Baseline characteristics and interim analysis data of patients with TRAPS
| Baseline | 6 months | 12 months | 18 months | |
|---|---|---|---|---|
| Number of patients, N | 16 | 13 | 10 | 6 |
| Median age, years (min; max) | 23 (3; 43) | 17 (3; 43) | 16 (4; 38) | 25 (4; 43) |
| Females (%) | 11 (69) | 9 (69) | 7 (70) | 3 (50) |
| Median duration of prior CAN therapy at baseline, years (min; max) | 1.0 (0; 4) | 1.0 (0; 4) | 1.0 (0; 4) | 1.5 (0; 2) |
| Number (%) of patients in disease remission (physician assessment) | 9 (60.0) | 9 (81.8) | 7 (77.8) | 4 (80.0) |
| Physician Global Assessment, percentage of absent/mild-moderate/severe rating | 40 / 53 / 0 | 82 / 9 / 0 | 44 / 44 / 11 | 80 / 20 / 0 |
| Patient assessment of current disease activity; 0–10, median (min; max) | 1.5 (0; 5) | 1.0 (0; 4) | 1.0 (0; 6) | 0.0 (0; 3) |
| Patient assessment of current fatigue; 0–10, median (min; max) | 2.0 (0; 8) | 1.0 (0; 7) | 2,5 (0; 8) | 4.0 (0; 7) |
| Number (%) of patients without impairment of social life by the disease | 4 (50) | 5 (63) | 2 (33) | 3 (60) |
| Number (%) of patients with days absent from work/school during last 6 months | 8 (50) | 5 (39) | 5 (56) | 3 (50) |
| CRP, median (mg/dl) | 0.1 | 0.1 | 0.1 | 0.0 |
| SAA, median (mg/dl) | 0.5 | 0.4 | 0.4 | 0.3 |
| ESR, median (mm/h) | 7.0 | 5.0 | 5.0 | 5.0 |
| SAE | Number of events | Incidence rate per 100 patient years | ||
| Total | 3 | 14.7 | ||
| Circulatory collapse (non fatal) | 1 | 4.9 | ||
| Dizziness | 1 | 4.9 | ||
| Headache | 1 | 4.9 | ||
CRP, c-reactive protein; ESR, erythrocyte sedimentation rate; SAA, serum amyloid A; SAE, serious adverse event