title: An open-label extension study evaluating the safety and efficacy of romiplostim for up to 3.5 years in thrombocytopenic Japanese patients with immune thrombocytopenic purpura (ITP).
abstract: Long-term use of the thrombopoietin mimetic romiplostim was examined in Japanese patients with chronic immune thrombocytopenic purpura (ITP) in this open-label extension. The starting dose of romiplostim was the previous trial dose or 3 μg/kg/week, which was titrated up to 10 μg/kg/week to maintain platelet counts between 50 and 200 × 10(9)/L. As of April 2010, 44 patients had enrolled; 71 % women, median age 55.5 years, with five patients discontinuing romiplostim due to patient request (2), administrative decision (2), or not achieving study-defined platelet response (1). Median treatment duration was 100 weeks; median average weekly dose was 3.8 μg/kg. Twenty-eight patients (64 %) self-injected romiplostim. The most frequent adverse events were nasopharyngitis and headache. Nine patients (20 %) had a total of 14 serious adverse events (0.31/100 patient-weeks); of these, only oral hemorrhage was considered treatment related. Fifty hemorrhagic adverse events were reported in 20 patients (46 %) (1.12/100 patient-weeks). Ninety-six percent of patients had a platelet response (doubling of baseline platelet count and platelet count ≥ 50 × 10(9)/L). Of the 25 patients receiving concurrent ITP therapy at baseline, all reduced or discontinued the therapy. Eight patients (18 %) received rescue medications. Administration of up to 3.5 years of romiplostim increased platelet counts and was well tolerated in Japanese patients with chronic ITP.
authors.affiliation: Department of Hematology and Oncology, Tokai University Hospital, Kanagawa, Japan. whiteced@is.icc.u-tokai.ac.jp
authors.forename: Yukari
authors.initials: Y
authors.lastname: Shirasugi
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Ando
authors.forename: Koji
authors.initials: K
authors.lastname: Miyazaki
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Tomiyama
authors.forename: Koji
authors.initials: K
authors.lastname: Iwato
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Okamoto
authors.forename: Mineo
authors.initials: M
authors.lastname: Kurokawa
authors.forename: Keita
authors.initials: K
authors.lastname: Kirito
authors.forename: Satoshi
authors.initials: S
authors.lastname: Hashino
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Ninomiya
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Mori
authors.forename: Yuji
authors.initials: Y
authors.lastname: Yonemura
authors.forename: Kensuke
authors.initials: K
authors.lastname: Usuki
authors.forename: Helen
authors.initials: H
authors.lastname: Wei
authors.forename: Richard
authors.initials: R
authors.lastname: Lizambri
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000188:drug therapy*; D011961:Receptors, Fc / Q000008:administration & dosage / Q000627:therapeutic use*; D053628:Receptors, Thrombopoietin / Q000037:antagonists & inhibitors; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013926:Thrombopoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D011961:Receptors, Fc; D053628:Receptors, Thrombopoietin; D011993:Recombinant Fusion Proteins; D013926:Thrombopoietin; C488777:romiplostim