Kento Tomohisa, Toma Abe, Ken Sota, Akiho Kato, Shigeo Sakurako, Tokuda Kaoru and Taka Yoshizawa
Introduction: The effectiveness and safety of romiplostim were evaluated by immune thrombocytopenia (ITP) phase (newly diagnosed/ persistent/chronic) at romiplostim initiation.
Methods: This is a post hoc analysis of a prospective, Japanese, multicentre, observational study in adults with ITP who received ≥ 1 dose of romiplostim. Follow-up data were collected for ≤ 2 years. Outcomes included overall platelet response (≥ 1 platelet count ≥ 50 × 109/L at 2–24 weeks after romiplostim initiation) or durable platelet response (≥ 75% of measurements ≥ 50 × 109/L at 14–24 weeks) and adverse drug reactions (ADRs), evaluated by ITP phase.
Results: Data from 96 patients were analysed (newly diagnosed, n =18; persistent, n=25; chronic, n=53). During the 2- to 24-week follow-up, overall platelet response was achieved in 100% (95% confidence interval: 81.5–100), 100% (86.3–100), and 96.2% (87.0–99.5) of patients with newly diagnosed, persistent, or chronic ITP, respectively, and platelet responses were durable in 88.2% (63.6–98.5), 65.0% (40.8–84.6), and 69.4% (54.6–81.7) of patients. During the 2-year follow-up, ADRs occurred in 24.0–35.8% of patients across phases. Two patients with chronic ITP experienced bone marrow ADRs; no thrombotic ADRs occurred.
Conclusion: Romiplostim was effective and well tolerated in patients with newly diagnosed, persistent, or chronic ITP in routine clinical practice.
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