OncohematologyOncohematologyОнкогематология1818-83462413-4023Publishing House ABV Press12310.17650/1818-8346-2014-9-3-47-62PHARMACOTHERAPYФАРМАКОТЕРАПИЯLong-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacyБезопасность и эффективность длительной терапии ромиплостимом при хронической иммунной тромбоцитопенииKuterD. J.КутерД. Дж.
Russian Federation
kuter.david@MGH.harvard.eduBusselJ. B.БасселДж. Б.
Russian Federation
NewlandA.НьюлендЭ.
Russian Federation
BakerR. I.БаркурР. И.
Russian Federation
LyonsR. M.ЛайонсР. М.
Russian Federation
WasserJ.ВассерДж.
Russian Federation
ViallardJ.-F.ВиллардЖ.-Ф.
Russian Federation
MacikG.МасикГ.
Russian Federation
RummelM.РуммельМ.
Russian Federation
NieK.НиК.
Russian Federation
JunS.ЖунС.
Russian Federation
Massachusetts General Hospital, Boston, MAМногопрофильная больница штата Массачусетс, Бостон, Массачусетс, СШАDivision of Hematology, Departments of Pediatrics and Medicine, Weill Medical College of Cornell University, New York, NY, USAсекция гематологии, кафедры детских и внутренних болезней, Медицинский колледж имени Уайля Корнельского университета, Нью-Йорк, СШАDepartment of Haematology, The Royal London Hospital, Whitechapel, London, UKгематологическое отделение, Королевская больница Лондона, Уайтчепел, Лондон, ВеликобританияCentre for Thrombosis and Haemophilia, Royal Perth Hospital, Murdoch University, Perth, WA, AustraliaЦентр по лечению тромбозов и гемофилии, Королевская больница Перта, Университет имени Мердока, Перт, Западная Австралия, АвстралияCancer Care Centers South Texas / US Oncology, San Antonio, TXОнкологический центр Южного Техаса, Сан-Антонио, Техас, СШАDivision of Hematology-Oncology, Department of Medicine, University of Connecticut School of Medicine, Farmington, CT, USAсекция онкологии и гематологии, кафедра внутренних болезней, Медицинская школа Университета штата Коннектикут, Фармингтон, Коннектикут, СШАUniversitй Victor Segalen Bordeaux 2, Hфpital Haut-Lйvкque, CHU de Bordeaux, Pessac, FranceУниверситет имени Виктора Сегалена, Бордо, и больница От-Левек, Бордо, Пессак, ФранцияUniversity of Virginia, Charlottesville, VA, USAУниверситет штата Вирджиния, Шарлоттесвилл, Вирджиния, СШАKlinikum der Justus-Liebig-Universität, Giessen, GermanyКлиника университета имени Юстуса Либига, Гиссен, ГерманияAmgen Inc., Thousand Oaks, CA, USAКомпания Amgen Inc., Таузенд-Оакс, Калифорния, СШАAmgen Inc., Thousand Oaks, CA, USAКомпания Amgen Inc., Таузенд-Оакс, Калифорния, США3010201493476230012015300120152014https://oncohematology.abvpress.ru/ongm/article/view/123

Romiplostim was effective, safe, and well-tolerated over 6–12 months of continuous treatment in Phase 3 trials in patients with immune thrombocytopenia (ITP). This report describes up to 5 years of weekly treatment with romiplostim in 292 adult ITP patients in a long-term, single-arm, open-label study. Outcome measures included adverse events (including bleeding, thrombosis, malignancy, and reticulin / fibrosis), platelet response (platelet count >50 × 109 per litre), and the proportion of patients requiring rescue treatments. Treatment – related serious adverse events were infrequent and did not increase with longer treatment. No new classes of adverse events emerged. Thrombotic events occurred in 6.5 % of patients and were not associated with platelet count. Median platelet counts of 50–200 × 109 per litre were maintainedwith stable doses of romiplostim (mean 5–8 μg / kg; generally self-administered at home) throughout the study. A platelet response was achieved at least once by 95 % of patients, with a platelet response maintained by all patients on a median 92 % of study visits. There was a low rate of bleeding and infrequent need for rescue treatments. In conclusion, this study demonstrated that romiplostim was safe and welltolerated over 614 patient-years of exposure in ITP patients, and that efficacy was maintained with stable dosing for up to 5 years of continuous treatment.

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