Table 1.
Patient demographics and characteristics
| ITT population | SRI non-responders | SRI responders | Overall |
| (n=358) | (n=475) | (n=833) | |
| Female, n (%) | 335 (93.6) | 451 (94.9) | 786 (94.4) |
| Mean age, years (SD) | 39.1 (12.65) | 38.1 (11.98) | 38.6 (12.28) |
| Median SLE disease duration, years (range) | 5.0 (0–38) | 4.0 (0–33) | 4.4 (0–38) |
| Mean baseline SELENA-SLEDAI score (SD) | 9.8 (3.09) | 10.9 (3.08) | 10.4 (3.14) |
| SELENA-SLEDAI score ≤9, n (%) | 169 (47.2) | 144 (30.3) | 313 (37.6) |
| SELENA-SLEDAI score ≥10, n (%) | 189 (52.8) | 331 (69.7) | 520 (62.4) |
| BILAG organ domain involvement*, n (%) | |||
| ≥1A or 2B | 246 (68.7) | 351 (73.9) | 597 (71.7) |
| ≥1A | 61 (17.0) | 77 (16.2) | 138 (16.6) |
| ≥1B | 325 (90.8) | 429 (90.3) | 754 (90.5) |
| No A or B | 19 (5.3) | 23 (4.8) | 42 (5.0) |
| PGA, mean (SD) | 1.6 (0.46) | 1.6 (0.42) | 1.6 (0.44) |
| Prednisone, n (%) | |||
| 0 mg/day | 59 (16.5) | 54 (11.4) | 113 (13.6) |
| >0 to ≤7.5 mg/day | 85 (23.7) | 133 (28.0) | 218 (26.2) |
| >7.5 mg/day | 214 (59.8) | 288 (60.6) | 502 (60.3) |
| ≥1 SFI flare, n (%)† | 66 (18.4) | 83 (17.5) | 149 (17.9) |
| ≥1 severe SFI flare, n (%)† | 8 (2.2) | 4 (0.8) | 12 (1.4) |
| Anti-dsDNA-positive (≥30 IU/mL), n (%) | 250 (69.8) | 345 (72.6) | 595 (71.4) |
| Low C3 (<90 mg/dL), n (%) | 144 (40.2) | 210 (44.2) | 354 (42.5) |
| Low C4 (<10 mg/dL), n (%) | 94 (26.3) | 121 (25.5) | 215 (25.8) |
| CD20+ B cells median cell count 10^9/L (range) |
0.1065 (0.007–1.517) | 0.1065 (0.004–1.323) | 0.1065 (0.004–1.517) |
*Patients may be included in more than one category.
†During the screening period (day −35 to day 0).
Anti-dsDNA, anti-double-stranded DNA; BILAG, British Isles Lupus Assessment Group;ITT, intent-to-treat (all randomised patients treated with ≥1 dose of study treatment); PGA, Physician’s Global Assessment;SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index;SFI, Systemic Lupus Erythematosus Flare Index;SRI, Systemic Lupus Erythematosus Responder Index.