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Multicenter Study Observational Study
A large observational study of patients with primary immune thrombocytopenia receiving romiplostim in European clinical practice.
- Michael Steurer, Philippe Quittet, Helen A Papadaki, Dominik Selleslag, Jean-François Viallard, Georgia Kaiafa, Ann Janssens, Tomas Kozak, Hans Wadenvik, Marieke Schoonen, Laura Belton, and Georg Kreuzbauer.
- Division of Haematology and Oncology, Innsbruck Medical University, Innsbruck, Austria.
- Eur. J. Haematol. 2017 Feb 1; 98 (2): 112-120.
ObjectiveRomiplostim has maintained long-term platelet counts in patients with immune thrombocytopenia (ITP) for up to 5 yr in clinical studies. This prospective observational study aimed to describe romiplostim utilisation and outcomes in European clinical practice.MethodsAdults with primary ITP who received romiplostim in routine care were eligible.ResultsThree-hundred and forty patients were eligible for analysis, of whom 299 (88%) completed the 2-yr observation period. The median age was 62 yr, with 43% of patients aged ≥65 yr, and two-thirds of patients initiated romiplostim before splenectomy. The median average weekly dose of romiplostim was 2.8 μg/kg. The median baseline platelet count was 20 × 109 /L, which increased after 2 wk of romiplostim treatment and remained >50 × 109 /L thereafter. After romiplostim initiation, there was a decrease in rates of grade ≥3 bleeding events (from 12 to 2 per 100 patient-years) and ITP-related hospitalisations (from 87 to 33 per 100 patient-years). The rate of thrombotic events was 2 per 100 patient-years, and bone marrow fibrosis occurred in two patients.ConclusionsRomiplostim dosing, effectiveness and safety in an unselected real-world ITP population seemed comparable with that observed in clinical studies.© 2016 Amgen Inc. European Journal of Haematology. Published by John Wiley & Sons Ltd.
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