Demographic characteristics and disease features
| Combined placebo (n=11) | Repository corticotropin injection 40 U (n=13) | Repository corticotropin injection 80 U (n=12) | Combined repository corticotropin injection (n=25) | |
|---|---|---|---|---|
| Mean age (SD), years | 39.1 (9.1) | 42.6 (12.7) | 43.2 (7.2) | 42.9 (10.2) |
| Female, n (%) | 10 (90.9) | 12 (92.3) | 12 (100) | 24 (96.0) |
| Race, n (%) | ||||
| White | 5 (45.5) | 9 (69.2) | 9 (75.0) | 18 (72.0) |
| Black | 6 (54.5) | 3 (23.1) | 3 (25.0) | 6 (24.0) |
| hSLEDAI score, mean (SD) | 9.8 (2.1) | 8.7 (2.9) | 11.3 (3.3) | 10.0 (3.3) |
| Mean BILAG global score (SD) | 15.4 (9.6) | 13.1 (6.6) | 18.6 (3.4) | 15.7 (5.9) |
| Mean CLASI total activity score (SD) | 6.1 (6.6) | 5.9 (7.0) | 7.0 (5.8) | 6.4 (6.3) |
| Mean Tender and Swollen Joint Count (SD) | 4.2 (4.8) | 2.9 (3.4) | 8.6 (6.8)* | 5.6 (6.0) |
| Mean PGA (SD), mm | 52.6 (12.5) | 52.9 (14.3) | 55.9 (11.9) | 54.4 (13.0) |
| PGA categories, n (%) | ||||
| None | 0 | 0 | 0 | 0 |
| Mild | 1 (9.1) | 1 (7.7) | 1 (8.3) | 2 (8.0) |
| Moderate | 8 (72.7) | 10 (76.9) | 9 (75.0) | 19 (76.0) |
| Severe | 2 (18.2) | 2 (15.4) | 2 (16.7) | 4 (16.0) |
| Anti-dsDNA >5 IU/mL, n (%) | 6 (54.5) | 9 (69.2) | 6 (50.0) | 15 (60.0) |
| Complement C3 <LLN (0.87 g/L), n (%) | 3 (27.3) | 3 (23.1) | 4 (33.3) | 7 (28.0) |
| Complement C4 <LLN (0.19 g/L), n (%) | 6 (54.5) | 6 (46.2) | 2 (16.7) | 8 (32.0) |
| Mean prednisone (SD), mg/day | 16.4 (8.1) | 10.8 (2.6)† | 9.2 (1.2)‡ | 10.0 (2.2)‡ |
| Antimalarials, n (%) | 8 (72.7) | 11 (84.6) | 7 (58.3) | 18 (72.0) |
| Immunosuppressants, n (%) | 6 (54.5) | 4 (30.8) | 2 (16.7) | 6 (24.0) |
| Mycophenolate mofetil | 4 (36.4) | 2 (15.4) | 1 (8.3) | 3 (12.0) |
| Methotrexate | 3 (27.3) | 2 (15.4) | 1 (8.3) | 3 (12.0) |
| Azathioprine | 0 | 1 (7.7) | 2 (16.7) | 3 (12.0) |
*p=0.05 versus placebo; †p=0.007 versus placebo; ‡p=0.001 versus placebo.
PGA scores on a 100 mm visual analogue scale are categorised as follows: 0 point (none)=0 mm, 1 point (mild) >0–33.33 mm; 2 points (moderate) >33.33–66.67 mm and 3 points (severe) >66.67–100 mm.
BILAG, British Isles Lupus Assessment Group; CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; dsDNA, double-stranded DNA; hSLEDAI, hybrid SLE Disease Activity Index; LLN, lower limit of normal; PGA, Physician's Global Assessment.