Baseline characteristics for clinical outcome measures
| All patients | IFNGS test–high subgroup | IFNGS test–low subgroup | ||||
| Placebo N=102 | Anifrolumab 300 mg Q4W N=99 | Placebo N=76 | Anifrolumab 300 mg Q4W N=75 | Placebo N=26 | Anifrolumab 300 mg Q4W N=24 | |
| Rash measured by SLEDAI-2K, n (%) | ||||||
| Present | 88 (86.3) | 88 (88.9) | 65 (85.5) | 67 (89.3) | 23 (88.5) | 21 (87.5) |
| Absent | 14 (13.7) | 11 (11.1) | 11 (14.5) | 8 (10.7) | 3 (11.5) | 3 (12.5) |
| Rash measured by BILAG, n (%)* | ||||||
| A | 15 (14.7) | 20 (20.2) | 14 (18.4) | 16 (21.3) | 1 (3.8) | 4 (16.7) |
| B | 70 (68.6) | 62 (62.6) | 50 (65.8) | 45 (60.0) | 20 (76.9) | 17 (70.8) |
| C | 3 (2.9) | 5 (5.1) | 1 (1.3) | 5 (6.7) | 2 (7.7) | 0 (0) |
| D/E | 14 (13.7) | 12 (12.1) | 11 (14.5) | 9 (12.0) | 3 (11.5) | 3 (12.5) |
| Rash measured by mCLASI, n (%) | ||||||
| Activity score >0 | 89 (87.3) | 92 (92.9) | 67 (88.2) | 70 (93.3) | 22 (84.6) | 22 (91.7) |
| Arthritis measured by SLEDAI-2K, n (%) | ||||||
| Present | 99 (97.1) | 97 (98.0) | 73 (96.1) | 73 (97.3) | 26 (100.0) | 24 (100.0) |
| Absent | 3 (2.9) | 2 (2.0) | 3 (3.9) | 2 (2.7) | 0 (0) | 0 (0) |
| Arthritis measured by BILAG, n (%)* | ||||||
| A | 29 (28.4) | 36 (36.4) | 20 (26.3) | 27 (36.0) | 9 (34.6) | 9 (37.5) |
| B | 66 (64.7) | 58 (58.6) | 52 (68.4) | 44 (58.7) | 14 (53.8) | 14 (58.3) |
| C | 4 (3.9) | 5 (5.1) | 1 (1.3) | 4 (5.3) | 3 (11.5) | 1 (4.2) |
| D/E | 3 (2.9) | 0 (0) | 3 (3.9) | 0 (0) | 0 (0) | 0 (0) |
| Swollen and tender joint counts | ||||||
| Mean (SD) | 7.8 (6.5) | 8.2 (6.0) | 7.5 (6.4) | 7.7 (5.7) | 8.6 (6.8) | 9.8 (6.6) |
A, severe disease; B, moderate disease; C, mild disease; D/E, clear of disease activity.
BILAG, British Isles Lupus Assesment Group; mCLASI, modified Cutaneous Lupus Erythematosus Disease Area and Severity Index; IFNGS, interferon gene signature; Q4W, every 4 weeks; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000.