Demographics and baseline clinical characteristics (mITT population)
| Sifalimumab | ||||
|---|---|---|---|---|
| Placebo (N=108) | 200 mg* (N=108) | 600 mg* (N=108) | 1200 mg* (N=107) | |
| Age (years), mean (SD) | 38.4 (12.3) | 39.9 (11.4) | 40.0 (11.3) | 39.4 (12.1) |
| Female, n (%) | 101 (93.5) | 103 (95.4) | 97 (89.8) | 97 (90.7) |
| Weight (kg), mean (SD) | 66.2 (16.2) | 68.5 (17.0) | 66.7 (16.6) | 67.6 (16.7) |
| Height (cm), mean (SD) | 161.0 (8.2) | 161.4 (9.4) | 161.6 (9.4) | 160.7 (9.2) |
| Race, n (%) | ||||
| White | 63 (58.3) | 67 (62.0) | 67 (62.0) | 56 (52.3) |
| Asian | 19 (17.6) | 14 (13.0) | 16 (14.8) | 16 (15.0) |
| Black | 7 (6.5) | 8 (7.4) | 7 (6.5) | 11 (10.3) |
| American–Indian/Alaskan native | 8 (7.4) | 4 (3.7) | 3 (2.8) | 5 (4.7) |
| Other† | 11 (10.2) | 15 (13.9) | 15 (13.9) | 19 (17.8) |
| Ethnicity non-Hispanic, n (%) | 68 (63.0) | 72 (66.7) | 68 (63.0) | 63 (58.9) |
| Region, n (%)‡ | ||||
| 1 | 74 (68.5) | 75 (69.4) | 74 (68.5) | 73 (68.2) |
| 2 | 34 (31.5) | 33 (30.6) | 34 (31.5) | 34 (31.8) |
| Duration of SLE§ (months), mean (SD) | 90.4 (74.9) | 103.9 (84.9) | 98.6 (82.6) | 100.6 (94.9) |
| IFN-high, n (%) | 88 (81.5) | 87 (80.6) | 88 (81.5) | 87 (81.3) |
| Swollen joint count, mean (SD)¶ | 6.3 (5.1) | 6.6 (5.4) | 6.8 (5.3) | 6.4 (5.2) |
| Tender joint count, mean (SD)¶ | 10.1 (7.5) | 10.4 (7.7) | 8.6 (6.8) | 9.3 (7.2) |
| Low complement concentrations, n (%) | ||||
| C3 | 47 (43.5) | 45 (41.7) | 46 (42.6) | 47 (43.9) |
| C4 | 27 (25.0) | 29 (26.9) | 28 (25.9) | 31 (29.0) |
| Antinuclear antibody positive, n (%)** | 106 (99.1) | 106 (99.1) | 105 (97.2) | 104 (99.0) |
| Anti-Smith antibody positive, n (%)†† | 28 (25.9) | 29 (26.9) | 21 (19.6) | 26 (24.8) |
| Anti-dsDNA positive, n (%)‡‡ | ||||
| Multiplex assay | 30 (28.0) | 30 (27.8) | 27 (25.0) | 29 (27.4) |
| Farr assay | 82 (79.6) | 85 (83.3) | 87 (82.9) | 80 (78.4) |
| Concomitant immunomodulatory medications, n (%) | ||||
| Antimalarial | 77 (71.3) | 77 (71.3) | 83 (76.9) | 79 (73.8) |
| Azathioprine | 28 (25.9) | 31 (28.7) | 31 (28.7) | 21 (19.6) |
| Methotrexate | 14 (13.0) | 17 (15.7) | 17 (15.7) | 16 (15.0) |
| Mycophenolate | 13 (12.0) | 11 (10.2) | 5 (4.6) | 12 (11.2) |
| Corticosteroids | 93 (86.1) | 96 (88.9) | 87 (80.6) | 92 (86.0) |
| Dosage (mg/day)***, mean (SD) | 11.1 (5.5) | 10.9 (5.5) | 10.8 (5.7) | 11.6 (5.8) |
| SLEDAI-2K global score, mean (SD) | 11.1 (4.1) | 11.0 (4.0) | 11.3 (4.6) | 11.7 (4.7) |
| Score <10 | 40 (37.0) | 46 (42.6) | 39 (36.1) | 42 (39.3) |
| Score ≥10 | 68 (63.0) | 62 (57.4) | 69 (63.9) | 65 (60.7) |
| BILAG-2004 global score, mean (SD) | 18.6 (4.9) | 19.5 (5.2) | 19.8 (6.4) | 19.0 (5.6) |
| PGA, mean (SD) | 1.83 (0.39) | 1.81 (0.37) | 1.73 (0.39) | 1.77 (0.40) |
| CLASI activity score, mean (SD) | 8.5 (8.5) | 8.1 (7.4) | 8.1 (7.2) | 6.8 (6.2) |
Multiplex assay: Placebo: N=107; 1200 mg: N=106; assessment at screening.
Farr assay: Placebo: N=103; 200 mg: N=102; 600 mg: N=105; 1200 mg: N=102; assessment on day 1.
*Days 1, 15 and 29, and then every 28 days thereafter.
†Other included one patient on placebo who identified herself as American–Indian, black and white.
‡Region 1 (high standard-of-care response): central America, South America, eastern Europe and Asia; Region 2 (low standard-of-care response): North America, western Europe and South Africa.
§Duration from diagnosis to study entry.
¶A total of 28 joints were assessed.
**Placebo: N=107; 200 mg: N=107; 1200 mg: N=105; assessments at screening.
††600 mg: N=107; 1200 mg: N=105, assessments at screening.
‡‡The multiplex assay, AtheNA Multi-Lyte ANA-II Plus test system was used for screening and to calculate SLEDAI-2K scores throughout the study. The differences between the multiplex and Farr assays were due to a low sensitivity cut-off point of the multiplex assay.37
***Prednisone dosage or equivalent.
BILAG-2004, British Isles Lupus Assessment Group; CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; dsDNA, double-stranded DNA; IFN, interferon; PGA, Physician's Global Assessment; mITT, modified intention-to-treat; SLE, systemic lupus erythematosus; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000.