title: Impact of self-administration of romiplostim by patients with chronic immune thrombocytopenia compared with administration by a healthcare provider.
abstract: OBJECTIVE
  This post hoc analysis evaluated romiplostim self-administration (SA group) vs. romiplostim administration by a healthcare provider in a clinical setting (HCP group) in patients with chronic immune thrombocytopenia (ITP).
  
  
  METHODS
  Outcomes from 3 ITP trials allowing self-administration in patients achieving a stable romiplostim dose for ≥3 consecutive weeks were compared. Evaluations were conducted for 12-wk treatment intervals. Efficacy endpoints included percentage of patients and weeks with platelets within the target range of 50-200 × 10(9) /L and safety.
  
  
  RESULTS
  Baseline characteristics suggested less severe disease in the SA groups (n = 563) than in the HCP groups (n = 241). The SA groups had greater proportions of patients achieving the target platelet range (55-58% vs. 40-52%) and greater proportions of weeks with a platelet response (75-88% vs. 47-76%) than the HCP groups. The rate of romiplostim discontinuation was twofold to fivefold lower in the SA groups than in the HCP groups. Rates of duration-adjusted adverse events (AEs), serious AEs and treatment-related AEs were also lower in the SA groups.
  
  
  CONCLUSIONS
  In conclusion, in adults with ITP receiving romiplostim, self-administration was comparable to healthcare provider administration in terms of efficacy and safety profiles, suggesting that self-administration of romiplostim is a feasible option for certain patients with ITP.
authors.affiliation: AZ Sint-Jan, Brugge-Oostende, Belgium.
authors.forename: Dominik
authors.initials: D
authors.lastname: Selleslag
authors.forename: Robert
authors.initials: R
authors.lastname: Bird
authors.forename: Ivy
authors.initials: I
authors.lastname: Altomare
authors.forename: Aristoteles
authors.initials: A
authors.lastname: Giagounidis
authors.forename: Ann
authors.initials: A
authors.lastname: Janssens
authors.forename: Ingrid
authors.initials: I
authors.lastname: Pabinger
authors.forename: Vinod
authors.initials: V
authors.lastname: Pullarkat
authors.forename: Helen
authors.initials: H
authors.lastname: Wei
authors.forename: Georg
authors.initials: G
authors.lastname: Kreuzbauer
mesh_terms: D002908:Chronic Disease; D017326:Clinical Trials, Phase III as Topic; D005260:Female; D006801:Humans; D008297:Male; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000188:drug therapy* / Q000601:surgery; D016032:Randomized Controlled Trials as Topic; D011961:Receptors, Fc / Q000008:administration & dosage / Q000627:therapeutic use*; D053628:Receptors, Thrombopoietin / Q000819:agonists; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012646:Self Administration; 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
keywords: diagnosis; primary immune thrombocytopenia; romiplostim; self-administration; splenectomy; treatment