Table 2.
Primary and secondary outcomes according to the treatment regimen
| Outcome | Triplet regimen (N = 90) | Historical cohort (N = 180) | P |
|---|---|---|---|
| Primary outcome | |||
| Composite of death and refractoriness | |||
| All patients | 2 (2.2%) | 22 (12.2%)* | .01 |
| According to French Severity score | |||
| 0-2 | 2 (2.8%) | 15 (8.3%) | <.01 |
| 3-4 | 0 | 7 (33%) | |
| Secondary outcomes | |||
| Death | 1 (1.1%) | 12 (6.7%) | .06 |
| Refractoriness | 1 (1.1%) | 16 (18%)† | .01 |
| Exacerbations | 3 (3.4%) | 70 (44%) | <.01 |
| Time to durable platelet count recovery | 5 (4-6) | 12 (6-17) | <.01 |
| Number of daily TPE until remission | 5 (4-7) | 10 (6-16) | <.01 |
| Volume of plasma (L) until remission | 24.2 (18.3-30.2) | 44.4 (26.3-74.3) | <.01 |
| Time to ADAMTS13 activity > 20% (days) | 28 (14-42) | 48 (24-83) | <.01 |
| Length of hospitalization (days) | 13 (9-19) | 22 (15-30) | .01 |
| Thromboembolic events | 11 (12%) | 20 (11.1%) | .79 |
Data are given as median (25th-75th percentile) for quantitative variables and as n (%) for qualitative variables. Patients at high risk of early death of iTTP were defined by a French severity score ≥ 3 (cerebral involvement: yes = 1/no = 0, LDH: >10×ULN = 1/≤10×ULN = 0, age: >60 y = 2/>40 and ≤60 y = 1/≤40 y = 0).12
*
Includes 10 refractory patients who survived (only 1 event per patient was considered).
†
Includes 6 deaths.