Table 1.
Patient demographics and disease characteristics
| Anifrolumab combined (n=96) | Anifrolumab BR (n=45) | Anifrolumab IR (n=51) | Placebo (n=49) | ||
| Patient demographics | |||||
| Age, years | Median (range) | 34.5 (18, 67) | 34.0 (19, 67) | 35.0 (18, 65) | 32.0 (18, 58) |
| Sex | Female, n (%) | 82 (85.4) | 37 (82.2) | 45 (88.2) | 38 (77.6) |
| Weight | Mean (SD), kg | 65.4 (15.0) | 62.7 (12.3) | 67.7 (16.8) | 65.6 (13.3) |
| BMI | Mean (SD) | 25.1 (5.06) | 24.0 (3.77) | 26.0 (5.85) | 24.5 (3.93) |
| >28 kg/m2, n (%) | 23 (24.0) | 7 (15.6) | 16 (31.4) | 9 (18.4) | |
| Race, n (%) | White | 42 (43.8) | 17 (37.8) | 25 (49.0) | 24 (49.0) |
| Black/African American | 6 (6.3) | 2 (4.4) | 4 (7.8) | 1 (2.0) | |
| Asian | 18 (18.8) | 11 (24.4) | 7 (13.7) | 10 (20.4) | |
| Native Hawaiian/Pacific Islander | 1 (1.0) | 1 (2.2) | 0 | 0 | |
| American Indian/Alaska Native | 4 (4.2) | 3 (6.7) | 1 (2.0) | 0 | |
| Other | 25 (26.0) | 11 (24.4) | 14 (27.5) | 14 (28.6) | |
| Hispanic or Latino ethnicity, n (%) | 45 (46.9) | 22 (48.9) | 23 (45.1) | 20 (40.8) | |
| Geographic region, n (%) | Asia Pacific | 18 (18.8) | 10 (22.2) | 8 (15.7) | 9 (18.4) |
| Europe | 26 (27.1) | 10 (22.2) | 16 (31.4) | 15 (30.6) | |
| Latin America | 34 (35.4) | 14 (31.1) | 20 (39.2) | 16 (32.7) | |
| North America | 18 (18.8) | 11 (24.4) | 7 (13.7) | 9 (18.4) | |
| Baseline disease characteristics | |||||
| Time from initial LN diagnosis to randomisation, mean (range), months | 6.8 (0.4, 306.9) |
3.4 (1.1, 212.7) |
15.7 (0.4, 306.9) |
37.0 (0.7, 328.3) |
|
| Renal biopsy result at screening, n (%) | Class III | 17 (17.7) | 7 (15.6) | 10 (19.6) | 6 (12.2) |
| Class III+V | 11 (11.5) | 7 (15.6) | 4 (7.8) | 5 (10.2) | |
| Class IV | 53 (55.2) | 26 (57.8) | 27 (52.9) | 30 (61.2) | |
| Class IV+V | 15 (15.6) | 5 (11.1) | 10 (19.6) | 8 (16.3) | |
| 24-hour UPCR, mg/mg | Mean (SD) | 3.10 (2.18) | 3.36 (2.50) | 2.86 (1.85) | 3.71 (3.20) |
| >3.0, n (%) | 36 (37.5) | 19 (42.2) | 17 (33.3) | 23 (46.9) | |
| eGFR* mL/min/1.73 m2 | Mean (SD) | 97.1 (44.77) | 100.2 (46.77) | 94.4 (43.22) | 87.3 (35.43) |
| ≥60, n (%) | 73 (76.0) | 35 (77.8) | 38 (74.5) | 39 (79.6) | |
| SLEDAI-2K† score | Mean (SD) | 10.7 (4.83) | 10.4 (4.63) | 11.0 (5.04) | 11.3 (4.38) |
| ≥10, n (%) | 51 (53.1) | 23 (51.1) | 28 (54.9) | 29 (59.2) | |
| Non-renal SLEDAI-2K† score | Mean (SD) | 4.7 (3.12) | 5.2 (3.44) | 4.2 (2.74) | 4.7 (2.30) |
| IFNGS status | High, n (%) | 91 (94.8) | 44 (97.8) | 47 (92.2) | 46 (93.9) |
| Serology, n (%) | ANA positive‡ | 90 (93.8) | 44 (97.8) | 46 (90.2) | 49 (100) |
| Anti-dsDNA positive§ | 76 (79.2) | 37 (82.2) | 39 (76.5) | 39 (79.6) | |
| Low C3¶ | 57 (59.4) | 30 (66.7) | 27 (52.9) | 42 (85.7) | |
| Low C4¶ | 24 (25.0) | 10 (22.2) | 14 (27.5) | 20 (40.8) | |
| Baseline treatments | |||||
| Oral glucocorticoids** | Yes, n (%) | 94 (97.9) | 43 (95.6) | 51 (100) | 48 (98.0) |
| Dosage, mean (SD), mg/day | 22.6 (10.63) | 21.9 (10.4) | 23.2 (10.88) | 21.9 (11.20) | |
| ≥20 mg/day, n (%) | 67 (69.8) | 31 (68.9) | 36 (70.6) | 33 (67.3) | |
| MMF before randomisation | Yes, n (%) | 72 (75.0) | 36 (80.0) | 36 (70.6) | 33 (67.3) |
| Dosage, mean (SD), g/day | 1.81 (0.502) | 1.82 (0.551) | 1.79 (0.460) | 1.77 (0.469) | |
| Concomitant ACEI/ARB treatment, n (%) | 63 (65.6) | 27 (60.0) | 36 (70.6) | 33 (67.3) | |
| Antimalarials, n (%) | 57 (59.4) | 31 (68.9) | 26 (51.0) | 35 (71.4) | |
Baseline is defined as the last measurement prior to randomisation and dose administration on day 1.
*eGFR is calculated using the MDRD formula.
†The SLEDAI-2K is a 24-item weighted score of lupus activity that ranges from 0 to 105, with higher scores indicating greater disease activity.
‡ANA positive was defined as a titre ≥1:40.
§Anti-dsDNA positive was defined as an anti-dsDNA level above the assay cut-off for positive.
¶Low complement level at baseline was defined as a complement level below lower limit of normal.
**Baseline oral glucocorticoid dosage is defined as the maximum daily dose of prednisone or equivalent taken between day 1 and day 7, inclusive.
ACEI, ACE inhibitors; ANA, antinuclear antibodies; anti-dsDNA, anti-double-stranded DNA; ARB, angiotensin receptor blockers; BMI, body mass index; BR, basic regimen; C3, complement 3; C4, complement 4; eGFR, estimated glomerular filtration rate; IFNGS, interferon gene signature; IR, intensified regimen; LN, lupus nephritis; MDRD, modification of diet in renal disease; MMF, mycophenolate mofetil; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000; UPCR, urine protein–creatinine ratio.