TABLE II -.
Summary of the data on efficacy, mortality and manifestation of other events during an acute episode of iTTP
| Efficacy parameter | PEX and immunosuppression | Source | Relative Risk (RR) | Caplacizumab + PEX and immunosuppression | Source |
|---|---|---|---|---|---|
| Clinical response criterion | |||||
| % of patients with exacerbation* after acute episode of iTTP | 36.30% | (25) | 0.12 | 4.23% | (17) |
| Probability of non-fatal stroke during an acute episode of iTTP | 4.44% | (25) | 0.69 | 3.06%** | (17) |
| Probability of non-fatal myocardial infarction during an acute episode of iTTP | 4.39% | (25) | 1.03 | 4.52%** | (17) |
| Mortality | |||||
| Probability of death during an acute episode of iTTP | 13.20% | (25) | 0.00 | 0.0%** | (17) |
| Other events during an acute episode of iTTP | |||||
| Probability of pulmonary embolism | 0,00% | (17) | NA | 1.41% | (17) |
| Probability of deep vein thrombosis | 4,11 | (17) | 1,03 | 4.23% | (17) |
| Rate of infections per patient during plasmapheresis | 1,31 | (17) | 0,44 | 0.57 | (17) |
| Rate of treatment-related serious bleeding events per patient | 0,00% | (17) | NA | 0.13 | (17) |
*Exacerbation is defined as a reduction in platelet count (<150,000/mm3) for 3 consecutive days, if a new acute thrombotic episode occurs in the first 30 days after the end of plasmapheresis.
**The data corresponding to caplacizumab in combination with PEX and immunosuppression were calculated by applying the estimated RR in the HERCULES study (16) to the data reported in the table for PEX and immunosuppression.