MI-CP151 patient summary information
| Sifalimumab (all doses, N=39) | Sifalimumab (0.3 mpk, N=7) | Sifalimumab (1.0 mpk, N=8) | Sifalimumab (3.0 mpk, N=16) | Sifalimumab (10 mpk, N=8) | Placebo (N=12) | |
|---|---|---|---|---|---|---|
| Age, years | 51.3 (20–77) | 47.3 (29–59) | 52.4 (20–77) | 51.8 (21–76) | 52.8 (37–67) | 51 (33–67) |
| % Female | 74 (29/39) | 88 (4/7) | 88 (7/8) | 69 (11/16) | 88 (7/8) | 58 (7/12) |
| % Caucasian | 79 (31/39) | 100 (7/7) | 63 (5/8) | 82 (13/16) | 75 (6/8) | 67 (8/12) |
| % Hispanic | 15 (6/39) | 14 (1/7) | 13 (1/8) | 25 (4/16) | 0 (0/8) | 17 (2/12) |
| % Dermatomyositis | 54 (21/39) | 29 (2/7) | 38 (3/8) | 81 (13/16) | 38 (3/8) | 42 (5/12) |
| Viral reactivation history | 6 (15.4%) | 1 (14.3%) | 2 (25.0%) | 2 (12.5%) | 1 (12.5%) | 2 (16.7%) |
| Mean baseline MMT8 (max=150) | 117.7 | 123.6 | 113.8 | 112.9* | 125.9 | 119.8 |
| % Corticosteroid use at baseline | 84.6 | 85.7 | 87.5 | 100 | 50 | 66.7 |
| Disease duration, months, median (range) | 40.3 (3–361.5) | 31.5 (3–153.9) | 23.6 (15.3–361.5) | 53.1* (13.8–217.2) | 35.4 (4.3–109.9) | 36.9 (10.8–76.9) |
| % Signature positive | 72 (28/39) | 86 (6/7) | 100 (8/8) | 63 (10/16) | 50 (4/8) | 83 (10/12) |
*Indicates average from cohorts 3 mpk IFN gene signature (IFNGS) positive (N=7) and 3 mpk IFNGS negative (N=9).
See supplementary material (available online only) for IFNGS-positive blood and muscle patient counts at each time point. IFNGS-positive patient counts above are provided for those with available microarray data at day 0 in either blood or muscle specimens, or both. Only these IFNGS-positive patients are used in the analyses presented.