/47 (21.3) |
| Prednisone dose reduced by ≥25% or to ≤7.5 mg/day at week 48, n (%) | 22/54 (40.7)‡ | 19.5 (1.9, 37.0) | 0.036 | 10/45 (22.2) | 0.9 (−15.9, 17.8) | 0.912 | 18/51 (35.3) | 14.0 (−3.6, 31.6) | 0.125 | 10/47 (21.3) |
| Number of severe flares | 0.3 (0.67)‡ | −0.58 (−0.88, -0.28) | 0.012 | 0.4 (0.73) | −0.47 (−0.77, -0.18) | 0.091 | 0.5 (0.78) | −0.44 (−0.74, -0.14) | 0.132 | 0.9 (1.13) |
| Duration of SRI-4 response, days | 170.9 (95.4) | 23.8 (−18.9, 66.5) | 0.750 | 178.9 (100.8) | 31.9 (−10.8, 74.6) | 0.596 | 181.9 (102.05) | 34.9 (−9.0, 78.7) | 0.541 | 147.1 (91.02) |
| SRI-5 response, n (%) | 39/62 (62.9)* | 40.3 (24.4, 56.2) | <0.001 | 34/63 (54.0)* | 31.4 (15.3, 47.5) | <0.001 | 37/62 (59.7)* | 37.1 (21.1, 53.1) | <0.001 | 14/62 (22.6) |
| SRI-6 response, n (%) | 39/62 (62.9)* | 40.3 (24.4, 56.2) | <0.001 | 33/63 (52.4)* | 29.8 (13.7, 45.9) | <0.001 | 35/62 (56.5)* | 33.9 (17.7, 50.0) | <0.001 | 14/62 (22.6) |
| SRI-7 response, n (%) | 30/62 (48.4)* | 38.7 (24.3, 53.2) | <0.001 | 22/63 (34.9)* | 25.2 (11.4, 39.1) | <0.001 | 25/62 (40.3)* | 30.6 (16.4, 44.9) | <0.001 | 6/62 (9.7) |
| SRI-8 response, n (%) | 30/62 (48.4)* | 38.7 (24.3, 53.2) | <0.001 | 20/63 (31.7)† | 22.1 (8.4, 35.7) | 0.002 | 23/62 (37.1)* | 27.4 (13.3, 41.5) | <0.001 | 6/62 (9.7) |
All efficacy endpoints were analysed using LOCF. Data are listed by n (%) or by mean (SD).
The missing data of the primary efficacy indicators were filled with the last observation.
*P<0.001, telitacicept group versus placebo.
†P<0.01, telitacicept group versus placebo.
‡P<0.05, telitacicept group versus placebo.
BILAG, British Isles Lupus Assessment Group; CNS, central nervous system; LOCF, last observation carried forward; NA, not applicable; PGA, Physician’s Global Assessment; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index; SRI, Systemic Lupus Erythematosus Responder Index.