TABLE 1.
Study, year | Design | Funding | Patients on fostamatinib | Country | Age, years b | Male, n (%) | Duration of ITP, years b | Prior treatments b , c | Splenectomy (%) | Baseline platelets, ×109 cells/L b |
---|---|---|---|---|---|---|---|---|---|---|
Kuwana, 2023 [18] | Phase III RCT | Industry | 22 | Japan | 61 (25–81) | 4 (18) | 12 (1–41) | 2 (1–7) d | 5 (23) | 19 (3–28) |
Bussel, 2018 [16] | Two Phase III RCTs | Industry | 101 | International | 54 (20–88) | 40 (40) | 8.7 (0.3–53) | 3.0 (1–13) | 34 (34) | 16.1 (1–51) |
FIT‐1 | 51 | North America, Europe, Australia | 57 (20–88) | 21 (41) | 7.5 (0.6–53) | 3 (1–9) | 20 (39) | 16.2 (1–51) | ||
FIT‐2 | 50 | Europe | 50 (21–82) | 19 (38) | 8.8 (0.3–50.2) | 3 (1–13) | 14 (28) | 15.9 (1–33) | ||
Dranitsaris, 2023 [30] | Retrospective cohort | Industry | 51 | United States | 59 (21–88) | 16 (31) | 4.5 (1–21) | 3 (2–6) | 20 (39) | 21 (4–46) |
Bussel, 2022 [23, 36] | Retrospective cohort abstract | Industry | 318 | NR | 67 (19–100) | NR | NR | NR | NR | 32 (NR) |
Moezi, 2022 [37] | Retrospective cohort abstract | Industry | 46 | United States | 58 (NR) | 16 (35) | NR | 2 (NR) | 16 (35) | 19 (3–70) |
Cooper, 2021 e [20] | Prospective cohort (FIT‐3) | Industry | 146 | NR | 53 (20–88) | 58 (40) | 8.4 (<1–53) | 3 (1–13) | 51 (35) | 16 (NR) |
Podolanczuk, 2009 [19] | Prospective cohort | Industry | 16 | United States | 66 (31–81) | 6 (38) | 9 (1–≥29) | 5 (2–≥3) | 11 (69) | 16 (2–28) |
Grantab, 2022 [38] | Case series abstract | NR | 5 | NR | 77 (56–94) | 3 (60) | 5 (0.6–18) | 2 (2–5) | 0 (0) | 14 (<10–26) |
Liu, 2022 [21] | Case series | None | 7 | United Kingdom | 80 (63–94) | 3 (43) | 6 (0.5–30) | 2 (1–6) | 1 (14) | 25 (10–193) |
Mehta, 2022 [22] | Case series | Industry | 5 | NR | 79 (60–90) | 4 (80) | 6 (0.2–8.3) | 2 (1–6) | NR | 39 (17–59) |
Hughes, 2021 [39] | Case series | NR | 5 | NR | 69 (22–75) | 3 (60) | 6 (1–8) | 3 (3–6) | 1 (20) | 35 (4–264) |
Abbreviations: ITP, immune thrombocytopenic purpura; RCT, randomized controlled trial.
NR, not reported.
Unless otherwise noted, values are the median (range [i.e., minimum, maximum]).
Prior unique treatments counted as falling within the following categories: corticosteroid, IVIG/IV Anti D, thrombopoietin (TPO) agents, immunosuppressants, splenectomy, rituximab, danazol, chemotherapy, and other (i.e., dapsone).
Kuwana et al. report splenectomy separately and is not included in this count.
Cooper et al. (FIT‐3) is a prospective cohort that includes follow‐up of participants from the FIT‐1 and FIT‐2 randomized trials.