title: Evaluation of bleeding-related episodes in patients with immune thrombocytopenia (ITP) receiving romiplostim or medical standard of care.
abstract: Romiplostim increases platelet counts and reduces the risk of bleeding in patients with immune thrombocytopenia (ITP). This post hoc analysis compared the effect of romiplostim versus medical standard of care (SOC) on clinically relevant bleeding-related episodes (BREs) in a 52-week open-label study of patients with ITP. BREs were defined as actual bleeding events and/or use of rescue medication. Nonsplenectomized adult patients with ITP were randomized to receive weekly subcutaneous injections of romiplostim (n = 157) or SOC (n = 77). The rate of all BREs (per 100 patient-weeks) was lower in patients treated with romiplostim (3.1) than in those treated with SOC (9.4); the relative rate (romiplostim/SOC) was 0.33 (95 % CI 0.27-0.40). The rate of BREs associated with immunoglobulin (Ig) rescue medication was also lower for romiplostim (0.2) than SOC (4.8); the relative rate (romiplostim/SOC) was 0.05 (95 % CI 0.03-0.08). BRE rates were lower in patients with platelet counts ≥50 × 10(9)/L, and patients treated with romiplostim spent more time with platelet counts ≥50 × 10(9)/L than did patients treated with SOC. Bleeding-related hospitalizations were rare in both groups. Thus, romiplostim treatment provided greater reductions in all BREs, as well as BREs involving Ig rescue medications, than did SOC.
authors.affiliation: Department of Haematology, St. George's Hospital, London, UK. roberto.stasi@libero.it
authors.forename: Roberto
authors.initials: R
authors.lastname: Stasi
authors.forename: Magaral
authors.initials: M
authors.lastname: Murali
authors.forename: Marc
authors.initials: M
authors.lastname: Michel
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Viallard
authors.forename: Aristoteles
authors.initials: A
authors.lastname: Giagounidis
authors.forename: Ann
authors.initials: A
authors.lastname: Janssens
authors.forename: Jason
authors.initials: J
authors.lastname: Legg
authors.forename: Robert
authors.initials: R
authors.lastname: Deuson
authors.forename: Mark D
authors.initials: MD
authors.lastname: Danese
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006470:Hemorrhage / Q000453:epidemiology / Q000209:etiology*; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000150:complications* / Q000628:therapy*; D011961:Receptors, Fc / Q000627:therapeutic use*; D053628:Receptors, Thrombopoietin / Q000819:agonists; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use*; D059039:Standard of Care; D013926:Thrombopoietin / Q000627:therapeutic use*
chemical_list: D016756:Immunoglobulins, Intravenous; D011961:Receptors, Fc; D053628:Receptors, Thrombopoietin; D011993:Recombinant Fusion Proteins; D013926:Thrombopoietin; C488777:romiplostim