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A large observational study of patients with primary immune thrombocytopenia receiving romiplostim in European clinical practice

M. Steurer, P. Quittet, HA. Papadaki, D. Selleslag, JF. Viallard, G. Kaiafa, A. Janssens, T. Kozak, H. Wadenvik, M. Schoonen, L. Belton, G. Kreuzbauer,

. 2017 ; 98 (2) : 112-120. [pub] 20160926

Jazyk angličtina Země Anglie, Velká Británie

Typ dokumentu časopisecké články, multicentrická studie, pozorovací studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc17013573

OBJECTIVE: Romiplostim 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. METHODS: Adults with primary ITP who received romiplostim in routine care were eligible. RESULTS: Three-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 × 10(9) /L, which increased after 2 wk of romiplostim treatment and remained >50 × 10(9) /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. CONCLUSIONS: Romiplostim dosing, effectiveness and safety in an unselected real-world ITP population seemed comparable with that observed in clinical studies.

Citace poskytuje Crossref.org

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$a OBJECTIVE: Romiplostim has maintained long-term platelet counts in patients with immune thrombocytopenia (ITP) for up to 5 yr in clinical studies. This prospective observational study aimed to describe romiplostim utilisation and outcomes in European clinical practice. METHODS: Adults with primary ITP who received romiplostim in routine care were eligible. RESULTS: Three-hundred and forty patients were eligible for analysis, of whom 299 (88%) completed the 2-yr observation period. The median age was 62 yr, with 43% of patients aged ≥65 yr, and two-thirds of patients initiated romiplostim before splenectomy. The median average weekly dose of romiplostim was 2.8 μg/kg. The median baseline platelet count was 20 × 10(9) /L, which increased after 2 wk of romiplostim treatment and remained >50 × 10(9) /L thereafter. After romiplostim initiation, there was a decrease in rates of grade ≥3 bleeding events (from 12 to 2 per 100 patient-years) and ITP-related hospitalisations (from 87 to 33 per 100 patient-years). The rate of thrombotic events was 2 per 100 patient-years, and bone marrow fibrosis occurred in two patients. CONCLUSIONS: Romiplostim dosing, effectiveness and safety in an unselected real-world ITP population seemed comparable with that observed in clinical studies.
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$a Quittet, Philippe $u Haematology Department, Hôpital Saint Eloi, Montpellier, France.
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$a Papadaki, Helen A $u Department of Haematology, University of Crete School of Medicine, University Hospital of Heraklion, Crete, Greece.
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$a Selleslag, Dominik $u Department of Haematology, A-Z Sint-Jan, Bruges-Oostende, Belgium.
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$a Viallard, Jean-François $u Hôpital du Haut Lévèque, University of Bordeaux, Pessac, France.
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$a Kaiafa, Georgia $u AHEPA University General Hospital, Medical Propedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
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$a Janssens, Ann $u Department of Haematology, University Hospitals Leuven, Leuven, Belgium.
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$a Kozak, Tomas $u 3rd Medical Faculty, Charles University, Prague, Czech Republic.
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$a Wadenvik, Hans $u Section of Haematology, Sahlgrenska University Hospital, Gothenburg, Sweden.
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$a Schoonen, Marieke $u Center for Observational Research, Uxbridge, UK.
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$a Belton, Laura $u Biostatistics, LB Biostatistics, London, UK.
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$a Kreuzbauer, Georg $u International Medical Development and Research, Amgen (Europe) GmbH, Zug, Switzerland.
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