Efficacy endpoints at weeks 8 and 52 (mITT population)
| Week 0 (baseline) | Week 8 (OLE baseline) | Week 52 | ||||
| RCI/RCI | Placebo/RCI | RCI/RCI | Placebo/RCI | RCI/RCI | Placebo/RCI | |
| Total hSLEDAI | 10.0 (3.3) | 9.8 (2.1) | 5.8 (3.0) | 9.1 (3.4) | 3.5 (3.5) | 3.3 (2.5) |
| Total BILAG-2004 | 15.7 (5.9) | 15.4 (9.6) | 6.8 (4.3) | 13.5 (8.8) | 4.6 (6.0) | 2.6 (2.9) |
| CLASI activity score* | 6.7 (6.3) | 7.4 (6.6) | 3.9 (4.3) | 7.0 (7.0) | 1.3 (1.6) | 0.5 (0.8) |
| Tender and swollen joint count* | 7.4 (5.8) | 5.1 (4.9) | 1.4 (2.3) | 2.2 (3.2) | 0.9 (2.5) | 1.6 (2.6) |
| Physician’s Global Assessment | 54.4 (13.0) | 52.6 (12.5) | 28.7 (21.1) | 39.1 (27.2) | 15.6 (16.5) | 11.7 (13.2) |
| Novel responder index, n/N (%) | n/a | n/a | 11/25 (44.0) | 3/11 (27.3) | 3/25 (12.0) | 4/11 (36.4) |
| Revised novel responder index,† n/N (%) | n/a | n/a | 15/25 (60.0) | 4/11 (36.4) | 12/25 (48.0) | 6/11 (54.5) |
| SLE responder index, n/N (%) | n/a | n/a | 13/25 (52.0) | 1/11 (9.1) | 10/25 (40.0) | 6/11 (54.5) |
| hSLEDAI decrease ≥4, n/N (%) | n/a | n/a | 15/25 (60.0) | 1/11 (9.1) | 10/25 (40.0) | 6/11 (54.5) |
| Prednisone <7.5 mg/day, n/N (%) | n/a | n/a | n/a | n/a | 9/25 (36.0) | 3/11 (27.3) |
| Severe flare (SFI), n/N (%) | n/a | n/a | 2/25 (8.0) | 1/11 (9.1) | 4/25 (16.0) | 3/11 (27.3) |
Data reported as mean (SD) unless indicated otherwise.
*Calculated for patients with score >0 at double-blind baseline.
†Novel responder index calculated using SRI definition for BILAG worsening (no new BILAG A and not more than one new BILAG B).
BILAG, British Isles Lupus Assessment Group; CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; hSLEDAI, hybrid Systemic Lupus Erythematosus Disease Activity Index; mITT, modified intent-to-treat; n/a, not applicable; OLE, open-label extension; RCI, repository corticotropin injection; SFI, Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) Flare Index.