Table 2.
Efficacy of oral fostamatinib in patients with chronic immune thrombocytopenia in the pooled analysis of two randomized, double-blind, 24-week phase 3 trials [10]
| Outcome | Total study population | FOS subgroups based on overall response to FOS | ||
|---|---|---|---|---|
| FOS (n = 101) | PL (n = 49) | With an overall response (n = 43) | Without an overall response (n = 58) | |
| Stable responsea (% of pts) | 18* | 2 | ||
| Overall responseb (% of pts) | 43* | 14 | ||
| Bleeding-related serious AE (% of pts) | 10 | 0 | 7 | |
| Bleeding-related moderate-to-severe AE (% of pts) | 16 | 9 | 10 | |
| Use of rescue medication (% of pts) | 45 | 16 | 34 | |
AE adverse event, FOS fostamatinib, PL placebo, pts patients
*p < 0.01 vs PL
aPrimary endpoint; defined as platelet counts ≥ 50 × 109/L on at least 4 of 6 clinic visits that occurred every 2 weeks during weeks 14–24, without requiring rescue therapy after week 10
bDefined as ≥ 1 platelet count ≥ 50 × 109/L during weeks 0–12; determined in a post hoc analysis