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Romiplostim for Primary Immune Thrombocytopenia (ITP) in Routine Clinical Practice: Results from a Multicentre Observational Study in Germany.

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INTRODUCTION The effectiveness and safety of romiplostim were evaluated by immune thrombocytopenia (ITP) phase (newly diagnosed/persistent/chronic) at romiplostim initiation. METHODS Post hoc analysis of a prospective, German, multicentre, observational study… Click to show full abstract

INTRODUCTION The effectiveness and safety of romiplostim were evaluated by immune thrombocytopenia (ITP) phase (newly diagnosed/persistent/chronic) at romiplostim initiation. METHODS Post hoc analysis of a prospective, German, 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 x 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 2-24-week follow-up, overall platelet response was achieved in 100% (95% confidence interval [CI]: 81.5-100), 100% (86.3-100), and 96.2% (87.0-99.5) of patients with newly diagnosed, persistent, or chronic ITP, respectively; 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.

Keywords: diagnosed persistent; itp; persistent chronic; thrombocytopenia itp; newly diagnosed; immune thrombocytopenia

Journal Title: Acta haematologica
Year Published: 2021

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