Placebo | Anifrolumab300 mg* | P-Value | Anifrolumab1000 mg* | P-Value | |
---|---|---|---|---|---|
Organ domain improvement at Day 365 | |||||
BILAG, n (%) | |||||
Mucocutaneous | 24/87 (27.6) | 49/84 (58.3) | <0.001 | 33/82 (40.2) | 0.069 |
Musculoskeletal | 47/95 (49.5) | 64/94 (68.1) | 0.005 | 54/91 (59.3) | 0.149 |
SLEDAI-2K, n (%) | |||||
Mucocutaneous | 38/100 (38.0) | 61/99 (61.6) | <0.001 | 51/102 (50.0) | 0.082 |
Musculoskeletal | 42/99 (42.4) | 55/97 (56.7) | 0.032 | 50/98 (51.0) | 0.197 |
Immunological | 4/53 (7.5) | 9/43 (20.9) | 0.068 | 18/59 (30.5) | 0.004 |
Organ domain worsening at Day 365 | |||||
SLEDAI-2K, n (%) | |||||
Immunological | 7/79 (8.9) | 11/82 (13.4) | – | 6/79 (7.6) | – |
*Every 28 days from Day 1 to Day 337. BILAG, British Isles Lupus Assessment Group; SLEDAI-2K, SLE Disease Activity Index 2000